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This acute brain dysfunction,","confidence":0.880859375,"confidence_rate":0.9987570741951141},{"cnt":[[245,1794],[1852,1794],[1852,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1793,"width":1608,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd41a3fb893746dcb079afc13cc6ecb9","type":"text","conversion_output":true,"text":"manifested as delirium and coma, occurs in \\(50 \\%-70 \\%\\) of MV septic patients and is a significant","text_display":" manifested as delirium and coma, occurs in \\(50 \\%-70 \\%\\) of MV septic patients and is a significant","confidence":0.99462890625,"confidence_rate":0.9999466789470377},{"cnt":[[245,1891],[1833,1891],[1833,1940],[245,1940]],"region":{"top_left_x":244,"top_left_y":1890,"width":1589,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e559bd091c724a998a2ac774afffba61","type":"text","conversion_output":true,"text":"contributor not only to death but also to functional and cognitive decline, which can persist for","text_display":" contributor not only to death but also to functional and cognitive decline, which can persist for","confidence":1,"confidence_rate":1},{"cnt":[[245,1985],[1818,1985],[1818,2039],[245,2039]],"region":{"top_left_x":244,"top_left_y":1985,"width":1574,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5464193819e2477f9657bbe5d6dacc0e","type":"text","conversion_output":true,"text":"years after recovery of lung and other organ function, levying significant costs to patients and","text_display":" years after recovery of lung and other organ function, levying significant costs to patients and","confidence":1,"confidence_rate":1},{"cnt":[[245,2082],[1858,2082],[1858,2133],[245,2133]],"region":{"top_left_x":244,"top_left_y":2081,"width":1615,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bc51aa333224cb5bd15704be33a7945","type":"text","conversion_output":true,"text":"society. The gamma-aminobutyric acid (GABA)-ergic benzodiazepines, in particular, have been","text_display":" society. The gamma-aminobutyric acid (GABA)-ergic benzodiazepines, in particular, have been","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[245,2179],[1841,2179],[1841,2228],[245,2228]],"region":{"top_left_x":244,"top_left_y":2178,"width":1598,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"038acc2ce1594e43bd5a2b43b89115a8","type":"text","conversion_output":true,"text":"shown to increase brain dysfunction, promote infection, and prolong MV. Therefore, the short-","text_display":" shown to increase brain dysfunction, promote infection, and prolong MV. Therefore, the short","confidence":1,"confidence_rate":1},{"cnt":[[245,2273],[1815,2273],[1815,2325],[245,2325]],"region":{"top_left_x":244,"top_left_y":2273,"width":1572,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b663a50d3114c6db63267bea7173a7d","type":"text","conversion_output":true,"text":"acting GABA-ergic sedative propofol and the alpha2 agonist dexmedetomidine are becoming","text_display":"acting GABA-ergic sedative propofol and the alpha2 agonist dexmedetomidine are becoming","confidence":1,"confidence_rate":1},{"cnt":[[245,2368],[1824,2368],[1824,2419],[245,2419]],"region":{"top_left_x":244,"top_left_y":2367,"width":1581,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5004fc711c2e47938e625a460242f130","type":"text","conversion_output":true,"text":"widely used to sedate septic MV patients. There are only a few randomized trials, however, to","text_display":" widely used to sedate septic MV patients. There are only a few randomized trials, however, to","confidence":1,"confidence_rate":1},{"cnt":[[1852,2578],[1886,2578],[1886,2625],[1852,2625]],"region":{"top_left_x":1851,"top_left_y":2578,"width":36,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc433c869c4c4f5987c905c8726a7679","type":"page_info","conversion_output":false,"text":"2","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-03","page":3,"lines":[{"cnt":[[245,249],[1833,249],[1833,305],[245,305]],"region":{"top_left_x":244,"top_left_y":249,"width":1589,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9f38c970c8a4eafb9336c369dbaff30","type":"text","conversion_output":true,"text":"guide clinicians when selecting between these and other sedatives, and none have explored the","text_display":"\nguide clinicians when selecting between these and other sedatives, and none have explored the","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[243,346],[1880,346],[1880,402],[243,402]],"region":{"top_left_x":242,"top_left_y":345,"width":1638,"height":57},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d5afdd5d25a459ab66d9637107a0ffd","type":"text","conversion_output":true,"text":"mechanisms underlying the differences in outcomes, though some data indicate that GABA-ergic","text_display":" mechanisms underlying the differences in outcomes, though some data indicate that GABA-ergic","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1878,443],[1878,501],[245,501]],"region":{"top_left_x":244,"top_left_y":442,"width":1634,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10d5a094ffb34d7a949201d9fc281781","type":"text","conversion_output":true,"text":"and alpha2 agonist agents have very different effects on innate immunity, apoptosis, arousability,","text_display":" and alpha2 agonist agents have very different effects on innate immunity, apoptosis, arousability,","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,537],[1794,537],[1794,595],[245,595]],"region":{"top_left_x":244,"top_left_y":537,"width":1550,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"082345475ce44508977eefa7f399d5f8","type":"text","conversion_output":true,"text":"and respiratory drive. The MENDS2 study will determine whether sedation of mechanically","text_display":" and respiratory drive. The MENDS2 study will determine whether sedation of mechanically","confidence":1,"confidence_rate":1},{"cnt":[[245,632],[1762,632],[1762,690],[245,690]],"region":{"top_left_x":244,"top_left_y":631,"width":1518,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60ca47e1ad33436c8d25b687a192f8c9","type":"text","conversion_output":true,"text":"ventilated severely septic patients with an alpha2 agonist (dexmedetomidine) rather than a","text_display":" ventilated severely septic patients with an alpha2 agonist (dexmedetomidine) rather than a","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[1880,726],[1880,786],[245,786]],"region":{"top_left_x":244,"top_left_y":726,"width":1636,"height":61},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17661d25a6264f47bc6db997c1180668","type":"text","conversion_output":true,"text":"GABAergic agent (propofol) will increase days alive without delirium or coma and increase days","text_display":" GABAergic agent (propofol) will increase days alive without delirium or coma and increase days","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[245,825],[1491,825],[1491,883],[245,883]],"region":{"top_left_x":244,"top_left_y":825,"width":1248,"height":59},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75a48e9d8ced4c598d4d61b44a622e18","type":"text","conversion_output":true,"text":"alive and free from mechanical ventilation (ventilator-free days or VFDs).","text_display":" alive and free from mechanical ventilation (ventilator-free days or VFDs).","confidence":0.998046875,"confidence_rate":0.9999752530298087},{"cnt":[[236,975],[629,975],[629,1046],[236,1046]],"region":{"top_left_x":236,"top_left_y":975,"width":394,"height":72},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd7ff83e018449fe8521ae997cced1db","type":"section_header","conversion_output":false,"children_ids":["ef253c26846e4dcb844eb327849661e0"],"text":"","text_display":""},{"cnt":[[245,984],[621,984],[621,1038],[245,1038]],"region":{"top_left_x":244,"top_left_y":983,"width":377,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef253c26846e4dcb844eb327849661e0","type":"text","conversion_output":true,"parent_id":"fd7ff83e018449fe8521ae997cced1db","text":"1.2 Study Objectives","text_display":"\n\n\\subsection*{1.2 Study Objectives}","confidence":1,"confidence_rate":1},{"cnt":[[245,1100],[1852,1100],[1852,1156],[245,1156]],"region":{"top_left_x":244,"top_left_y":1100,"width":1608,"height":56},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a9981416dc3459da2f44ddf8a5cb9a1","type":"text","conversion_output":true,"text":"The MENDS2 study is a multicenter, double-blind, randomized trial investigating the effects of","text_display":"\n\nThe MENDS2 study is a multicenter, double-blind, randomized trial investigating the effects of","confidence":1,"confidence_rate":1},{"cnt":[[245,1195],[1869,1195],[1869,1253],[245,1253]],"region":{"top_left_x":244,"top_left_y":1194,"width":1626,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc0bf8a887e04e61be900c316d668003","type":"text","conversion_output":true,"text":"sedatives-the alpha2 agonist dexmedetomidine and the GABAergic propofol-in mechanically","text_display":" sedatives-the alpha2 agonist dexmedetomidine and the GABAergic propofol-in mechanically","confidence":1,"confidence_rate":1},{"cnt":[[245,1291],[1504,1291],[1504,1347],[245,1347]],"region":{"top_left_x":244,"top_left_y":1291,"width":1260,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3038dc694e1540ebb2718df8ec8b9dd7","type":"text","conversion_output":true,"text":"ventilated severely septic patients. The study evaluates the following aims:","text_display":" ventilated severely septic patients. The study evaluates the following aims:","confidence":0.9990234375,"confidence_rate":0.9999879378548738},{"cnt":[[305,1388],[1880,1388],[1880,1446],[305,1446]],"region":{"top_left_x":305,"top_left_y":1387,"width":1575,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0795e28ce984a16aa935d9b43c7ce69","type":"text","conversion_output":true,"text":"- Aim 1: To determine whether sedation of mechanically ventilated severely septic patients","text_display":"\n- Aim 1: To determine whether sedation of mechanically ventilated severely septic patients","confidence":1,"confidence_rate":1},{"cnt":[[370,1482],[1807,1482],[1807,1540],[370,1540]],"region":{"top_left_x":369,"top_left_y":1482,"width":1438,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8028e35034c4a71b4d8556ae903e43c","type":"text","conversion_output":true,"text":"with an alpha2 agonist (dexmedetomidine) rather than a GABAergic agent (propofol)","text_display":" with an alpha2 agonist (dexmedetomidine) rather than a GABAergic agent (propofol)","confidence":1,"confidence_rate":1},{"cnt":[[370,1581],[1863,1581],[1863,1635],[370,1635]],"region":{"top_left_x":369,"top_left_y":1581,"width":1494,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c32ad7ae4a7841bea7eedb0a02fd169a","type":"text","conversion_output":true,"text":"will (Aim 1A) increase days alive without delirium or coma (delirium/coma-free days or","text_display":" will (Aim 1A) increase days alive without delirium or coma (delirium/coma-free days or","confidence":0.9931640625,"confidence_rate":0.9999246247139267},{"cnt":[[370,1676],[1721,1676],[1721,1732],[370,1732]],"region":{"top_left_x":369,"top_left_y":1675,"width":1352,"height":57},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9aa59fe9bc04b1395fc72e6b8f817fb","type":"text","conversion_output":true,"text":"DCFDs) and (Aim 1B) increase days alive and free from mechanical ventilation","text_display":" DCFDs) and (Aim 1B) increase days alive and free from mechanical ventilation","confidence":1,"confidence_rate":1},{"cnt":[[370,1772],[900,1772],[900,1828],[370,1828]],"region":{"top_left_x":369,"top_left_y":1772,"width":532,"height":57},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93c2b93ed69249ed81905d3541a67f46","type":"text","conversion_output":true,"text":"(ventilator-free days or VFDs).","text_display":" (ventilator-free days or VFDs).","confidence":1,"confidence_rate":1},{"cnt":[[305,1869],[1878,1869],[1878,1927],[305,1927]],"region":{"top_left_x":305,"top_left_y":1869,"width":1573,"height":59},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa83596aa8e54e388ffa9c22780856a6","type":"text","conversion_output":true,"text":"- Aim 2: To determine whether sedation of mechanically ventilated severely septic patients","text_display":"\n- Aim 2: To determine whether sedation of mechanically ventilated severely septic patients","confidence":1,"confidence_rate":1},{"cnt":[[370,1964],[1809,1964],[1809,2022],[370,2022]],"region":{"top_left_x":369,"top_left_y":1963,"width":1440,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0573799d0e2f45d6aa6f65ab09cc16d6","type":"text","conversion_output":true,"text":"with an alpha2 agonist (dexmedetomidine) rather than a GABAergic agent (propofol)","text_display":" with an alpha2 agonist (dexmedetomidine) rather than a GABAergic agent (propofol)","confidence":1,"confidence_rate":1},{"cnt":[[370,2058],[1876,2058],[1876,2116],[370,2116]],"region":{"top_left_x":369,"top_left_y":2058,"width":1507,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca08f7643b3249449d596c83d1a3d7f8","type":"text","conversion_output":true,"text":"will (Aim 2A) improve 90-day survival and (Aim 2B) decrease incidence and severity of","text_display":" will (Aim 2A) improve 90-day survival and (Aim 2B) decrease incidence and severity of","confidence":0.99853515625,"confidence_rate":0.9999837121583983},{"cnt":[[370,2157],[1055,2157],[1055,2213],[370,2213]],"region":{"top_left_x":369,"top_left_y":2157,"width":686,"height":56},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a9dd50df3e442d7ab043c07f1121a19","type":"text","conversion_output":true,"text":"long-term cognitive impairment (LTCI).","text_display":" long-term cognitive impairment (LTCI).","confidence":1,"confidence_rate":1},{"cnt":[[309,2254],[1880,2254],[1880,2310],[309,2310]],"region":{"top_left_x":309,"top_left_y":2253,"width":1571,"height":57},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d75765d9e204988bbf02af1393b7744","type":"text","conversion_output":true,"text":"- Aim 3: To determine whether sedation of mechanically ventilated severely septic patients","text_display":"\n- Aim 3: To determine whether sedation of mechanically ventilated severely septic patients","confidence":1,"confidence_rate":1},{"cnt":[[370,2348],[1807,2348],[1807,2404],[370,2404]],"region":{"top_left_x":369,"top_left_y":2348,"width":1438,"height":57},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cccdac6171944d691968f11b6b78865","type":"text","conversion_output":true,"text":"with an alpha2 agonist (dexmedetomidine) rather than a GABAergic agent (propofol)","text_display":" with an alpha2 agonist (dexmedetomidine) rather than a GABAergic agent (propofol)","confidence":1,"confidence_rate":1},{"cnt":[[370,2445],[1876,2445],[1876,2499],[370,2499]],"region":{"top_left_x":369,"top_left_y":2444,"width":1507,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5888ce136a0e4281b4499f0194dd8efb","type":"text","conversion_output":true,"text":"will reduce pro- and anti-inflammatory cytokines (CRP, interleukin-1 [IL-1], IL-6, IL-10,","text_display":" will reduce pro- and anti-inflammatory cytokines (CRP, interleukin-1 [IL-1], IL-6, IL-10,","confidence":1,"confidence_rate":1},{"cnt":[[1848,2574],[1886,2574],[1886,2628],[1848,2628]],"region":{"top_left_x":1847,"top_left_y":2573,"width":40,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92e08c84fbd748e3aad86d27073051fd","type":"page_info","conversion_output":false,"text":"3","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-04","page":4,"lines":[{"cnt":[[367,249],[1687,249],[1687,305],[367,305]],"region":{"top_left_x":367,"top_left_y":249,"width":1320,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88f79b724ace4780a75ba8f950ea325d","type":"text","conversion_output":true,"text":"sTNFR1, HMGB1). We intend to present the results of Aim 3 in a subsequent","text_display":"\nsTNFR1, HMGB1). We intend to present the results of Aim 3 in a subsequent","confidence":1,"confidence_rate":1},{"cnt":[[365,348],[578,348],[578,402],[365,402]],"region":{"top_left_x":365,"top_left_y":348,"width":213,"height":54},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55c705eb386740cdbefa4cd7857cf458","type":"text","conversion_output":true,"text":"manuscript.","text_display":" manuscript.","confidence":1,"confidence_rate":1},{"cnt":[[232,503],[694,503],[694,569],[232,569]],"region":{"top_left_x":232,"top_left_y":502,"width":462,"height":68},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9aee49c48e4c48af99a020bdf2e18e1b","type":"section_header","conversion_output":false,"children_ids":["3261fff2bd4944cebd457c76c6c92b3f"],"text":"","text_display":""},{"cnt":[[241,511],[685,511],[685,561],[241,561]],"region":{"top_left_x":240,"top_left_y":511,"width":446,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3261fff2bd4944cebd457c76c6c92b3f","type":"text","conversion_output":true,"parent_id":"9aee49c48e4c48af99a020bdf2e18e1b","text":"2. STUDY METHODS","text_display":"\n\n\\section*{2. 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Upon meeting inclusion and","confidence":1,"confidence_rate":1},{"cnt":[[241,915],[1878,915],[1878,969],[241,969]],"region":{"top_left_x":240,"top_left_y":915,"width":1638,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5bf8deb26c44acc88ae66a9ad2135e1","type":"text","conversion_output":true,"text":"none of the exclusion criteria, patients were consented, enrolled and then randomized to either of","text_display":" none of the exclusion criteria, patients were consented, enrolled and then randomized to either of","confidence":1,"confidence_rate":1},{"cnt":[[241,1014],[649,1014],[649,1063],[241,1063]],"region":{"top_left_x":240,"top_left_y":1014,"width":409,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dba304e59d64bb394c45be9995c48fa","type":"text","conversion_output":true,"text":"the two treatment arms.","text_display":" the two treatment arms.","confidence":1,"confidence_rate":1},{"cnt":[[234,1100],[898,1100],[898,1167],[234,1167]],"region":{"top_left_x":234,"top_left_y":1100,"width":665,"height":67},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91aef0fd046845538f8eb6dc63f63e2f","type":"section_header","conversion_output":false,"children_ids":["ed8c4a63df2942529b1ba53ce3f3c905"],"text":"","text_display":""},{"cnt":[[241,1109],[887,1109],[887,1158],[241,1158]],"region":{"top_left_x":240,"top_left_y":1108,"width":648,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed8c4a63df2942529b1ba53ce3f3c905","type":"text","conversion_output":true,"parent_id":"91aef0fd046845538f8eb6dc63f63e2f","text":"2.2 Inclusion and Exclusion criteria","text_display":"\n\n\\subsection*{2.2 Inclusion and Exclusion criteria}","confidence":1,"confidence_rate":1},{"cnt":[[243,1225],[1858,1225],[1858,1278],[243,1278]],"region":{"top_left_x":242,"top_left_y":1224,"width":1617,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b5acb795fc742c9a236f22e9af359c3","type":"text","conversion_output":true,"text":"Consecutive patients were eligible for inclusion in the MENDS2 study if they were: [1] an adult","text_display":"\n\nConsecutive patients were eligible for inclusion in the MENDS2 study if they were: [1] an adult","confidence":1,"confidence_rate":1},{"cnt":[[241,1319],[1833,1319],[1833,1373],[241,1373]],"region":{"top_left_x":240,"top_left_y":1319,"width":1593,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03e4adbba45a4ea4901447751b11c923","type":"text","conversion_output":true,"text":"patient ( \\(\\geq 18\\) years old) [2] in a medical or surgical ICU and [3] on MV, requiring sedation and","text_display":" patient ( \\(\\geq 18\\) years old) [2] in a medical or surgical ICU and [3] on MV, requiring sedation and","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[243,1414],[1867,1414],[1867,1470],[243,1470]],"region":{"top_left_x":242,"top_left_y":1413,"width":1625,"height":57},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2a5b2caa35f4806a9d5468ba5a3528a","type":"text","conversion_output":true,"text":"[4] have a suspected or known infection. Patients were excluded if they met any of the exclusion","text_display":" [4] have a suspected or known infection. Patients were excluded if they met any of the exclusion","confidence":1,"confidence_rate":1},{"cnt":[[241,1508],[664,1508],[664,1562],[241,1562]],"region":{"top_left_x":240,"top_left_y":1508,"width":424,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2b3c57bea3749959b5b6a2b45f34d02","type":"text","conversion_output":true,"text":"criteria listed in Table 1.","text_display":" criteria listed in Table 1.","confidence":1,"confidence_rate":1},{"cnt":[[234,1663],[604,1663],[604,1729],[234,1729]],"region":{"top_left_x":234,"top_left_y":1662,"width":370,"height":68},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb74579b15a04e45b712fac0c97b345d","type":"section_header","conversion_output":false,"children_ids":["35680a69125e412685f970db734fce80"],"text":"","text_display":""},{"cnt":[[241,1669],[595,1669],[595,1721],[241,1721]],"region":{"top_left_x":240,"top_left_y":1669,"width":356,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35680a69125e412685f970db734fce80","type":"text","conversion_output":true,"parent_id":"bb74579b15a04e45b712fac0c97b345d","text":"2.3 Randomization","text_display":"\n\n\\subsection*{2.3 Randomization}","confidence":1,"confidence_rate":1},{"cnt":[[241,1783],[1848,1783],[1848,1841],[241,1841]],"region":{"top_left_x":240,"top_left_y":1783,"width":1608,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43bbc1b83fcc4a1caa65880fd7b926c2","type":"text","conversion_output":true,"text":"Randomization to dexmedetomidine and propofol was conducted in \\(1: 1\\) ratio using a computer-","text_display":"\n\nRandomization to dexmedetomidine and propofol was conducted in \\(1: 1\\) ratio using a computer","confidence":0.941108226776123,"confidence_rate":0.9993808332578286},{"cnt":[[241,1878],[1833,1878],[1833,1936],[241,1936]],"region":{"top_left_x":240,"top_left_y":1877,"width":1593,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42485d2e5c8b49eeaed1974e1408a92b","type":"text","conversion_output":true,"text":"generated permuted-block randomization scheme, stratified by study site and age ( \\(<65\\) vs \\(\\geq 65\\)","text_display":"generated permuted-block randomization scheme, stratified by study site and age ( \\(<65\\) vs \\(\\geq 65\\)","confidence":0.7344698097335822,"confidence_rate":0.996887617300332},{"cnt":[[241,1979],[1779,1979],[1779,2035],[241,2035]],"region":{"top_left_x":240,"top_left_y":1978,"width":1539,"height":57},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6538049582c34fcda39ed6ef8bcdb0dd","type":"text","conversion_output":true,"text":"years). 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Any unlock of the database will be performed only to correct","text_display":" cleaning and will be documented. 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The study was repowered/resized due to concerns about the","text_display":" during the 14-day study period. The study was repowered/resized due to concerns about the","confidence":1,"confidence_rate":1},{"cnt":[[245,1388],[1818,1388],[1818,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1387,"width":1574,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9f69755edb043b0b425cc2c392e281b","type":"text","conversion_output":true,"text":"feasibility of completing study enrollment. Our initial sample size of 530 patients provided us","text_display":" feasibility of completing study enrollment. Our initial sample size of 530 patients provided us","confidence":0.974609375,"confidence_rate":0.9997503367119603},{"cnt":[[245,1487],[1858,1487],[1858,1540],[245,1540]],"region":{"top_left_x":244,"top_left_y":1486,"width":1615,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9123923677e244f19e7cffbffa07fa2f","type":"text","conversion_output":true,"text":"with \\(>90 \\%\\) power to detect a difference of 1.5 delirium/coma-free days between the two groups","text_display":" with \\(>90 \\%\\) power to detect a difference of 1.5 delirium/coma-free days between the two groups","confidence":0.7055611380377513,"confidence_rate":0.9966196887590095},{"cnt":[[245,1581],[1852,1581],[1852,1635],[245,1635]],"region":{"top_left_x":244,"top_left_y":1581,"width":1608,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79b0ade1706d477fb5c2fa045d644beb","type":"text","conversion_output":true,"text":"and an absolute difference in mortality of \\(10 \\%\\). With approval from the Data Safety Monitoring","text_display":" and an absolute difference in mortality of \\(10 \\%\\). With approval from the Data Safety Monitoring","confidence":0.6611394882202148,"confidence_rate":0.9959514485972988},{"cnt":[[245,1676],[1848,1676],[1848,1729],[245,1729]],"region":{"top_left_x":244,"top_left_y":1675,"width":1604,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5025381994ca45bea1110213d20a2bbe","type":"text","conversion_output":true,"text":"Board (DSMB), we re-sized to enroll 420 patients, which assuming a 2 -sided alpha of 0.05 will","text_display":" Board (DSMB), we re-sized to enroll 420 patients, which assuming a 2 -sided alpha of 0.05 will","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[245,1772],[1850,1772],[1850,1826],[245,1826]],"region":{"top_left_x":244,"top_left_y":1772,"width":1606,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c1d0dceaa264ea9806f5ce8dc746a27","type":"text","conversion_output":true,"text":"provide \\(>80 \\%\\) power to demonstrate a difference 1.5 DCFDs between dexmedetomidine and","text_display":" provide \\(>80 \\%\\) power to demonstrate a difference 1.5 DCFDs between dexmedetomidine and","confidence":0.5657288341315517,"confidence_rate":0.9940217266050844},{"cnt":[[245,1869],[1760,1869],[1760,1923],[245,1923]],"region":{"top_left_x":244,"top_left_y":1869,"width":1516,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f3db4584acd4a8fbb3923b86d024209","type":"text","conversion_output":true,"text":"propofol (primary outcome), which we believe has face validity as a clinically meaningful","text_display":" propofol (primary outcome), which we believe has face validity as a clinically meaningful","confidence":1,"confidence_rate":1},{"cnt":[[245,1964],[1846,1964],[1846,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1963,"width":1602,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21291edbbada43a7a377e407ab3910e0","type":"text","conversion_output":true,"text":"difference in the duration of acute brain injury. Importantly, this sample size also provides \\(80 \\%\\)","text_display":" difference in the duration of acute brain injury. Importantly, this sample size also provides \\(80 \\%\\)","confidence":0.95166015625,"confidence_rate":0.9995095531138396},{"cnt":[[245,2062],[1727,2062],[1727,2116],[245,2116]],"region":{"top_left_x":244,"top_left_y":2062,"width":1484,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb4636dea4dd4c11a80d883822124c93","type":"text","conversion_output":true,"text":"power to detect a 10\\% absolute improvement in 90-day survival with dexmedetomidine,","text_display":" power to detect a 10\\% absolute improvement in 90-day survival with dexmedetomidine,","confidence":0.6259765625,"confidence_rate":0.9946909346598897},{"cnt":[[245,2157],[1833,2157],[1833,2209],[245,2209]],"region":{"top_left_x":244,"top_left_y":2157,"width":1589,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"761cd96841294c1996e9056df6c31d89","type":"text","conversion_output":true,"text":"assuming the 90-day mortality in patients receiving propofol to be 30\\% (which is conservative","text_display":" assuming the 90-day mortality in patients receiving propofol to be 30\\% (which is conservative","confidence":0.5147136095911264,"confidence_rate":0.9932459259531597},{"cnt":[[245,2252],[1828,2252],[1828,2305],[245,2305]],"region":{"top_left_x":244,"top_left_y":2251,"width":1585,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcd2ebbcd64a44e093df1118a1eef700","type":"text","conversion_output":true,"text":"given the \\(25 \\%\\) mortality at 28 days in the both the recent PROWESS-Shock control group and","text_display":" given the \\(25 \\%\\) mortality at 28 days in the both the recent PROWESS-Shock control group and","confidence":0.9453389644622803,"confidence_rate":0.999438040725788},{"cnt":[[243,2346],[1386,2346],[1386,2400],[243,2400]],"region":{"top_left_x":242,"top_left_y":2346,"width":1144,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc4fef37431a4b99aa5cbeeb073588a9","type":"text","conversion_output":true,"text":"MENDS [dexmedetomidine vs lorazepam] study lorazepam group).","text_display":" MENDS [dexmedetomidine vs lorazepam] study lorazepam group).","confidence":1,"confidence_rate":1},{"cnt":[[1848,2574],[1886,2574],[1886,2628],[1848,2628]],"region":{"top_left_x":1847,"top_left_y":2573,"width":40,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ce31d1d3744455a94bd4a9a3eaf277e","type":"page_info","conversion_output":false,"text":"5","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-06","page":6,"lines":[{"cnt":[[243,249],[1846,249],[1846,305],[243,305]],"region":{"top_left_x":242,"top_left_y":249,"width":1604,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30f830e807654b4d893c6b721b3c7b9f","type":"text","conversion_output":true,"text":"Power Analyses for Long-Term Cognitive Impairment (Aim 2B): We assumed to follow \\(\\geq 80 \\%\\)","text_display":"\n\nPower Analyses for Long-Term Cognitive Impairment (Aim 2B): We assumed to follow \\(\\geq 80 \\%\\)","confidence":0.9985356330871582,"confidence_rate":0.9999835345159404},{"cnt":[[245,346],[1764,346],[1764,402],[245,402]],"region":{"top_left_x":244,"top_left_y":345,"width":1520,"height":57},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d2569175b93451992235b9c1cca99ae","type":"text","conversion_output":true,"text":"of survivors for evaluation of LTCI. Based on the expected mortality rates (see above), we","text_display":" of survivors for evaluation of LTCI. Based on the expected mortality rates (see above), we","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1601,443],[1601,496],[245,496]],"region":{"top_left_x":244,"top_left_y":442,"width":1357,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36ab86ac2963491c914f7993d14b4a5b","type":"text","conversion_output":true,"text":"expected an overall \\(25 \\%\\) mortality across the two groups and planned to test 252","text_display":" expected an overall \\(25 \\%\\) mortality across the two groups and planned to test 252","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1762,537],[1762,595],[245,595]],"region":{"top_left_x":244,"top_left_y":537,"width":1518,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6114751a17b4eb3b4d5d116847a72ac","type":"text","conversion_output":true,"text":"\\((=420 \\times 0.75 \\times 0.80)\\) patients for LTCI at 6 months. With 252 patients, we will have up to 17","text_display":" \\((=420 \\times 0.75 \\times 0.80)\\) patients for LTCI at 6 months. With 252 patients, we will have up to 17","confidence":0.53125,"confidence_rate":0.993500363491115},{"cnt":[[245,632],[1828,632],[1828,690],[245,690]],"region":{"top_left_x":244,"top_left_y":631,"width":1585,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b54eb9f2fa54957bf1daa5d364e8e67","type":"text","conversion_output":true,"text":"degrees of freedom in our multivariable linear regression to account for potential confounders.","text_display":" degrees of freedom in our multivariable linear regression to account for potential confounders.","confidence":1,"confidence_rate":1},{"cnt":[[243,728],[1803,728],[1803,784],[243,784]],"region":{"top_left_x":242,"top_left_y":728,"width":1561,"height":57},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5eb34ea6138a442a9c648e5a1e7fc67a","type":"text","conversion_output":true,"text":"The proposed study will have adequate-indeed abundant-ability to assess the independent","text_display":" The proposed study will have adequate-indeed abundant-ability to assess the independent","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[245,825],[1669,825],[1669,879],[245,879]],"region":{"top_left_x":244,"top_left_y":825,"width":1426,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80b75f1cbf4945239f9ba6835d5f4e27","type":"text","conversion_output":true,"text":"effect of the intervention on cognitive impairment while controlling for confounders.","text_display":" effect of the intervention on cognitive impairment while controlling for confounders.","confidence":0.9956073760986328,"confidence_rate":0.9999510867538558},{"cnt":[[236,915],[956,915],[956,982],[236,982]],"region":{"top_left_x":236,"top_left_y":915,"width":721,"height":67},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c77628d295a4a26a4eba45bd06be2a8","type":"section_header","conversion_output":false,"children_ids":["c3273336d50047b694fe70806306b75f"],"text":"","text_display":""},{"cnt":[[245,920],[947,920],[947,973],[245,973]],"region":{"top_left_x":244,"top_left_y":919,"width":704,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3273336d50047b694fe70806306b75f","type":"text","conversion_output":true,"parent_id":"7c77628d295a4a26a4eba45bd06be2a8","text":"2.5 Study treatments and interventions","text_display":"\n\n\\subsection*{2.5 Study treatments and interventions}","confidence":1,"confidence_rate":1},{"cnt":[[245,1018],[1828,1018],[1828,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1018,"width":1585,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d96d0462f9b643ee9daa566e9dd9fa20","type":"text","conversion_output":true,"text":"Study treatment and interventions are summarized in the study aids provided in Supplement 1.","text_display":"\n\nStudy treatment and interventions are summarized in the study aids provided in Supplement 1.","confidence":1,"confidence_rate":1},{"cnt":[[236,1203],[870,1203],[870,1265],[236,1265]],"region":{"top_left_x":236,"top_left_y":1203,"width":635,"height":63},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"233ea58405a942e18d481cfdf9ce2008","type":"section_header","conversion_output":false,"children_ids":["6256fa5f042a4cf7bb006cc61bffc9bb"],"text":"","text_display":""},{"cnt":[[243,1210],[862,1210],[862,1257],[243,1257]],"region":{"top_left_x":242,"top_left_y":1209,"width":620,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6256fa5f042a4cf7bb006cc61bffc9bb","type":"text","conversion_output":true,"parent_id":"233ea58405a942e18d481cfdf9ce2008","text":"3. STATISTICAL PRINCIPLES","text_display":"\n\n\\section*{3. STATISTICAL PRINCIPLES}","confidence":1,"confidence_rate":1},{"cnt":[[245,1302],[1833,1302],[1833,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1301,"width":1589,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5f76342ba5c4a3fb5fcff57cb18ac96","type":"text","conversion_output":true,"text":"Statistical analysis will be conducted in accordance to the plan outlined in this SAP. Statistical","text_display":"\n\nStatistical analysis will be conducted in accordance to the plan outlined in this SAP. Statistical","confidence":1,"confidence_rate":1},{"cnt":[[245,1401],[1313,1401],[1313,1457],[245,1457]],"region":{"top_left_x":244,"top_left_y":1400,"width":1069,"height":57},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbf38325a11f46eaba512e3e853e4cb7","type":"text","conversion_output":true,"text":"analysis will abide by these general statistical principles below.","text_display":" analysis will abide by these general statistical principles below.","confidence":1,"confidence_rate":1},{"cnt":[[236,1551],[694,1551],[694,1622],[236,1622]],"region":{"top_left_x":236,"top_left_y":1551,"width":458,"height":72},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d6b3f53241148ebb83ff08c8117dd3f","type":"section_header","conversion_output":false,"children_ids":["f0f26ebe015e4c5c8e8aa862fe5077a3"],"text":"","text_display":""},{"cnt":[[245,1560],[685,1560],[685,1613],[245,1613]],"region":{"top_left_x":244,"top_left_y":1559,"width":442,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0f26ebe015e4c5c8e8aa862fe5077a3","type":"text","conversion_output":true,"parent_id":"1d6b3f53241148ebb83ff08c8117dd3f","text":"3.1 Descriptive statistics","text_display":"\n\n\\subsection*{3.1 Descriptive statistics}","confidence":1,"confidence_rate":1},{"cnt":[[243,1676],[1751,1676],[1751,1729],[243,1729]],"region":{"top_left_x":242,"top_left_y":1675,"width":1509,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce02822345a04a0d9d5c4f510a8e7f0c","type":"text","conversion_output":true,"text":"Patient flow information as recommended by CONSORT guidelines will be presented for","text_display":"\n\nPatient flow information as recommended by CONSORT guidelines will be presented for","confidence":1,"confidence_rate":1},{"cnt":[[245,1770],[1869,1770],[1869,1828],[245,1828]],"region":{"top_left_x":244,"top_left_y":1770,"width":1626,"height":59},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4c5a58bf7514948859893ea2cbf304c","type":"text","conversion_output":true,"text":"patients randomized and receiving study intervention, including screening, exclusions, refusal of","text_display":" patients randomized and receiving study intervention, including screening, exclusions, refusal of","confidence":1,"confidence_rate":1},{"cnt":[[245,1867],[1790,1867],[1790,1923],[245,1923]],"region":{"top_left_x":244,"top_left_y":1866,"width":1546,"height":57},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af3e54506cd84d83b4b584cdfc5111eb","type":"text","conversion_output":true,"text":"consent, withdrawals, deaths, and hospital discharge status. Demographics, baseline clinical","text_display":" consent, withdrawals, deaths, and hospital discharge status. Demographics, baseline clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,1964],[1815,1964],[1815,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1963,"width":1572,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e6099f4bb23497983bc16003c053faa","type":"text","conversion_output":true,"text":"status and ICU characteristics will be described overall as well as by treatment using medians","text_display":" status and ICU characteristics will be described overall as well as by treatment using medians","confidence":1,"confidence_rate":1},{"cnt":[[245,2058],[1807,2058],[1807,2116],[245,2116]],"region":{"top_left_x":244,"top_left_y":2058,"width":1563,"height":59},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f34b0d40946248b2b0c5ed26642890c6","type":"text","conversion_output":true,"text":"and interquartile ranges for continuous variables and frequency (\\%) for categorical variables.","text_display":" and interquartile ranges for continuous variables and frequency (\\%) for categorical variables.","confidence":1,"confidence_rate":1},{"cnt":[[245,2153],[1833,2153],[1833,2211],[245,2211]],"region":{"top_left_x":244,"top_left_y":2152,"width":1589,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1efdbb47a8ed426782b3e75590d5b33a","type":"text","conversion_output":true,"text":"Significance testing of baseline differences between treatment groups will not be performed in","text_display":" Significance testing of baseline differences between treatment groups will not be performed in","confidence":1,"confidence_rate":1},{"cnt":[[245,2252],[1863,2252],[1863,2305],[245,2305]],"region":{"top_left_x":244,"top_left_y":2251,"width":1619,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db33789cb4f5417ba6956d70d21f8fa2","type":"text","conversion_output":true,"text":"keeping with CONSORT 2010 guidelines for reporting parallel group randomized clinical trials.","text_display":" keeping with CONSORT 2010 guidelines for reporting parallel group randomized clinical trials.","confidence":1,"confidence_rate":1},{"cnt":[[1848,2574],[1886,2574],[1886,2628],[1848,2628]],"region":{"top_left_x":1847,"top_left_y":2573,"width":40,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d7881eeda84481792de04a2c05059e9","type":"page_info","conversion_output":false,"text":"6","text_display":"","confidence":0.99951171875,"confidence_rate":0.99951171875}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-07","page":7,"lines":[{"cnt":[[232,243],[950,243],[950,312],[232,312]],"region":{"top_left_x":232,"top_left_y":242,"width":718,"height":70},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0e9f25fbf824ff289592d6c8e27f83c","type":"section_header","conversion_output":false,"children_ids":["938b4ff5d8b74663a72a219c786753b7"],"text":"","text_display":""},{"cnt":[[243,249],[939,249],[939,303],[243,303]],"region":{"top_left_x":242,"top_left_y":249,"width":697,"height":54},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"938b4ff5d8b74663a72a219c786753b7","type":"text","conversion_output":true,"parent_id":"c0e9f25fbf824ff289592d6c8e27f83c","text":"3.2 Confidence Intervals and P-Values","text_display":"\n\n\\subsection*{3.2 Confidence Intervals and P-Values}","confidence":1,"confidence_rate":1},{"cnt":[[245,365],[1841,365],[1841,423],[245,423]],"region":{"top_left_x":244,"top_left_y":365,"width":1598,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7ab93b9c7254142a1f1855b21bb6851","type":"text","conversion_output":true,"text":"Our protocol a priori specified one interim analysis at \\(N =300\\) before the final analysis for early","text_display":"\n\nOur protocol a priori specified one interim analysis at \\(N =300\\) before the final analysis for early","confidence":0.98779296875,"confidence_rate":0.9998862828645091},{"cnt":[[245,464],[1766,464],[1766,518],[245,518]],"region":{"top_left_x":244,"top_left_y":464,"width":1523,"height":54},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5836652f9754eb0b057766e2b55dd52","type":"text","conversion_output":true,"text":"stopping due to safety and efficacy based on DCFD and 90-day mortality. To maintain the","text_display":" stopping due to safety and efficacy based on DCFD and 90-day mortality. To maintain the","confidence":1,"confidence_rate":1},{"cnt":[[245,559],[1800,559],[1800,614],[245,614]],"region":{"top_left_x":244,"top_left_y":558,"width":1557,"height":57},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"681749c3d0a34fd9b634833251e7e38f","type":"text","conversion_output":true,"text":"overall study wise alpha level at 0.05 , with interim analysis, it was specified that the level of","text_display":" overall study wise alpha level at 0.05 , with interim analysis, it was specified that the level of","confidence":0.990234375,"confidence_rate":0.9999074229511014},{"cnt":[[245,655],[1863,655],[1863,709],[245,709]],"region":{"top_left_x":244,"top_left_y":655,"width":1619,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f35ccbc8016489492456e1e0f16d39c","type":"text","conversion_output":true,"text":"statistical significance for the final analyses for the primary outcome would be adjusted to 0.044","text_display":" statistical significance for the final analyses for the primary outcome would be adjusted to 0.044","confidence":1,"confidence_rate":1},{"cnt":[[245,750],[1835,750],[1835,806],[245,806]],"region":{"top_left_x":244,"top_left_y":749,"width":1591,"height":57},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3386f0bf02a94cc39f5b9e6132a4e8d4","type":"text","conversion_output":true,"text":"(based on O'Brien Fleming method). The level of statistical significance for all other outcomes","text_display":" (based on O'Brien Fleming method). The level of statistical significance for all other outcomes","confidence":1,"confidence_rate":1},{"cnt":[[245,846],[1880,846],[1880,900],[245,900]],"region":{"top_left_x":244,"top_left_y":846,"width":1636,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b35e49f2f28408fb6ea54071e70321b","type":"text","conversion_output":true,"text":"will be at the 0.05 level. \\(95 \\%\\) confidence intervals will be reported along with all effect estimates","text_display":" will be at the 0.05 level. \\(95 \\%\\) confidence intervals will be reported along with all effect estimates","confidence":0.9892714023590088,"confidence_rate":0.999902828469062},{"cnt":[[245,941],[1734,941],[1734,999],[245,999]],"region":{"top_left_x":244,"top_left_y":941,"width":1490,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aab029cab33f4780b63880ee528ba089","type":"text","conversion_output":true,"text":"due to it being the standard in which confidence intervals are typically reported and how","text_display":" due to it being the standard in which confidence intervals are typically reported and how","confidence":1,"confidence_rate":1},{"cnt":[[245,1038],[1755,1038],[1755,1094],[245,1094]],"region":{"top_left_x":244,"top_left_y":1037,"width":1512,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fbd722f98bc410fa13453618dc9a355","type":"text","conversion_output":true,"text":"statistical software outputs are constructed. Presentation of results will emphasize clinical","text_display":" statistical software outputs are constructed. Presentation of results will emphasize clinical","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[245,1134],[1558,1134],[1558,1188],[245,1188]],"region":{"top_left_x":244,"top_left_y":1134,"width":1314,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01282bf12b85445a86e5ba38454ed1c3","type":"text","conversion_output":true,"text":"significance, effect sizes and confidence intervals over statistical significance.","text_display":" significance, effect sizes and confidence intervals over statistical significance.","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[236,1283],[685,1283],[685,1356],[236,1356]],"region":{"top_left_x":236,"top_left_y":1282,"width":450,"height":74},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65945fcdccc643e9b82f49d3b74f54c7","type":"section_header","conversion_output":false,"children_ids":["21f1dbda55594b7faf85ca226a64adef"],"text":"","text_display":""},{"cnt":[[245,1293],[677,1293],[677,1347],[245,1347]],"region":{"top_left_x":244,"top_left_y":1293,"width":433,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21f1dbda55594b7faf85ca226a64adef","type":"text","conversion_output":true,"parent_id":"65945fcdccc643e9b82f49d3b74f54c7","text":"3.3 Modeling Principles","text_display":"\n\n\\subsection*{3.3 Modeling Principles}","confidence":1,"confidence_rate":1},{"cnt":[[245,1409],[1766,1409],[1766,1465],[245,1465]],"region":{"top_left_x":244,"top_left_y":1409,"width":1523,"height":57},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7dade0c99ec46ad96e306abfbeff2d3","type":"text","conversion_output":true,"text":"Whenever possible (based on variable distribution), we will not assume linear associations","text_display":"\n\nWhenever possible (based on variable distribution), we will not assume linear associations","confidence":1,"confidence_rate":1},{"cnt":[[245,1504],[1850,1504],[1850,1558],[245,1558]],"region":{"top_left_x":244,"top_left_y":1503,"width":1606,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"992d8f19967c4edfb2d51d57a126b263","type":"text","conversion_output":true,"text":"between covariates and outcomes; rather, nonlinear associations between continuous covariates","text_display":" between covariates and outcomes; rather, nonlinear associations between continuous covariates","confidence":1,"confidence_rate":1},{"cnt":[[245,1601],[1863,1601],[1863,1656],[245,1656]],"region":{"top_left_x":244,"top_left_y":1600,"width":1619,"height":57},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4dfce94e056412f9cf1515331b12f90","type":"text","conversion_output":true,"text":"and outcomes will be permitted by inclusion of restricted cubic splines with 3 knots. To account","text_display":" and outcomes will be permitted by inclusion of restricted cubic splines with 3 knots. 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For all secondary and","text_display":" analyzing multiple, prospectively defined outcomes in a clinical trial. For all secondary and","confidence":1,"confidence_rate":1},{"cnt":[[245,2355],[1833,2355],[1833,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2354,"width":1589,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21470e30b8514934b6d1c1a1f78462ba","type":"text","conversion_output":true,"text":"exploratory outcomes and subgroup analyses, caution will be exercised in the interpretation of","text_display":" exploratory outcomes and subgroup analyses, caution will be exercised in the interpretation of","confidence":1,"confidence_rate":1},{"cnt":[[1848,2574],[1886,2574],[1886,2628],[1848,2628]],"region":{"top_left_x":1847,"top_left_y":2573,"width":40,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de41cf458df24a89be11c39fb88cd684","type":"page_info","conversion_output":false,"text":"7","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-08","page":8,"lines":[{"cnt":[[245,249],[1824,249],[1824,305],[245,305]],"region":{"top_left_x":244,"top_left_y":249,"width":1581,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"624498a4ff1344dd8d91d7d57d336ad6","type":"text","conversion_output":true,"text":"results by noting the number of nominally significant tests that would be expected to occur by","text_display":"\nresults by noting the number of nominally significant tests that would be expected to occur by","confidence":1,"confidence_rate":1},{"cnt":[[245,344],[496,344],[496,397],[245,397]],"region":{"top_left_x":244,"top_left_y":343,"width":253,"height":55},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e5411d44fb94125b4b2bc43d984e2d4","type":"text","conversion_output":true,"text":"chance alone \\({ }^{3}\\).","text_display":" chance alone \\({ }^{3}\\).","confidence":1,"confidence_rate":1},{"cnt":[[234,529],[563,529],[563,599],[234,599]],"region":{"top_left_x":234,"top_left_y":528,"width":329,"height":72},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"351de5d6b7664ae39d545bae70617f0a","type":"section_header","conversion_output":false,"children_ids":["9c9b98fd72714bcaa47c5fae8677fd1d"],"text":"","text_display":""},{"cnt":[[243,537],[552,537],[552,591],[243,591]],"region":{"top_left_x":242,"top_left_y":537,"width":311,"height":54},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c9b98fd72714bcaa47c5fae8677fd1d","type":"text","conversion_output":true,"parent_id":"351de5d6b7664ae39d545bae70617f0a","text":"3.5 Missing Data","text_display":"\n\n\\subsection*{3.5 Missing Data}","confidence":1,"confidence_rate":1},{"cnt":[[370,636],[1871,636],[1871,690],[370,690]],"region":{"top_left_x":369,"top_left_y":635,"width":1503,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"083ae8c8b6fe42afacc145b2c95cccb1","type":"text","conversion_output":true,"text":"Data for missing in-hospital variables will be imputed using simple imputation or clinical","text_display":"\n\nData for missing in-hospital variables will be imputed using simple imputation or clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1721,730],[1721,784],[245,784]],"region":{"top_left_x":244,"top_left_y":730,"width":1477,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b376ef50741423e89f56391bad5a380","type":"text","conversion_output":true,"text":"imputation rules when appropriate; details on these rules and the imputation process for","text_display":" imputation rules when appropriate; details on these rules and the imputation process for","confidence":1,"confidence_rate":1},{"cnt":[[245,827],[1880,827],[1880,879],[245,879]],"region":{"top_left_x":244,"top_left_y":827,"width":1636,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3668b6f50ef4d55a71ff21131461073","type":"text","conversion_output":true,"text":"summary variables (e.g., days alive and free of delirium and coma) are detailed in the Definitions","text_display":" summary variables (e.g., days alive and free of delirium and coma) are detailed in the Definitions","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,922],[1755,922],[1755,978],[245,978]],"region":{"top_left_x":244,"top_left_y":921,"width":1512,"height":57},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db229cc295cb4a3eb7ecdc526aac1723","type":"text","conversion_output":true,"text":"and Derived Variables section in Supplement 2. Simple imputation of completely missing","text_display":" and Derived Variables section in Supplement 2. 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In all cases, decisions and","text_display":" outcome, model-based multiple imputation strategies will be used. In all cases, decisions and","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1772,1306],[1772,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1306,"width":1529,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b411b8044314801ac21ceeb5fba307a","type":"text","conversion_output":true,"text":"processes will be documented both in data management and analysis code and in statistical","text_display":" processes will be documented both in data management and analysis code and in statistical","confidence":1,"confidence_rate":1},{"cnt":[[245,1401],[1846,1401],[1846,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1400,"width":1602,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a72e02379d304b27bf1a1b82cbbc7909","type":"text","conversion_output":true,"text":"reports. TICS scores from patients that were not available at follow-up will not be imputed, but","text_display":" reports. TICS scores from patients that were not available at follow-up will not be imputed, but","confidence":1,"confidence_rate":1},{"cnt":[[245,1497],[1850,1497],[1850,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1497,"width":1606,"height":57},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6a5e42d415149bb9a1bbdad7bae27d8","type":"text","conversion_output":true,"text":"those with partially missing data will be imputed using model-based imputation with covariates","text_display":" those with partially missing data will be imputed using model-based imputation with covariates","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1704,1594],[1704,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1594,"width":1460,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6c32617ffaf473c931788dd9087c856","type":"text","conversion_output":true,"text":"age at enrollment, gender, BMI, education, first language English, insurance, Charlson","text_display":" age at enrollment, gender, BMI, education, first language English, insurance, Charlson","confidence":1,"confidence_rate":1},{"cnt":[[245,1689],[1828,1689],[1828,1742],[245,1742]],"region":{"top_left_x":244,"top_left_y":1688,"width":1585,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2abaf079b906485c907bddad18d3c06d","type":"text","conversion_output":true,"text":"comorbidities index, Benzodiazepine exposure after ICU admission to the midnight of the day","text_display":" comorbidities index, Benzodiazepine exposure after ICU admission to the midnight of the day","confidence":1,"confidence_rate":1},{"cnt":[[245,1783],[1837,1783],[1837,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1783,"width":1593,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac0df20f03d74ff9a364852d0860afec","type":"text","conversion_output":true,"text":"before enrollment and long-term assessments (KATZ ADL, FAQ, EQ-5D, Digit Span, Logical","text_display":" before enrollment and long-term assessments (KATZ ADL, FAQ, EQ-5D, Digit Span, Logical","confidence":1,"confidence_rate":1},{"cnt":[[245,1880],[1674,1880],[1674,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1879,"width":1430,"height":57},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7cba1d8165bc40ac916c3eec31c50465","type":"text","conversion_output":true,"text":"Memory I, Logical Memory II, Similarities, COWA, Hayling Sentence Completion).","text_display":" Memory I, Logical Memory II, Similarities, COWA, Hayling Sentence Completion).","confidence":1,"confidence_rate":1},{"cnt":[[1848,2574],[1886,2574],[1886,2628],[1848,2628]],"region":{"top_left_x":1847,"top_left_y":2573,"width":40,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7670d1d8b4344786945062549ec7b218","type":"page_info","conversion_output":false,"text":"8","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-09","page":9,"lines":[{"cnt":[[232,243],[1070,243],[1070,314],[232,314]],"region":{"top_left_x":232,"top_left_y":242,"width":838,"height":72},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95fa12c88b324a3dba267f98ffd33759","type":"section_header","conversion_output":false,"children_ids":["e83e4d5c4e6b4529a1131fdc99a39da9"],"text":"","text_display":""},{"cnt":[[243,249],[1061,249],[1061,303],[243,303]],"region":{"top_left_x":242,"top_left_y":249,"width":820,"height":54},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e83e4d5c4e6b4529a1131fdc99a39da9","type":"text","conversion_output":true,"parent_id":"95fa12c88b324a3dba267f98ffd33759","text":"3.6 Rigor, Transparency and Reproducibility","text_display":"\n\n\\subsection*{3.6 Rigor, Transparency and Reproducibility}","confidence":1,"confidence_rate":1},{"cnt":[[243,367],[1858,367],[1858,423],[243,423]],"region":{"top_left_x":242,"top_left_y":367,"width":1617,"height":57},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72beabbf5bac4f72be84cf1f414fa268","type":"text","conversion_output":true,"text":"To enhance rigor, transparency and reproducibility in research, we will ensure all aspects of this","text_display":"\n\nTo enhance rigor, transparency and reproducibility in research, we will ensure all aspects of this","confidence":1,"confidence_rate":1},{"cnt":[[245,464],[1867,464],[1867,518],[245,518]],"region":{"top_left_x":244,"top_left_y":464,"width":1623,"height":54},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"478bc2aebbae4fcd9a0f6baa4b6b3093","type":"text","conversion_output":true,"text":"study are transparent and easily reproduced by independent investigators. 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All the analysis code will be made publicly","confidence":1,"confidence_rate":1},{"cnt":[[245,655],[1141,655],[1141,709],[245,709]],"region":{"top_left_x":244,"top_left_y":655,"width":897,"height":54},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b5f704672784d9e8e76b4dd0d09af82","type":"text","conversion_output":true,"text":"available post publication of the primary manuscript.","text_display":" available post publication of the primary manuscript.","confidence":1,"confidence_rate":1},{"cnt":[[232,761],[1846,761],[1846,831],[232,831]],"region":{"top_left_x":232,"top_left_y":760,"width":1614,"height":72},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59782ec1289f4392a4ca5c7efe2476e7","type":"section_header","conversion_output":false,"children_ids":["110416160bab4ad3963e0f1f8ccf1a48"],"text":"","text_display":""},{"cnt":[[243,769],[1837,769],[1837,823],[243,823]],"region":{"top_left_x":242,"top_left_y":769,"width":1595,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"110416160bab4ad3963e0f1f8ccf1a48","type":"text","conversion_output":true,"parent_id":"59782ec1289f4392a4ca5c7efe2476e7","text":"4. 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STATISTICAL ANALYSIS","text_display":"\n\n\\section*{5. STATISTICAL ANALYSIS}","confidence":1,"confidence_rate":1},{"cnt":[[236,761],[692,761],[692,821],[236,821]],"region":{"top_left_x":236,"top_left_y":760,"width":456,"height":61},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33c1c0461c6443819e39676c7260c8e2","type":"section_header","conversion_output":false,"children_ids":["6fd4a440645e46c89d7f4081fed97c61"],"text":"","text_display":""},{"cnt":[[245,767],[685,767],[685,814],[245,814]],"region":{"top_left_x":244,"top_left_y":766,"width":442,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fd4a440645e46c89d7f4081fed97c61","type":"text","conversion_output":true,"parent_id":"33c1c0461c6443819e39676c7260c8e2","text":"5.1 Outcome Definitions","text_display":"\n\n\\subsection*{5.1 Outcome Definitions}","confidence":1,"confidence_rate":1},{"cnt":[[236,911],[552,911],[552,978],[236,978]],"region":{"top_left_x":236,"top_left_y":910,"width":317,"height":68},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63f6e969309d4c7c9f80435b6ce7b373","type":"section_header","conversion_output":false,"children_ids":["65d5fddfbebc4b02832913999d43de37"],"text":"","text_display":""},{"cnt":[[245,920],[544,920],[544,969],[245,969]],"region":{"top_left_x":244,"top_left_y":919,"width":300,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65d5fddfbebc4b02832913999d43de37","type":"text","conversion_output":true,"parent_id":"63f6e969309d4c7c9f80435b6ce7b373","text":"Primary outcome","text_display":"\n\n\\section*{Primary outcome}","confidence":1,"confidence_rate":1},{"cnt":[[245,1027],[1841,1027],[1841,1081],[245,1081]],"region":{"top_left_x":244,"top_left_y":1026,"width":1598,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57caa3c82f23403294b2001a0c118b7b","type":"text","conversion_output":true,"text":"The primary outcome is delirium/coma-free days (DCFDs) over a 14-day study period, defined","text_display":"\n\nThe primary outcome is delirium/coma-free days (DCFDs) over a 14-day study period, defined","confidence":0.9614443778991699,"confidence_rate":0.9995862060055651},{"cnt":[[245,1124],[1858,1124],[1858,1175],[245,1175]],"region":{"top_left_x":244,"top_left_y":1123,"width":1615,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"747b58fe4a9c4e05b244e88c5003fa25","type":"text","conversion_output":true,"text":"as the number of days during the 14-day intervention period (from randomization, which will be","text_display":" as the number of days during the 14-day intervention period (from randomization, which will be","confidence":0.97802734375,"confidence_rate":0.9997756044683879},{"cnt":[[245,1216],[1869,1216],[1869,1274],[245,1274]],"region":{"top_left_x":244,"top_left_y":1216,"width":1626,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a77ce7452ee043699e2e58ecb89e08d6","type":"text","conversion_output":true,"text":"Study Day 1, until Study Day 14) that the patient was alive and free of delirium and coma. Study","text_display":" Study Day 1, until Study Day 14) that the patient was alive and free of delirium and coma. Study","confidence":1,"confidence_rate":1},{"cnt":[[245,1315],[1863,1315],[1863,1369],[245,1369]],"region":{"top_left_x":244,"top_left_y":1314,"width":1619,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87277065c3a24230b442358f05c67393","type":"text","conversion_output":true,"text":"outcomes are presented in Table 2, and study timelines and assessments are provided in Table 3.","text_display":" outcomes are presented in Table 2, and study timelines and assessments are provided in Table 3.","confidence":1,"confidence_rate":1},{"cnt":[[236,1472],[642,1472],[642,1540],[236,1540]],"region":{"top_left_x":236,"top_left_y":1471,"width":407,"height":70},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e90a4038dd3c4e86aa912afdcad24162","type":"section_header","conversion_output":false,"children_ids":["0f6bf10088fd466c9a3e2134815b70fd"],"text":"","text_display":""},{"cnt":[[245,1478],[634,1478],[634,1532],[245,1532]],"region":{"top_left_x":244,"top_left_y":1478,"width":390,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f6bf10088fd466c9a3e2134815b70fd","type":"text","conversion_output":true,"parent_id":"e90a4038dd3c4e86aa912afdcad24162","text":"5.2 Analysis Methods","text_display":"\n\n\\subsection*{5.2 Analysis Methods}","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1768,1594],[1768,1652],[245,1652]],"region":{"top_left_x":244,"top_left_y":1594,"width":1525,"height":59},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cde1fd278544476bbe67a31fbdd96e70","type":"text","conversion_output":true,"text":"All in-hospital outcomes will be analyzed using both univariate methods and multivariable","text_display":"\n\nAll in-hospital outcomes will be analyzed using both univariate methods and multivariable","confidence":1,"confidence_rate":1},{"cnt":[[245,1693],[1846,1693],[1846,1749],[245,1749]],"region":{"top_left_x":244,"top_left_y":1692,"width":1602,"height":57},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed291f5cecae49fcbfadb0d1afa4a722","type":"text","conversion_output":true,"text":"regression, adjusting for covariates noted below. Though baseline patient characteristics should","text_display":" regression, adjusting for covariates noted below. Though baseline patient characteristics should","confidence":1,"confidence_rate":1},{"cnt":[[245,1790],[1843,1790],[1843,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1789,"width":1600,"height":57},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"497d58b93a504ba79283d87dc05a7a1a","type":"text","conversion_output":true,"text":"theoretically be balanced between treatment groups due to randomization, adjustment increases","text_display":" theoretically be balanced between treatment groups due to randomization, adjustment increases","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[245,1882],[1807,1882],[1807,1940],[245,1940]],"region":{"top_left_x":244,"top_left_y":1882,"width":1563,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67b33b454cd1471bb5730d770629736e","type":"text","conversion_output":true,"text":"our power and precision. Adjusted analyses will be considered the primary analyses. We will","text_display":" our power and precision. Adjusted analyses will be considered the primary analyses. We will","confidence":1,"confidence_rate":1},{"cnt":[[245,1981],[1846,1981],[1846,2035],[245,2035]],"region":{"top_left_x":244,"top_left_y":1980,"width":1602,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ded83c918c742ff99b27e5639f0d2e1","type":"text","conversion_output":true,"text":"adjust all coefficient variances using Huber-White sandwich estimation, clustered by study site.","text_display":" adjust all coefficient variances using Huber-White sandwich estimation, clustered by study site.","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[1854,2075],[1854,2129],[245,2129]],"region":{"top_left_x":244,"top_left_y":2075,"width":1611,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"933b908ab06a4a309afc713f4a1a22ca","type":"text","conversion_output":true,"text":"This will help account for unmeasured variability and correlation among patients within a given","text_display":" This will help account for unmeasured variability and correlation among patients within a given","confidence":1,"confidence_rate":1},{"cnt":[[245,2174],[322,2174],[322,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2174,"width":79,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57cc4ea0146b4eb5be0d52f6965f950a","type":"text","conversion_output":true,"text":"site.","text_display":" site.","confidence":1,"confidence_rate":1},{"cnt":[[1830,2574],[1886,2574],[1886,2628],[1830,2628]],"region":{"top_left_x":1830,"top_left_y":2573,"width":57,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e0cd8c70101439d9b5bcd9ee9475f80","type":"page_info","conversion_output":false,"text":"11","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-12","page":12,"lines":[{"cnt":[[236,243],[872,243],[872,312],[236,312]],"region":{"top_left_x":236,"top_left_y":242,"width":637,"height":70},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"581930fc83954d00940fb8f47cae842c","type":"section_header","conversion_output":false,"children_ids":["4cb9a11bcdef413081f251f350797a6b"],"text":"","text_display":""},{"cnt":[[245,249],[866,249],[866,303],[245,303]],"region":{"top_left_x":244,"top_left_y":249,"width":622,"height":54},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cb9a11bcdef413081f251f350797a6b","type":"text","conversion_output":true,"parent_id":"581930fc83954d00940fb8f47cae842c","text":"In-Hospital Continuous Outcomes","text_display":"\n\n\\section*{In-Hospital Continuous Outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[243,365],[1871,365],[1871,423],[243,423]],"region":{"top_left_x":242,"top_left_y":365,"width":1630,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b82a5e5af35c498eb33c137ef7314518","type":"text","conversion_output":true,"text":"We will use proportional odds logistic regression for continuous outcomes that are non-normally","text_display":"\n\nWe will use proportional odds logistic regression for continuous outcomes that are non-normally","confidence":1,"confidence_rate":1},{"cnt":[[243,460],[1846,460],[1846,520],[243,520]],"region":{"top_left_x":242,"top_left_y":459,"width":1604,"height":61},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"780728c5051c4edaa0a5a1ddce9744d5","type":"text","conversion_output":true,"text":"distributed (e.g., delirium/coma-free days; ventilator-free days) with covariates as listed below;","text_display":" distributed (e.g., delirium/coma-free days; ventilator-free days) with covariates as listed below;","confidence":0.9985356330871582,"confidence_rate":0.9999857725269791},{"cnt":[[243,556],[1861,556],[1861,614],[243,614]],"region":{"top_left_x":242,"top_left_y":556,"width":1619,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1de14014e66248329976b0a354f21682","type":"text","conversion_output":true,"text":"this method assumes an ordinal outcome but does not assume that it follows a specific statistical","text_display":" this method assumes an ordinal outcome but does not assume that it follows a specific statistical","confidence":1,"confidence_rate":1},{"cnt":[[245,649],[1871,649],[1871,711],[245,711]],"region":{"top_left_x":244,"top_left_y":648,"width":1628,"height":64},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e88bb2b507c4af6b121cb5181b1ecc9","type":"text","conversion_output":true,"text":"distribution. Both adjusted odds ratios as well as adjusted medians will be reported as estimates \\({ }^{4}\\).","text_display":" distribution. Both adjusted odds ratios as well as adjusted medians will be reported as estimates \\({ }^{4}\\).","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[236,799],[715,799],[715,866],[236,866]],"region":{"top_left_x":236,"top_left_y":799,"width":480,"height":67},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"278fda4072084648b5243f5e1b81d829","type":"section_header","conversion_output":false,"children_ids":["15809ae509814c9eb0ed4ce8f840a4f6"],"text":"","text_display":""},{"cnt":[[245,808],[707,808],[707,857],[245,857]],"region":{"top_left_x":244,"top_left_y":807,"width":463,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15809ae509814c9eb0ed4ce8f840a4f6","type":"text","conversion_output":true,"parent_id":"278fda4072084648b5243f5e1b81d829","text":"Time-to-Event Outcomes","text_display":"\n\n\\section*{Time-to-Event Outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[245,930],[1824,930],[1824,986],[245,986]],"region":{"top_left_x":244,"top_left_y":930,"width":1581,"height":57},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9b3f5fb21724eb9a0c5cca77689a9bc","type":"text","conversion_output":true,"text":"We will use Cox proportional hazards regression for mortality with covariates as listed below.","text_display":"\n\nWe will use Cox proportional hazards regression for mortality with covariates as listed below.","confidence":1,"confidence_rate":1},{"cnt":[[245,1021],[1762,1021],[1762,1081],[245,1081]],"region":{"top_left_x":244,"top_left_y":1020,"width":1518,"height":61},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aae01f2c366146e2a135048dc7d85cbe","type":"text","conversion_output":true,"text":"For time-to-event outcomes with competing risks, we will use Fine-Gray \\({ }^{5}\\) competing risks","text_display":" For time-to-event outcomes with competing risks, we will use Fine-Gray \\({ }^{5}\\) competing risks","confidence":1,"confidence_rate":1},{"cnt":[[245,1121],[436,1121],[436,1175],[245,1175]],"region":{"top_left_x":244,"top_left_y":1121,"width":193,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6db27ffdb4af4af2bcac4e2231f5b094","type":"text","conversion_output":true,"text":"regression.","text_display":" regression.","confidence":1,"confidence_rate":1},{"cnt":[[234,1263],[662,1263],[662,1334],[234,1334]],"region":{"top_left_x":234,"top_left_y":1263,"width":428,"height":72},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d48e21e9da35486fb55cbebc3775996f","type":"section_header","conversion_output":false,"children_ids":["462fdf3b352d485abde3fb7e7170272a"],"text":"","text_display":""},{"cnt":[[243,1272],[651,1272],[651,1328],[243,1328]],"region":{"top_left_x":242,"top_left_y":1271,"width":409,"height":57},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"462fdf3b352d485abde3fb7e7170272a","type":"text","conversion_output":true,"parent_id":"d48e21e9da35486fb55cbebc3775996f","text":"Long-Term Outcomes","text_display":"\n\n\\section*{Long-Term Outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[243,1396],[1858,1396],[1858,1454],[243,1454]],"region":{"top_left_x":242,"top_left_y":1396,"width":1617,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47e15b6010284c73ad05b9070dd05961","type":"text","conversion_output":true,"text":"We will analyze the primary long-term outcome, the TICS score, using multivariable regression","text_display":"\n\nWe will analyze the primary long-term outcome, the TICS score, using multivariable regression","confidence":1,"confidence_rate":1},{"cnt":[[245,1491],[1682,1491],[1682,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1491,"width":1439,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a3b96a193d6460e82a6c58c5bf0266c","type":"text","conversion_output":true,"text":"with treatment and adjusting for other covariates mentioned below. Depending on the","text_display":" with treatment and adjusting for other covariates mentioned below. Depending on the","confidence":1,"confidence_rate":1},{"cnt":[[245,1586],[1704,1586],[1704,1646],[245,1646]],"region":{"top_left_x":244,"top_left_y":1585,"width":1460,"height":61},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e14031370a5d4d4c976eeec57d95ada3","type":"text","conversion_output":true,"text":"distribution of the outcome, we will use linear regression, or proportional odds logistic","text_display":" distribution of the outcome, we will use linear regression, or proportional odds logistic","confidence":1,"confidence_rate":1},{"cnt":[[245,1684],[1659,1684],[1659,1740],[245,1740]],"region":{"top_left_x":244,"top_left_y":1684,"width":1415,"height":57},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25b86aadd76b40008c801036e1b4848d","type":"text","conversion_output":true,"text":"regression, as appropriate. This will be the primary analysis model for this outcome.","text_display":" regression, as appropriate. This will be the primary analysis model for this outcome.","confidence":1,"confidence_rate":1},{"cnt":[[370,1779],[1779,1779],[1779,1837],[370,1837]],"region":{"top_left_x":369,"top_left_y":1778,"width":1410,"height":59},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07f03a0d32f44541b224fbc0b0ac194e","type":"text","conversion_output":true,"text":"As a sensitivity analysis, we will also define a patient as being cognitively impaired","text_display":"\n\nAs a sensitivity analysis, we will also define a patient as being cognitively impaired","confidence":1,"confidence_rate":1},{"cnt":[[245,1876],[1815,1876],[1815,1931],[245,1931]],"region":{"top_left_x":244,"top_left_y":1875,"width":1572,"height":57},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cefa33813c694733b52352840dd39953","type":"text","conversion_output":true,"text":"based on whether they are \\(>=2 SD\\) in 1 test \\(OR >=1.5 SD\\) in any two tests, where the tests we","text_display":" based on whether they are \\(>=2 SD\\) in 1 test \\(OR >=1.5 SD\\) in any two tests, where the tests we","confidence":0.98876953125,"confidence_rate":0.9998982573687564},{"cnt":[[245,1970],[1867,1970],[1867,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1970,"width":1623,"height":61},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84f52b910bdb473ab15feb2cb8485cf5","type":"text","conversion_output":true,"text":"will consider are the Digit Span, Logical Memory I, Logical Memory II, Similarities, Controlled","text_display":" will consider are the Digit Span, Logical Memory I, Logical Memory II, Similarities, Controlled","confidence":1,"confidence_rate":1},{"cnt":[[245,2067],[1854,2067],[1854,2125],[245,2125]],"region":{"top_left_x":244,"top_left_y":2066,"width":1611,"height":59},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5418b3aafe704efba126c223fba0f14c","type":"text","conversion_output":true,"text":"Oral Word Association, and Hayling Sentence Completion. We will analyze this outcome using","text_display":" Oral Word Association, and Hayling Sentence Completion. We will analyze this outcome using","confidence":1,"confidence_rate":1},{"cnt":[[245,2161],[1502,2161],[1502,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2161,"width":1258,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a902aa64b9bb46ff87bb9ea67dbce1ba","type":"text","conversion_output":true,"text":"multivariable logistic regression adjusting for covariates mentioned below.","text_display":" multivariable logistic regression adjusting for covariates mentioned below.","confidence":1,"confidence_rate":1},{"cnt":[[370,2258],[1800,2258],[1800,2316],[370,2316]],"region":{"top_left_x":369,"top_left_y":2258,"width":1432,"height":59},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58f01a5999c9456db461719b9bcc2f15","type":"text","conversion_output":true,"text":"Since mortality is hypothesized to have an association with treatment, the analysis of","text_display":"\n\nSince mortality is hypothesized to have an association with treatment, the analysis of","confidence":1,"confidence_rate":1},{"cnt":[[245,2355],[1850,2355],[1850,2413],[245,2413]],"region":{"top_left_x":244,"top_left_y":2354,"width":1606,"height":59},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebf80d548c444571bca469cd2b8026ab","type":"text","conversion_output":true,"text":"survivors with assessments may be susceptible to survivor bias. To deal with this potential bias,","text_display":" survivors with assessments may be susceptible to survivor bias. To deal with this potential bias,","confidence":1,"confidence_rate":1},{"cnt":[[245,2449],[1725,2449],[1725,2507],[245,2507]],"region":{"top_left_x":244,"top_left_y":2449,"width":1482,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fdaea91d7994e488d7bb1b222165d96","type":"text","conversion_output":true,"text":"we will conduct a sensitivity analyses using the continuous TICS score. We will use the","text_display":" we will conduct a sensitivity analyses using the continuous TICS score. We will use the","confidence":0.99560546875,"confidence_rate":0.9999521292373095},{"cnt":[[1830,2574],[1886,2574],[1886,2628],[1830,2628]],"region":{"top_left_x":1830,"top_left_y":2573,"width":57,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de1fad426ea2461080244c8bc5315e66","type":"page_info","conversion_output":false,"text":"12","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-13","page":13,"lines":[{"cnt":[[243,245],[1815,245],[1815,305],[243,305]],"region":{"top_left_x":242,"top_left_y":244,"width":1574,"height":62},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a837d3af5bf4141b3f52c37e819a522","type":"text","conversion_output":true,"text":"unadjusted composite endpoint approach described in Lachin \\({ }^{6}\\), where the composite endpoint","text_display":"\nunadjusted composite endpoint approach described in Lachin \\({ }^{6}\\), where the composite endpoint","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[243,344],[561,344],[561,397],[243,397]],"region":{"top_left_x":242,"top_left_y":343,"width":319,"height":55},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5034d3a6ef584445b96009fbbf3ecc55","type":"text","conversion_output":true,"text":"will be defined as:","text_display":" will be defined as:","confidence":1,"confidence_rate":1},{"cnt":[[243,443],[1676,443],[1676,496],[243,496]],"region":{"top_left_x":242,"top_left_y":442,"width":1434,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83b6d598eb834c0786fa544197bca638","type":"text","conversion_output":true,"text":"- If the patient dies prior to assessment or is missing assessments days between","text_display":"\n- If the patient dies prior to assessment or is missing assessments days between","confidence":1,"confidence_rate":1},{"cnt":[[243,537],[1798,537],[1798,595],[243,595]],"region":{"top_left_x":242,"top_left_y":537,"width":1557,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c2c4e44e2fc417c9ae6d235fb8fd897","type":"text","conversion_output":true,"text":"randomization and death/date of last follow-up (for patients who were lost to follow up)/ 180","text_display":" randomization and death/date of last follow-up (for patients who were lost to follow up)/ 180","confidence":0.855539083480835,"confidence_rate":0.9983928032176376},{"cnt":[[243,632],[1291,632],[1291,690],[243,690]],"region":{"top_left_x":242,"top_left_y":631,"width":1050,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"584a09bc73d6498987add7d86718543b","type":"text","conversion_output":true,"text":"days for those who were assessed but had missing TICS score","text_display":" days for those who were assessed but had missing TICS score","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[1790,726],[1790,784],[245,784]],"region":{"top_left_x":244,"top_left_y":726,"width":1546,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bd388412a794a4d81445ffb7657b219","type":"text","conversion_output":true,"text":"- If the patient survives and is successfully assessed: days between randomization and","text_display":"\n- If the patient survives and is successfully assessed: days between randomization and","confidence":1,"confidence_rate":1},{"cnt":[[365,825],[1233,825],[1233,879],[365,879]],"region":{"top_left_x":365,"top_left_y":825,"width":869,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eae44bf41259441fbbc29f458f955694","type":"text","conversion_output":true,"text":"planned assessment ( 180 days) + assessment score.","text_display":" planned assessment ( 180 days) + assessment score.","confidence":0.4214768868639567,"confidence_rate":0.985936058335499},{"cnt":[[236,971],[621,971],[621,1040],[236,1040]],"region":{"top_left_x":236,"top_left_y":971,"width":385,"height":69},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db13f9a5fe374084bc6ff814b7bdcad9","type":"section_header","conversion_output":false,"children_ids":["5bda0bb655d742b3886ab086dfd5491c"],"text":"","text_display":""},{"cnt":[[245,980],[610,980],[610,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":979,"width":367,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bda0bb655d742b3886ab086dfd5491c","type":"text","conversion_output":true,"parent_id":"db13f9a5fe374084bc6ff814b7bdcad9","text":"Model Assumptions","text_display":"\n\n\\section*{Model Assumptions}","confidence":1,"confidence_rate":1},{"cnt":[[243,1100],[1882,1100],[1882,1154],[243,1154]],"region":{"top_left_x":242,"top_left_y":1100,"width":1641,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"365d8f8c9c3d4a2fbe0c6abd7c8c2e6c","type":"text","conversion_output":true,"text":"Model assumptions will be evaluated graphically. Proportional odds assumptions will be checked","text_display":"\n\nModel assumptions will be evaluated graphically. Proportional odds assumptions will be checked","confidence":1,"confidence_rate":1},{"cnt":[[245,1190],[1850,1190],[1850,1250],[245,1250]],"region":{"top_left_x":244,"top_left_y":1190,"width":1606,"height":61},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd910aea275b4445a11916d62b57541f","type":"text","conversion_output":true,"text":"using multiple cutoffs for proportional odds assumption \\({ }^{7}\\), and Schoenfeld residuals will be used","text_display":" using multiple cutoffs for proportional odds assumption \\({ }^{7}\\), and Schoenfeld residuals will be used","confidence":1,"confidence_rate":1},{"cnt":[[245,1291],[1777,1291],[1777,1347],[245,1347]],"region":{"top_left_x":244,"top_left_y":1291,"width":1533,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a1d2ea48dbd41c8b9a3a40fc55cbc77","type":"text","conversion_output":true,"text":"for proportional hazards. If linear regression is used for long-term outcomes, we will check","text_display":" for proportional hazards. If linear regression is used for long-term outcomes, we will check","confidence":1,"confidence_rate":1},{"cnt":[[243,1388],[1603,1388],[1603,1446],[243,1446]],"region":{"top_left_x":242,"top_left_y":1387,"width":1361,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89e55279cb47462bb5ca7478ace4dc81","type":"text","conversion_output":true,"text":"residual vs fitted plots and quantile-quantile plots to ensure assumptions are met.","text_display":" residual vs fitted plots and quantile-quantile plots to ensure assumptions are met.","confidence":1,"confidence_rate":1},{"cnt":[[236,1532],[458,1532],[458,1596],[236,1596]],"region":{"top_left_x":236,"top_left_y":1531,"width":222,"height":66},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"685c1efc04094e979f6c22810fd3158a","type":"section_header","conversion_output":false,"children_ids":["7b02e79d9b4a42268c61d9275761039e"],"text":"","text_display":""},{"cnt":[[245,1538],[449,1538],[449,1588],[245,1588]],"region":{"top_left_x":244,"top_left_y":1538,"width":206,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b02e79d9b4a42268c61d9275761039e","type":"text","conversion_output":true,"parent_id":"685c1efc04094e979f6c22810fd3158a","text":"Covariates","text_display":"\n\n\\section*{Covariates}","confidence":0.99951171875,"confidence_rate":0.9999674404968649},{"cnt":[[245,1650],[1644,1650],[1644,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1650,"width":1400,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce65e1ed75ae4f66a29a9e1da5514149","type":"text","conversion_output":true,"text":"Covariates for all multivariable regression models except 90-day mortality include:","text_display":"\n\nCovariates for all multivariable regression models except 90-day mortality include:","confidence":1,"confidence_rate":1},{"cnt":[[309,1745],[784,1745],[784,1798],[309,1798]],"region":{"top_left_x":309,"top_left_y":1744,"width":476,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8981a9f4545d4e59a717feda212e2ff8","type":"text","conversion_output":true,"text":"- Age at study enrollment","text_display":"\n- Age at study enrollment","confidence":1,"confidence_rate":1},{"cnt":[[309,1843],[552,1843],[552,1888],[309,1888]],"region":{"top_left_x":309,"top_left_y":1843,"width":244,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c0622e7532c4bc099496600f616b8aa","type":"text","conversion_output":true,"text":"- Education","text_display":"\n- Education","confidence":1,"confidence_rate":1},{"cnt":[[309,1938],[1865,1938],[1865,1989],[309,1989]],"region":{"top_left_x":309,"top_left_y":1937,"width":1556,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c7fad62209647268bd444bf4aa74ae3","type":"text","conversion_output":true,"text":"- Baseline cognitive function, via the Informant Questionnaire on Cognitive Decline in the","text_display":"\n- Baseline cognitive function, via the Informant Questionnaire on Cognitive Decline in the","confidence":1,"confidence_rate":1},{"cnt":[[370,2032],[1540,2032],[1540,2086],[370,2086]],"region":{"top_left_x":369,"top_left_y":2032,"width":1172,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a5df605dcb64525b7f54d411a3eb5c0","type":"text","conversion_output":true,"text":"Elderly (IQCODE) (performed via patient or surrogate questionnaire)","text_display":" Elderly (IQCODE) (performed via patient or surrogate questionnaire)","confidence":1,"confidence_rate":1},{"cnt":[[309,2127],[1457,2127],[1457,2181],[309,2181]],"region":{"top_left_x":309,"top_left_y":2126,"width":1148,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a17806e439a4fc4874e450fc8dd91aa","type":"text","conversion_output":true,"text":"- Preexisting comorbidities, via the Charlson Comorbidities Index","text_display":"\n- Preexisting comorbidities, via the Charlson Comorbidities Index","confidence":1,"confidence_rate":1},{"cnt":[[309,2226],[1807,2226],[1807,2279],[309,2279]],"region":{"top_left_x":309,"top_left_y":2225,"width":1498,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aaf318d4e08244df96af07176943b065","type":"text","conversion_output":true,"text":"- Sequential Organ Failure Assessment (SOFA) on the day of enrollment excluding the","text_display":"\n- Sequential Organ Failure Assessment (SOFA) on the day of enrollment excluding the","confidence":1,"confidence_rate":1},{"cnt":[[370,2320],[1798,2320],[1798,2374],[370,2374]],"region":{"top_left_x":369,"top_left_y":2320,"width":1430,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46f2207ec2e84965aa98d0233fe1fe28","type":"text","conversion_output":true,"text":"central nervous system (CNS) component since delirium and coma are accounted for","text_display":" central nervous system (CNS) component since delirium and coma are accounted for","confidence":1,"confidence_rate":1},{"cnt":[[370,2415],[552,2415],[552,2469],[370,2469]],"region":{"top_left_x":369,"top_left_y":2414,"width":184,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"023881b146b4423a80b2c6784fc394c7","type":"text","conversion_output":true,"text":"separately","text_display":" separately","confidence":1,"confidence_rate":1},{"cnt":[[1830,2574],[1886,2574],[1886,2628],[1830,2628]],"region":{"top_left_x":1830,"top_left_y":2573,"width":57,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8f8c74fb0184d5c91cac2265bfa3eaa","type":"page_info","conversion_output":false,"text":"13","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-14","page":14,"lines":[{"cnt":[[309,251],[1820,251],[1820,303],[309,303]],"region":{"top_left_x":309,"top_left_y":251,"width":1511,"height":52},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e9b2baf91ac490e9dc6351c7bdb3235","type":"text","conversion_output":true,"text":"- Level of arousal at randomization via the Richmond Agitation-Sedation Scale (RASS)","text_display":"\n- Level of arousal at randomization via the Richmond Agitation-Sedation 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(haloperidol","confidence":1,"confidence_rate":1},{"cnt":[[370,541],[1846,541],[1846,591],[370,591]],"region":{"top_left_x":369,"top_left_y":541,"width":1477,"height":50},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72a45d3a18dc47179c9e3e20a3643c0f","type":"text","conversion_output":true,"text":"(iv) equivalents) and benzodiazepines (midazolam equivalents) between ICU admission","text_display":" (iv) equivalents) and benzodiazepines (midazolam equivalents) between ICU admission","confidence":1,"confidence_rate":1},{"cnt":[[370,636],[1828,636],[1828,685],[370,685]],"region":{"top_left_x":369,"top_left_y":635,"width":1460,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b381520b6cf46f3af856a92de5f088d","type":"text","conversion_output":true,"text":"and midnight prior to enrollment. Exposure will be defined as total dose/kg and will be","text_display":" and midnight prior to enrollment. Exposure will be defined as total dose/kg and will be","confidence":0.9990236759185791,"confidence_rate":0.9999893826542317},{"cnt":[[370,730],[1663,730],[1663,780],[370,780]],"region":{"top_left_x":369,"top_left_y":730,"width":1294,"height":50},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17763f158fd84323988754cb694f8e78","type":"text","conversion_output":true,"text":"cube-rooted in the models to mitigate the influence of extremely high values.","text_display":" cube-rooted in the models to mitigate the influence of extremely high values.","confidence":1,"confidence_rate":1},{"cnt":[[309,827],[1798,827],[1798,879],[309,879]],"region":{"top_left_x":309,"top_left_y":827,"width":1490,"height":52},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3616573c6a8d4baaa8066972fe274acd","type":"text","conversion_output":true,"text":"- Medical vs surgical - Surgical patients are those who have a recorded ICU admission","text_display":"\n- Medical vs surgical - Surgical patients are those who have a recorded ICU admission","confidence":1,"confidence_rate":1},{"cnt":[[370,924],[1826,924],[1826,973],[370,973]],"region":{"top_left_x":369,"top_left_y":923,"width":1458,"height":51},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b3d10af20774c8e96f47b7a94616514","type":"text","conversion_output":true,"text":"reason involving surgery; had surgery between hospital admission and ICU admission;","text_display":" reason involving surgery; had surgery between hospital admission and ICU admission;","confidence":1,"confidence_rate":1},{"cnt":[[370,1018],[1796,1018],[1796,1068],[370,1068]],"region":{"top_left_x":369,"top_left_y":1018,"width":1428,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16e4efaac3e745349eee1b427d6ea7d9","type":"text","conversion_output":true,"text":"and/or went to the operating room between ICU admission and study enrollment. 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All","confidence":1,"confidence_rate":1},{"cnt":[[370,1117],[1214,1117],[1214,1167],[370,1167]],"region":{"top_left_x":369,"top_left_y":1117,"width":845,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c49786cd6d94d53b7815aa8353e702b","type":"text","conversion_output":true,"text":"other patients will be considered medical patients.","text_display":" other patients will be considered medical patients.","confidence":1,"confidence_rate":1},{"cnt":[[309,1212],[1843,1212],[1843,1261],[309,1261]],"region":{"top_left_x":309,"top_left_y":1211,"width":1535,"height":51},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ac61c4279994176866ed1dcb887c913","type":"text","conversion_output":true,"text":"- Infection type (from 48 hours before enrollment until end of treatment period-study day","text_display":"\n- Infection type (from 48 hours before enrollment until end of treatment period-study day","confidence":1,"confidence_rate":1},{"cnt":[[374,1306],[1742,1306],[1742,1356],[374,1356]],"region":{"top_left_x":373,"top_left_y":1306,"width":1370,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc9b4f110d094b44b4ff21a63cddc8d6","type":"text","conversion_output":true,"text":"14, treatment withdrawal, hospital discharge or death.): Confirmed Gram positive","text_display":" 14, treatment withdrawal, hospital discharge or death.): Confirmed Gram positive","confidence":0.99072265625,"confidence_rate":0.9998903513491048},{"cnt":[[370,1403],[1837,1403],[1837,1452],[370,1452]],"region":{"top_left_x":369,"top_left_y":1402,"width":1468,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a060bb09041c47eeafcd42a8c15d29fb","type":"text","conversion_output":true,"text":"(yes/no), Gram negative (yes/no), viral (yes/no), fungal (yes/no), or suspected infection","text_display":" (yes/no), Gram negative (yes/no), viral (yes/no), fungal (yes/no), or suspected infection","confidence":1,"confidence_rate":1},{"cnt":[[370,1500],[1815,1500],[1815,1549],[370,1549]],"region":{"top_left_x":369,"top_left_y":1499,"width":1447,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e64c5e1e25c94a54a07ba16d5be46846","type":"text","conversion_output":true,"text":"but culture negative. Patients may have more than one type of infection. These will be","text_display":" but culture negative. Patients may have more than one type of infection. These will be","confidence":0.99658203125,"confidence_rate":0.9999623762753774},{"cnt":[[370,1594],[1863,1594],[1863,1644],[370,1644]],"region":{"top_left_x":369,"top_left_y":1594,"width":1494,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"52cc03e33d024e9abae03ef35193611e","type":"text","conversion_output":true,"text":"modeled as separate variables in the model. If there is very limited variability that causes","text_display":" modeled as separate variables in the model. If there is very limited variability that causes","confidence":1,"confidence_rate":1},{"cnt":[[370,1691],[1826,1691],[1826,1738],[370,1738]],"region":{"top_left_x":369,"top_left_y":1690,"width":1458,"height":49},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58fe67faf5ce4d86997e7682fcea3a18","type":"text","conversion_output":true,"text":"convergence issues, we will combine the fungal and viral variables. If the convergence","text_display":" convergence issues, we will combine the fungal and viral variables. If the convergence","confidence":1,"confidence_rate":1},{"cnt":[[370,1788],[1858,1788],[1858,1837],[370,1837]],"region":{"top_left_x":369,"top_left_y":1787,"width":1490,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a122534026d4bd9b04ae376019530a7","type":"text","conversion_output":true,"text":"issues persist, we will create a single variable with multiple levels: Gram Positive, Gram","text_display":" issues persist, we will create a single variable with multiple levels: Gram Positive, Gram","confidence":1,"confidence_rate":1},{"cnt":[[370,1882],[1072,1882],[1072,1931],[370,1931]],"region":{"top_left_x":369,"top_left_y":1882,"width":704,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1003cabdaa444facb8b29eaa5d8772e1","type":"text","conversion_output":true,"text":"Negative, Culture negative, Viral/Fungal.","text_display":" Negative, Culture negative, Viral/Fungal.","confidence":1,"confidence_rate":1},{"cnt":[[245,1979],[1858,1979],[1858,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1978,"width":1615,"height":53},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4948f45a8dbb4d9d8775354347869785","type":"text","conversion_output":true,"text":"Prior to modeling, we will perform redundancy analyses to ensure that no covariates completely","text_display":"\n\nPrior to modeling, we will perform redundancy analyses to ensure that no covariates completely","confidence":1,"confidence_rate":1},{"cnt":[[245,2073],[1826,2073],[1826,2125],[245,2125]],"region":{"top_left_x":244,"top_left_y":2073,"width":1583,"height":52},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"abb1154d87bf48caa967ddd7c3fac8f2","type":"text","conversion_output":true,"text":"explain any of the others (resulting in multicollinearity) using an adjusted \\(R^{\\wedge} 2\\) cutoff of 0.7 . If","text_display":" explain any of the others (resulting in multicollinearity) using an adjusted \\(R^{\\wedge} 2\\) cutoff of 0.7 . If","confidence":0.9873046875,"confidence_rate":0.9998908043675849},{"cnt":[[245,2170],[1865,2170],[1865,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":1621,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f537c03a85c54df692b3ce734cb3f3a6","type":"text","conversion_output":true,"text":"any covariates are highly correlated, only one of them based on clinical relevance will be kept in","text_display":" any covariates are highly correlated, only one of them based on clinical relevance will be kept in","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,2264],[1742,2264],[1742,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2264,"width":1499,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53030270e1bb4c33b9d8bca074d00177","type":"text","conversion_output":true,"text":"the model. If there are covariates with very limited variability that cause the model to not","text_display":" the model. If there are covariates with very limited variability that cause the model to not","confidence":1,"confidence_rate":1},{"cnt":[[245,2363],[1059,2363],[1059,2413],[245,2413]],"region":{"top_left_x":244,"top_left_y":2363,"width":816,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97a1eef8539b462ca5c1c0f2f2a7a3be","type":"text","conversion_output":true,"text":"converge, they will be removed from the model.","text_display":" converge, they will be removed from the model.","confidence":1,"confidence_rate":1},{"cnt":[[1830,2574],[1882,2574],[1882,2617],[1830,2617]],"region":{"top_left_x":1830,"top_left_y":2573,"width":53,"height":44},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"869f402e91e845e2b30b0d37281f7bc0","type":"page_info","conversion_output":false,"text":"14","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-15","page":15,"lines":[{"cnt":[[245,249],[1755,249],[1755,305],[245,305]],"region":{"top_left_x":244,"top_left_y":249,"width":1512,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3aec5cff916459f8cdc26453f0302c8","type":"text","conversion_output":true,"text":"Covariates for 90-day mortality will include age, baseline cognitive function, Pre-existing","text_display":"\n\nCovariates for 90-day mortality will include age, baseline cognitive function, Pre-existing","confidence":0.9926791191101074,"confidence_rate":0.9999234632410767},{"cnt":[[245,346],[1762,346],[1762,402],[245,402]],"region":{"top_left_x":244,"top_left_y":345,"width":1518,"height":57},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45ec4ee83d61410b8e8f7f3d7c6b0cf0","type":"text","conversion_output":true,"text":"comorbidities, SOFA on the day of enrollment excluding the CNS component, Medical vs","text_display":" comorbidities, SOFA on the day of enrollment excluding the CNS component, Medical vs","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1027,443],[1027,496],[245,496]],"region":{"top_left_x":244,"top_left_y":442,"width":783,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19884e561f6c4a57bf1511da3a3ce67a","type":"text","conversion_output":true,"text":"surgical and Infection type as specified above.","text_display":" surgical and Infection type as specified above.","confidence":1,"confidence_rate":1},{"cnt":[[236,593],[537,593],[537,662],[236,662]],"region":{"top_left_x":236,"top_left_y":592,"width":302,"height":70},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"623cb732fa3a415cb09f2cc1205b51d6","type":"section_header","conversion_output":false,"children_ids":["de712956a1074756b7b0fcae6a1a3344"],"text":"","text_display":""},{"cnt":[[243,602],[531,602],[531,655],[243,655]],"region":{"top_left_x":242,"top_left_y":601,"width":289,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de712956a1074756b7b0fcae6a1a3344","type":"text","conversion_output":true,"parent_id":"623cb732fa3a415cb09f2cc1205b51d6","text":"Safety Analysis","text_display":"\n\n\\section*{Safety Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[245,761],[1755,761],[1755,814],[245,814]],"region":{"top_left_x":244,"top_left_y":760,"width":1512,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1a5c0acbfd94f4a8ea97db5a39a5802","type":"text","conversion_output":true,"text":"In addition to the primary and secondary outcomes detailed above, descriptive analysis of","text_display":"\n\nIn addition to the primary and secondary outcomes detailed above, descriptive analysis of","confidence":1,"confidence_rate":1},{"cnt":[[245,855],[1332,855],[1332,909],[245,909]],"region":{"top_left_x":244,"top_left_y":855,"width":1089,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e350bbaf797440418da7ee980a80bcff","type":"text","conversion_output":true,"text":"specified safety outcomes will be performed as described below.","text_display":" specified safety outcomes will be performed as described below.","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[1837,971],[1837,1027],[245,1027]],"region":{"top_left_x":244,"top_left_y":971,"width":1593,"height":56},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2586bf69f1db43dba3659c24d4bc964e","type":"text","conversion_output":true,"text":"The safety endpoints below will be tracked starting from randomization until conclusion of the","text_display":"\n\nThe safety endpoints below will be tracked starting from randomization until conclusion of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1068],[1687,1068],[1687,1124],[245,1124]],"region":{"top_left_x":244,"top_left_y":1067,"width":1443,"height":57},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f7d6001e6794979996030e53c8be6bc","type":"text","conversion_output":true,"text":"combined Treatment/Post Study Drug Period, hospital discharge, death or withdrawal","text_display":" combined Treatment/Post Study Drug Period, hospital discharge, death or withdrawal","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[1757,1164],[1757,1218],[245,1218]],"region":{"top_left_x":244,"top_left_y":1164,"width":1514,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faaa80c99bc547c8930f7ff74b9d94be","type":"text","conversion_output":true,"text":"(whichever happens first). For patients who do not have hospital discharge and death time","text_display":" (whichever happens first). For patients who do not have hospital discharge and death time","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1218,1259],[1218,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1258,"width":975,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56d59f79f405478685c62ba7cbf5a63f","type":"text","conversion_output":true,"text":"available, they will be tracked until their withdrawal date.","text_display":" available, they will be tracked until their withdrawal date.","confidence":1,"confidence_rate":1},{"cnt":[[309,1354],[1867,1354],[1867,1412],[309,1412]],"region":{"top_left_x":309,"top_left_y":1353,"width":1558,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53e19160f0f8464e8bdc348242fbe045","type":"text","conversion_output":true,"text":"1. Proportion of patients and days with hypotension (defined as systolic blood pressure < 80","text_display":"\n1. Proportion of patients and days with hypotension (defined as systolic blood pressure < 80","confidence":0.7580564201089146,"confidence_rate":0.9971187684954322},{"cnt":[[370,1452],[511,1452],[511,1506],[370,1506]],"region":{"top_left_x":369,"top_left_y":1452,"width":143,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10bf35036b814613b56fe2d840146b73","type":"text","conversion_output":true,"text":"mmHg)","text_display":" mmHg)","confidence":0.9580280780792236,"confidence_rate":0.9957213603340027},{"cnt":[[305,1547],[1811,1547],[1811,1601],[305,1601]],"region":{"top_left_x":305,"top_left_y":1546,"width":1507,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ac7e43d0bbf411e9f66b8da6c32ba19","type":"text","conversion_output":true,"text":"2. Mean daily cardiovascular (CV) SOFA for patients along with proportion of days CV","text_display":"\n2. Mean daily cardiovascular (CV) SOFA for patients along with proportion of days CV","confidence":1,"confidence_rate":1},{"cnt":[[370,1644],[569,1644],[569,1691],[370,1691]],"region":{"top_left_x":369,"top_left_y":1643,"width":201,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8e673b02ce841abb67f3fe7b27ee5f2","type":"text","conversion_output":true,"text":"SOFA >=2","text_display":" SOFA >=2","confidence":0.9722299575805664,"confidence_rate":0.9978359663943199},{"cnt":[[305,1740],[1867,1740],[1867,1794],[305,1794]],"region":{"top_left_x":305,"top_left_y":1740,"width":1562,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b79dd922bb094211833d3e78d9427341","type":"text","conversion_output":true,"text":"3. Proportion of patients with arrhythmias (tachycardia [HR > 100] and/or bradycardia [HR","text_display":"\n3. Proportion of patients with arrhythmias (tachycardia [HR > 100] and/or bradycardia [HR","confidence":0.9863464774098247,"confidence_rate":0.9998537597458763},{"cnt":[[370,1835],[483,1835],[483,1888],[370,1888]],"region":{"top_left_x":369,"top_left_y":1834,"width":115,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9af05ca0c82744d587c1727947a3459d","type":"text","conversion_output":true,"text":"< 60])","text_display":" < 60])","confidence":1,"confidence_rate":1},{"cnt":[[305,1929],[1828,1929],[1828,1983],[305,1983]],"region":{"top_left_x":305,"top_left_y":1929,"width":1524,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9fa557e9f074292874ccdf32d5646dd","type":"text","conversion_output":true,"text":"4. Proportion of patients with severe lactate acidosis (as defined by lactate \\(>5\\) ) as well as","text_display":"\n4. Proportion of patients with severe lactate acidosis (as defined by lactate \\(>5\\) ) as well as","confidence":0.7325522899627686,"confidence_rate":0.9969233509807643},{"cnt":[[370,2028],[1717,2028],[1717,2082],[370,2082]],"region":{"top_left_x":369,"top_left_y":2028,"width":1348,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8facaa5ad2a14dae984f6f3880421a7c","type":"text","conversion_output":true,"text":"median days with severe lactic acidosis among those with severe lactic acidosis.","text_display":" median days with severe lactic acidosis among those with severe lactic acidosis.","confidence":1,"confidence_rate":1},{"cnt":[[305,2123],[1497,2123],[1497,2176],[305,2176]],"region":{"top_left_x":305,"top_left_y":2122,"width":1193,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e05141c234c4f19bff52c93c23f1c66","type":"text","conversion_output":true,"text":"5. Mean triglyceride and cortisol levels at 7 - and 14 -day assessments","text_display":"\n5. Mean triglyceride and cortisol levels at 7 - and 14 -day assessments","confidence":0.972718441626057,"confidence_rate":0.9996627323744205},{"cnt":[[305,2219],[1708,2219],[1708,2273],[305,2273]],"region":{"top_left_x":305,"top_left_y":2219,"width":1404,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bdf0a4654c042e2bd28e04ab0f7f092","type":"text","conversion_output":true,"text":"6. Proportion of patients with triglycerides \\(>500\\) and cortisol <20 at 7 - and 14 -day","text_display":"\n6. Proportion of patients with triglycerides \\(>500\\) and cortisol <20 at 7 - and 14 -day","confidence":0.4348849027141899,"confidence_rate":0.9916244250006154},{"cnt":[[370,2320],[582,2320],[582,2361],[370,2361]],"region":{"top_left_x":369,"top_left_y":2320,"width":214,"height":42},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"289c83414e224327a606d31233789066","type":"text","conversion_output":true,"text":"assessments","text_display":" assessments","confidence":1,"confidence_rate":1},{"cnt":[[1830,2574],[1886,2574],[1886,2628],[1830,2628]],"region":{"top_left_x":1830,"top_left_y":2573,"width":57,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a584bc80e2646958238913479a520c7","type":"page_info","conversion_output":false,"text":"15","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-16","page":16,"lines":[{"cnt":[[305,249],[1867,249],[1867,305],[305,305]],"region":{"top_left_x":305,"top_left_y":249,"width":1562,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4c795ed145f4edba745f448849adf76","type":"text","conversion_output":true,"text":"7. Proportion of patients showing signs of withdrawal from study agent based on vital signs","text_display":"\n7. Proportion of patients showing signs of withdrawal from study agent based on vital signs","confidence":1,"confidence_rate":1},{"cnt":[[370,346],[1044,346],[1044,402],[370,402]],"region":{"top_left_x":369,"top_left_y":345,"width":676,"height":57},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"781d0d064db440a8969383e1ad8adcaf","type":"text","conversion_output":true,"text":"(tachycardia HR >100) and diaphoresis.","text_display":" (tachycardia HR >100) and diaphoresis.","confidence":0.8691352233290672,"confidence_rate":0.9967435334115677},{"cnt":[[236,518],[758,518],[758,582],[236,582]],"region":{"top_left_x":236,"top_left_y":517,"width":523,"height":66},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"474b5a45807b4be88fc2ad1002b9586c","type":"section_header","conversion_output":false,"children_ids":["405c22d7bf2a418f94ca8b440d60c9b6"],"text":"","text_display":""},{"cnt":[[243,524],[750,524],[750,574],[243,574]],"region":{"top_left_x":242,"top_left_y":524,"width":508,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"405c22d7bf2a418f94ca8b440d60c9b6","type":"text","conversion_output":true,"parent_id":"474b5a45807b4be88fc2ad1002b9586c","text":"6. SOFTWARE DETAILS","text_display":"\n\n\\section*{6. SOFTWARE DETAILS}","confidence":1,"confidence_rate":1},{"cnt":[[243,640],[1729,640],[1729,698],[243,698]],"region":{"top_left_x":242,"top_left_y":640,"width":1488,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9280a1f230a4e6c9d7d828b2a0d7350","type":"text","conversion_output":true,"text":"R version 3.5.2 (2018-12-20) or above will be used for all analyses. Versions of specific","text_display":"\n\nR version 3.5.2 (2018-12-20) or above will be used for all analyses. Versions of specific","confidence":0.8857421875,"confidence_rate":0.9987100948194841},{"cnt":[[245,739],[1837,739],[1837,793],[245,793]],"region":{"top_left_x":244,"top_left_y":739,"width":1593,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db15e4eda3c94a87999c7d079bdd5bfe","type":"text","conversion_output":true,"text":"packages used for analysis will be noted in the analysis report. The checkpoint package will be","text_display":" packages used for analysis will be noted in the analysis report. The checkpoint package will be","confidence":1,"confidence_rate":1},{"cnt":[[245,834],[1850,834],[1850,889],[245,889]],"region":{"top_left_x":244,"top_left_y":833,"width":1606,"height":57},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a1591a710a44e5fa724e747fb611f81","type":"text","conversion_output":true,"text":"used to preserve R package versions throughout the manuscript submission and review process.","text_display":" used to preserve R package versions throughout the manuscript submission and review process.","confidence":0.6234375690110028,"confidence_rate":0.9954230630538409},{"cnt":[[236,1016],[612,1016],[612,1085],[236,1085]],"region":{"top_left_x":236,"top_left_y":1016,"width":377,"height":69},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09b33b2034164f50adb286af031c9c0b","type":"section_header","conversion_output":false,"children_ids":["470e559a7aee4516b3c11d272e075d57"],"text":"","text_display":""},{"cnt":[[243,1023],[604,1023],[604,1076],[243,1076]],"region":{"top_left_x":242,"top_left_y":1022,"width":362,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"470e559a7aee4516b3c11d272e075d57","type":"text","conversion_output":true,"parent_id":"09b33b2034164f50adb286af031c9c0b","text":"7. CONCLUSION","text_display":"\n\n\\section*{7. CONCLUSION}","confidence":1,"confidence_rate":1},{"cnt":[[245,1121],[1794,1121],[1794,1175],[245,1175]],"region":{"top_left_x":244,"top_left_y":1121,"width":1550,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7635dd35832411b8b9cf705e8e609cd","type":"text","conversion_output":true,"text":"This document presents the formal Statistical Analysis Plan for the MENDS2 study. Further","text_display":"\n\nThis document presents the formal Statistical Analysis Plan for the MENDS2 study. Further","confidence":1,"confidence_rate":1},{"cnt":[[245,1216],[1729,1216],[1729,1274],[245,1274]],"region":{"top_left_x":244,"top_left_y":1216,"width":1486,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"089c996aadfa41d383e17f95361fef25","type":"text","conversion_output":true,"text":"details regarding variable definitions, unadjusted and exploratory analyses and Database","text_display":" details regarding variable definitions, unadjusted and exploratory analyses and Database","confidence":1,"confidence_rate":1},{"cnt":[[245,1311],[1257,1311],[1257,1369],[245,1369]],"region":{"top_left_x":244,"top_left_y":1310,"width":1013,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"020cb14130e84f4182673a02f0e90834","type":"text","conversion_output":true,"text":"Cleaning \\& Lock Procedures are provided in Supplement 2.","text_display":" Cleaning \\& Lock Procedures are provided in Supplement 2.","confidence":1,"confidence_rate":1},{"cnt":[[1830,2574],[1886,2574],[1886,2628],[1830,2628]],"region":{"top_left_x":1830,"top_left_y":2573,"width":57,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e729ae4c1d524a4090a84c7838cf1a50","type":"page_info","conversion_output":false,"text":"16","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-17","page":17,"lines":[{"cnt":[[234,243],[812,243],[812,312],[234,312]],"region":{"top_left_x":234,"top_left_y":242,"width":579,"height":70},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b43cdc3ab82546f6b0d9404855fbe767","type":"figure_label","conversion_output":true,"text":"Table 1: Study exclusion criteria","text_display":"\n\nTable 1: Study exclusion criteria","confidence":1,"confidence_rate":1},{"cnt":[[262,352],[1854,352],[1854,406],[262,406]],"region":{"top_left_x":262,"top_left_y":352,"width":1593,"height":55},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0eed9c2767454a04a801d8497fdeb8e0","type":"text","conversion_output":true,"text":"- Rapidly resolving organ failure, indicated by planned immediate discontinuation of MV, at","text_display":"\n- Rapidly resolving organ failure, indicated by planned immediate discontinuation of MV, at","confidence":0.970703125,"confidence_rate":0.9996903125574037},{"cnt":[[322,449],[978,449],[978,501],[322,501]],"region":{"top_left_x":322,"top_left_y":449,"width":656,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8cf9ce74038465baecdef86300ef86a","type":"text","conversion_output":true,"text":"time of screening for study enrollment","text_display":" time of screening for study enrollment","confidence":1,"confidence_rate":1},{"cnt":[[262,546],[767,546],[767,604],[262,604]],"region":{"top_left_x":262,"top_left_y":545,"width":505,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ee5472471ee4c228b194bb2a9f56566","type":"text","conversion_output":true,"text":"- Pregnant or breastfeeding","text_display":"\n- Pregnant or breastfeeding","confidence":1,"confidence_rate":1},{"cnt":[[262,645],[1846,645],[1846,700],[262,700]],"region":{"top_left_x":262,"top_left_y":644,"width":1584,"height":57},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cc590693df5469e99df9ee01ea8ccca","type":"text","conversion_output":true,"text":"- Severe dementia or neurodegenerative disease, defined as either cognitive impairment that","text_display":"\n- Severe dementia or neurodegenerative disease, defined as either cognitive impairment that","confidence":1,"confidence_rate":1},{"cnt":[[320,739],[1755,739],[1755,797],[320,797]],"region":{"top_left_x":320,"top_left_y":739,"width":1436,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28f32e989a4b4b4abf1c3b0241a178ff","type":"text","conversion_output":true,"text":"makes the patient incapable of living independently at baseline or IQCODE >4.5,123","text_display":" makes the patient incapable of living independently at baseline or IQCODE >4.5,123","confidence":0.9555359140504152,"confidence_rate":0.9994773443406819},{"cnt":[[322,836],[1755,836],[1755,892],[322,892]],"region":{"top_left_x":322,"top_left_y":835,"width":1434,"height":57},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d44fad3bc9aa46e1819a204cfe16625c","type":"text","conversion_output":true,"text":"measured using a patient's qualified surrogate. This exclusion also pertains to mental","text_display":" measured using a patient's qualified surrogate. This exclusion also pertains to mental","confidence":1,"confidence_rate":1},{"cnt":[[322,932],[1854,932],[1854,988],[322,988]],"region":{"top_left_x":322,"top_left_y":932,"width":1533,"height":57},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e224363c447446febe3a8b3e9ed6b3cb","type":"text","conversion_output":true,"text":"illnesses requiring long-term institutionalization, acquired or congenital mental retardation,","text_display":" illnesses requiring long-term institutionalization, acquired or congenital mental retardation,","confidence":1,"confidence_rate":1},{"cnt":[[322,1027],[1811,1027],[1811,1085],[322,1085]],"region":{"top_left_x":322,"top_left_y":1026,"width":1490,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"213716fe7d42423bb7476764b3eaa1f5","type":"text","conversion_output":true,"text":"severe neuromuscular disorders, Parkinson's disease, Huntington's disease, Alzheimer's","text_display":" severe neuromuscular disorders, Parkinson's disease, Huntington's disease, Alzheimer's","confidence":1,"confidence_rate":1},{"cnt":[[322,1124],[1811,1124],[1811,1179],[322,1179]],"region":{"top_left_x":322,"top_left_y":1123,"width":1490,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21d06871008c4b56849f14906a0ae5db","type":"text","conversion_output":true,"text":"and debilitating cerebrovascular disease. It also excludes patients in coma or with severe","text_display":" and debilitating cerebrovascular disease. It also excludes patients in coma or with severe","confidence":1,"confidence_rate":1},{"cnt":[[322,1220],[1824,1220],[1824,1274],[322,1274]],"region":{"top_left_x":322,"top_left_y":1220,"width":1503,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89f57b10e7ec4f12a20f0dbcb8e4768d","type":"text","conversion_output":true,"text":"cognitive deficits due to structural brain diseases such as stroke, intracranial hemorrhage,","text_display":" cognitive deficits due to structural brain diseases such as stroke, intracranial hemorrhage,","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[322,1315],[1457,1315],[1457,1371],[322,1371]],"region":{"top_left_x":322,"top_left_y":1314,"width":1135,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"230dc35b3c05446ab34149ebe5f174c3","type":"text","conversion_output":true,"text":"cranial trauma, malignancy, anoxic brain injury, or cerebral edema.","text_display":" cranial trauma, malignancy, anoxic brain injury, or cerebral edema.","confidence":1,"confidence_rate":1},{"cnt":[[262,1414],[1652,1414],[1652,1472],[262,1472]],"region":{"top_left_x":262,"top_left_y":1413,"width":1391,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86b3d427205f457f8fc2ed8724be8330","type":"text","conversion_output":true,"text":"- Present history of 2nd or 3rd degree heart block, or persistent bradycardia < 50","text_display":"\n- Present history of 2nd or 3rd degree heart block, or persistent bradycardia < 50","confidence":0.9975605006329715,"confidence_rate":0.9999715994754681},{"cnt":[[322,1508],[1766,1508],[1766,1566],[322,1566]],"region":{"top_left_x":322,"top_left_y":1508,"width":1445,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61cab9a572254d17a51047a5e67ad366","type":"text","conversion_output":true,"text":"beats/minute that requires intervention (e.g., atropine, glycopyrrolate). If patient has a","text_display":" beats/minute that requires intervention (e.g., atropine, glycopyrrolate). If patient has a","confidence":0.994631290435791,"confidence_rate":0.9999433366277997},{"cnt":[[320,1607],[1863,1607],[1863,1663],[320,1663]],"region":{"top_left_x":320,"top_left_y":1607,"width":1543,"height":56},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d4021ec996340c793abb2c762863d23","type":"text","conversion_output":true,"text":"pacemaker for bradyarrythmias, then patient does not meet this exclusion criterion and may","text_display":" pacemaker for bradyarrythmias, then patient does not meet this exclusion criterion and may","confidence":1,"confidence_rate":1},{"cnt":[[322,1702],[531,1702],[531,1755],[322,1755]],"region":{"top_left_x":322,"top_left_y":1701,"width":209,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c24d6fc90bd440e0ad2759115cd82915","type":"text","conversion_output":true,"text":"be enrolled.","text_display":" be 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decision to institute a specific treatment plan involving benzodiazepines (either as","confidence":1,"confidence_rate":1},{"cnt":[[322,1994],[1635,1994],[1635,2047],[322,2047]],"region":{"top_left_x":322,"top_left_y":1993,"width":1313,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66e7a398a86f4604a29b405767053c20","type":"text","conversion_output":true,"text":"continuous infusions or intermittent intravenous boluses) for this dependency.","text_display":" continuous infusions or intermittent intravenous boluses) for this dependency.","confidence":0.99951171875,"confidence_rate":0.999994115673962},{"cnt":[[262,2093],[1854,2093],[1854,2151],[262,2151]],"region":{"top_left_x":262,"top_left_y":2092,"width":1593,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c9d3d517d634650a1419c964bac8a1f","type":"text","conversion_output":true,"text":"- Active seizures during this ICU admission being treated with intravenous benzodiazepines.","text_display":"\n- Active seizures during this ICU admission being treated with intravenous benzodiazepines.","confidence":1,"confidence_rate":1},{"cnt":[[262,2191],[1721,2191],[1721,2247],[262,2247]],"region":{"top_left_x":262,"top_left_y":2191,"width":1459,"height":57},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5df66ddc584a4515a17ec606db4cbb2b","type":"text","conversion_output":true,"text":"- Expected death within 24 hours of enrollment or lack of commitment to aggressive","text_display":"\n- Expected death within 24 hours of enrollment or lack of commitment to aggressive","confidence":1,"confidence_rate":1},{"cnt":[[320,2286],[1781,2286],[1781,2344],[320,2344]],"region":{"top_left_x":320,"top_left_y":2285,"width":1462,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f64a1e3d7eca4c14bfa5c29184b1d6b2","type":"text","conversion_output":true,"text":"treatment by family or the medical team (e.g., likely to withdraw life support measures","text_display":" treatment by family or the medical team (e.g., likely to withdraw life support measures","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[322,2380],[795,2380],[795,2438],[322,2438]],"region":{"top_left_x":322,"top_left_y":2380,"width":473,"height":59},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47e2c6b5ea654654905999fd6a1154a9","type":"text","conversion_output":true,"text":"within 24 hrs of screening).","text_display":" within 24 hrs of 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The","text_display":"\n- Inability to understand English or deafness that will preclude delirium evaluation. The","confidence":1,"confidence_rate":1},{"cnt":[[322,352],[1811,352],[1811,406],[322,406]],"region":{"top_left_x":322,"top_left_y":352,"width":1490,"height":55},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1c092acf59d4c9f9013ebd6e01d28bf","type":"text","conversion_output":true,"text":"inability to understand English (for example in Spanish-only or Mandarin-only speaking","text_display":" inability to understand English (for example in Spanish-only or Mandarin-only speaking","confidence":1,"confidence_rate":1},{"cnt":[[322,449],[1837,449],[1837,501],[322,501]],"region":{"top_left_x":322,"top_left_y":449,"width":1515,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c12d1dd557e14afa8fd195453eaad7bc","type":"text","conversion_output":true,"text":"patients) will not result in exclusion at centers where the research staff is proficient and/or","text_display":" patients) will not result in exclusion at centers where the research staff is proficient and/or","confidence":1,"confidence_rate":1},{"cnt":[[322,546],[1854,546],[1854,595],[322,595]],"region":{"top_left_x":322,"top_left_y":545,"width":1533,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30ddb188934b43e991e2bf24d17a09e2","type":"text","conversion_output":true,"text":"translation services are actively available in that particular language; these patients will not","text_display":" translation services are actively available in that particular language; these patients will not","confidence":1,"confidence_rate":1},{"cnt":[[322,640],[1779,640],[1779,690],[322,690]],"region":{"top_left_x":322,"top_left_y":640,"width":1457,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9f0b803ac314e39b1d5a38abc5e98fa","type":"text","conversion_output":true,"text":"be followed in the long-term follow-up phase of the trial since the testing materials are","text_display":" be followed in the long-term follow-up phase of the trial since the testing materials are","confidence":1,"confidence_rate":1},{"cnt":[[320,735],[1807,735],[1807,788],[320,788]],"region":{"top_left_x":320,"top_left_y":734,"width":1487,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26d69050e6be45a1b7a755132defe0ca","type":"text","conversion_output":true,"text":"primarily available only in English. Patients with laryngectomies and those with hearing","text_display":" primarily available only in English. 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Variable & Description & *Time frame \\\\\n\\hline \\multicolumn{3}{|l|}{Primary outcome} \\\\\n\\hline Delirium/coma-free days (DCFD) & Number of days during the 14-day intervention period (from randomization, which will be Study Day 1, until Study Day 14) that the patient was alive and free of delirium and coma & 14 days \\\\\n\\hline \\multicolumn{3}{|l|}{Secondary outcomes} \\\\\n\\hline Ventilator-Free Days (VFD) & Days alive and free of mechanical ventilation & 28 days \\\\\n\\hline Survival & Time to death & 90 days \\\\\n\\hline Long-term outcomes & The TICS score will be the primary long-term outcome. Descriptive statistics for other long-term outcomes such as Katz ADL, Functional Activities Questionnaire (FAQ), EQ-5D and a validated phone battery for neuropsychological function testing (e.g., TICS, Digit Span, Logical Memory I, Logical Memory II, Similarities, Controlled Oral Word Association, Hayling Sentence Completion) will be reported. & 6 months \\\\\n\\hline Organ Dysfunction & Will be defined as ever vs never. Kidney, \\(Cr >2 mg / dL\\); Lung, \\(PaO 2 / FiO 2<300\\) or \\(SaO 2 / FiO 2 <315\\); Liver, total bilirubin > \\(2 mg / dL\\); Coagulation, Platelet count < \\(100,000 / mm 3\\); and Hemodynamic, need for vasopressor. Descriptives for this outcome will computed both overall and by treatment group and no hypothesis testing will be performed. & 14 days \\\\\n\\hline Acute Respiratory Distress Syndrome & Ever had ARDS during intervention phase? Descriptives for this outcome will computed both overall and by treatment group and no hypothesis testing will be performed & 14 days \\\\\n\\hline \\multicolumn{3}{|l|}{Exploratory outcomes} \\\\\n\\hline Delirium duration & Number of days the patient had delirium & 14 days \\\\\n\\hline Duration of hyperactive delirium & Number of days the patient had hyperactive delirium (defined as CAM-ICU positive and RASS \\(+1,+2,+3\\), or +4 ) & 14 days \\\\\n\\hline Duration of hypoactive delirium & Number of days the patient had hypoactive delirium (defined as CAM-ICU positive and RASS \\(-3,-2,-1\\), or 0 ) & 14 days \\\\\n\\hline Coma duration & Number of days the patient had coma (defined as RASS-4 or -5 or RASS missing and CAM-ICU Unable to Assess) & 14 days \\\\\n\\hline ICU mortality & Death while in the ICU & 30 days \\\\\n\\hline Hospital mortality & Death while in the hospital & 30 days \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 2: Primary, secondary and exploratory outcomes}\n\\begin{tabular}{|l|l|l|}\n\\hline Variable & Description & *Time frame \\\\\n\\hline \\multicolumn{3}{|l|}{Primary outcome} \\\\\n\\hline Delirium/coma-free days (DCFD) & Number of days during the 14-day intervention period (from randomization, which will be Study Day 1, until Study Day 14) that the patient was alive and free of delirium and coma & 14 days \\\\\n\\hline \\multicolumn{3}{|l|}{Secondary outcomes} \\\\\n\\hline Ventilator-Free Days (VFD) & Days alive and free of mechanical ventilation & 28 days \\\\\n\\hline Survival & Time to death & 90 days \\\\\n\\hline Long-term outcomes & The TICS score will be the primary long-term outcome. Descriptive statistics for other long-term outcomes such as Katz ADL, Functional Activities Questionnaire (FAQ), EQ-5D and a validated phone battery for neuropsychological function testing (e.g., TICS, Digit Span, Logical Memory I, Logical Memory II, Similarities, Controlled Oral Word Association, Hayling Sentence Completion) will be reported. & 6 months \\\\\n\\hline Organ Dysfunction & Will be defined as ever vs never. Kidney, \\(Cr >2 mg / dL\\); Lung, \\(PaO 2 / FiO 2<300\\) or \\(SaO 2 / FiO 2 <315\\); Liver, total bilirubin > \\(2 mg / dL\\); Coagulation, Platelet count < \\(100,000 / mm 3\\); and Hemodynamic, need for vasopressor. Descriptives for this outcome will computed both overall and by treatment group and no hypothesis testing will be performed. & 14 days \\\\\n\\hline Acute Respiratory Distress Syndrome & Ever had ARDS during intervention phase? 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effects","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[264,746],[556,746],[556,792],[264,792]],"region":{"top_left_x":263,"top_left_y":746,"width":293,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9791edeb7f664e30a2c979ca7629b720","type":"text","conversion_output":false,"parent_id":"4e23e89264424ebd869946df3c737f53","text":"Heterogeneity of","text_display":"Heterogeneity of","confidence":1,"confidence_rate":1},{"cnt":[[264,790],[550,790],[550,836],[264,836]],"region":{"top_left_x":263,"top_left_y":789,"width":288,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"654b0fde45504967b5d82de411334893","type":"text","conversion_output":false,"parent_id":"4e23e89264424ebd869946df3c737f53","text":"treatment effects","text_display":" treatment effects","confidence":1,"confidence_rate":1},{"cnt":[[706,741],[1563,741],[1563,937],[706,937]],"region":{"top_left_x":705,"top_left_y":740,"width":858,"height":197},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d286cf2c5794a5488841be2be4a03bd","type":"complex_cell","conversion_output":false,"parent_id":"01766978f2944b7c83d6204553291ef2","children_ids":["1105943fb31c4a09b481d4dfe2ec1bd6","1ad0fe2b29ed4188b45536de03bdd221","b45d01a1c3cd47d8ade0904b1da5d0a9","190cb361e65d4055a82b82a45b9b3086"],"text":"Heterogeneity of treatment effects will be assessed for age at enrollment, Baseline cognition (measured by the IQCODE; continuous covariate), Medical vs surgical patients","text_display":"Heterogeneity of treatment effects will be assessed for age at enrollment, Baseline cognition (measured by the IQCODE; continuous covariate), Medical vs surgical patients","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[711,743],[1415,743],[1415,792],[711,792]],"region":{"top_left_x":711,"top_left_y":743,"width":705,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1105943fb31c4a09b481d4dfe2ec1bd6","type":"text","conversion_output":false,"parent_id":"2d286cf2c5794a5488841be2be4a03bd","text":"Heterogeneity of treatment effects will be","text_display":"Heterogeneity of treatment effects will be","confidence":1,"confidence_rate":1},{"cnt":[[711,790],[1554,790],[1554,842],[711,842]],"region":{"top_left_x":711,"top_left_y":789,"width":844,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ad0fe2b29ed4188b45536de03bdd221","type":"text","conversion_output":false,"parent_id":"2d286cf2c5794a5488841be2be4a03bd","text":"assessed for age at enrollment, Baseline cognition","text_display":" assessed for age at enrollment, Baseline cognition","confidence":1,"confidence_rate":1},{"cnt":[[711,839],[1380,839],[1380,885],[711,885]],"region":{"top_left_x":711,"top_left_y":838,"width":669,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b45d01a1c3cd47d8ade0904b1da5d0a9","type":"text","conversion_output":false,"parent_id":"2d286cf2c5794a5488841be2be4a03bd","text":"(measured by the IQCODE; continuous","text_display":" (measured by the IQCODE; continuous","confidence":1,"confidence_rate":1},{"cnt":[[711,888],[1374,888],[1374,932],[711,932]],"region":{"top_left_x":711,"top_left_y":887,"width":664,"height":45},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"190cb361e65d4055a82b82a45b9b3086","type":"text","conversion_output":false,"parent_id":"2d286cf2c5794a5488841be2be4a03bd","text":"covariate), Medical vs surgical patients","text_display":" covariate), Medical vs surgical 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*Variable & Enrollment & Treatment Period \\& Post-Study Drug Period & 6 Month Follow-up & 12 Month Follow-up \\\\\n\\hline Pre-Hospital Function Assessment (ADL, IADL/FAQ, IQCODE, AUDIT) & X & & & \\\\\n\\hline Demographics, Comorbidities,APACHE II & X & & & \\\\\n\\hline SOFA & X & Daily & & \\\\\n\\hline Rhythm strip assessment for advanced heart block & X & Daily & & \\\\\n\\hline Pregnancy test (either urine or serum Beta hCG) & X & & & \\\\\n\\hline Blood draw: IL-1, IL-6, IL-10, CRP, sTNFR1, HMGB1 & & Approximately Days 1,3,5,7,14 & & \\\\\n\\hline Blood draw: whole blood AChE and BuChE at participating sites (Blood draw above will be used when possible) & & Approximately Days 1,3,5,7,14 & & \\\\\n\\hline Hematology/Chemistry, Neuroimaging & X & Daily & & \\\\\n\\hline Co-administered sedative/analgesic/antipsychotic medications & & Daily & & \\\\\n\\hline RASS (target/actual), CAM-ICU & & 1-2x daily & & \\\\\n\\hline Bush Francis Catatonia Rating Scale (BFCRS), and Delirium Motor Subtype Scale (DMSS) at participating sites & & 1-2x daily & & \\\\\n\\hline Hospital-acquired infections (blood, urine, sputum) & & Daily & & \\\\\n\\hline ABCDE Protocol Compliance \\& Sepsis/Ventilator tracking & & Daily & & \\\\\n\\hline Safety assessments. 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Coma duration as an additional outcome, to aid in","confidence":1,"confidence_rate":1},{"cnt":[[370,1087],[1779,1087],[1779,1137],[370,1137]],"region":{"top_left_x":369,"top_left_y":1087,"width":1410,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d4f03a893904d3488a8a47046e9f017","type":"text","conversion_output":true,"text":"elucidating relationship between treatment and primary outcome of DCFDs; will be","text_display":" elucidating relationship between treatment and primary outcome of DCFDs; will be","confidence":1,"confidence_rate":1},{"cnt":[[370,1134],[1222,1134],[1222,1184],[370,1184]],"region":{"top_left_x":369,"top_left_y":1134,"width":854,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b342c214556470e851d91ea6dee65e8","type":"text","conversion_output":true,"text":"analyzed in the same manner as delirium duration.","text_display":" analyzed in the same manner as delirium duration.","confidence":1,"confidence_rate":1},{"cnt":[[305,1182],[1848,1182],[1848,1231],[305,1231]],"region":{"top_left_x":305,"top_left_y":1181,"width":1543,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"308c8c8d6805465eb4b243e81fd3d6a7","type":"text","conversion_output":true,"text":"- ICU and Hospital mortality: To model this outcome, discharged alive from hospital will","text_display":"\n- ICU and Hospital mortality: To model this outcome, discharged alive from hospital will","confidence":1,"confidence_rate":1},{"cnt":[[370,1229],[1828,1229],[1828,1280],[370,1280]],"region":{"top_left_x":369,"top_left_y":1228,"width":1460,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7299ae1ac65442a97e4c8350f40ad96","type":"text","conversion_output":true,"text":"be considered a competing event for hospital mortality, and discharged alive from ICU","text_display":" be considered a competing event for hospital mortality, and discharged alive from ICU","confidence":1,"confidence_rate":1},{"cnt":[[370,1276],[1850,1276],[1850,1330],[370,1330]],"region":{"top_left_x":369,"top_left_y":1276,"width":1481,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d579da278294328947cb5c1bccc319b","type":"text","conversion_output":true,"text":"will be a competing event for ICU mortality. Patients who withdrew in the hospital with","text_display":" will be a competing event for ICU mortality. Patients who withdrew in the hospital with","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[370,1326],[1766,1326],[1766,1377],[370,1377]],"region":{"top_left_x":369,"top_left_y":1325,"width":1398,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94259bbfa83e41ec97b1f0a5140ec0c5","type":"text","conversion_output":true,"text":"no discharge or death information available are censored at the time of withdrawal.","text_display":" no discharge or death information available are censored at the time of withdrawal.","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[370,1371],[1815,1371],[1815,1424],[370,1424]],"region":{"top_left_x":369,"top_left_y":1370,"width":1447,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c688a81aefdc47bca4a7360c1395011d","type":"text","conversion_output":true,"text":"Cumulative incidences of both the outcome and competing risk along with a modified","text_display":" Cumulative incidences of both the outcome and competing risk along with a modified","confidence":1,"confidence_rate":1},{"cnt":[[370,1420],[1835,1420],[1835,1472],[370,1472]],"region":{"top_left_x":369,"top_left_y":1420,"width":1466,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dd22d175d484692a7a57b4093420ef2","type":"text","conversion_output":true,"text":"chi-squared test for the difference between groups in the subdistribution of interest will","text_display":" chi-squared test for the difference between groups in the subdistribution of interest will","confidence":1,"confidence_rate":1},{"cnt":[[370,1470],[1693,1470],[1693,1521],[370,1521]],"region":{"top_left_x":369,"top_left_y":1469,"width":1324,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1d5de101ca14deea331e150e679b684","type":"text","conversion_output":true,"text":"be described. For the adjusted analysis, will we use Fine-Gray competing risks","text_display":" be described. For the adjusted analysis, will we use Fine-Gray competing risks","confidence":1,"confidence_rate":1},{"cnt":[[370,1517],[1250,1517],[1250,1566],[370,1566]],"region":{"top_left_x":369,"top_left_y":1516,"width":882,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b5acaa1a2bf4b37b22b1623f58251d9","type":"text","conversion_output":true,"text":"regression, treating discharge as our competing risk.","text_display":" regression, treating discharge as our competing risk.","confidence":1,"confidence_rate":1},{"cnt":[[305,1564],[1648,1564],[1648,1613],[305,1613]],"region":{"top_left_x":305,"top_left_y":1564,"width":1343,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8adbd702078c4311a1098f2346f317d2","type":"text","conversion_output":true,"text":"- ICU-free days: This outcome will be analyzed similar to VFDs and DCFDs.","text_display":"\n- ICU-free days: This outcome will be analyzed similar to VFDs and DCFDs.","confidence":1,"confidence_rate":1},{"cnt":[[305,1611],[1824,1611],[1824,1665],[305,1665]],"region":{"top_left_x":305,"top_left_y":1611,"width":1520,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35c64c91074f4380b989643751c6f8f8","type":"text","conversion_output":true,"text":"- Time to successful ICU discharge in 30-days: Since ICU Discharge has the competing","text_display":"\n- Time to successful ICU discharge in 30-days: Since ICU Discharge has the competing","confidence":0.99853515625,"confidence_rate":0.9999835291504493},{"cnt":[[367,1661],[1850,1661],[1850,1708],[367,1708]],"region":{"top_left_x":367,"top_left_y":1660,"width":1483,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6da7d2307005497a9b4d70982a95c51f","type":"text","conversion_output":true,"text":"risk of death, we will describe the cumulative incidences of both the outcome of interest","text_display":" risk of death, we will describe the cumulative incidences of both the outcome of interest","confidence":1,"confidence_rate":1},{"cnt":[[370,1706],[1813,1706],[1813,1760],[370,1760]],"region":{"top_left_x":369,"top_left_y":1705,"width":1445,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfcf1d08b2e249968106e88c92f91f2d","type":"text","conversion_output":true,"text":"and competing risk, along with a modified chi-squared test for the difference between","text_display":" and competing risk, along with a modified chi-squared test for the difference between","confidence":1,"confidence_rate":1},{"cnt":[[370,1757],[1865,1757],[1865,1807],[370,1807]],"region":{"top_left_x":369,"top_left_y":1757,"width":1496,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e430f29305e4bdead1bd25d7675274f","type":"text","conversion_output":true,"text":"groups in the subdistribution of interest. For the adjusted analysis, will we use Fine-Gray","text_display":" groups in the subdistribution of interest. For the adjusted analysis, will we use Fine-Gray","confidence":1,"confidence_rate":1},{"cnt":[[370,1805],[1850,1805],[1850,1854],[370,1854]],"region":{"top_left_x":369,"top_left_y":1804,"width":1481,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd1ba831ccbf49ad90015c877d4e4834","type":"text","conversion_output":true,"text":"competing risks regression, treating death as our competing risk. Patients who withdrew","text_display":" competing risks regression, treating death as our competing risk. Patients who withdrew","confidence":1,"confidence_rate":1},{"cnt":[[370,1852],[1848,1852],[1848,1901],[370,1901]],"region":{"top_left_x":369,"top_left_y":1851,"width":1479,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8c91a70032941e89fff363af5843e2a","type":"text","conversion_output":true,"text":"in the hospital with no discharge or death information available are censored at the time","text_display":" in the hospital with no discharge or death information available are censored at the time","confidence":0.9970703125,"confidence_rate":0.9999687878548241},{"cnt":[[370,1899],[1858,1899],[1858,1953],[370,1953]],"region":{"top_left_x":369,"top_left_y":1899,"width":1490,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50f7c2fc43464e30a201875c29696513","type":"text","conversion_output":true,"text":"of withdrawal; we censor at x. 01 days anyone who has experienced neither death nor the","text_display":" of withdrawal; we censor at x. 01 days anyone who has experienced neither death nor the","confidence":0.99267578125,"confidence_rate":0.9999226222303292},{"cnt":[[370,1949],[1781,1949],[1781,2000],[370,2000]],"region":{"top_left_x":369,"top_left_y":1948,"width":1413,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dbb4018f39b45d69c5e92dcecf8d7bd","type":"text","conversion_output":true,"text":"outcome of interest by x days (where x is the end of the time frame specified for the","text_display":" outcome of interest by x days (where x is the end of the time frame specified for the","confidence":0.9814777374267578,"confidence_rate":0.999816723192181},{"cnt":[[370,1996],[1841,1996],[1841,2047],[370,2047]],"region":{"top_left_x":369,"top_left_y":1995,"width":1473,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2a267f0572f4e2197cf94f172b48d65","type":"text","conversion_output":true,"text":"outcome). We will detail how many and when patients were censored for each analysis.","text_display":" outcome). We will detail how many and when patients were censored for each analysis.","confidence":1,"confidence_rate":1},{"cnt":[[305,2045],[1757,2045],[1757,2095],[305,2095]],"region":{"top_left_x":305,"top_left_y":2045,"width":1453,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4c2ccb7d67342958bb1f06e37d51e9b","type":"text","conversion_output":true,"text":"- Daily compliance on the first five elements (A-E) of the ICU Liberation ABCDEF","text_display":"\n- Daily compliance on the first five elements (A-E) of the ICU Liberation ABCDEF","confidence":1,"confidence_rate":1},{"cnt":[[370,2093],[1734,2093],[1734,2142],[370,2142]],"region":{"top_left_x":369,"top_left_y":2092,"width":1365,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"889fbb6bdd6049caa5ca5f125fd39ffd","type":"text","conversion_output":true,"text":"Bundle during the intervention period (number and \\% of eligible days compliant;","text_display":" Bundle during the intervention period (number and \\% of eligible days compliant;","confidence":1,"confidence_rate":1},{"cnt":[[370,2140],[827,2140],[827,2189],[370,2189]],"region":{"top_left_x":369,"top_left_y":2139,"width":459,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f282ca5dd7234fc4bca900fb7d1d875c","type":"text","conversion_output":true,"text":"descriptive statistics only).","text_display":" descriptive statistics only).","confidence":1,"confidence_rate":1},{"cnt":[[305,2187],[1132,2187],[1132,2239],[305,2239]],"region":{"top_left_x":305,"top_left_y":2187,"width":828,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83800a2e98774d1da27fe0e6cf83999b","type":"text","conversion_output":true,"text":"- Severity of Shock: Descriptive statistics only","text_display":"\n- Severity of Shock: Descriptive statistics only","confidence":1,"confidence_rate":1},{"cnt":[[305,2234],[1790,2234],[1790,2288],[305,2288]],"region":{"top_left_x":305,"top_left_y":2234,"width":1485,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e585f15bb1464b1d811aca990bf44b9e","type":"text","conversion_output":true,"text":"- Heterogeneity of treatment effects: We will assess heterogeneity of treatment effects","text_display":"\n- Heterogeneity of treatment effects: We will assess heterogeneity of treatment effects","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[370,2282],[1811,2282],[1811,2333],[370,2333]],"region":{"top_left_x":369,"top_left_y":2281,"width":1443,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b5c4820fb5a4be58b050203f917eff0","type":"text","conversion_output":true,"text":"using separate multivariable regression models that include interaction terms between","text_display":" using separate multivariable regression models that include interaction terms between","confidence":1,"confidence_rate":1},{"cnt":[[370,2331],[1343,2331],[1343,2383],[370,2383]],"region":{"top_left_x":369,"top_left_y":2331,"width":974,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a98d9288efc47b181e3f63428cec35d","type":"text","conversion_output":true,"text":"treatment group and the following clinical characteristics:","text_display":" treatment group and the following clinical characteristics:","confidence":1,"confidence_rate":1},{"cnt":[[432,2380],[1027,2380],[1027,2430],[432,2430]],"region":{"top_left_x":431,"top_left_y":2380,"width":596,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a972da940a14f17a546ad3bb1412962","type":"text","conversion_output":true,"text":"- Age at enrollment (continuous)","text_display":"\n- Age at enrollment (continuous)","confidence":1,"confidence_rate":1},{"cnt":[[432,2428],[1663,2428],[1663,2477],[432,2477]],"region":{"top_left_x":431,"top_left_y":2427,"width":1232,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"422e11d063a849ef9c7e8bc66f76304e","type":"text","conversion_output":true,"text":"- Baseline cognition (measured by the IQCODE; continuous covariate)","text_display":"\n- Baseline cognition (measured by the IQCODE; continuous covariate)","confidence":1,"confidence_rate":1},{"cnt":[[1826,2574],[1886,2574],[1886,2628],[1826,2628]],"region":{"top_left_x":1826,"top_left_y":2573,"width":61,"height":55},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c20cd1ca45a4f349f8b9f8683bec5b5","type":"page_info","conversion_output":false,"text":"22","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-23","page":23,"lines":[{"cnt":[[434,254],[971,254],[971,303],[434,303]],"region":{"top_left_x":433,"top_left_y":253,"width":539,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"924709db798d4feba4839f2b7a1992cd","type":"text","conversion_output":true,"text":"- Medical vs surgical patients","text_display":"\n- Medical vs surgical patients","confidence":1,"confidence_rate":1},{"cnt":[[236,425],[1111,425],[1111,496],[236,496]],"region":{"top_left_x":236,"top_left_y":425,"width":875,"height":72},"line":2,"column":0,"font_size":56,"is_printed":true,"is_handwritten":false,"id":"f33183f07e124fee9dbdb52146767612","type":"section_header","conversion_output":false,"children_ids":["925134496f294d12bfb9980344b13c17"],"text":"","text_display":""},{"cnt":[[243,430],[1106,430],[1106,492],[243,492]],"region":{"top_left_x":242,"top_left_y":429,"width":865,"height":63},"line":3,"column":0,"font_size":56,"is_printed":true,"is_handwritten":false,"id":"925134496f294d12bfb9980344b13c17","type":"text","conversion_output":true,"parent_id":"f33183f07e124fee9dbdb52146767612","text":"Definitions and Derived Variables","text_display":"\n\n\\section*{Definitions and Derived Variables}","confidence":1,"confidence_rate":1},{"cnt":[[236,552],[853,552],[853,625],[236,625]],"region":{"top_left_x":236,"top_left_y":552,"width":617,"height":74},"line":4,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"b14a7511eb60412e8348025edfbef5c7","type":"section_header","conversion_output":false,"children_ids":["a5847779b22b489ba37631fa2b5f6ee2"],"text":"","text_display":""},{"cnt":[[245,556],[849,556],[849,621],[245,621]],"region":{"top_left_x":244,"top_left_y":556,"width":605,"height":65},"line":5,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"a5847779b22b489ba37631fa2b5f6ee2","type":"text","conversion_output":true,"parent_id":"b14a7511eb60412e8348025edfbef5c7","text":"Delirium/Coma-Free Days","text_display":"\n\n\\section*{Delirium/Coma-Free Days}","confidence":1,"confidence_rate":1},{"cnt":[[245,632],[1852,632],[1852,681],[245,681]],"region":{"top_left_x":244,"top_left_y":631,"width":1608,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d7d591fcbda494da622b03e2dcc50fe","type":"text","conversion_output":true,"text":"This primary outcome variable is calculated over the intervention period ( 14 days including and","text_display":"\n\nThis primary outcome variable is calculated over the intervention period ( 14 days including and","confidence":0.935546875,"confidence_rate":0.9993595895001209},{"cnt":[[245,679],[1777,679],[1777,728],[245,728]],"region":{"top_left_x":244,"top_left_y":678,"width":1533,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ec6d86575054903a00fbbfd6183c40b","type":"text","conversion_output":true,"text":"immediately following randomization). It is defined as days alive and without delirium and","text_display":" immediately following randomization). It is defined as days alive and without delirium and","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[1790,726],[1790,776],[245,776]],"region":{"top_left_x":244,"top_left_y":726,"width":1546,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b03d125c03ba4c26aeb83b17e46af5f5","type":"text","conversion_output":true,"text":"coma. This definition makes no assumptions about the sequence in which delirium, coma or","text_display":" coma. This definition makes no assumptions about the sequence in which delirium, coma or","confidence":1,"confidence_rate":1},{"cnt":[[245,773],[1760,773],[1760,827],[245,827]],"region":{"top_left_x":244,"top_left_y":773,"width":1516,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b0ed450fb3f4aa7a5702a57b96c692f","type":"text","conversion_output":true,"text":"normal mental states occurred during the 14-day treatment period; all days during which a","text_display":" normal mental states occurred during the 14-day treatment period; all days during which a","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[245,821],[1745,821],[1745,874],[245,874]],"region":{"top_left_x":244,"top_left_y":820,"width":1501,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"037635163e14480894e02ddd8c7296bf","type":"text","conversion_output":true,"text":"participant was alive and free of delirium and coma will contribute to the total number of","text_display":" participant was alive and free of delirium and coma will contribute to the total number of","confidence":1,"confidence_rate":1},{"cnt":[[245,870],[1629,870],[1629,922],[245,922]],"region":{"top_left_x":244,"top_left_y":870,"width":1385,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21f421778e0645eb8bcd302b0c601162","type":"text","conversion_output":true,"text":"delirium/coma-free days regardless of whether or not they occurred consecutively.","text_display":" delirium/coma-free days regardless of whether or not they occurred consecutively.","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[236,965],[1059,965],[1059,1038],[236,1038]],"region":{"top_left_x":236,"top_left_y":964,"width":824,"height":74},"line":12,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"5262adc6dc61400f94e6f61105e588a8","type":"section_header","conversion_output":false,"children_ids":["59a74c968a91439db894612155bd974f"],"text":"","text_display":""},{"cnt":[[245,971],[1055,971],[1055,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":971,"width":811,"height":63},"line":13,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"59a74c968a91439db894612155bd974f","type":"text","conversion_output":true,"parent_id":"5262adc6dc61400f94e6f61105e588a8","text":"Mental Status (Delirium and Coma)","text_display":"\n\n\\section*{Mental Status (Delirium and Coma)}","confidence":1,"confidence_rate":1},{"cnt":[[236,1074],[1257,1074],[1257,1145],[236,1145]],"region":{"top_left_x":236,"top_left_y":1074,"width":1021,"height":72},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46c3453d68ec4fcba22d6de32fe9f3ae","type":"section_header","conversion_output":false,"children_ids":["cfdd2328903d4279a850a8bce39de93b"],"text":"","text_display":""},{"cnt":[[245,1079],[1248,1079],[1248,1141],[245,1141]],"region":{"top_left_x":244,"top_left_y":1078,"width":1005,"height":63},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfdd2328903d4279a850a8bce39de93b","type":"text","conversion_output":true,"parent_id":"46c3453d68ec4fcba22d6de32fe9f3ae","text":"Determining Mental Status Using CAM and RASS","text_display":"\n\n\\section*{Determining Mental Status Using CAM and RASS}","confidence":1,"confidence_rate":1},{"cnt":[[245,1182],[1654,1182],[1654,1235],[245,1235]],"region":{"top_left_x":244,"top_left_y":1181,"width":1411,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb965547e0e344c39ec30638510dab3f","type":"text","conversion_output":true,"text":"We will determine mental status for a given assessment using the following criteria:","text_display":"\n\nWe will determine mental status for a given assessment using the following criteria:","confidence":1,"confidence_rate":1},{"cnt":[[309,1233],[1592,1233],[1592,1283],[309,1283]],"region":{"top_left_x":309,"top_left_y":1233,"width":1283,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"071046e477ed4808bf7109bbcb79bff0","type":"text","conversion_output":true,"text":"1. Comatose: RASS -4 or -5 , or RASS missing and CAM Unable to Assess","text_display":"\n1. Comatose: RASS -4 or -5 , or RASS missing and CAM Unable to Assess","confidence":0.9738063812255859,"confidence_rate":0.9996682702551941},{"cnt":[[305,1280],[1283,1280],[1283,1330],[305,1330]],"region":{"top_left_x":305,"top_left_y":1280,"width":978,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c542012d6264eff863ed9b152708211","type":"text","conversion_output":true,"text":"2. Delirious: RASS missing or \\(>=-3\\), and CAM Positive","text_display":"\n2. Delirious: RASS missing or \\(>=-3\\), and CAM Positive","confidence":1,"confidence_rate":1},{"cnt":[[305,1328],[1270,1328],[1270,1379],[305,1379]],"region":{"top_left_x":305,"top_left_y":1327,"width":965,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80854b0702e24a7f98565912c17fa409","type":"text","conversion_output":true,"text":"3. Normal: RASS missing or \\(>=-3\\), and CAM Negative","text_display":"\n3. Normal: RASS missing or \\(>=-3\\), and CAM Negative","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[245,1431],[1858,1431],[1858,1482],[245,1482]],"region":{"top_left_x":244,"top_left_y":1430,"width":1615,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceee396abc4b422b952bb019787de82f","type":"text","conversion_output":true,"text":"Patients could have multiple assessments on a given study day. On a given day, a patient will be","text_display":"\n\nPatients could have multiple assessments on a given study day. On a given day, a patient will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1478],[1869,1478],[1869,1532],[245,1532]],"region":{"top_left_x":244,"top_left_y":1478,"width":1626,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a95b1e72d304ca6ba8957ce67ee0d8f","type":"text","conversion_output":true,"text":"considered delirious if any assessment was considered delirious; comatose if no assessments met","text_display":" considered delirious if any assessment was considered delirious; comatose if no assessments met","confidence":1,"confidence_rate":1},{"cnt":[[245,1525],[1871,1525],[1871,1577],[245,1577]],"region":{"top_left_x":244,"top_left_y":1525,"width":1628,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63a26cb98b764b69a948550f72b588a8","type":"text","conversion_output":true,"text":"criteria for delirium and at least one was considered comatose; and normal if no assessments met","text_display":" criteria for delirium and at least one was considered comatose; and normal if no assessments met","confidence":1,"confidence_rate":1},{"cnt":[[245,1573],[1800,1573],[1800,1626],[245,1626]],"region":{"top_left_x":244,"top_left_y":1572,"width":1557,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76b68401165c4ef083639fabeeb53537","type":"text","conversion_output":true,"text":"criteria for delirium or coma, and at least one was considered normal. If there are conflicting","text_display":" criteria for delirium or coma, and at least one was considered normal. If there are conflicting","confidence":1,"confidence_rate":1},{"cnt":[[245,1622],[1854,1622],[1854,1674],[245,1674]],"region":{"top_left_x":244,"top_left_y":1622,"width":1611,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9193cf4281c840fe9c1ce5ec765149ab","type":"text","conversion_output":true,"text":"assessments where CAM is 'Unable to Assess' and RASS -4 or -5, then patient will be assigned","text_display":" assessments where CAM is 'Unable to Assess' and RASS -4 or -5, then patient will be assigned","confidence":0.8734586345833184,"confidence_rate":0.9986061835391835},{"cnt":[[245,1671],[1830,1671],[1830,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1671,"width":1587,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"886ab6d32d62483680562dd2b22b0e96","type":"text","conversion_output":true,"text":"a mental status of coma. If RASS is -3 or -2 , since prior studies state that this highly correlates","text_display":" a mental status of coma. If RASS is -3 or -2 , since prior studies state that this highly correlates","confidence":1,"confidence_rate":1},{"cnt":[[245,1719],[1848,1719],[1848,1772],[245,1772]],"region":{"top_left_x":244,"top_left_y":1718,"width":1604,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"862a08b38b8244898745165e89a63f6f","type":"text","conversion_output":true,"text":"with delirium, patients will be assigned a mental status of delirium. RASS assessment of 0 to - 1","text_display":" with delirium, patients will be assigned a mental status of delirium. 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Therefore, for eligible patient-days","text_display":" were alive and free of brain dysfunction on all missing days. Therefore, for eligible patient-days","confidence":1,"confidence_rate":1},{"cnt":[[245,2125],[1876,2125],[1876,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2124,"width":1632,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d6352feb6184c50a5e893055adf2ab7","type":"text","conversion_output":true,"text":"with missing mental status, we will perform simple imputation, including the following variables","text_display":" with missing mental status, we will perform simple imputation, including the following variables","confidence":1,"confidence_rate":1},{"cnt":[[245,2174],[776,2174],[776,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2174,"width":532,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e191a14e9604f2e926f9211275cfdbc","type":"text","conversion_output":true,"text":"as covariates in the imputation.","text_display":" as covariates in the 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benzodiazepine)","confidence":1,"confidence_rate":1},{"cnt":[[432,301],[1867,301],[1867,350],[432,350]],"region":{"top_left_x":431,"top_left_y":300,"width":1436,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1899f57b11394a6bb28b981275ba6a63","type":"text","conversion_output":true,"text":"- Variables indicating severity of illness (CV SOFA, creatinine, platelets, P/F ratio,","text_display":"\n- Variables indicating severity of illness (CV SOFA, creatinine, platelets, P/F ratio,","confidence":1,"confidence_rate":1},{"cnt":[[494,348],[831,348],[831,397],[494,397]],"region":{"top_left_x":494,"top_left_y":348,"width":338,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44d8b2e7e4824c5caaa956792650e9d5","type":"text","conversion_output":true,"text":"S/F ratio, bilirubin)","text_display":" S/F ratio, 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Tool (CPOT),","confidence":1,"confidence_rate":1},{"cnt":[[492,490],[1869,490],[1869,544],[492,544]],"region":{"top_left_x":491,"top_left_y":489,"width":1379,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bd0ee8e3c6349b497b936f7ccc8c97d","type":"text","conversion_output":true,"text":"and CAM-ICU Feature 1(cam_f1), and CAM-ICU Feature 2(cam_f2), and CAM-","text_display":" and CAM-ICU Feature 1(cam_f1), and CAM-ICU Feature 2(cam_f2), and CAM","confidence":1,"confidence_rate":1},{"cnt":[[494,537],[1506,537],[1506,591],[494,591]],"region":{"top_left_x":494,"top_left_y":537,"width":1013,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e208c2330a464c2f88c5d3bf6e51aa5a","type":"text","conversion_output":true,"text":"ICU Feature 3(cam_f3), and CAM-ICU Feature 4(cam_f4))","text_display":"ICU Feature 3(cam_f3), and CAM-ICU Feature 4(cam_f4))","confidence":1,"confidence_rate":1},{"cnt":[[243,645],[1794,645],[1794,696],[243,696]],"region":{"top_left_x":242,"top_left_y":644,"width":1552,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c2b8d1a271945c294eebe4250cef4f6","type":"text","conversion_output":true,"text":"All summary variables (e.g. delirium/coma-free days, delirium duration, and coma duration,","text_display":"\n\nAll summary variables (e.g. delirium/coma-free days, delirium duration, and coma duration,","confidence":1,"confidence_rate":1},{"cnt":[[243,692],[1828,692],[1828,743],[243,743]],"region":{"top_left_x":242,"top_left_y":691,"width":1587,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95134dd4756b48e4a85a0b726024d2d4","type":"text","conversion_output":true,"text":"VFD) are presented using imputed mental status. For VFD's and ICU-Free days, patients who","text_display":" VFD) are presented using imputed mental status. For VFD's and ICU-Free days, patients who","confidence":1,"confidence_rate":1},{"cnt":[[245,739],[1216,739],[1216,788],[245,788]],"region":{"top_left_x":244,"top_left_y":739,"width":973,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b835bdbed7404217896be939c27b05b4","type":"text","conversion_output":true,"text":"withdrew will have their last observation carried forward.","text_display":" withdrew will have their last observation carried forward.","confidence":1,"confidence_rate":1},{"cnt":[[236,846],[718,846],[718,930],[236,930]],"region":{"top_left_x":236,"top_left_y":846,"width":482,"height":85},"line":11,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"1bc1fcaf2fbf419092d5fdc923b02f8d","type":"section_header","conversion_output":false,"children_ids":["470fb63485c3454a87552feb46b7df04"],"text":"","text_display":""},{"cnt":[[245,853],[711,853],[711,924],[245,924]],"region":{"top_left_x":244,"top_left_y":852,"width":468,"height":72},"line":12,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"470fb63485c3454a87552feb46b7df04","type":"text","conversion_output":true,"parent_id":"1bc1fcaf2fbf419092d5fdc923b02f8d","text":"Severity of Illness","text_display":"\n\n\\section*{Severity of Illness}","confidence":1,"confidence_rate":1},{"cnt":[[243,941],[1545,941],[1545,995],[243,995]],"region":{"top_left_x":242,"top_left_y":941,"width":1303,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"054669492a3240e7a99e062fea6aa156","type":"text","conversion_output":true,"text":"Missing values for SOFA components will be handled in the following ways:","text_display":"\n\nMissing values for SOFA components will be handled in the following ways:","confidence":0.998535871389322,"confidence_rate":0.9999812155418875},{"cnt":[[234,1040],[1573,1040],[1573,1121],[234,1121]],"region":{"top_left_x":234,"top_left_y":1039,"width":1339,"height":83},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27f07412a98e4814aa0aa443056cec11","type":"section_header","conversion_output":false,"children_ids":["62c49dd481b0461785574b37d4399811"],"text":"","text_display":""},{"cnt":[[243,1048],[1566,1048],[1566,1115],[243,1115]],"region":{"top_left_x":242,"top_left_y":1048,"width":1325,"height":68},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62c49dd481b0461785574b37d4399811","type":"text","conversion_output":true,"parent_id":"27f07412a98e4814aa0aa443056cec11","text":"SOFA (Enrollment + daily throughout intervention period)","text_display":"\n\n\\section*{SOFA (Enrollment + daily throughout intervention period)}","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[305,1124],[1021,1124],[1021,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1123,"width":716,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e053946458441508e4d275e15fc7134","type":"text","conversion_output":true,"text":"- Substitutions for specific components:","text_display":"\n- Substitutions for specific components:","confidence":1,"confidence_rate":1},{"cnt":[[432,1169],[1738,1169],[1738,1222],[432,1222]],"region":{"top_left_x":431,"top_left_y":1168,"width":1308,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97e6c4fbd17b4cd4ab435d4b4908c1a5","type":"text","conversion_output":true,"text":"- Respiratory: If P/F ratio is not available, we will use the lowest S/F ratio \\({ }^{8}\\).","text_display":"\n- Respiratory: If P/F ratio is not available, we will use the lowest S/F ratio \\({ }^{8}\\).","confidence":0.9917066079797223,"confidence_rate":0.9999141482882807},{"cnt":[[432,1220],[1796,1220],[1796,1270],[432,1270]],"region":{"top_left_x":431,"top_left_y":1220,"width":1366,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4f7f29e78e34f5899d62cde4a3d23f0","type":"text","conversion_output":true,"text":"- Central nervous system: Since GCS was not collected, we will use the lowest","text_display":"\n- Central nervous system: Since GCS was not collected, we will use the lowest","confidence":1,"confidence_rate":1},{"cnt":[[494,1263],[939,1263],[939,1317],[494,1317]],"region":{"top_left_x":494,"top_left_y":1263,"width":445,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87771211cff043a29a38c79bbaead72d","type":"text","conversion_output":true,"text":"RASS available that day \\({ }^{9}\\).","text_display":" RASS available that day \\({ }^{9}\\).","confidence":0.99951171875,"confidence_rate":0.9999883714843234},{"cnt":[[305,1315],[1867,1315],[1867,1366],[305,1366]],"region":{"top_left_x":305,"top_left_y":1314,"width":1562,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae0454e59f6f4a77babd7eb61149820b","type":"text","conversion_output":true,"text":"- Missing data at enrollment: For patients missing at least one SOFA component score, we","text_display":"\n- Missing data at enrollment: For patients missing at least one SOFA component score, we","confidence":1,"confidence_rate":1},{"cnt":[[370,1362],[1841,1362],[1841,1416],[370,1416]],"region":{"top_left_x":369,"top_left_y":1362,"width":1473,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f1f2c124fa54e40957065c6857db22d","type":"text","conversion_output":true,"text":"will impute the next available value within the following two calendar days. If none are","text_display":" will impute the next available value within the following two calendar days. If none are","confidence":1,"confidence_rate":1},{"cnt":[[370,1412],[1248,1412],[1248,1463],[370,1463]],"region":{"top_left_x":369,"top_left_y":1411,"width":880,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dee86b5311640628a04fd3ec9aecbdb","type":"text","conversion_output":true,"text":"available, we will assume a normal value ( 0 points).","text_display":" available, we will assume a normal value ( 0 points).","confidence":0.8278040885925293,"confidence_rate":0.9969067814204304},{"cnt":[[234,1512],[539,1512],[539,1583],[234,1583]],"region":{"top_left_x":234,"top_left_y":1512,"width":306,"height":72},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e7be04a15464b2ebb8366ad45a0bdb5","type":"section_header","conversion_output":false,"children_ids":["4457eb0214f44f7db63d22a26dea9c61"],"text":"","text_display":""},{"cnt":[[243,1521],[531,1521],[531,1575],[243,1575]],"region":{"top_left_x":242,"top_left_y":1521,"width":289,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4457eb0214f44f7db63d22a26dea9c61","type":"text","conversion_output":true,"parent_id":"2e7be04a15464b2ebb8366ad45a0bdb5","text":"Medications","text_display":"\n\n\\section*{Medications}","confidence":1,"confidence_rate":1},{"cnt":[[305,1592],[1843,1592],[1843,1644],[305,1644]],"region":{"top_left_x":305,"top_left_y":1591,"width":1539,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c11f6f645da40448a4c1967badae2f3","type":"text","conversion_output":true,"text":"- Benzodiazepines include midazolam, lorazepam, and/or diazepam. Doses are expressed","text_display":"\n- Benzodiazepines include midazolam, lorazepam, and/or diazepam. Doses are expressed","confidence":0.9941432476043701,"confidence_rate":0.9999340025101695},{"cnt":[[367,1641],[819,1641],[819,1691],[367,1691]],"region":{"top_left_x":367,"top_left_y":1641,"width":452,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"209e5510c7344348a0f0d25e76ab90f4","type":"text","conversion_output":true,"text":"in midazolam equivalents.","text_display":" in midazolam equivalents.","confidence":1,"confidence_rate":1},{"cnt":[[305,1689],[1777,1689],[1777,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1688,"width":1472,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95725bbb5ef7496b81f98b8d3da49129","type":"text","conversion_output":true,"text":"- Opioids include fentanyl, morphine, remifentanil and/or hydromorphone. Doses are","text_display":"\n- Opioids include fentanyl, morphine, remifentanil and/or hydromorphone. Doses are","confidence":0.9990234375,"confidence_rate":0.9999887697222805},{"cnt":[[370,1736],[947,1736],[947,1790],[370,1790]],"region":{"top_left_x":369,"top_left_y":1735,"width":579,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cad7db359d7d41b0993121dd281ad5e0","type":"text","conversion_output":true,"text":"expressed in fentanyl equivalents.","text_display":" expressed in fentanyl equivalents.","confidence":1,"confidence_rate":1},{"cnt":[[305,1783],[1704,1783],[1704,1837],[305,1837]],"region":{"top_left_x":305,"top_left_y":1783,"width":1399,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5403be5b43a48f2ad6a311d4e6b406f","type":"text","conversion_output":true,"text":"- Antipsychotics include haloperidol, ziprasidone, quetiapine, olanzapine, and/or","text_display":"\n- Antipsychotics include haloperidol, ziprasidone, quetiapine, olanzapine, and/or","confidence":1,"confidence_rate":1},{"cnt":[[367,1833],[1452,1833],[1452,1884],[367,1884]],"region":{"top_left_x":367,"top_left_y":1832,"width":1086,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e220ef995a304601b12243994d3f9e89","type":"text","conversion_output":true,"text":"risperidone. Doses are expressed in haloperidol (iv) equivalents.","text_display":" risperidone. Doses are expressed in haloperidol (iv) equivalents.","confidence":1,"confidence_rate":1},{"cnt":[[243,1934],[1837,1934],[1837,1996],[243,1996]],"region":{"top_left_x":242,"top_left_y":1933,"width":1595,"height":63},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16af035c8a4d4a50a33c258b96626e55","type":"text","conversion_output":true,"text":"Baseline IQCODE: If no questions (out of 16) are answered, then the patient's IQCODE","text_display":"\n\nBaseline IQCODE: If no questions (out of 16) are answered, then the patient's IQCODE","confidence":0.9776184558868408,"confidence_rate":0.9997456973744216},{"cnt":[[245,2000],[1850,2000],[1850,2054],[245,2054]],"region":{"top_left_x":244,"top_left_y":2000,"width":1606,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d172976110aa41e1b6547a54e9fa61c1","type":"text","conversion_output":true,"text":"score is considered as missing. If data are partially available, then patient mean will be imputed","text_display":" score is considered as missing. If data are partially available, then patient mean will be imputed","confidence":1,"confidence_rate":1},{"cnt":[[245,2054],[1794,2054],[1794,2108],[245,2108]],"region":{"top_left_x":244,"top_left_y":2053,"width":1550,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"860ee7ec6e0947a2ad4db5daa524a760","type":"text","conversion_output":true,"text":"for missing questions (i.e., mean of all non-missing questions). Final IQCODE score will be","text_display":" for missing questions (i.e., mean of all non-missing questions). Final IQCODE score will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2110],[1089,2110],[1089,2163],[245,2163]],"region":{"top_left_x":244,"top_left_y":2109,"width":846,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"078dc6292c8d4d57922f34c421727fc5","type":"text","conversion_output":true,"text":"calculated by taking the mean of all the questions.","text_display":" calculated by taking the mean of all the questions.","confidence":1,"confidence_rate":1},{"cnt":[[245,2170],[1837,2170],[1837,2232],[245,2232]],"region":{"top_left_x":244,"top_left_y":2169,"width":1593,"height":64},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbeb5c3ec59547ba8efd6f72e949c18e","type":"text","conversion_output":true,"text":"Baseline KATZ ADL: If no questions (out of 6) are answered, then the patient's KATZ","text_display":"\nBaseline KATZ ADL: If no questions (out of 6) are answered, then the patient's KATZ","confidence":0.5883729457855225,"confidence_rate":0.9939909195583276},{"cnt":[[245,2239],[1798,2239],[1798,2292],[245,2292]],"region":{"top_left_x":244,"top_left_y":2238,"width":1555,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29bb414a5ed049928dd2d8b5f23b403a","type":"text","conversion_output":true,"text":"ADL score is considered as missing. If data are partially available, then patient mean will be","text_display":" ADL score is considered as missing. If data are partially available, then patient mean will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2295],[1880,2295],[1880,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2294,"width":1636,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db2ec2fe280b4792863048fbcb95095c","type":"text","conversion_output":true,"text":"imputed for missing questions. (i.e., mean of all non-missing questions). Final ADL score will be","text_display":" imputed for missing questions. (i.e., mean of all non-missing questions). Final ADL score will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2350],[947,2350],[947,2404],[245,2404]],"region":{"top_left_x":244,"top_left_y":2350,"width":704,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7636e67ea260457fa6d19e095f756a88","type":"text","conversion_output":true,"text":"calculated by adding up all the questions.","text_display":" calculated by adding up all the questions.","confidence":1,"confidence_rate":1},{"cnt":[[1826,2574],[1886,2574],[1886,2628],[1826,2628]],"region":{"top_left_x":1826,"top_left_y":2573,"width":61,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15273b438af04fd8aea2943cc1c9e597","type":"page_info","conversion_output":false,"text":"24","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-25","page":25,"lines":[{"cnt":[[245,258],[1796,258],[1796,316],[245,316]],"region":{"top_left_x":244,"top_left_y":257,"width":1553,"height":59},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3e51fda3e7940279ecbb9b2d17d0532","type":"text","conversion_output":true,"text":"Baseline FAQ: If no questions (out of 10) are answered, then the patient's FAQ score is","text_display":"\n\nBaseline FAQ: If no questions (out of 10) are answered, then the patient's FAQ score is","confidence":0.7900132841896266,"confidence_rate":0.9974412626607307},{"cnt":[[245,327],[1768,327],[1768,376],[245,376]],"region":{"top_left_x":244,"top_left_y":326,"width":1525,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33329a4bc67a422087868263c7625f55","type":"text","conversion_output":true,"text":"considered as missing. If data are partially available, then patient mean will be imputed for","text_display":" considered as missing. If data are partially available, then patient mean will be imputed for","confidence":1,"confidence_rate":1},{"cnt":[[245,382],[1837,382],[1837,432],[245,432]],"region":{"top_left_x":244,"top_left_y":382,"width":1593,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c2e965a599a4e718ffa3101d425cb62","type":"text","conversion_output":true,"text":"missing questions (i.e., mean of all non-missing questions). Final FAQ score will be calculated","text_display":" missing questions (i.e., mean of all non-missing questions). 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These outcomes are typically not normally","text_display":" ventilator-free days) using the Mann-Whitney test. These outcomes are typically not normally","confidence":1,"confidence_rate":1},{"cnt":[[245,945],[1783,945],[1783,995],[245,995]],"region":{"top_left_x":244,"top_left_y":945,"width":1540,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7983d708aa6248c8b64b519ab7b9e783","type":"text","conversion_output":true,"text":"distributed; therefore, the assumptions for a test assuming normality would be violated. The","text_display":" distributed; therefore, the assumptions for a test assuming normality would be violated. The","confidence":1,"confidence_rate":1},{"cnt":[[245,993],[1826,993],[1826,1042],[245,1042]],"region":{"top_left_x":244,"top_left_y":992,"width":1583,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf924fbe8b8149039efe06dd423695ad","type":"text","conversion_output":true,"text":"nonparametric Mann-Whitney test does not assume that the outcome has a normal distribution","text_display":" nonparametric Mann-Whitney test does not assume that the outcome has a normal distribution","confidence":1,"confidence_rate":1},{"cnt":[[245,1040],[1678,1040],[1678,1089],[245,1089]],"region":{"top_left_x":244,"top_left_y":1039,"width":1434,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c841f73a02b49c9b612a444730bfaae","type":"text","conversion_output":true,"text":"and thus provides more power and reliability in the case of a non-normal distribution.","text_display":" and thus provides more power and reliability in the case of a non-normal distribution.","confidence":1,"confidence_rate":1},{"cnt":[[245,1143],[1811,1143],[1811,1192],[245,1192]],"region":{"top_left_x":244,"top_left_y":1142,"width":1568,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa3c92f9895d44a9aa401e430ec10baa","type":"text","conversion_output":true,"text":"The primary long-term outcome will be the TICS score. Depending on the distribution of this","text_display":"\n\nThe primary long-term outcome will be the TICS score. Depending on the distribution of this","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[245,1195],[1813,1195],[1813,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1194,"width":1570,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c46c7faf42344f00bb023c8a300b7452","type":"text","conversion_output":true,"text":"outcome, we will use either the independent two-sample t-test or the Mann-Whitney test. The","text_display":" outcome, we will use either the independent two-sample t-test or the Mann-Whitney test. The","confidence":0.9794921875,"confidence_rate":0.9997841793589018},{"cnt":[[245,1242],[1820,1242],[1820,1289],[245,1289]],"region":{"top_left_x":244,"top_left_y":1241,"width":1576,"height":49},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59426c9bb3bf49beafcb4b221a9229fb","type":"text","conversion_output":true,"text":"distribution of the other long-term outcome measures (Digit Span, Logical Memory I, Logical","text_display":" distribution of the other long-term outcome measures (Digit Span, Logical Memory I, Logical","confidence":1,"confidence_rate":1},{"cnt":[[245,1285],[1699,1285],[1699,1334],[245,1334]],"region":{"top_left_x":244,"top_left_y":1284,"width":1456,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"702d72b9190f4e51b60256e5894e3b2e","type":"text","conversion_output":true,"text":"Memory II, ADL, FAQ, Quality of Life EQ - 5D \\({ }^{10}\\), Similarities, Controlled Oral Word","text_display":" Memory II, ADL, FAQ, Quality of Life EQ - 5D \\({ }^{10}\\), Similarities, Controlled Oral Word","confidence":0.9228515625,"confidence_rate":0.9991893501875166},{"cnt":[[245,1336],[1841,1336],[1841,1386],[245,1386]],"region":{"top_left_x":244,"top_left_y":1336,"width":1598,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8f5bb3dd8ae407f8568d2630135b439","type":"text","conversion_output":true,"text":"Association, Hayling Sentence Completion, Logical Memory I and Logical Memory II) will be","text_display":" Association, Hayling Sentence Completion, Logical Memory I and Logical Memory II) will be","confidence":0.99853515625,"confidence_rate":0.9999844052526365},{"cnt":[[245,1384],[1764,1384],[1764,1433],[245,1433]],"region":{"top_left_x":244,"top_left_y":1383,"width":1520,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9dfc45c345384010b9e3986ed6f73e53","type":"text","conversion_output":true,"text":"described overall as well as by treatment group. We do not plan to compare these outcome","text_display":" described overall as well as by treatment group. We do not plan to compare these outcome","confidence":1,"confidence_rate":1},{"cnt":[[245,1431],[1833,1431],[1833,1480],[245,1480]],"region":{"top_left_x":244,"top_left_y":1430,"width":1589,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cb3cf449b4643468d995d9b2ee7010b","type":"text","conversion_output":true,"text":"measures between treatment groups using formal hypothesis testing in the primary manuscript.","text_display":" measures between treatment groups using formal hypothesis testing in the primary manuscript.","confidence":1,"confidence_rate":1},{"cnt":[[241,1590],[814,1590],[814,1652],[241,1652]],"region":{"top_left_x":240,"top_left_y":1589,"width":575,"height":64},"line":21,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"357c888270ef460a9ac212e091b89143","type":"section_header","conversion_output":false,"children_ids":["d45b4a0d948243f8abd8ddc18cdda3aa"],"text":"","text_display":""},{"cnt":[[245,1594],[810,1594],[810,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1594,"width":566,"height":54},"line":22,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"d45b4a0d948243f8abd8ddc18cdda3aa","type":"text","conversion_output":true,"parent_id":"357c888270ef460a9ac212e091b89143","text":"Time to Event Outcomes","text_display":"\n\n\\section*{Time to Event Outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[245,1691],[1841,1691],[1841,1742],[245,1742]],"region":{"top_left_x":244,"top_left_y":1690,"width":1598,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f9855bd3bbb439a8de2b036fc6e48a8","type":"text","conversion_output":true,"text":"We will describe and test for differences in 90-day survival using Kaplan-Meier curves and the","text_display":"\n\nWe will describe and test for differences in 90-day survival using Kaplan-Meier curves and the","confidence":0.82763671875,"confidence_rate":0.998090905791028},{"cnt":[[245,1745],[1841,1745],[1841,1796],[245,1796]],"region":{"top_left_x":244,"top_left_y":1744,"width":1598,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64813825e80649ba8777a4145635e875","type":"text","conversion_output":true,"text":"log-rank test, respectively. \"Time 0 \" will be the time of randomization. For analysis of time-to-","text_display":" log-rank test, respectively. \"Time 0 \" will be the time of randomization. For analysis of time-to","confidence":0.98974609375,"confidence_rate":0.9999027703902427},{"cnt":[[245,1800],[1803,1800],[1803,1850],[245,1850]],"region":{"top_left_x":244,"top_left_y":1800,"width":1559,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45e3915ccee34dd1a469e6b67f4f0a25","type":"text","conversion_output":true,"text":"event outcomes with competing risks, we will describe the cumulative incidences of both the","text_display":"event outcomes with competing risks, we will describe the cumulative incidences of both the","confidence":1,"confidence_rate":1},{"cnt":[[245,1856],[1775,1856],[1775,1906],[245,1906]],"region":{"top_left_x":244,"top_left_y":1856,"width":1531,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"446b5d1a372d47fb8a85e69eaf2f1adc","type":"text","conversion_output":true,"text":"outcome of interest and each competing risk, along with a modified chi-squared test for the","text_display":" outcome of interest and each competing risk, along with a modified chi-squared test for the","confidence":1,"confidence_rate":1},{"cnt":[[245,1912],[1852,1912],[1852,1962],[245,1962]],"region":{"top_left_x":244,"top_left_y":1912,"width":1608,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17df2dcc62114a2cb8f16e2e3c1479ba","type":"text","conversion_output":true,"text":"difference between groups in the subdistribution of interest. We will detail how many and when","text_display":" difference between groups in the subdistribution of interest. We will detail how many and when","confidence":1,"confidence_rate":1},{"cnt":[[245,1968],[935,1968],[935,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1967,"width":691,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dda81b354ee47a39676a1de047cfb10","type":"text","conversion_output":true,"text":"patients were censored for each analysis.","text_display":" patients were censored for each analysis.","confidence":1,"confidence_rate":1},{"cnt":[[236,2138],[889,2138],[889,2219],[236,2219]],"region":{"top_left_x":236,"top_left_y":2137,"width":654,"height":83},"line":29,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"9a2ed867fe0345b6a5eb45fb3d344681","type":"section_header","conversion_output":false,"children_ids":["4075f4b67f504742b14d63ef5c338355"],"text":"","text_display":""},{"cnt":[[245,2144],[883,2144],[883,2215],[245,2215]],"region":{"top_left_x":244,"top_left_y":2144,"width":640,"height":72},"line":30,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"4075f4b67f504742b14d63ef5c338355","type":"text","conversion_output":true,"parent_id":"9a2ed867fe0345b6a5eb45fb3d344681","text":"Timing of Final Analysis","text_display":"\n\n\\section*{Timing of Final Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[236,2264],[1390,2264],[1390,2340],[236,2340]],"region":{"top_left_x":236,"top_left_y":2264,"width":1155,"height":76},"line":31,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"e4df5bd35f8c496db7563c3a8dd12802","type":"section_header","conversion_output":false,"children_ids":["bbdab3c52a1a44bf9b3febe05b89b874"],"text":"","text_display":""},{"cnt":[[243,2269],[1384,2269],[1384,2333],[243,2333]],"region":{"top_left_x":242,"top_left_y":2268,"width":1142,"height":66},"line":32,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"bbdab3c52a1a44bf9b3febe05b89b874","type":"text","conversion_output":true,"parent_id":"e4df5bd35f8c496db7563c3a8dd12802","text":"In-Hospital Database Cleaning \\& Lock Procedures","text_display":"\n\n\\section*{In-Hospital Database Cleaning \\& Lock Procedures}","confidence":1,"confidence_rate":1},{"cnt":[[245,2344],[1695,2344],[1695,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2343,"width":1452,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aae5bdae67f049058d5927c790e32939","type":"text","conversion_output":true,"text":"MENDS2 uses the REDCap electronic data capture platform for data collection. Upon","text_display":"\n\nMENDS2 uses the REDCap electronic data capture platform for data collection. Upon","confidence":1,"confidence_rate":1},{"cnt":[[245,2393],[1815,2393],[1815,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2393,"width":1572,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8de1581df264e5a9b7bd81810459fee","type":"text","conversion_output":true,"text":"completion of the in-hospital portion of the MENDS2 study, the following procedures will be","text_display":" completion of the in-hospital portion of the MENDS2 study, the following procedures will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2441],[1429,2441],[1429,2490],[245,2490]],"region":{"top_left_x":244,"top_left_y":2440,"width":1185,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e29dfe240cc40db8e87ff61ea7f67ed","type":"text","conversion_output":true,"text":"followed and documented within the Database Cleaning \\& Lock SOP:","text_display":" followed and documented within the Database Cleaning \\& Lock SOP:","confidence":1,"confidence_rate":1},{"cnt":[[1826,2574],[1886,2574],[1886,2628],[1826,2628]],"region":{"top_left_x":1826,"top_left_y":2573,"width":61,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70a6867eec4748de94b8777b1b90794c","type":"page_info","conversion_output":false,"text":"25","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5be7bfe6-2574-47d0-9dd0-17d4217523f2-26","page":26,"lines":[{"cnt":[[312,254],[1828,254],[1828,301],[312,301]],"region":{"top_left_x":311,"top_left_y":253,"width":1518,"height":48},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"392b5269bfe64af6aa948deca735a066","type":"text","conversion_output":true,"text":"1. The Vanderbilt Coordinating Center (VCC) will work with site coordinators to address","text_display":"\n1. The Vanderbilt Coordinating Center (VCC) will work with site coordinators to address","confidence":1,"confidence_rate":1},{"cnt":[[370,301],[1792,301],[1792,350],[370,350]],"region":{"top_left_x":369,"top_left_y":300,"width":1423,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"602180f4b18f4ad190306f5198aec269","type":"text","conversion_output":true,"text":"all data issues revealed by ongoing data cleaning. This process will continue until all","text_display":" all data issues revealed by ongoing data cleaning. This process will continue until all","confidence":1,"confidence_rate":1},{"cnt":[[370,352],[840,352],[840,391],[370,391]],"region":{"top_left_x":369,"top_left_y":352,"width":472,"height":40},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0979fe1d77f4e3a85fa358029e02a68","type":"text","conversion_output":true,"text":"issues have been addressed.","text_display":" issues have been addressed.","confidence":1,"confidence_rate":1},{"cnt":[[309,400],[1841,400],[1841,445],[309,445]],"region":{"top_left_x":309,"top_left_y":399,"width":1533,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87e534af42a743df9658258da8be8cc7","type":"text","conversion_output":true,"text":"2. Upon completion of In-Hospital data cleaning, the REDCap database MENDS2 Study:","text_display":"\n2. Upon completion of In-Hospital data cleaning, the REDCap database MENDS2 Study:","confidence":1,"confidence_rate":1},{"cnt":[[370,447],[1244,447],[1244,492],[370,492]],"region":{"top_left_x":369,"top_left_y":446,"width":875,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff7c6c891fc3409284f17396605f729e","type":"text","conversion_output":true,"text":"Exclusion Log will be locked in the following way:","text_display":" Exclusion Log will be locked in the following way:","confidence":1,"confidence_rate":1},{"cnt":[[434,494],[1815,494],[1815,541],[434,541]],"region":{"top_left_x":433,"top_left_y":494,"width":1383,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b4af119ffe84cec98b236c69dd92326","type":"text","conversion_output":true,"text":"a. Initially all users with current \"view and edit\" user privileges will be moved to","text_display":"\na. Initially all users with current \"view and edit\" user privileges will be moved to","confidence":1,"confidence_rate":1},{"cnt":[[494,541],[960,541],[960,591],[494,591]],"region":{"top_left_x":494,"top_left_y":541,"width":467,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"498addd1b0a341c79eb505e724db2123","type":"text","conversion_output":true,"text":"\"read only\" user privileges.","text_display":" \"read only\" user privileges.","confidence":1,"confidence_rate":1},{"cnt":[[434,591],[1721,591],[1721,638],[434,638]],"region":{"top_left_x":433,"top_left_y":590,"width":1288,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de666e7d91944b12bb67749b94601787","type":"text","conversion_output":true,"text":"b. After the window closes for sites to export their data the database will be","text_display":"\nb. After the window closes for sites to export their data the database will be","confidence":1,"confidence_rate":1},{"cnt":[[494,640],[1790,640],[1790,685],[494,685]],"region":{"top_left_x":494,"top_left_y":640,"width":1296,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71d93b5a8c19435f985de915af676abb","type":"text","conversion_output":true,"text":"permanently moved to inactive status (meaning that no data can be changed).","text_display":" permanently moved to inactive status (meaning that no data can be changed).","confidence":1,"confidence_rate":1},{"cnt":[[309,688],[1841,688],[1841,733],[309,733]],"region":{"top_left_x":309,"top_left_y":687,"width":1533,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00a6609dff13436aa3238a25dfc610b4","type":"text","conversion_output":true,"text":"3. Upon completion of In-Hospital data cleaning, the REDCap database MENDS2 Study:","text_display":"\n3. Upon completion of In-Hospital data cleaning, the REDCap database MENDS2 Study:","confidence":1,"confidence_rate":1},{"cnt":[[370,735],[1369,735],[1369,780],[370,780]],"region":{"top_left_x":369,"top_left_y":734,"width":1000,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce7ae031c909404f994f791e20e275c8","type":"text","conversion_output":true,"text":"In-Hospital Database will be locked in the following way:","text_display":"\n\nIn-Hospital Database will be locked in the following way:","confidence":1,"confidence_rate":1},{"cnt":[[370,769],[1867,769],[1867,831],[370,831]],"region":{"top_left_x":369,"top_left_y":769,"width":1498,"height":63},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b308bedd6b348a5a55873bb525be64c","type":"text","conversion_output":true,"text":"Initially all study site personnel will be restricted to \"read-only\" user access for the entire","text_display":"\nInitially all study site personnel will be restricted to \"read-only\" user access for the entire","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[1858,829],[1858,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":1615,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09a1aff403ac438b81bbe39837ae0b83","type":"text","conversion_output":true,"text":"database. 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