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documents/10.1056_nejmoa1802670/sap_mmd.zip

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+version https://git-lfs.github.com/spec/v1
+oid sha256:f7d333299df2204822ecdc1c06ec074534b7c3e8504e5b410aa743c3982cf247
+size 196269

documents/10.1056_nejmoa1802670/sap_tex.zip

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+version https://git-lfs.github.com/spec/v1
+oid sha256:89afd6b8f55df84c33aabb0574ff73f2aba59eef05a5f776a92c6ff7cac92301
+size 197877

documents/10.1056_nejmoa1802686/protocol_mmd.zip

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+version https://git-lfs.github.com/spec/v1
+oid sha256:00793f1060d325ad8f77e141fe5e3189f82b669268824b6030d54018da56ed29
+size 508146

documents/10.1056_nejmoa1802686/protocol_tex.zip

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+version https://git-lfs.github.com/spec/v1
+oid sha256:59beeaf1ab41f430c5d76ab184b5794ece69bdcaaddecdc2f783ff7d4dbd0be3
+size 514162

documents/10.1056_nejmoa2201662/DEDUP_NOTE.md

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+# Identical source PDFs
+
+`protocol.pdf` and `sap.pdf` in this folder are **byte-identical** (sha256 `fea5d546558052e81ca068cac423c9ca060a6aea22397f780ab7194bcb2fc574`).

documents/10.1056_nejmoa2205973/DEDUP_NOTE.md

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+# Identical source PDFs
+
+`protocol.pdf` and `sap.pdf` in this folder are **byte-identical** (sha256 `43f05a972e02f57accf491b1db4582d1256d65aa4018714d4aadd3c86b5d1bdc`).

documents/10.1056_nejmoa2206660/DEDUP_NOTE.md

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+# Identical source PDFs
+
+`protocol.pdf` and `sap.pdf` in this folder are **byte-identical** (sha256 `7c33070c388a10313d75023e2b060da4d2c30348c0d8bb4aedd60399d6341d5d`).

documents/10.1056_nejmoa2207940/protocol.html

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+g[data-mml-node="mtable"] > .mjx-dotted, svg[data-table] > g > .mjx-dotted {
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+}
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+}
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+}
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+  <div id="preview" class="preview scrollEditor">
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+      <div>A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis: Maximized Extended Enrollment Addendum</div>
+<div>NCT03518086</div>
+<div>Approval Date: 19-Mar-2018</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="1.-protocol-addendum-i6t-mc-aman(5)">
+1. Protocol Addendum I6T-MC-AMAN(5)</h2>
+<h2 type="section" data-unnumbered="true" class="section-title" id="a-phase-3%2C-multicenter%2C-randomized%2C-double-blind%2C-parallel%2C-placebo-controlled-induction-study-of-mirikizumab-in-conventional-failed-and-biologic-failed-patients-with-moderately-to-severely-active-ulcerative-colitis%3A-maximized-extended-enrollment-addendum">
+A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis: Maximized Extended Enrollment Addendum</h2>
+<h2 type="section" data-unnumbered="true" class="section-title" id="confidential-information">
+Confidential Information</h2>
+<div>The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical investigation of mirikizumab (LY3074828), unless such persons are bound by a confidentiality agreement with Eli Lilly and Company or its subsidiaries.</div>
+<div>Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries.</div>
+<div>Mirikizumab (LY3074828)</div>
+<div>This addendum is to be performed in addition to all procedures required by protocol I6T-MC-AMAN or any subsequent amendments to that protocol.</div>
+<div>Eli Lilly and Company<br>
+Indianapolis, Indiana USA 46285</div>
+<div>Protocol Addendum(5) Electronically Signed and Approved by Lilly on date provided below.</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="2.-table-of-contents">
+2. Table of Contents</h2>
+<div>Protocol Addendum I6T-MC-AMAN (5)<br>
+A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis: Maximized Extended Enrollment Addendum<br>
+Section Page</div>
+<ol>
+<li>Protocol Addendum I6T-MC-AMAN(5) A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis: Maximized Extended Enrollment Addendum ..... 1</li>
+<li>Table of Contents ..... 2</li>
+<li>Rationale for Addendum ..... 4</li>
+<li>Protocol Additions ..... 5<br>
+4.1. Extended Enrollment ..... 5<br>
+4.2. Investigational Plan ..... 5<br>
+4.3. Discontinuation of Study in Extended Enrollment Phase ..... 5<br>
+4.4. Statistical and Analytical Plans ..... 6<br>
+4.4.1. Determination of Sample Size ..... 6<br>
+4.4.2. Statistical and Analytical Plans ..... 6<br>
+4.4.2.1. General Considerations ..... 6<br>
+4.4.2.2. Interim Analyses ..... 6</li>
+</ol>
+<h2 type="section" data-unnumbered="true" class="section-title" id="list-of-figures">
+List of Figures</h2>
+<h2 type="section" data-unnumbered="true" class="section-title" id="figure">
+Figure</h2>
+<div>Page<br>
+Figure AMAN(5).1. Milestones for Global and ME2 Cohort enrollment through global and local submissions ..... 5</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="3.-rationale-for-addendum">
+3. Rationale for Addendum</h2>
+<div>Regulatory agencies of some countries require local patient data from a specific number of patients for registration in their countries. This addendum provides a mechanism to meet these country-level registration requirements in a single pivotal study.</div>
+<div>The purpose of this addendum is to enable patient enrollment to continue in these countries if the prespecified number of patients from the respective countries cannot be enrolled in the main protocol (Study I6T-MC-AMAN [AMAN]). Hereafter, patients enrolled in the main protocol will be referred to as the Global Cohort, and patients enrolled under the extended enrollment addendum will be referred to as the Maximized Extended Enrollment (ME2) Cohort. The number of patients enrolled in the ME2 Cohort will depend on the local guidelines and the number of patients from those countries already enrolled in the Global Cohort.</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="4.-protocol-additions">
+4. Protocol Additions</h2>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.1.-extended-enrollment">
+4.1. Extended Enrollment</h3>
+<div>Once the protocol milestone of last-patient-enters-treatment (LPET) for the Global Cohort is reached, enrollment will continue for those countries participating in the ME2 cohort, if needed, until sufficient numbers of patients are enrolled to meet the regulatory needs for those countries. Enrollment in the Global Cohort from the respective country is required before enrolling patients in the ME2 Cohort from the same country.</div>
+<div>Figure AMAN(5). 1 shows the milestones for enrollment in Study AMAN (Global Cohort and ME2 Cohort) through global and local submissions.</div>
+<div class="table" number="1">
+<div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/6024ddee-2f30-453f-92d7-6ca49539e309-6.jpg?height=690&width=1533&top_left_y=842&top_left_x=296" alt="" style="max-width: 100%;"/></div><div class="caption_figure">Figure AMAN(5).1. Milestones for Global and ME2 Cohort enrollment through global and local submissions.</div></div>
+<div>Abbreviations: <span class="math-inline ">
+<mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="7.52ex" height="1.731ex" role="img" focusable="false" viewBox="0 -683 3323.8 765"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mi"><path data-c="1D437" d="M287 628Q287 635 230 637Q207 637 200 638T193 647Q193 655 197 667T204 682Q206 683 403 683Q570 682 590 682T630 676Q702 659 752 597T803 431Q803 275 696 151T444 3L430 1L236 0H125H72Q48 0 41 2T33 11Q33 13 36 25Q40 41 44 43T67 46Q94 46 127 49Q141 52 146 61Q149 65 218 339T287 628ZM703 469Q703 507 692 537T666 584T629 613T590 629T555 636Q553 636 541 636T512 636T479 637H436Q392 637 386 627Q384 623 313 339T242 52Q242 48 253 48T330 47Q335 47 349 47T373 46Q499 46 581 128Q617 164 640 212T683 339T703 469Z"></path></g><g data-mml-node="mi" transform="translate(828,0)"><path data-c="1D435" d="M231 637Q204 637 199 638T194 649Q194 676 205 682Q206 683 335 683Q594 683 608 681Q671 671 713 636T756 544Q756 480 698 429T565 360L555 357Q619 348 660 311T702 219Q702 146 630 78T453 1Q446 0 242 0Q42 0 39 2Q35 5 35 10Q35 17 37 24Q42 43 47 45Q51 46 62 46H68Q95 46 128 49Q142 52 147 61Q150 65 219 339T288 628Q288 635 231 637ZM649 544Q649 574 634 600T585 634Q578 636 493 637Q473 637 451 637T416 636H403Q388 635 384 626Q382 622 352 506Q352 503 351 500L320 374H401Q482 374 494 376Q554 386 601 434T649 544ZM595 229Q595 273 572 302T512 336Q506 337 429 337Q311 337 310 336Q310 334 293 263T258 122L240 52Q240 48 252 48T333 46Q422 46 429 47Q491 54 543 105T595 229Z"></path></g><g data-mml-node="mi" transform="translate(1587,0)"><path data-c="1D43F" d="M228 637Q194 637 192 641Q191 643 191 649Q191 673 202 682Q204 683 217 683Q271 680 344 680Q485 680 506 683H518Q524 677 524 674T522 656Q517 641 513 637H475Q406 636 394 628Q387 624 380 600T313 336Q297 271 279 198T252 88L243 52Q243 48 252 48T311 46H328Q360 46 379 47T428 54T478 72T522 106T564 161Q580 191 594 228T611 270Q616 273 628 273H641Q647 264 647 262T627 203T583 83T557 9Q555 4 553 3T537 0T494 -1Q483 -1 418 -1T294 0H116Q32 0 32 10Q32 17 34 24Q39 43 44 45Q48 46 59 46H65Q92 46 125 49Q139 52 144 61Q147 65 216 339T285 628Q285 635 228 637Z"></path></g><g data-mml-node="mo" transform="translate(2545.8,0)"><path data-c="3D" d="M56 347Q56 360 70 367H707Q722 359 722 347Q722 336 708 328L390 327H72Q56 332 56 347ZM56 153Q56 168 72 173H708Q722 163 722 153Q722 140 707 133H70Q56 140 56 153Z"></path></g></g></g></svg></mjx-container></span> database lock; <span class="math-inline ">
+<mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="5.852ex" height="1.731ex" role="img" focusable="false" viewBox="0 -683 2586.8 765"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mi"><path data-c="1D438" d="M492 213Q472 213 472 226Q472 230 477 250T482 285Q482 316 461 323T364 330H312Q311 328 277 192T243 52Q243 48 254 48T334 46Q428 46 458 48T518 61Q567 77 599 117T670 248Q680 270 683 272Q690 274 698 274Q718 274 718 261Q613 7 608 2Q605 0 322 0H133Q31 0 31 11Q31 13 34 25Q38 41 42 43T65 46Q92 46 125 49Q139 52 144 61Q146 66 215 342T285 622Q285 629 281 629Q273 632 228 634H197Q191 640 191 642T193 659Q197 676 203 680H757Q764 676 764 669Q764 664 751 557T737 447Q735 440 717 440H705Q698 445 698 453L701 476Q704 500 704 528Q704 558 697 578T678 609T643 625T596 632T532 634H485Q397 633 392 631Q388 629 386 622Q385 619 355 499T324 377Q347 376 372 376H398Q464 376 489 391T534 472Q538 488 540 490T557 493Q562 493 565 493T570 492T572 491T574 487T577 483L544 351Q511 218 508 216Q505 213 492 213Z"></path></g><g data-mml-node="mi" transform="translate(764,0)"><path data-c="1D448" d="M107 637Q73 637 71 641Q70 643 70 649Q70 673 81 682Q83 683 98 683Q139 681 234 681Q268 681 297 681T342 682T362 682Q378 682 378 672Q378 670 376 658Q371 641 366 638H364Q362 638 359 638T352 638T343 637T334 637Q295 636 284 634T266 623Q265 621 238 518T184 302T154 169Q152 155 152 140Q152 86 183 55T269 24Q336 24 403 69T501 205L552 406Q599 598 599 606Q599 633 535 637Q511 637 511 648Q511 650 513 660Q517 676 519 679T529 683Q532 683 561 682T645 680Q696 680 723 681T752 682Q767 682 767 672Q767 650 759 642Q756 637 737 637Q666 633 648 597Q646 592 598 404Q557 235 548 205Q515 105 433 42T263 -22Q171 -22 116 34T60 167V183Q60 201 115 421Q164 622 164 628Q164 635 107 637Z"></path></g><g data-mml-node="mo" transform="translate(1808.8,0)"><path data-c="3D" d="M56 347Q56 360 70 367H707Q722 359 722 347Q722 336 708 328L390 327H72Q56 332 56 347ZM56 153Q56 168 72 173H708Q722 163 722 153Q722 140 707 133H70Q56 140 56 153Z"></path></g></g></g></svg></mjx-container></span> European Union; FPV <span class="math-inline " data-overflow="visible">
+<mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="1.76ex" height="1.505ex" role="img" focusable="false" viewBox="0 -583 778 665"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="3D" d="M56 347Q56 360 70 367H707Q722 359 722 347Q722 336 708 328L390 327H72Q56 332 56 347ZM56 153Q56 168 72 173H708Q722 163 722 153Q722 140 707 133H70Q56 140 56 153Z"></path></g></g></g></svg></mjx-container></span> first patient visit; LPET <span class="math-inline " data-overflow="visible">
+<mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="1.76ex" height="1.505ex" role="img" focusable="false" viewBox="0 -583 778 665"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="3D" d="M56 347Q56 360 70 367H707Q722 359 722 347Q722 336 708 328L390 327H72Q56 332 56 347ZM56 153Q56 168 72 173H708Q722 163 722 153Q722 140 707 133H70Q56 140 56 153Z"></path></g></g></g></svg></mjx-container></span> last patient entered treatment; LPV <span class="math-inline " data-overflow="visible">
+<mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="1.76ex" height="1.505ex" role="img" focusable="false" viewBox="0 -583 778 665"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="3D" d="M56 347Q56 360 70 367H707Q722 359 722 347Q722 336 708 328L390 327H72Q56 332 56 347ZM56 153Q56 168 72 173H708Q722 163 722 153Q722 140 707 133H70Q56 140 56 153Z"></path></g></g></g></svg></mjx-container></span> last patient visit; ME2 <span class="math-inline " data-overflow="visible">
+<mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="1.76ex" height="1.505ex" role="img" focusable="false" viewBox="0 -583 778 665"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="3D" d="M56 347Q56 360 70 367H707Q722 359 722 347Q722 336 708 328L390 327H72Q56 332 56 347ZM56 153Q56 168 72 173H708Q722 163 722 153Q722 140 707 133H70Q56 140 56 153Z"></path></g></g></g></svg></mjx-container></span> Maximized Extended Enrollment; US = United States.</div>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.2.-investigational-plan">
+4.2. Investigational Plan</h3>
+<div>The objectives, enrollment criteria, randomization ratio, treatment, and evaluations of risk/benefit for patients enrolled in the ME2 Cohort will be identical to those for patients enrolled in the Global Cohort from these countries, including both those described in the main protocol, as well as in any applicable protocol addenda.</div>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.3.-discontinuation-of-study-in-extended-enrollment-phase">
+4.3. Discontinuation of Study in Extended Enrollment Phase</h3>
+<div>Enrollment in the ME2 Cohort will be discontinued if results from the Global Cohort demonstrate futility, lack of efficacy, and/or an unacceptable safety profile.</div>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.4.-statistical-and-analytical-plans">
+4.4. Statistical and Analytical Plans</h3>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.4.1.-determination-of-sample-size">
+4.4.1. Determination of Sample Size</h3>
+<div>The total number of patients enrolled in each country is based on the minimum number of patients needed to support local registration. The number of patients enrolled in the ME2 Cohort is dependent on the number of patients enrolled from each of the respective countries in Global Cohort as part of the protocol-defined sample size of 1160 patients. If a country fully meets patient enrollment needs in the Global Cohort, no patient will be enrolled under this addendum for that country.</div>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.4.2.-statistical-and-analytical-plans">
+4.4.2. Statistical and Analytical Plans</h3>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.4.2.1.-general-considerations">
+4.4.2.1. General Considerations</h3>
+<div>The benefit/risk profile to support global registrations will be based on the safety and efficacy analyses of Global Cohort. Patients enrolled in the ME2 Cohort will not be included in the primary global analysis, as described in the statistical methods outlined in the main protocol of Study AMAN.</div>
+<div>Patients enrolled in the ME2 Cohort will be analyzed separately using the statistical methodology described in the main protocol of Study AMAN. The data from the ME2 Cohort will be used in the respective countries to demonstrate similarity between local patients and the intent to treat (ITT) population enrolled in the Global Cohort. Patients in the ME2 Cohort (and their investigators) will remain blinded until the ME2 Cohort is locked and unblinded.</div>
+<div>As necessary, country-specific efficacy and safety analyses will be summarized for enrolled patients from each of the participating countries by pooling each country's patients from the Global Cohort and the ME2 Cohort. All analyses will be for descriptive purposes only. Details of the analyses are described in the statistical analysis plan.</div>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="4.4.2.2.-interim-analyses">
+4.4.2.2. Interim Analyses</h3>
+<div>No interim analyses are planned for the ME2 Cohort.</div>
+<div>Leo Document ID = a6acf895-ab55-4624-9612-4f848da2b73a<br>
+Approver: PPD<br>
+Approval Date &amp; Time: 19-Mar-2018 15:42:35 GMT<br>
+Signature meaning: Approved<br>
+Approver: PPD<br>
+Approval Date &amp; Time: 19-Mar-2018 15:42:35 GMT<br>
+Signature meaning: Approved</div>
+
+    </div>
+  </div>
+</body>
+</html>

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+  display: inline-block !important;
+  page-break-inside: avoid;
+  max-width: 100%;
+  padding: 0;
+  line-height: 0;
+}
+.math-inline[data-overflow="visible"] mjx-container {
+  overflow: visible;
+}
+.math-inline mjx-container mjx-assistive-mml {
+  max-width: 100%;
+}
+.math-block {
+  align-items: center;
+  page-break-after: auto;
+  page-break-inside: avoid;
+  margin: 0;
+  display: block;
+}
+.math-inline {
+  display: inline-flex;
+  max-width: 100%;
+}
+.math-block[data-width="full"] {
+  overflow-x: auto;
+  display: flex;
+}
+.math-block[data-width="full"] mjx-container[jax=SVG][display=true] {
+  display: flex;
+  flex: 1 1;
+  justify-content: center;
+}
+svg .math-inline {
+  display: initial;
+  max-width: initial;
+}
+svg .math-inline mjx-container {
+  max-width: initial;
+}
+svg mjx-container {
+  overflow: visible;
+  padding: 0;
+}
+svg .math-block[data-width="full"] {
+  overflow: visible;
+}
+.math-block, .math-inline {
+  --mmd-highlight-color: rgba(0, 147, 255, 0.25);
+  --mmd-highlight-text-color: #1e2029;
+}
+.math-block[data-highlight-color] mjx-container[jax="SVG"] > svg {
+  background-color: var(--mmd-highlight-color);
+}
+.math-block[data-highlight-text-color] mjx-container[jax="SVG"] > svg {
+  color: var(--mmd-highlight-text-color);
+}
+.math-inline[data-highlight-color] mjx-container[jax="SVG"] {
+  background-color: var(--mmd-highlight-color);
+}
+.math-inline[data-highlight-text-color] mjx-container[jax="SVG"] {
+  color: var(--mmd-highlight-text-color);
+}
+.math-block p {
+  flex-shrink: 1;
+}
+.math-block mjx-container {
+  margin: 0 !important;
+}
+.math-error {
+  background-color: yellow;
+  color: red;
+}
+#preview-content img, #setText img {
+  max-width: 100%;
+}
+#preview-content blockquote, #setText blockquote {
+  page-break-inside: avoid;
+  color: #666;
+  margin: 0 0 1em 0;
+  padding-left: 3em;
+  border-left: .5em solid #eee;
+}
+#preview-content pre, #setText pre {
+  border: none;
+  padding: 0;
+  overflow: auto;
+  font-size: 85%;
+  line-height: 1.45;
+  border-radius: 6px;
+  box-sizing: border-box;
+  background: #f8f8fa;
+}
+#preview-content pre code, #setText pre code {
+  padding: 1rem;
+  display: block;
+  overflow-x: auto;
+  line-height: 24px;
+}
+#preview-content table, #setText table {
+  display: table;
+  overflow: auto;
+  max-width: 100%;
+  border-collapse: collapse;
+  page-break-inside: avoid;
+  margin-bottom: 1em;
+}
+#preview-content table th, #setText table th {
+  text-align: center;
+  font-weight: bold;
+}
+#preview-content table td, #setText table td,
+#preview-content table th, #setText table th {
+  border: 1px solid #dfe2e5;
+  padding: 6px 13px;
+}
+#preview-content table tr, #setText table tr {
+  background-color: #fff;
+  border-top: 1px solid #c6cbd1;
+}
+#preview-content table tr:nth-child(2n), #setText table tr:nth-child(2n) {
+  background-color: #f6f8fa;
+}
+.main-title,
+#preview-content .main-title, #setText .main-title {
+  text-align: center;
+  line-height: 1.2;
+  margin: 0 auto 1em auto;
+}
+.author,
+#preview-content .author, #setText .author {
+  text-align: center;
+  margin: 0 auto;
+  display: flex;
+  justify-content: center;
+  flex-wrap: wrap;
+}
+.author p,
+#preview-content .author p, #setText .author p {
+  min-width: 30%;
+  max-width: 50%;
+  padding: 0 7px;
+}
+.author > p > span,
+#preview-content .author > p > span, #setText .author > p > span {
+  display: block;
+  text-align: center;
+}
+.section-title,
+#preview-content .section-title, #setText .section-title {
+  margin-top: 1.5em;
+}
+.abstract,
+#preview-content .abstract, #setText .abstract {
+  text-align: justify;
+  margin-bottom: 1em;
+}
+.abstract p,
+#preview-content .abstract p, #setText .abstract p {
+  margin-bottom: 0;
+}
+#preview-content sup, #setText sup {
+  top: -.5em;
+  position: relative;
+  font-size: 75%;
+  line-height: 0;
+  vertical-align: baseline;
+}
+.text-url,
+#preview-content .text-url, #setText .text-url {
+  color: #0B93ff;
+  cursor: text;
+  pointer-events: none;
+}
+.text-url a:hover,
+#preview-content .text-url a:hover, #setText .text-url a:hover {
+  color: #0B93ff;
+}
+mark,
+#preview-content mark, #setText mark {
+  background-color: #feffe6;
+}
+span[data-underline-type] mark,
+#preview-content span[data-underline-type] mark,
+#setText span[data-underline-type] mark {
+  background: inherit;
+  background-color: #feffe6;
+  padding-top: 0;
+  padding-bottom: 0;
+}
+*[data-has-dotfill] {
+  position: relative;
+  overflow: hidden;
+}
+*[data-has-dotfill] .dotfill::after {
+  position: absolute;
+  padding-left: .25ch;
+  content: " . . . . . . . . . . . . . . . . . . . "
+      ". . . . . . . . . . . . . . . . . . . . . . . "
+      ". . . . . . . . . . . . . . . . . . . . . . . "
+      ". . . . . . . . . . . . . . . . . . . . . . . "
+      ". . . . . . . . . . . . . . . . . . . . . . . "
+      ". . . . . . . . . . . . . . . . . . . . . . . "
+      ". . . . . . . . . . . . . . . . . . . . . . . ";
+  text-align: right;
+}
+.smiles,
+#preview-content .smiles, #setText .smiles {
+  text-align: center;
+}
+div.svg-container,
+#preview-content > div.svg-container,
+#setText > div.svg-container {
+  display: flex;
+  justify-content: center;
+}
+@media print {
+  #preview {
+    font-size: 10pt !important;
+  }
+  .math-block svg, .math-inline svg {
+    shape-rendering: crispEdges;
+    margin-top: 1px;
+  }
+  #preview-content img, #setText img {
+    display: block;
+  }
+  #preview-content .figure_img img, #setText .figure_img img {
+    display: inline;
+  }
+  #preview-content h1, #preview-content h2, #preview-content h3,
+  #preview-content h4, #preview-content h5, #preview-content h6,
+  #setText h1, #setText h2, #setText h3,
+  #setText h4, #setText h5, #setText h6 {
+    page-break-inside: avoid;
+    position: relative;
+    border: 2px solid transparent;
+  }
+  #preview-content h1::after, #preview-content h2::after, #preview-content h3::after,
+  #preview-content h4::after, #preview-content h5::after, #preview-content h6::after,
+  #setText h1::after, #setText h2::after, #setText h3::after,
+  #setText h4::after, #setText h5::after, #setText h6::after {
+    content: "";
+    display: block;
+    height: 100px;
+    margin-bottom: -100px;
+    position: relative;
+  }
+}
+#preview-content code, #setText code {
+  font-family: Inconsolata;
+  font-size: inherit;
+  display: initial;
+  background: #f8f8fa;
+}
+#preview-content .mmd-highlight code, #setText .mmd-highlight code,
+#preview-content pre.mmd-highlight code, #setText pre.mmd-highlight code {
+  background-color: transparent;
+}
+#preview-content pre code, #setText pre code {
+  font-family: 'DM Mono', Inconsolata, monospace;
+  color: #333;
+  font-size: 15px;
+}
+.hljs-comment, .hljs-quote,
+#preview-content .hljs-comment, #setText .hljs-comment,
+#preview-content .hljs-quote, #setText .hljs-quote {
+  color: #998;
+  font-style: italic;
+}
+.hljs-command,
+#preview-content .hljs-command, #setText .hljs-command {
+  color: #005cc5;
+}
+.hljs-keyword, .hljs-selector-tag, .hljs-subst,
+#preview-content .hljs-keyword, #setText .hljs-keyword,
+#preview-content .hljs-selector-tag, #setText .hljs-selector-tag,
+#preview-content .hljs-subst, #setText .hljs-subst {
+  color: #d73a49;
+  font-weight: bold;
+}
+.hljs-number, .hljs-literal, .hljs-variable,
+.hljs-template-variable, .hljs-tag .hljs-attr,
+#preview-content .hljs-number, #setText .hljs-number,
+#preview-content .hljs-literal, #setText .hljs-literal,
+#preview-content .hljs-variable, #setText .hljs-variable,
+#preview-content .hljs-template-variable, #setText .hljs-template-variable,
+#preview-content .hljs-tag .hljs-attr, #setText .hljs-tag .hljs-attr {
+  color: #005cc5;
+}
+.hljs-string, .hljs-doctag,
+#preview-content .hljs-string, #setText .hljs-string,
+#preview-content .hljs-doctag, #setText .hljs-doctag {
+  color: #24292e;
+}
+.hljs-title, .hljs-section, .hljs-selector-id,
+#preview-content .hljs-title, #setText .hljs-title,
+#preview-content .hljs-section, #setText .hljs-section,
+#preview-content .hljs-selector-id, #setText .hljs-selector-id {
+  color: #6f42c1;
+  font-weight: bold;
+}
+.hljs-subst,
+#preview-content .hljs-subst, #setText .hljs-subst {
+  font-weight: normal;
+}
+.hljs-type, .hljs-class .hljs-title,
+#preview-content .hljs-type, #setText .hljs-type,
+#preview-content .hljs-class .hljs-title, #setText .hljs-class .hljs-title {
+  color: #458;
+  font-weight: bold;
+}
+.hljs-tag, .hljs-name, .hljs-attribute,
+#preview-content .hljs-tag, #setText .hljs-tag,
+#preview-content .hljs-name, #setText .hljs-name,
+#preview-content .hljs-attribute, #setText .hljs-attribute {
+  color: #000080;
+  font-weight: normal;
+}
+.hljs-regexp, .hljs-link,
+#preview-content .hljs-regexp, #setText .hljs-regexp,
+#preview-content .hljs-link, #setText .hljs-link {
+  color: #009926;
+}
+.hljs-symbol, .hljs-bullet,
+#preview-content .hljs-symbol, #setText .hljs-symbol,
+#preview-content .hljs-bullet, #setText .hljs-bullet {
+  color: #990073;
+}
+.hljs-built_in, .hljs-builtin-name,
+#preview-content .hljs-built_in, #setText .hljs-built_in,
+#preview-content .hljs-builtin-name, #setText .hljs-builtin-name {
+  color: #24292e;
+}
+.hljs-meta,
+#preview-content .hljs-meta, #setText .hljs-meta {
+  color: #999;
+  font-weight: bold;
+}
+.hljs-meta-keyword,
+#preview-content .hljs-meta-keyword, #setText .hljs-meta-keyword {
+  color: #d73a49;
+}
+.hljs-meta-string,
+#preview-content .hljs-meta-string, #setText .hljs-meta-string {
+  color: #032f62;
+}
+.hljs-deletion,
+#preview-content .hljs-deletion, #setText .hljs-deletion {
+  background: #fdd;
+}
+.hljs-addition,
+#preview-content .hljs-addition, #setText .hljs-addition {
+  background: #dfd;
+}
+.hljs-emphasis,
+#preview-content .hljs-emphasis, #setText .hljs-emphasis {
+  font-style: italic;
+}
+.hljs-strong,
+#preview-content .hljs-strong, #setText .hljs-strong {
+  font-weight: bold;
+}
+.table_tabular,
+#preview-content .table_tabular, #setText .table_tabular {
+  overflow-x: auto;
+  padding: 0 2px 0.5em 2px;
+}
+.tabular,
+#preview-content .tabular, #setText .tabular {
+  display: inline-table !important;
+  width: auto;
+  table-layout: auto;
+  border-collapse: collapse;
+  border-spacing: 0;
+  margin: 0 0 1em;
+  font-size: inherit;
+  height: fit-content;
+}
+.tabular th,
+#preview-content .tabular th, #setText .tabular th {
+  border: none !important;
+  padding: 6px 13px;
+  background-color: transparent;
+  font-weight: bold;
+}
+.tabular tr,
+#preview-content .tabular tr, #setText .tabular tr {
+  border-top: none !important;
+  border-bottom: none !important;
+  background-color: transparent;
+}
+.tabular td,
+#preview-content .tabular td, #setText .tabular td {
+  border-style: none !important;
+  background-color: #fff;
+  border-color: #000 !important;
+  word-break: keep-all;
+  padding: 0.1em 0.5em !important;
+}
+.tabular td > p,
+#preview-content .tabular td > p, #setText .tabular td > p {
+  margin-bottom: 0;
+  margin-top: 0;
+}
+.tabular td._empty,
+#preview-content .tabular td._empty, #setText .tabular td._empty {
+  height: 1.3em;
+}
+.tabular td .f,
+#preview-content .tabular td .f, #setText .tabular td .f {
+  opacity: 0;
+}
+#preview-content .sub-table table, #setText .sub-table table {
+  margin-bottom: 0;
+}
+html[data-theme="dark"] .tabular tr,
+html[data-theme="dark"] #preview-content .tabular tr, html[data-theme="dark"] #setText .tabular tr,
+html[data-theme="dark"] .tabular td,
+html[data-theme="dark"] #preview-content .tabular td, html[data-theme="dark"] #setText .tabular td {
+  background-color: #202226;
+  border-color: #fff !important;
+}
+.figure_img,
+#preview-content .figure_img, #setText .figure_img {
+  margin-bottom: 0.5em;
+  overflow-x: auto;
+}
+div.figure_img img,
+#preview-content div.figure_img img, #setText div.figure_img img {
+  display: inline;
+  margin: 0;
+}
+ol.enumerate, ul.itemize,
+#preview-content ol.enumerate, #setText ol.enumerate,
+#preview-content ul.itemize, #setText ul.itemize {
+  padding-inline-start: 40px;
+  margin: 0 0 1em 0;
+}
+li > ol.enumerate, li > ul.itemize,
+#preview-content li > ol.enumerate, #setText li > ol.enumerate,
+#preview-content li > ul.itemize, #setText li > ul.itemize {
+  margin: 0;
+}
+ul.itemize > li,
+#preview-content ul.itemize > li, #setText ul.itemize > li {
+  position: relative;
+  min-height: 1.4em;
+  margin-bottom: 0;
+}
+.enumerate > .li_enumerate,
+#preview-content .enumerate > .li_enumerate, #setText .enumerate > .li_enumerate {
+  margin-bottom: 0;
+}
+.itemize > li > span.li_level, .li_enumerate.not_number > span.li_level,
+#preview-content .itemize > li > span.li_level, #setText .itemize > li > span.li_level,
+#preview-content .li_enumerate.not_number > span.li_level, #setText .li_enumerate.not_number > span.li_level {
+  position: absolute;
+  right: 100%;
+  white-space: nowrap;
+  width: max-content;
+  display: flex;
+  justify-content: flex-end;
+  padding-right: 10px;
+  box-sizing: border-box;
+}
+.li_enumerate.not_number,
+#preview-content .li_enumerate.not_number, #setText .li_enumerate.not_number {
+  position: relative;
+  display: inline-block;
+  list-style-type: none;
+  min-height: 1.4em;
+}
+.itemize > li > span.li_level .math-inline,
+.enumerate > li > span.li_level .math-inline,
+#preview-content .itemize > li > span.li_level .math-inline,
+#setText .itemize > li > span.li_level .math-inline,
+#preview-content .enumerate > li > span.li_level .math-inline,
+#setText .enumerate > li > span.li_level .math-inline {
+  display: inline-block;
+}
+#preview {
+  font-family: 'CMU Serif', 'Georgia', Helvetica, Arial, sans-serif;
+  font-size: 17px;
+  visibility: visible;
+  word-break: break-word;
+  padding: 2.5em;
+  max-width: 800px;
+  margin: auto;
+  box-sizing: content-box;
+}
+#preview h1, #preview h2, #preview h3, #preview h4, #preview h5, #preview strong {
+  font-family: 'CMU Serif Bold', 'Georgia', Helvetica, Arial, sans-serif;
+}
+#preview i, #preview em {
+  font-family: 'CMU Serif Italic', 'Georgia', Helvetica, Arial, sans-serif;
+}
+.mmd-menu {
+  max-width: 320px;
+  position: absolute;
+  background-color: white;
+  color: black;
+  width: auto;
+  padding: 5px 0;
+  border: 1px solid #E5E6EB;
+  margin: 0;
+  cursor: default;
+  font: menu;
+  text-align: left;
+  text-indent: 0;
+  text-transform: none;
+  line-height: normal;
+  letter-spacing: normal;
+  word-spacing: normal;
+  word-wrap: normal;
+  white-space: nowrap;
+  float: none;
+  z-index: 201;
+  border-radius: 5px;
+  -webkit-border-radius: 5px;
+  -moz-border-radius: 5px;
+  -khtml-border-radius: 5px;
+  box-shadow: 0 10px 20px #808080;
+  -webkit-box-shadow: 0 10px 20px #808080;
+  -moz-box-shadow: 0 10px 20px #808080;
+  -khtml-box-shadow: 0 10px 20px #808080;
+}
+.mmd-menu:focus { outline: none; }
+.mmd-menu.mmd-menu-sm {
+  max-width: 100vw;
+  padding-bottom: 34px;
+  border-radius: 0;
+  -webkit-border-radius: 0;
+  -moz-border-radius: 0;
+  -khtml-border-radius: 0;
+}
+.mmd-menu-item-icon {
+  color: #1E2029;
+  margin-left: auto;
+  align-items: center;
+  display: none;
+  flex-shrink: 0;
+}
+.mmd-menu-item {
+  padding: 8px 1.25rem;
+  display: flex;
+  background: transparent;
+  height: 52px;
+  max-height: 52px;
+}
+.mmd-menu-item:focus { outline: none; }
+.mmd-menu-item.active {
+  background-color: #e1e0e5;
+}
+.mmd-menu-item.active .mmd-menu-item-icon {
+  display: flex;
+}
+.mmd-menu-item-container {
+  overflow: hidden;
+}
+.mmd-menu-item-title {
+  color: #1E2029;
+  white-space: nowrap;
+  text-overflow: ellipsis;
+  overflow: hidden;
+  font-size: 14px;
+  line-height: 20px;
+}
+.mmd-menu-item-value {
+  color: #7d829c;
+  white-space: nowrap;
+  text-overflow: ellipsis;
+  overflow: hidden;
+  font-size: 12px;
+  line-height: 16px;
+}
+html[data-theme="dark"] .mmd-menu-item-title {
+  color: #ebefe7;
+}
+html[data-theme="dark"] .mmd-menu-item.active .mmd-menu-item-title {
+  color: #1E2029;
+}
+html[data-theme="dark"] .mmd-menu {
+  background-color: #33363a;
+}
+.mmd-context-menu-overlay {
+  background: rgba(0, 0, 0, 0.56);
+}
+.ClipboardButton {
+  padding: 0;
+  margin: 0.5rem;
+  display: inline-block;
+  cursor: pointer;
+  color: rgb(36, 41, 47);
+  background: rgb(246, 248, 250);
+  border-radius: 6px;
+  border: 1px solid rgba(31, 35, 40, 0.15);
+  box-shadow: rgba(31, 35, 40, 0.04) 0 1px 0 0, rgba(255, 255, 255, 0.25) 0 1px 0 0 inset;
+  position: relative;
+}
+.ClipboardButton:hover {
+  background-color: rgb(243, 244, 246);
+  border-color: rgba(31, 35, 40, 0.15);
+  transition-duration: .1s;
+}
+td .mmd-clipboard-copy-container {
+  line-height: 0;
+}
+td .ClipboardButton {
+  margin: 1px;
+  line-height: 0;
+}
+td .ClipboardButton .mmd-clipboard-icon {
+  margin: 1px !important;
+  transform: scale(0.6);
+}
+.mmd-clipboard-icon {
+  fill: currentColor;
+  vertical-align: text-bottom;
+}
+.mmd-clipboard-copy-icon {
+  color: rgb(101, 109, 118);
+}
+.mmd-clipboard-check-icon {
+  color: rgb(26, 127, 55);
+}
+.mmd-tooltipped-no-delay:hover::before,
+.mmd-tooltipped-no-delay:hover::after {
+  animation-delay: 0s;
+}
+.mmd-tooltipped:hover::before,
+.mmd-tooltipped:hover::after {
+  display: inline-block;
+  text-decoration: none;
+  animation-name: tooltip-appear;
+  animation-duration: .1s;
+  animation-fill-mode: forwards;
+  animation-timing-function: ease-in;
+  animation-delay: .4s;
+}
+.mmd-tooltipped-w::before {
+  top: 50%;
+  bottom: 50%;
+  left: -7px;
+  margin-top: -6px;
+  border-left-color: rgb(36, 41, 47);
+}
+.mmd-tooltipped::before {
+  position: absolute;
+  z-index: 1000001;
+  display: none;
+  width: 0;
+  height: 0;
+  color: rgb(36, 41, 47);
+  pointer-events: none;
+  content: "";
+  border: 6px solid transparent;
+  opacity: 0;
+}
+.mmd-tooltipped-w::after {
+  right: 100%;
+  bottom: 50%;
+  margin-right: 6px;
+  transform: translateY(50%);
+}
+.mmd-tooltipped::after {
+  position: absolute;
+  z-index: 1000000;
+  display: none;
+  padding: 0.5em 0.75em;
+  font: normal normal 11px/1.5 'CMU Serif', 'Georgia', Helvetica, Arial, sans-serif;
+  -webkit-font-smoothing: subpixel-antialiased;
+  color: white;
+  text-align: center;
+  text-decoration: none;
+  text-shadow: none;
+  text-transform: none;
+  letter-spacing: normal;
+  word-wrap: break-word;
+  white-space: pre;
+  pointer-events: none;
+  content: attr(aria-label);
+  background: rgb(36, 41, 47);
+  border-radius: 6px;
+  opacity: 0;
+}</style>
+</head>
+<body>
+  <div id="preview" class="preview scrollEditor">
+    <div id="container-ruller" />
+    <div id="preview-content">
+      <div>Statistical Analysis Plan (China) I6T-MC-AMAN<br>
+A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1)</div>
+<div>NCT03518086<br>
+Approval Date: 02-MAR-2021</div>
+<h1 type="title" class="main-title" id="1.-statistical-analysis-plan-for-maximum-extended-enrollment-addendum-for-i6t-mc-aman%3A-a-phase-3%2C-multicenter%2C-randomized%2C-double-blind%2C-parallel%2C-placebo-controlled-induction-study-of-mirikizumab-in-conventional-failed-and-biologic-failed-patients-with-moderately-to-severely-active-ulcerative-colitis">
+1. Statistical Analysis Plan for Maximum Extended Enrollment Addendum for I6T-MC-AMAN: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis </h1>
+<h2 type="section" data-unnumbered="true" class="section-title" id="confidential-information">
+Confidential Information</h2>
+<div>The information contained in this document is confidential and the information contained within it may not be reproduced or otherwise disseminated without the approval of Eli Lilly and Company or its subsidiaries.</div>
+<div>Note to Regulatory Authorities: this document may contain protected personal data and/or commercially confidential information exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries.</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="mirikizumab-(ly3074828)-ulcerative-colitis">
+Mirikizumab (LY3074828) Ulcerative Colitis</h2>
+<div>Study I6T-MC-AMAN is a Phase 3, multicenter, randomized, double-blind, parallel, placebo-controlled induction study of Mirikizumab in conventional-failed and biologic-failed patients with moderately to severely active ulcerative colitis. The study consists of a 12week induction period where subjects will receive 1 of 2 treatment arms ( <span class="math-inline ">
+<mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.464ex;" xmlns="http://www.w3.org/2000/svg" width="9.225ex" height="1.971ex" role="img" focusable="false" viewBox="0 -666 4077.4 871"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mn"><path data-c="33" d="M127 463Q100 463 85 480T69 524Q69 579 117 622T233 665Q268 665 277 664Q351 652 390 611T430 522Q430 470 396 421T302 350L299 348Q299 347 308 345T337 336T375 315Q457 262 457 175Q457 96 395 37T238 -22Q158 -22 100 21T42 130Q42 158 60 175T105 193Q133 193 151 175T169 130Q169 119 166 110T159 94T148 82T136 74T126 70T118 67L114 66Q165 21 238 21Q293 21 321 74Q338 107 338 175V195Q338 290 274 322Q259 328 213 329L171 330L168 332Q166 335 166 348Q166 366 174 366Q202 366 232 371Q266 376 294 413T322 525V533Q322 590 287 612Q265 626 240 626Q208 626 181 615T143 592T132 580H135Q138 579 143 578T153 573T165 566T175 555T183 540T186 520Q186 498 172 481T127 463Z"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(500,0)"></path><path data-c="30" d="M96 585Q152 666 249 666Q297 666 345 640T423 548Q460 465 460 320Q460 165 417 83Q397 41 362 16T301 -15T250 -22Q224 -22 198 -16T137 16T82 83Q39 165 39 320Q39 494 96 585ZM321 597Q291 629 250 629Q208 629 178 597Q153 571 145 525T137 333Q137 175 145 125T181 46Q209 16 250 16Q290 16 318 46Q347 76 354 130T362 333Q362 478 354 524T321 597Z" transform="translate(1000,0)"></path></g><g data-mml-node="mo" transform="translate(1722.2,0)"><path data-c="2212" d="M84 237T84 250T98 270H679Q694 262 694 250T679 230H98Q84 237 84 250Z"></path></g><g data-mml-node="mi" transform="translate(2722.4,0)"><path data-c="1D45A" d="M21 287Q22 293 24 303T36 341T56 388T88 425T132 442T175 435T205 417T221 395T229 376L231 369Q231 367 232 367L243 378Q303 442 384 442Q401 442 415 440T441 433T460 423T475 411T485 398T493 385T497 373T500 364T502 357L510 367Q573 442 659 442Q713 442 746 415T780 336Q780 285 742 178T704 50Q705 36 709 31T724 26Q752 26 776 56T815 138Q818 149 821 151T837 153Q857 153 857 145Q857 144 853 130Q845 101 831 73T785 17T716 -10Q669 -10 648 17T627 73Q627 92 663 193T700 345Q700 404 656 404H651Q565 404 506 303L499 291L466 157Q433 26 428 16Q415 -11 385 -11Q372 -11 364 -4T353 8T350 18Q350 29 384 161L420 307Q423 322 423 345Q423 404 379 404H374Q288 404 229 303L222 291L189 157Q156 26 151 16Q138 -11 108 -11Q95 -11 87 -5T76 7T74 17Q74 30 112 181Q151 335 151 342Q154 357 154 369Q154 405 129 405Q107 405 92 377T69 316T57 280Q55 278 41 278H27Q21 284 21 287Z"></path></g><g data-mml-node="mi" transform="translate(3600.4,0)"><path data-c="1D454" d="M311 43Q296 30 267 15T206 0Q143 0 105 45T66 160Q66 265 143 353T314 442Q361 442 401 394L404 398Q406 401 409 404T418 412T431 419T447 422Q461 422 470 413T480 394Q480 379 423 152T363 -80Q345 -134 286 -169T151 -205Q10 -205 10 -137Q10 -111 28 -91T74 -71Q89 -71 102 -80T116 -111Q116 -121 114 -130T107 -144T99 -154T92 -162L90 -164H91Q101 -167 151 -167Q189 -167 211 -155Q234 -144 254 -122T282 -75Q288 -56 298 -13Q311 35 311 43ZM384 328L380 339Q377 350 375 354T369 368T359 382T346 393T328 402T306 405Q262 405 221 352Q191 313 171 233T151 117Q151 38 213 38Q269 38 323 108L331 118L384 328Z"></path></g></g></g></svg></mjx-container></span> mirikizumab or placebo) every 4 weeks.</div>
+<div>Eli Lilly and Company Indianapolis, Indiana USA 46285</div>
+<div>Protocol I6T-MC-AMAN<br>
+Phase 3</div>
+<div>Statistical Analysis Plan Addendum Version 1 electronically signed and approved by Lilly on date provided below.</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="2.-table-of-contents">
+2. Table of Contents</h2>
+<div>Section Page</div>
+<ol>
+<li>Statistical Analysis Plan for Maximum Extended Enrollment Addendum for I6T-MC-AMAN: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis ..... 1</li>
+<li>Table of Contents ..... 2</li>
+<li>Revision History ..... 3</li>
+<li>Study Design of Protocol Addendum ..... 5</li>
+<li>A Priori Statistical Methods ..... 6<br>
+5.1. General Considerations ..... 6<br>
+5.2. Analysis Methods ..... 6</li>
+<li>Unblinding Plan ..... 7</li>
+</ol>
+<h2 type="section" data-unnumbered="true" class="section-title" id="table-of-contents">
+Table of Contents</h2>
+<h2 type="section" data-unnumbered="true" class="section-title" id="figure">
+Figure</h2>
+<div>Page<br>
+Figure AMAN.5.1. Milestones for Global and ME2 Cohort enrollment through global and local submissions. ..... 5</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="3.-revision-history">
+3. Revision History</h2>
+<div>I6T-MC-AMAN (AMAN) ME2 Statistical Analysis Plan (SAP) Addendum Version 1 was approved prior to the Week 12 database lock of patients for Study I6T-MC-AMAN (AMAN) primary study cohort.</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="4.-study-design-of-protocol-addendum">
+4. Study Design of Protocol Addendum</h2>
+<div>The detailed rationale and description for the study design of the protocol Maximum Extended Enrollment (ME2) addendum for Study AMAN is described in the Protocol Addendum I6T-MC-AMAN(5).</div>
+<div>Once the protocol milestone of last-patient-enters-treatment (LPET) for the Global Cohort is reached, enrollment will continue for those countries participating in the ME2 cohort, if needed, until sufficient numbers of patients are enrolled to meet the regulatory needs for those countries. Enrollment in the Global Cohort from the respective country is required before enrolling patients in the ME2 Cohort from the same country.</div>
+<div>Figure AMAN.5.1 shows the milestones for enrollment in Study AMAN (Global Cohort and ME2 Cohort) through global and local submissions.<br>
+<figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/ab25796f-44ca-46e8-884a-fd7d6635e5fa-6.jpg?height=248&amp;width=1406&amp;top_left_y=953&amp;top_left_x=292" alt="" data-align="center"></figure></div>
+<div class="table" number="1">
+<div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/ab25796f-44ca-46e8-884a-fd7d6635e5fa-6.jpg?height=556&width=1483&top_left_y=1263&top_left_x=385" alt="" style="max-width: 100%;"/></div><div class="caption_figure">Figure AMAN.5.1. Milestones for Global and ME2 Cohort enrollment through global and local submissions.</div></div>
+<div>Approximately 184 patients from China (from the primary study cohort and ME2 cohort combined) were planned to be enrolled.</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="5.-a-priori-statistical-methods">
+5. A Priori Statistical Methods</h2>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="5.1.-general-considerations">
+5.1. General Considerations</h3>
+<div>As described in the Study AMAN ME2 protocol addendum, the global cohort includes all patients who are enrolled for the purpose of primary study Week 12 database lock. The ME2 cohort includes additional Chinese patients enrolled to meet country-specific sample size requirements. Patients who are randomized in China on or after the date 28 October 2020 will be considered to be in the China ME2 cohort.</div>
+<div>The analyses for the Study AMAN protocol will be conducted on the global cohort. The details of the analyses are described in the global AMAN SAP. This China ME2 SAP addendum describes the efficacy and safety analyses based on the Chinese patients, defined as all randomized patients from sites in China for both the primary study cohort and the ME2 cohort. The analysis of this Chinese population will be based upon statistical considerations provided in the global AMAN SAP. The China ME2 SAP addendum will not need to be updated solely to change which subset of tables, figures, and listings will be produced for the China population. Additional displays/analyses may be performed as deemed necessary.</div>
+<h3 type="subsection" data-unnumbered="true" class="sub_section-title" id="5.2.-analysis-methods">
+5.2. Analysis Methods</h3>
+<div>All analysis endpoint definitions, data handling, analysis population definitions and statistical analysis methods will be the same as in the global AMAN SAP unless otherwise specified. Descriptive summary statistics such as means and proportions will be reported. Analysis considerations such as those presented in the global cohort SAP will be used. For binary efficacy endpoints, the common risk differences (i.e., adjusted for baseline stratification factors) will be estimated. All analyses will be for descriptive purpose only. P-values for between-treatment comparisons may not be displayed for all analysis, and multiplicity adjustment will not be applied.</div>
+<div>The analyses of patient disposition, important protocol deviations, patient characteristics, prior and concomitant therapy will be as described in the global AMAN SAP. The efficacy analysis will be as described in the global AMAN SAP, except that country or region will be excluded from the analysis model. The safety analysis will be the same as described in the global AMAN SAP. The subgroup analysis will be as describe in global AMAN SAP except that the racial origin, ethnicity, and geographical region will not be included. The sensitivity analysis, if conducted, will be the same as in AMAN SAP. No interim analyses are planned for the patients enrolled in ME2 cohort.</div>
+<h2 type="section" data-unnumbered="true" class="section-title" id="6.-unblinding-plan">
+6. Unblinding Plan</h2>
+<div>Patients and site personnel will remain blinded until the ME2 final analysis is conducted, at the addendum completion, prespecified study team members will remain blinded to patient's treatment assignment in the ME2 cohort until the ME2 cohort final database lock. Details will be provided in a separate unblinding plan for Study AMAN, including the global main cohort and ME2 cohort.</div>
+<div>Leo Document ID = 6902da51-e4ec-4b54-a0ae-96145c4b2818</div>
+<div>Approver: PPD<br>
+Approval Date &amp; Time: 02-Mar-2021 00:52:44 GMT<br>
+Signature meaning: Approved</div>
+
+    </div>
+  </div>
+</body>
+</html>

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