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March 2016) has been amended and reissued as 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Amendment number & Date & Summary of changes & Reason for amendment \\\\\n\\hline 01 & 27 March 2017 & Section 2.2.3, two exploratory efficacy endpoints to analyze the change from baseline of the weekly number of migraine days /headache days of at least moderate severity are added. & Teva Clinical decision \\\\\n\\hline & & Section 3.3, the definition of FAS is changed from \"all patients in the ITT population who receive at least 1 dose of study drug and have at least \\(1\\) post baseline efficacy assessment on the primary endpoint\" to \"all patients in the ITT population who receive at least 1 dose of study drug and have at least \\(1 0\\) days of post baseline efficacy assessments on the primary endpoint\". & Per review comments from the FDA \\\\\n\\hline & & Section 4.2, the baseline for calculating weekly endpoints is added. & Teva Clinical decision \\\\\n\\hline & & Section 4.3, Germany is removed fromTable 2, Israel and Finland are added. & Germany did not participate in the 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Israel and Finland enrolled patients. \\\\\n\\hline & & Section 4.4, the hierarchical testing sequence is modified. & Teva Clinical decision \\\\\n\\hline & & Section 4.5, the missing data handling rule is modified. The BOCF imputation is removed. The monthly efficacy variables will be prorated to 28 days if the patient has \\(\\geq 10\\) days of e-diary data for the month. If a patient has <10 days of e-diary data for a month, the monthly number of days/hours of efficacy variables will be considered as missing. & Per review comments from the FDA \\\\\n\\hline & & \\begin{tabular}{l}\nSection 4.5, The missing data handling rule for calculating weekly efficacy variables is added. \\\\\nSection 4.6, the weekly window for the first month (28days) post the first dose is defined.\n\\end{tabular} & Teva Clinical decision \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline Amendment number & Date & Summary of changes & Reason for amendment \\\\\n\\hline 01 & 27 March 2017 & Section 2.2.3, two exploratory efficacy endpoints to analyze the change from baseline of the weekly number of migraine days /headache days of at least moderate severity are added. & Teva Clinical decision \\\\\n\\hline & & Section 3.3, the definition of FAS is changed from \"all patients in the ITT population who receive at least 1 dose of study drug and have at least \\(1\\) post baseline efficacy assessment on the primary endpoint\" to \"all patients in the ITT population who receive at least 1 dose of study drug and have at least \\(1 0\\) days of post baseline efficacy assessments on the primary endpoint\". & Per review comments from the FDA \\\\\n\\hline & & Section 4.2, the baseline for calculating weekly endpoints is added. & Teva Clinical decision \\\\\n\\hline & & Section 4.3, Germany is removed fromTable 2, Israel and Finland are added. & Germany did not participate in the study. 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Patients","text_display":"\nRandomization will be performed using electronic interactive response technology (IRT). 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Final study assessments will be performed at visit 5 (EOT visit),","text_display":"\nbe administered at visits 3 and 4. 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Assessments of migraine-related disability and change in quality of life (using the","text_display":" diary device. 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In addition, patients who consent to pharmacogenomic","text_display":" schedule of assessments (Table 1 ). 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Patients receiving","confidence":0.9965860823871253,"confidence_rate":0.9999677386494035},{"cnt":[[245,1023],[1858,1023],[1858,1074],[245,1074]],"region":{"top_left_x":244,"top_left_y":1022,"width":1615,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85aa273f29684055a92eb7581c55cc01","type":"text","conversion_output":true,"text":"active study drug in the current study will continue receiving the same treatment (ie, monthly sc","text_display":" active study drug in the current study will continue receiving the same treatment (ie, monthly sc","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[1914,1070],[1914,1124],[245,1124]],"region":{"top_left_x":244,"top_left_y":1069,"width":1671,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"772081383c3e409f802f5bdf9eb7c2cb","type":"text","conversion_output":true,"text":"TEV-48125 at 225 mg or quarterly sc TEV-48125 at 675 mg ), and patients receiving placebo in the","text_display":" TEV-48125 at 225 mg or quarterly sc TEV-48125 at 675 mg ), and patients receiving placebo in the","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[245,1121],[1833,1121],[1833,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1121,"width":1589,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"019f26fa2d4d4c5c8736b8abc6475693","type":"text","conversion_output":true,"text":"current study will be randomized in a \\(1: 1\\) ratio to receive monthly sc TEV- 48125 at 225 mg or","text_display":" current study will be randomized in a \\(1: 1\\) ratio to receive monthly sc TEV- 48125 at 225 mg or","confidence":0.9031100635183975,"confidence_rate":0.9990654750463489},{"cnt":[[245,1169],[1854,1169],[1854,1222],[245,1222]],"region":{"top_left_x":244,"top_left_y":1168,"width":1611,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a42becfc0814e9a8bba63105a00dadf","type":"text","conversion_output":true,"text":"quarterly sc TEV-48125 at 675 mg during the long-term safety and efficacy study. 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Patients who","confidence":1,"confidence_rate":1},{"cnt":[[245,1216],[1841,1216],[1841,1270],[245,1270]],"region":{"top_left_x":244,"top_left_y":1216,"width":1598,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57c513c142a84d2190e2840109b6c163","type":"text","conversion_output":true,"text":"withdraw from the study before completing the 12 -week evaluation period will have EOT visit","text_display":" withdraw from the study before completing the 12 -week evaluation period will have EOT visit","confidence":0.9794921875,"confidence_rate":0.9997928112901707},{"cnt":[[245,1265],[1850,1265],[1850,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1265,"width":1606,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe7952978d1c49d1bbfee97af7ebd8f2","type":"text","conversion_output":true,"text":"(visit 5) procedures and assessments performed on the last day they receive the study drug or as","text_display":" (visit 5) procedures and assessments performed on the last day they receive the study drug or as","confidence":1,"confidence_rate":1},{"cnt":[[245,1315],[1914,1315],[1914,1366],[245,1366]],"region":{"top_left_x":244,"top_left_y":1314,"width":1671,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f5bf24606974389838e0622b166523a","type":"text","conversion_output":true,"text":"soon as possible thereafter. Those patients who do not enter the long-term safety and efficacy study","text_display":" soon as possible thereafter. Those patients who do not enter the long-term safety and efficacy study","confidence":1,"confidence_rate":1},{"cnt":[[245,1362],[1893,1362],[1893,1416],[245,1416]],"region":{"top_left_x":244,"top_left_y":1362,"width":1649,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9948b244067a418bbe80357116f627ad","type":"text","conversion_output":true,"text":"for any reason will be offered to enter the long term safety extension for the purpose of evaluating","text_display":" for any reason will be offered to enter the long term safety extension for the purpose of evaluating","confidence":1,"confidence_rate":1},{"cnt":[[245,1412],[1807,1412],[1807,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1411,"width":1563,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21401bdbb4d84a1388214e658b1dbccc","type":"text","conversion_output":true,"text":"ADA approximately 7.5 months ( 225 days [the approximate equivalent of 5 half-lives]) after","text_display":" ADA approximately 7.5 months ( 225 days [the approximate equivalent of 5 half-lives]) after","confidence":1,"confidence_rate":1},{"cnt":[[245,1461],[1214,1461],[1214,1515],[245,1515]],"region":{"top_left_x":244,"top_left_y":1460,"width":970,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfefc1d7ca164f6c934fd8c392f13906","type":"text","conversion_output":true,"text":"administration of the last dose of study drug in this study.","text_display":" administration of the last dose of study drug in this study.","confidence":1,"confidence_rate":1},{"cnt":[[245,1530],[1841,1530],[1841,1583],[245,1583]],"region":{"top_left_x":244,"top_left_y":1529,"width":1598,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5635716edaf4433ac33a9d4f57ea67b","type":"text","conversion_output":true,"text":"The assessments and procedures performed during each study visit are detailed in Table 1. The","text_display":"\nThe assessments and procedures performed during each study visit are detailed in Table 1. The","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,1577],[892,1577],[892,1631],[245,1631]],"region":{"top_left_x":244,"top_left_y":1576,"width":648,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"610bd5b312c14dca81a1f7028def3ee5","type":"text","conversion_output":true,"text":"study schema is presented in Figure 1.","text_display":" study schema is presented in Figure 1.","confidence":1,"confidence_rate":1},{"cnt":[[245,1646],[1871,1646],[1871,1699],[245,1699]],"region":{"top_left_x":244,"top_left_y":1645,"width":1628,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49c7caf5e7fa428caa76b23def110f56","type":"text","conversion_output":true,"text":"The end of the study is defined as the date the last patient attends the EOT/early withdrawal visit","text_display":"\nThe end of the study is defined as the date the last patient attends the EOT/early withdrawal visit","confidence":1,"confidence_rate":1},{"cnt":[[245,1697],[397,1697],[397,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1697,"width":154,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2b1c78bb56b467d96a24af2eb764707","type":"text","conversion_output":true,"text":"(visit 5).","text_display":" (visit 5).","confidence":1,"confidence_rate":1},{"cnt":[[245,1766],[1848,1766],[1848,1818],[245,1818]],"region":{"top_left_x":244,"top_left_y":1766,"width":1604,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"827e41857f384f97ad3c8c10074173dd","type":"text","conversion_output":true,"text":"A total of 768 patients are planned to be randomized in a 1:1:1 ratio ( 256 patients per treatment","text_display":"\n\nA total of 768 patients are planned to be randomized in a 1:1:1 ratio ( 256 patients per treatment","confidence":0.9670572280883789,"confidence_rate":0.9996927297473005},{"cnt":[[245,1813],[1910,1813],[1910,1867],[245,1867]],"region":{"top_left_x":244,"top_left_y":1813,"width":1666,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae0999ef69994ddf889006219cea0c12","type":"text","conversion_output":true,"text":"group) to receive 3 monthly sc doses of TEV-48125 at \\(225 mg , 1 sc\\) dose of TEV-48125 at 675 mg","text_display":" group) to receive 3 monthly sc doses of TEV-48125 at \\(225 mg , 1 sc\\) dose of TEV-48125 at 675 mg","confidence":0.95607590675354,"confidence_rate":0.9995841793596634},{"cnt":[[245,1865],[1880,1865],[1880,1914],[245,1914]],"region":{"top_left_x":244,"top_left_y":1864,"width":1636,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b980c77b91614f30af152edd36453f15","type":"text","conversion_output":true,"text":"followed by 2 monthly sc doses of matching placebo, or 3 monthly sc doses of matching placebo.","text_display":" followed by 2 monthly sc doses of matching placebo, or 3 monthly sc doses of matching placebo.","confidence":0.99658203125,"confidence_rate":0.9999673926902055},{"cnt":[[1038,2557],[1091,2557],[1091,2608],[1038,2608]],"region":{"top_left_x":1037,"top_left_y":2556,"width":55,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea9bd9341dbe46cc9f2583271fa6ecbb","type":"page_info","conversion_output":false,"text":"17","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-19","page":19,"lines":[{"cnt":[[245,125],[1012,125],[1012,178],[245,178]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3800eda6bb24fa78d5fd42036f13553","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,174],[1543,174]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fb38aacd91a46d48f7cf6327c725efc","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[904,251],[904,305],[245,305]],"region":{"top_left_x":244,"top_left_y":251,"width":661,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5a8c065728f44338ba78a0cb5dceaa1","type":"figure_label","conversion_output":false,"text":"Figure 1: Overall Study Schema","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[299,329],[1852,329],[1852,1268],[299,1268]],"region":{"top_left_x":298,"top_left_y":328,"width":1554,"height":940},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50bad1e549f84d818929897e9feeb4aa","type":"diagram","conversion_output":true,"selected_labels":["f5a8c065728f44338ba78a0cb5dceaa1"],"text":"","text_display":"\n\n\\begin{figure}\n\\captionsetup{labelformat=empty}\n\\caption{Figure 1: Overall Study Schema}\n\\includegraphics[alt={},max width=\\textwidth]{https://cdn.mathpix.com/cropped/27095da8-d3cb-46c8-acc8-b1f7518b8cec-19.jpg?height=940&width=1554&top_left_y=328&top_left_x=298}\n\\end{figure}"},{"cnt":[[245,1315],[580,1315],[580,1351],[245,1351]],"region":{"top_left_x":244,"top_left_y":1314,"width":337,"height":38},"line":5,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fb62caabf5fa4d51afcb86c39c119fe5","type":"text","conversion_output":true,"text":"\\(PBO =\\) placebo; \\(V =\\) visit.","text_display":"\n\\(PBO =\\) placebo; \\(V =\\) visit.","confidence":0.9815158322453499,"confidence_rate":0.999481880527688},{"cnt":[[245,1349],[1674,1349],[1674,1390],[245,1390]],"region":{"top_left_x":244,"top_left_y":1349,"width":1430,"height":42},"line":6,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b883d598944149fb8ebe920b3196d421","type":"text","conversion_output":true,"text":"Note: Baseline refers to the 28 -day run-in period for headache variables and visit 2 (day 0 ) for all other variables.","text_display":"\nNote: Baseline refers to the 28 -day run-in period for headache variables and visit 2 (day 0 ) for all other variables.","confidence":0.9858765602111816,"confidence_rate":0.9998930574127487},{"cnt":[[1038,2557],[1091,2557],[1091,2608],[1038,2608]],"region":{"top_left_x":1037,"top_left_y":2556,"width":55,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efd0147a32d64c2a93a23f9b3f1d7332","type":"page_info","conversion_output":false,"text":"18","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-20","page":20,"lines":[{"cnt":[[245,129],[1008,129],[1008,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":764,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c9338233b60495d8fa0f98fd1636634","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2123,129],[2503,129],[2503,170],[2123,170]],"region":{"top_left_x":2122,"top_left_y":128,"width":381,"height":42},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2d35a119e8446d3b8b5d0100e61f559","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1128,254],[1128,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":884,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ee31d28721d4f608d67f22546227a12","type":"figure_label","conversion_output":false,"text":"Table 1: Study Procedures and Assessments","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[226,316],[2421,316],[2421,1738],[226,1738]],"region":{"top_left_x":225,"top_left_y":315,"width":2197,"height":1424},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5acbe2cfc46645199743c1302004a996","type":"table","conversion_output":true,"children_ids":["5ff6b223c29a4be88aee9bdccad5ea7d","aebb744e1ff74f58a251dac2d8c7759c","12c39c94276e4b6aa8d7d7e2acb2956c","e273e2314704413fba9efcef7edbc170","29cdaab721e44f4c869df2d18ca106b0","03fa30bf205847f1a26be8dcddaee39c","f9daa33be4f14a7f892e906aec5d405a","5c35448ef4ca4a33bae67b0c732df633","57acdbf6f3724b02bab8d650a8a0da73","723882f70c9146a996e5253eba460154","e4d2ffb2378c4ef6b072d89b0df28ea9","cb95bc8c234d43cd96c2b4fa82feb9b0","5628aeef9b2a480aaabbee42b91a733b","5f0a62d57eb74d11828c581137ec2247","bc1cf0ce999346379b6f953a6fbdad51","553e9cfcb4c14dfe951976aa8f951278","d5ac341869a3494f8b49ee0404e2ca69","1b1e82613f92452c91996214dd5bcbd8","b554f89ae3c34bdb8084e25388f4249e","32d7c5b697bd4b1abbe383b0a6d02ee7","ec977c080ecc49ffb78f9a161761e7c3","adb31d2683d74ead8f85ab90daef35f7","c0e0043743524fc0be023205fb19e956","d7b49c9d6fbc4f55a82802e39b589841","187b58db2cba4fdd8ff701d37af99cf6","0bc10a647d5b4c35955d34851f85fed0","5501fc9651a847e2908e5bdcca1a15cf","95b2a97ce4074dc49d0d2a7fa770adc2","52334b824e5445019da07077fc279caa","b578c4ea7f3c4ff2b34fda6b7eea7a10","7c75a2f71cdd4b04910a38ef687e3551","1d5ef0b9747b4744a1a16d7e6dd78f8f","867ceecced1d41ecb551137bea00a56f","4d46e04a05bc47c6a2a004b07fed261b","4d6719d1c4074911b3e2edbb2b466c9f","515d6b610dab484292a56ab15140632c","72880bdfe1b8433a83260a9fab0deb1c","42249ba70b6248979dd7a2b063442758","6ae8ad72563b4fb4872d4a8469bf5f43","3231187e14384e21ae6a1ae4b2ffec60","abbe6980c3114bc59e4c1f50bae1d5cc","3e19bd2f516f4524b607783975f0eeb5","443accdaddab42f3b242a0a5be89b026","99b1b780b9114ebd828386b49a76882a","a5aa27e6c1474232a5c42ca075690da6","14475721d9c04da4a9fd68c8ebc4c3eb","53a3055e28a347f5bf0a316495a09bfa","644b07cf20db45fe84633138234deac3","ed66cb9942984b249ea1af4ed6efd824","b27358eaffe94b00a448162527673cd2","02ccb900ae344810be66e56c0c436085","806d9c48eb374d109131707fd3301df1","fe80f86f984e4dfda7fe48a34be56cf4","21559e1459e24711a09ed147e7ebeaf2","12d4d50e334b451b857456cb30cf0604","54a2cf12cf114e9483c7ee7c54f109ec","93443ce7521b45779d4ed6124a6a88e1","1703b91638e6443a956407108829a6ff","d3159336ec1c4454a2ba271770b8a4bd","7c4c8ce1e6e64b3f889c6914928f65d0","d47dcb91ee914a1083a5cecb8357579f","f108050d261b47c3a3eb17a48e7d4dc2","f51007efbfa84cccb85bbb93dda0ec86","55684a81779c47eca02ef0294828fad4","ce1b2dde59944bd0a797e99543219253","5ea0d18921724f408e77c420edc35932","def648c57de0406296746cb53de23837","51bd40c759344482857b90f2d8b3a530","abf8bcb0c54e4b82930271a649c8c15d","27ea409d7d844edf9721b99a087e29ad","7472b97c1a3346a9b98a3a32381c2d5c","c638a59fa1d44cb18caa023f8b40c9da","b4d5c51ab9e9491e928bf0a0ad11222f","7bcd4e88c0b44be9a09db9af1eb9b3b3","ea0bd12ef7c745c8a644f99f6f004a95","dc3d52051ee64197aa5f0a5e11a14107","c914ea07992942b39c2d31b61e82a0c3","c142e02386734aa59bbb58957f729111","9673737c0d4348ec848e84b2fb9ddb3f","8f8988477c034ff2925094b560eb3403","8e58855f9fee4fcb9fa7e9ffae66ad0b","4d355229871d4c41841aa786b2a5a1a4","b658234f024a48bcba095c64fd153581","508de3975cc848e1b7ac3ea27d76daaf","2266de67c0c7468bac14f3635a00996d","97ab9ff3297446c2969ab737a7098814","c75d5c51a014486abdc171d9d8a7808d","5bea674dda064c39ad9bfbac5a69aca6","f144c61abed74a468df6f4f596e2d1bf","b1f6284a3649432991544519f56d34f6","0d9459a73ff24c01885258b6a9c1622d","b64c6f815c764395884e00b199c86895","371917c0d6774c919e369faed137204b","17c4b02500244c30976cb4df133ce0fa","073797c763c9434889cb6f2e6e1ecf89","a8079ad6af0242cbb98f5efc580d2933","fef9f98b8c144fbc91356bf9a1646fbc","2166b50591b749b2b27dc6693a58b478","c423f09cb4894e88a212d144eb3102c7","5741d418b348460f825c22cc8a863ed4"],"selected_labels":["2ee31d28721d4f608d67f22546227a12"],"text":"\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline Study period & Pretreatment period (incl. screening visit and run-in period) & \\multicolumn{4}{|c|}{Double-blind treatment period} \\\\\n\\hline Visit number & V1 & V2 & V3 & V4 & V5 \\\\\n\\hline Month number & Month -1 & Month 0 & Month 1 & Month 2 & Month 3 \\\\\n\\hline Procedures and assessments (completed before dosing, when applicable, unless otherwise noted) & Screening days -28 to -1 & Baseline dose 1 day 0 (+3 days) & Dose 2 day 28 ( \\(\\pm 3\\) days) & Dose 3 day 56 ( \\(\\pm 3\\) days) & EOT or early withdrawal day 84 ( \\(\\pm 3\\) days) \\\\\n\\hline Informed consent & X & & & & \\\\\n\\hline Medical and psychiatric history & X & & & & \\\\\n\\hline Prior medication history & X & & & & \\\\\n\\hline Record demographic characteristics & X & & & & \\\\\n\\hline Inclusion and exclusion criteria & X & X & & & \\\\\n\\hline Randomization & & X & & & \\\\\n\\hline Physical examination, including weight and height \\({ }^{ a }\\) & X & X & & & X \\\\\n\\hline Triplicate 12-lead ECG \\({ }^{\\text {b,c }}\\) & X & X & & & X \\\\\n\\hline Vital signs measurement \\({ }^{\\text {b }}\\) & X & X & X & X & X \\\\\n\\hline Adverse events \\({ }^{ d }\\) & X & X & X & X & X \\\\\n\\hline Concomitant medication inquiry & X & X & X & X & X \\\\\n\\hline Clinical laboratory tests \\({ }^{\\text {e }}\\) & X & X & X & X & X \\\\\n\\hline Serum \\(\\beta\\)-HCG test \\({ }^{ f }\\) & X & & & & \\\\\n\\hline Urine \\(\\beta\\)-HCG test \\({ }^{ f }\\) & & X & X & X & X \\\\\n\\hline FSH \\({ }^{\\text {g }}\\) & X & & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 1: Study Procedures and Assessments}\n\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline Study period & Pretreatment period (incl. screening visit and run-in period) & \\multicolumn{4}{|c|}{Double-blind treatment period} \\\\\n\\hline Visit number & V1 & V2 & V3 & V4 & V5 \\\\\n\\hline Month number & Month -1 & Month 0 & Month 1 & Month 2 & 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Primary Efficacy Endpoint","text_display":"\n\n\\subsection*{2.2.1. 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\\%\\) reduction in the monthly average number of","confidence":1,"confidence_rate":1},{"cnt":[[430,812],[1648,812],[1648,868],[430,868]],"region":{"top_left_x":429,"top_left_y":812,"width":1219,"height":56},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e132a3c845584421b1ebc570907722e4","type":"text","conversion_output":true,"text":"migraine days during the 12 -week period after the \\(1^{\\text {st }}\\) dose of study drug","text_display":" migraine days during the 12 -week period after the \\(1^{\\text {st }}\\) dose of study drug","confidence":0.91845703125,"confidence_rate":0.9991143491198482},{"cnt":[[370,885],[1865,885],[1865,939],[370,939]],"region":{"top_left_x":369,"top_left_y":885,"width":1496,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3761f1c61cce48009613d374a9f921e2","type":"text","conversion_output":true,"text":"- mean change from baseline (28-day run-in period) in the monthly average 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patients who use migraine-specific acute","confidence":1,"confidence_rate":1},{"cnt":[[430,1809],[999,1809],[999,1854],[430,1854]],"region":{"top_left_x":429,"top_left_y":1808,"width":571,"height":47},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34a293101ffe4a688242a5d96a05eb2b","type":"text","conversion_output":true,"text":"headache medications at baseline","text_display":" headache medications at baseline","confidence":1,"confidence_rate":1},{"cnt":[[370,1882],[1205,1882],[1205,1931],[370,1931]],"region":{"top_left_x":369,"top_left_y":1882,"width":837,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f935717d4aa547969cea9a3a0a16c272","type":"text","conversion_output":true,"text":"- total number of days with nausea or vomiting","text_display":"\n- total number of days with nausea or 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the TEV-48125","text_display":" migraine days during the 12 -week period after the \\(1^{\\text {st }}\\) dose of study drug for the TEV-48125","confidence":0.8126314374385402,"confidence_rate":0.998181676133814},{"cnt":[[370,868],[1772,868],[1772,917],[370,917]],"region":{"top_left_x":369,"top_left_y":867,"width":1404,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9f7505548654990a02178988a089841","type":"text","conversion_output":true,"text":"\\(225 / 225 / 225 mg\\) treatment group versus the placebo treatment group in patients not","text_display":" \\(225 / 225 / 225 mg\\) treatment group versus the placebo treatment group in patients 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resulting 2 -sided p -value from the first comparison is \\(\\leq 0.05\\), then the next comparison of","text_display":"\n\nIf the resulting 2 -sided p -value from the first comparison is \\(\\leq 0.05\\), then the next comparison of","confidence":0.998046875,"confidence_rate":0.9999831463934391},{"cnt":[[245,1248],[1897,1248],[1897,1298],[245,1298]],"region":{"top_left_x":244,"top_left_y":1248,"width":1654,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab0fcb9f4f074767a252eca0ce1a60d7","type":"text","conversion_output":true,"text":"interest will be interpreted inferentially at the alpha level of 0.05 . This process will continue either","text_display":" interest will be interpreted inferentially at the alpha level of 0.05 . This process will continue either","confidence":0.9990234375,"confidence_rate":0.9999913536688149},{"cnt":[[245,1298],[1910,1298],[1910,1347],[245,1347]],"region":{"top_left_x":244,"top_left_y":1297,"width":1666,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a1029686dde4f3a885746d2ee6a12a8","type":"text","conversion_output":true,"text":"until all comparisons of interest are interpreted inferentially or until the point at which the resulting","text_display":" until all comparisons of interest are interpreted inferentially or until the point at which the resulting","confidence":1,"confidence_rate":1},{"cnt":[[245,1345],[1775,1345],[1775,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1344,"width":1531,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cde5baf1a3624d0198478eea6000f30e","type":"text","conversion_output":true,"text":"2 -sided p value for a comparison of interest is \\(>0.05\\). At the point where \\(p >0.05\\), no further","text_display":" 2 -sided p value for a comparison of interest is \\(>0.05\\). At the point where \\(p >0.05\\), no further","confidence":0.9970703125,"confidence_rate":0.9999742635993027},{"cnt":[[245,1392],[1003,1392],[1003,1446],[245,1446]],"region":{"top_left_x":244,"top_left_y":1392,"width":760,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"232ef152a9cc460b89a3747a38c0be41","type":"text","conversion_output":true,"text":"comparisons will be interpreted inferentially.","text_display":" comparisons will be interpreted inferentially.","confidence":1,"confidence_rate":1},{"cnt":[[236,1480],[1302,1480],[1302,1549],[236,1549]],"region":{"top_left_x":236,"top_left_y":1480,"width":1066,"height":70},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c00d6feea1ef4234b80de7298431c5b8","type":"section_header","conversion_output":false,"children_ids":["422ddc4176014d94a58e31eb30bc447a"],"text":"","text_display":""},{"cnt":[[245,1487],[1296,1487],[1296,1543],[245,1543]],"region":{"top_left_x":244,"top_left_y":1486,"width":1052,"height":57},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"422ddc4176014d94a58e31eb30bc447a","type":"text","conversion_output":true,"parent_id":"c00d6feea1ef4234b80de7298431c5b8","text":"4.5. Handling Withdrawals and Missing Data","text_display":"\n\n\\subsection*{4.5. Handling Withdrawals and Missing Data}","confidence":0.9970703125,"confidence_rate":0.9999375766838463},{"cnt":[[245,1555],[1919,1555],[1919,1611],[245,1611]],"region":{"top_left_x":244,"top_left_y":1555,"width":1675,"height":57},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a24710d114424bbd8f6f16b38b2d378d","type":"text","conversion_output":true,"text":"If a patient has \\(\\geq 10\\) days of the e-diary data after \\(1^{\\text {st }}\\) dose of the study drug, his/her monthly average","text_display":"\n\nIf a patient has \\(\\geq 10\\) days of the e-diary data after \\(1^{\\text {st }}\\) dose of the study drug, his/her monthly average","confidence":0.998046875,"confidence_rate":0.9999844839708844},{"cnt":[[245,1609],[1811,1609],[1811,1661],[245,1661]],"region":{"top_left_x":244,"top_left_y":1609,"width":1568,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"861f1aee0b594e9da3e98479bdd0d33c","type":"text","conversion_output":true,"text":"number of days/hours of efficacy variables during the 12-week period or monthly number of","text_display":" number of days/hours of efficacy variables during the 12-week period or monthly number of","confidence":1,"confidence_rate":1},{"cnt":[[245,1659],[1691,1659],[1691,1708],[245,1708]],"region":{"top_left_x":244,"top_left_y":1658,"width":1447,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"173e7107888f4681b0e0e6161df97045","type":"text","conversion_output":true,"text":"days/hours of efficacy variables during the 4-week period will be prorated to \\(2 8\\) days.","text_display":" days/hours of efficacy variables during the 4-week period will be prorated to \\(2 8\\) days.","confidence":0.9858465194702148,"confidence_rate":0.9998530561966565},{"cnt":[[245,1727],[1858,1727],[1858,1777],[245,1777]],"region":{"top_left_x":244,"top_left_y":1727,"width":1615,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"247249b3342441bb8809a945d1f2fec7","type":"text","conversion_output":true,"text":"Multiple imputation (MI) method will be applied on the primary variable as sensitivity analyses.","text_display":"\n\nMultiple imputation (MI) method will be applied on the primary variable as sensitivity analyses.","confidence":1,"confidence_rate":1},{"cnt":[[245,1775],[1195,1775],[1195,1824],[245,1824]],"region":{"top_left_x":244,"top_left_y":1774,"width":951,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f241f4e261ea4fa1a99e570fb12e3a13","type":"text","conversion_output":true,"text":"The methods will be described in detail in Section 6.2.3.","text_display":" The methods will be described in detail in Section 6.2.3.","confidence":1,"confidence_rate":1},{"cnt":[[245,1846],[1927,1846],[1927,1897],[245,1897]],"region":{"top_left_x":244,"top_left_y":1845,"width":1684,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72b0e29272ba43ad98a1240eaaceae46","type":"text","conversion_output":true,"text":"A patient's monthly number of days/hours of efficacy variables during the 4-week period after each","text_display":"\n\nA patient's monthly number of days/hours of efficacy variables during the 4-week period after each","confidence":0.998046875,"confidence_rate":0.9999810192594005},{"cnt":[[245,1895],[1910,1895],[1910,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1894,"width":1666,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a19fe3116b043dca8440a5cd772d4f5","type":"text","conversion_output":true,"text":"dose of study drug will be calculated for months 1,2 , and 3 . If a patient has missing diary days in a","text_display":" dose of study drug will be calculated for months 1,2 , and 3 . If a patient has missing diary days in a","confidence":0.99951171875,"confidence_rate":0.9999957157942815},{"cnt":[[245,1942],[1407,1942],[1407,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1942,"width":1164,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"319bb7c392774f8eafa9983dcd5c8dba","type":"text","conversion_output":true,"text":"month, the following method will be used to handle the missing data.","text_display":" month, the following method will be used to handle the missing data.","confidence":1,"confidence_rate":1},{"cnt":[[370,2015],[1869,2015],[1869,2065],[370,2065]],"region":{"top_left_x":369,"top_left_y":2015,"width":1501,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d298ceb46c074303a56c81804ab9a8e3","type":"text","conversion_output":true,"text":"- If the patient has 10 or more days of e-diary data for a month, the monthly number of","text_display":"\n- If the patient has 10 or more days of e-diary data for a month, the monthly number of","confidence":1,"confidence_rate":1},{"cnt":[[432,2062],[1687,2062],[1687,2112],[432,2112]],"region":{"top_left_x":431,"top_left_y":2062,"width":1256,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c289736121446eb8c2b54d64720bc02","type":"text","conversion_output":true,"text":"days/hours of efficacy variables will be prorated to \\(2 8\\) days for that month.","text_display":" days/hours of efficacy variables will be prorated to \\(2 8\\) days for that month.","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[370,2136],[1882,2136],[1882,2185],[370,2185]],"region":{"top_left_x":369,"top_left_y":2135,"width":1514,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"585783b173b542f180ffa1687871e432","type":"text","conversion_output":true,"text":"- If the patient has less than 10 days of e-diary data for a month, the monthly number of","text_display":"\n- If the patient has less than 10 days of e-diary data for a month, the monthly number of","confidence":1,"confidence_rate":1},{"cnt":[[432,2183],[1485,2183],[1485,2237],[432,2237]],"region":{"top_left_x":431,"top_left_y":2182,"width":1054,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aba2eebeff0b49f592be829619a9680b","type":"text","conversion_output":true,"text":"days/hours of efficacy variables will be considered as missing.","text_display":" days/hours of efficacy variables will be considered as missing.","confidence":0.99853515625,"confidence_rate":0.9999784426193857},{"cnt":[[245,2252],[1807,2252],[1807,2301],[245,2301]],"region":{"top_left_x":244,"top_left_y":2251,"width":1563,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"670d90d3d06c4b57931731debc5df853","type":"text","conversion_output":true,"text":"The weekly number of migraine days and headache days of at least moderate severity will be","text_display":"\nThe weekly number of migraine days and headache days of at least moderate severity will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2299],[1910,2299],[1910,2350],[245,2350]],"region":{"top_left_x":244,"top_left_y":2298,"width":1666,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88a7bb883aa34cd09e697b4634b5ccb1","type":"text","conversion_output":true,"text":"calculated for the patients' first 28 calendar days of diary data after the \\(1^{\\text {st }}\\) dose of study drug. Each","text_display":" calculated for the patients' first 28 calendar days of diary data after the \\(1^{\\text {st }}\\) dose of study drug. Each","confidence":0.943359375,"confidence_rate":0.999540987493552},{"cnt":[[245,2346],[1824,2346],[1824,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2346,"width":1581,"height":54},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3329bf6e6e864dc8a71a10524d3a1399","type":"text","conversion_output":true,"text":"week is defined as 7 calendar days with week 1 counted from the \\(1^{\\text {st }}\\) dose date. If a patient has","text_display":" week is defined as 7 calendar days with week 1 counted from the \\(1^{\\text {st }}\\) dose date. If a patient has","confidence":0.9990234375,"confidence_rate":0.9999919253247671},{"cnt":[[245,2398],[1783,2398],[1783,2449],[245,2449]],"region":{"top_left_x":244,"top_left_y":2397,"width":1540,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2a283affd764c94a314aa482de5d6ec","type":"text","conversion_output":true,"text":"missing diary days in a week, the following method will be used to handle the missing data.","text_display":" missing diary days in a week, the following method will be used to handle the missing data.","confidence":1,"confidence_rate":1},{"cnt":[[1057,2557],[1113,2557],[1113,2608],[1057,2608]],"region":{"top_left_x":1057,"top_left_y":2556,"width":56,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e73941b6ae140c881482391c82b79cf","type":"page_info","conversion_output":false,"text":"30","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-32","page":32,"lines":[{"cnt":[[245,125],[1012,125],[1012,176],[245,176]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df3812c063a6480785d558f6be0d7695","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c94f3343acd42969d4dae16b40bde66","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,254],[1824,254],[1824,305],[370,305]],"region":{"top_left_x":369,"top_left_y":253,"width":1456,"height":53},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31a81a37ae224de5befaf29f18a9f992","type":"text","conversion_output":true,"text":"- If the patient has \\(\\geq 3\\) days of e-diary data for a week, the weekly number of days of","text_display":"\n- If the patient has \\(\\geq 3\\) days of e-diary data for a week, the weekly number of days of","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[432,305],[1412,305],[1412,354],[432,354]],"region":{"top_left_x":431,"top_left_y":305,"width":981,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70502421a6bf4571b556e42e75c5bd62","type":"text","conversion_output":true,"text":"efficacy variables will be prorated to 7 days for that week.","text_display":" efficacy variables will be prorated to 7 days for that week.","confidence":0.99951171875,"confidence_rate":0.9999928176655267},{"cnt":[[370,374],[1824,374],[1824,425],[370,425]],"region":{"top_left_x":369,"top_left_y":373,"width":1456,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06653f4b92d5457fbcd17ff4f39c6f06","type":"text","conversion_output":true,"text":"- If the patient has \\(< 3\\) days of e-diary data for a week, the weekly number of days of","text_display":"\n- If the patient has \\(< 3\\) days of e-diary data for a week, the weekly number of days of","confidence":0.998046875,"confidence_rate":0.9999796352611579},{"cnt":[[432,423],[1480,423],[1480,475],[432,475]],"region":{"top_left_x":431,"top_left_y":423,"width":1050,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2a9732ac7fa464a9c2dfd7e9626d0f3","type":"text","conversion_output":true,"text":"efficacy variables will be considered as missing for that week.","text_display":" efficacy variables will be considered as missing for that week.","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1790,494],[1790,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1546,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"879c20f2ebde4ed09031a62bda77e07d","type":"text","conversion_output":true,"text":"The handling of missing questionnaire items for the MSQOL questionnaire (Appendix D) is","text_display":"\n\nThe handling of missing questionnaire items for the MSQOL questionnaire (Appendix D) is","confidence":0.82421875,"confidence_rate":0.9979009093199612},{"cnt":[[245,541],[1227,541],[1227,591],[245,591]],"region":{"top_left_x":244,"top_left_y":541,"width":983,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2442a082ad34a7e99e3922e45400ed3","type":"text","conversion_output":true,"text":"discussed in Appendix E: scoring instruction for MSQOL.","text_display":" discussed in Appendix E: scoring instruction for MSQOL.","confidence":1,"confidence_rate":1},{"cnt":[[236,627],[1094,627],[1094,696],[236,696]],"region":{"top_left_x":236,"top_left_y":627,"width":858,"height":70},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37a40fce987c481e97354e5c6c73d803","type":"section_header","conversion_output":false,"children_ids":["b2c9746e7eff45fbbdcf675f1bc7bd96"],"text":"","text_display":""},{"cnt":[[243,632],[1085,632],[1085,690],[243,690]],"region":{"top_left_x":242,"top_left_y":631,"width":843,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2c9746e7eff45fbbdcf675f1bc7bd96","type":"text","conversion_output":true,"parent_id":"37a40fce987c481e97354e5c6c73d803","text":"4.6. Study Days and Visit Windows","text_display":"\n\n\\subsection*{4.6. Study Days and Visit Windows}","confidence":0.98876953125,"confidence_rate":0.9997028334622313},{"cnt":[[245,705],[1803,705],[1803,758],[245,758]],"region":{"top_left_x":244,"top_left_y":704,"width":1559,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"631afde7c49d466791c4e1b4a13eac3b","type":"text","conversion_output":true,"text":"Study days will be numbered relative to the \\(1^{\\text {st }}\\) day of study drug administration. The start of","text_display":"\n\nStudy days will be numbered relative to the \\(1^{\\text {st }}\\) day of study drug administration. The start of","confidence":0.865234375,"confidence_rate":0.9987310263990139},{"cnt":[[245,752],[1914,752],[1914,808],[245,808]],"region":{"top_left_x":244,"top_left_y":751,"width":1671,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b7eb2e788ed4d8891d5b7f85e29c10a","type":"text","conversion_output":true,"text":"treatment (visit 2 or day 1 ) is defined as the date on which a patient takes the \\(1^{\\text {st }}\\) dose of study drug,","text_display":" treatment (visit 2 or day 1 ) is defined as the date on which a patient takes the \\(1^{\\text {st }}\\) dose of study drug,","confidence":0.9956102357245982,"confidence_rate":0.9999664171472699},{"cnt":[[245,804],[1863,804],[1863,855],[245,855]],"region":{"top_left_x":244,"top_left_y":803,"width":1619,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d01f8ca7a4ef4bc8b8b2bbb5b9a510e7","type":"text","conversion_output":true,"text":"as recorded on the study drug administration CRF. Days will be numbered relative to study drug","text_display":" as recorded on the study drug administration CRF. Days will be numbered relative to study drug","confidence":1,"confidence_rate":1},{"cnt":[[245,855],[1914,855],[1914,904],[245,904]],"region":{"top_left_x":244,"top_left_y":855,"width":1671,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0fb22e2c1184b0eb5f004b3efca1243","type":"text","conversion_output":true,"text":"start (ie, \\(\\ldots,-2,-1,1,2, \\ldots\\); with day 1 being the start of study drug and day -1 being the day before","text_display":" start (ie, \\(\\ldots,-2,-1,1,2, \\ldots\\); with day 1 being the start of study drug and day -1 being the day before","confidence":0.8674761722033806,"confidence_rate":0.998742673975962},{"cnt":[[245,902],[642,902],[642,952],[245,952]],"region":{"top_left_x":244,"top_left_y":902,"width":399,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af42ae0d99d94ab2bc2bbf15603a016b","type":"text","conversion_output":true,"text":"the start of study drug).","text_display":" the start of study drug).","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[1846,971],[1846,1021],[245,1021]],"region":{"top_left_x":244,"top_left_y":971,"width":1602,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71d587d63d124e8390848a1582961efa","type":"text","conversion_output":true,"text":"The 4-week (28-day) visit windows for the e-diary based efficacy endpoints will be determined","text_display":"\n\nThe 4-week (28-day) visit windows for the e-diary based efficacy endpoints will be determined","confidence":0.95166015625,"confidence_rate":0.9994945432286642},{"cnt":[[245,1018],[1897,1018],[1897,1072],[245,1072]],"region":{"top_left_x":244,"top_left_y":1018,"width":1654,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9b6bb67a47c4f299e7227be56b24857","type":"text","conversion_output":true,"text":"based on the actual dosing day. The run-in phase is defined as day -28 to -1 before the \\(1^{\\text {st }}\\) injection","text_display":" based on the actual dosing day. The run-in phase is defined as day -28 to -1 before the \\(1^{\\text {st }}\\) injection","confidence":0.9980475902557373,"confidence_rate":0.999984611786269},{"cnt":[[245,1068],[1897,1068],[1897,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1067,"width":1654,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7be16be9f8554c2b8866a08f0ae520f9","type":"text","conversion_output":true,"text":"on day 1 . Treatment phase including month 1,2 and 3 is from the beginning of the \\(1^{\\text {st }}\\) injection of","text_display":" on day 1 . Treatment phase including month 1,2 and 3 is from the beginning of the \\(1^{\\text {st }}\\) injection of","confidence":0.9931743110064417,"confidence_rate":0.9999460716072799},{"cnt":[[245,1117],[1895,1117],[1895,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":1651,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00379b54c22747ae9f61cc95ce0091e3","type":"text","conversion_output":true,"text":"study drug to visit 5/day 84 or the end of treatment visit. The 3-month visit windows are separated","text_display":" study drug to visit 5/day 84 or the end of treatment visit. The 3-month visit windows are separated","confidence":0.7585086822509766,"confidence_rate":0.9974201463267167},{"cnt":[[245,1164],[1919,1164],[1919,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1675,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c5b6e241f1c42a88927e516a201691e","type":"text","conversion_output":true,"text":"by each dosing date/time. Month 1 is from the date/time of the \\(1^{\\text {st }}\\) dose of study drug administration","text_display":" by each dosing date/time. Month 1 is from the date/time of the \\(1^{\\text {st }}\\) dose of study drug administration","confidence":1,"confidence_rate":1},{"cnt":[[245,1210],[1888,1210],[1888,1265],[245,1265]],"region":{"top_left_x":244,"top_left_y":1209,"width":1645,"height":57},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36fbd76448244713bf1b2631868918a4","type":"text","conversion_output":true,"text":"on day 1 to the date/time just before the \\(2^{\\text {nd }}\\) dose. Month 2 is from the date/time of the \\(2^{\\text {nd }}\\) dose to","text_display":" on day 1 to the date/time just before the \\(2^{\\text {nd }}\\) dose. Month 2 is from the date/time of the \\(2^{\\text {nd }}\\) dose to","confidence":0.9264106750488281,"confidence_rate":0.9994580359292503},{"cnt":[[245,1257],[1882,1257],[1882,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1256,"width":1639,"height":57},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdcb904405e04314bd4245ecf8ca225a","type":"text","conversion_output":true,"text":"the date/time just before the \\(3^{\\text {rd }}\\) dose. Month 3 is from the date/time of the \\(3^{\\text {rd }}\\) dose to the end of","text_display":" the date/time just before the \\(3^{\\text {rd }}\\) dose. Month 3 is from the date/time of the \\(3^{\\text {rd }}\\) dose to the end of","confidence":0.9921972721349448,"confidence_rate":0.9999428240548356},{"cnt":[[245,1311],[844,1311],[844,1364],[245,1364]],"region":{"top_left_x":244,"top_left_y":1310,"width":601,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"678bf5438ad9431b99dd6a8ae44824bc","type":"text","conversion_output":true,"text":"the study on day 84 approximately.","text_display":" the study on day 84 approximately.","confidence":1,"confidence_rate":1},{"cnt":[[245,1381],[1837,1381],[1837,1433],[245,1433]],"region":{"top_left_x":244,"top_left_y":1381,"width":1593,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cebd7e2e85f24f99bf6f765804e2dbb9","type":"text","conversion_output":true,"text":"Throughout this document, all by month efficacy summaries for the headache data will refer to","text_display":"\nThroughout this document, all by month efficacy summaries for the headache data will refer to","confidence":1,"confidence_rate":1},{"cnt":[[245,1431],[593,1431],[593,1476],[245,1476]],"region":{"top_left_x":244,"top_left_y":1430,"width":349,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c31598f70fd4b2982e26f8097f8b8e8","type":"text","conversion_output":true,"text":"these visit windows.","text_display":" these visit windows.","confidence":1,"confidence_rate":1},{"cnt":[[245,1500],[1841,1500],[1841,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1499,"width":1598,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e40b6f0b295a4737958effb3aae2e20f","type":"text","conversion_output":true,"text":"The weekly (7-day) windows for calculating the weekly efficacy endpoints for the first 28 days","text_display":"\n\nThe weekly (7-day) windows for calculating the weekly efficacy endpoints for the first 28 days","confidence":0.998046875,"confidence_rate":0.9999808331754918},{"cnt":[[245,1547],[1865,1547],[1865,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1546,"width":1621,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d07bcfb3fd64457cbd0dd14fa7fe654f","type":"text","conversion_output":true,"text":"will be determined based on the \\(1^{\\text {st }}\\) dosing day. The first week is from day 1 to day 7 , the second","text_display":" will be determined based on the \\(1^{\\text {st }}\\) dosing day. The first week is from day 1 to day 7 , the second","confidence":1,"confidence_rate":1},{"cnt":[[245,1598],[1901,1598],[1901,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1598,"width":1658,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a565cfe56309473bbca670660eb3ee2c","type":"text","conversion_output":true,"text":"week is from day 8 to day 14 , the third week is from day 15 to day 21 , and the fourth week is from","text_display":" week is from day 8 to day 14 , the third week is from day 15 to day 21 , and the fourth week is from","confidence":0.6857001781463623,"confidence_rate":0.9967802815838009},{"cnt":[[245,1646],[1706,1646],[1706,1695],[245,1695]],"region":{"top_left_x":244,"top_left_y":1645,"width":1462,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"934cafa409684f21995c7340d2231292","type":"text","conversion_output":true,"text":"day 22 to day 28 . Only the days between the first and the second dose will be included.","text_display":" day 22 to day 28 . Only the days between the first and the second dose will be included.","confidence":1,"confidence_rate":1},{"cnt":[[245,1714],[1865,1714],[1865,1764],[245,1764]],"region":{"top_left_x":244,"top_left_y":1714,"width":1621,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"716fa1a0f26a4944b02bd72fa1b69574","type":"text","conversion_output":true,"text":"For all other by-visit summaries, if there are multiple assessments at a postbaseline visit then the","text_display":"\n\nFor all other by-visit summaries, if there are multiple assessments at a postbaseline visit then the","confidence":1,"confidence_rate":1},{"cnt":[[245,1766],[1914,1766],[1914,1815],[245,1815]],"region":{"top_left_x":244,"top_left_y":1766,"width":1671,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c077808df99c453fb9f58e505762f2ff","type":"text","conversion_output":true,"text":"last non-missing assessment at that visit will be used for the summary. This includes assessments at","text_display":" last non-missing assessment at that visit will be used for the summary. This includes assessments at","confidence":1,"confidence_rate":1},{"cnt":[[245,1813],[879,1813],[879,1858],[245,1858]],"region":{"top_left_x":244,"top_left_y":1813,"width":635,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef5bb0c09b974382aa7a2e986f0ae45e","type":"text","conversion_output":true,"text":"the scheduled and unscheduled visits.","text_display":" the scheduled and unscheduled visits.","confidence":1,"confidence_rate":1},{"cnt":[[245,1882],[1807,1882],[1807,1931],[245,1931]],"region":{"top_left_x":244,"top_left_y":1882,"width":1563,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0898050ab16b4645b6ca0b167c9624ee","type":"text","conversion_output":true,"text":"Endpoint for analyses and summaries is the last observed postbaseline data. For patients who","text_display":"\n\nEndpoint for analyses and summaries is the last observed postbaseline data. For patients who","confidence":1,"confidence_rate":1},{"cnt":[[245,1929],[1813,1929],[1813,1981],[245,1981]],"region":{"top_left_x":244,"top_left_y":1929,"width":1570,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34caeecb4ad5421aaa5578a9b068f67f","type":"text","conversion_output":true,"text":"withdraw from the study, data at the early termination visit will be excluded from the by-visit","text_display":" withdraw from the study, data at the early termination visit will be excluded from the by-visit","confidence":1,"confidence_rate":1},{"cnt":[[245,1979],[1240,1979],[1240,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1978,"width":996,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7af35fbd8ab24da69316bbb913b77d33","type":"text","conversion_output":true,"text":"summaries but will be included in the endpoint summaries.","text_display":" summaries but will be included in the endpoint summaries.","confidence":1,"confidence_rate":1},{"cnt":[[1061,2557],[1109,2557],[1109,2600],[1061,2600]],"region":{"top_left_x":1061,"top_left_y":2556,"width":48,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a4eaba0649b4ea98a9a21f61c5f29bc","type":"page_info","conversion_output":false,"text":"31","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-33","page":33,"lines":[{"cnt":[[245,127],[1012,127],[1012,174],[245,174]],"region":{"top_left_x":244,"top_left_y":126,"width":768,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87bc5ecc2f004100876ce198279259af","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"558c2d76f05a4a53998c2c013ec9d72c","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,314],[1218,314],[1218,367],[241,367]],"region":{"top_left_x":240,"top_left_y":313,"width":979,"height":55},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77d6fa3262794cb69fe9f2f7d3fa8d82","type":"section_header","conversion_output":false,"children_ids":["7400530d44c84cdc91cfdcd2e5965bb2"],"text":"","text_display":""},{"cnt":[[245,318],[1214,318],[1214,363],[245,363]],"region":{"top_left_x":244,"top_left_y":317,"width":970,"height":47},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7400530d44c84cdc91cfdcd2e5965bb2","type":"text","conversion_output":true,"parent_id":"77d6fa3262794cb69fe9f2f7d3fa8d82","text":"5. 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For categorical variables, patient counts and percentages will be provided.","text_display":" will be provided. For categorical variables, patient counts and percentages will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[1222,752],[1222,804],[245,804]],"region":{"top_left_x":244,"top_left_y":751,"width":979,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0131af73fcd42bfa7c1b2a4953a1a5b","type":"text","conversion_output":true,"text":"Categories for missing data will be presented if necessary.","text_display":" Categories for missing data will be presented if necessary.","confidence":1,"confidence_rate":1},{"cnt":[[241,838],[840,838],[840,904],[241,904]],"region":{"top_left_x":240,"top_left_y":837,"width":601,"height":68},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d757d988489e42ae96ef40efc3ed3503","type":"section_header","conversion_output":false,"children_ids":["0aa0028b098843be8d5fa0b4f8aa7ca8"],"text":"","text_display":""},{"cnt":[[245,844],[836,844],[836,900],[245,900]],"region":{"top_left_x":244,"top_left_y":844,"width":592,"height":57},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0aa0028b098843be8d5fa0b4f8aa7ca8","type":"text","conversion_output":true,"parent_id":"d757d988489e42ae96ef40efc3ed3503","text":"5.2. Patient Disposition","text_display":"\n\n\\subsection*{5.2. 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Patients who withdraw","text_display":" withdraw from the study will be summarized using descriptive statistics. Patients who withdraw","confidence":1,"confidence_rate":1},{"cnt":[[245,1186],[1886,1186],[1886,1235],[245,1235]],"region":{"top_left_x":244,"top_left_y":1185,"width":1643,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0ce8622a8e14896879641e9b814678d","type":"text","conversion_output":true,"text":"from the study will also be summarized using descriptive statistics by reason for withdrawal. The","text_display":" from the study will also be summarized using descriptive statistics by reason for withdrawal. The","confidence":1,"confidence_rate":1},{"cnt":[[245,1233],[1629,1233],[1629,1283],[245,1283]],"region":{"top_left_x":244,"top_left_y":1233,"width":1385,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91733805886a449487d6ad6972efa672","type":"text","conversion_output":true,"text":"denominator for calculating the percentages will be the number of ITT population.","text_display":" denominator for calculating the percentages will be the number of ITT population.","confidence":1,"confidence_rate":1},{"cnt":[[241,1319],[1351,1319],[1351,1386],[241,1386]],"region":{"top_left_x":240,"top_left_y":1319,"width":1112,"height":67},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f96513b218b146be994b4e8558f329ff","type":"section_header","conversion_output":false,"children_ids":["7572cd05b4f34b76a60048802c1f25d5"],"text":"","text_display":""},{"cnt":[[245,1326],[1347,1326],[1347,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1325,"width":1104,"height":57},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7572cd05b4f34b76a60048802c1f25d5","type":"text","conversion_output":true,"parent_id":"f96513b218b146be994b4e8558f329ff","text":"5.3. 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For categorical variables, treatment groups will be compared using a","text_display":" treatment as a factor. For categorical variables, treatment groups will be compared using a","confidence":1,"confidence_rate":1},{"cnt":[[245,1927],[1502,1927],[1502,1979],[245,1979]],"region":{"top_left_x":244,"top_left_y":1927,"width":1258,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2568bb7f6c754b958df71a353206e61a","type":"text","conversion_output":true,"text":"Pearson's chi-square test (or Fisher's exact test if cells sizes are too small).","text_display":" Pearson's chi-square test (or Fisher's exact test if cells sizes are too small).","confidence":0.9960954189300537,"confidence_rate":0.9999539748962739},{"cnt":[[241,2015],[784,2015],[784,2082],[241,2082]],"region":{"top_left_x":240,"top_left_y":2015,"width":545,"height":67},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6febabbe59b145b5b04e74324b782828","type":"section_header","conversion_output":false,"children_ids":["c2ca38d6f6f64c88b7d963a3ff13dd60"],"text":"","text_display":""},{"cnt":[[245,2020],[780,2020],[780,2078],[245,2078]],"region":{"top_left_x":244,"top_left_y":2019,"width":536,"height":59},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2ca38d6f6f64c88b7d963a3ff13dd60","type":"text","conversion_output":true,"parent_id":"6febabbe59b145b5b04e74324b782828","text":"5.4. Medical History","text_display":"\n\n\\subsection*{5.4. Medical History}","confidence":0.951171875,"confidence_rate":0.9979995834272986},{"cnt":[[245,2093],[1803,2093],[1803,2144],[245,2144]],"region":{"top_left_x":244,"top_left_y":2092,"width":1559,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a8baa579c3e414f9b067a3baa199281","type":"text","conversion_output":true,"text":"All medical history abnormalities will be coded using the Medical Dictionary for Regulatory","text_display":"\n\nAll medical history abnormalities will be coded using the Medical Dictionary for Regulatory","confidence":1,"confidence_rate":1},{"cnt":[[245,2144],[1818,2144],[1818,2194],[245,2194]],"region":{"top_left_x":244,"top_left_y":2144,"width":1574,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8b3755ac83c4483bd8ad48acc883a51","type":"text","conversion_output":true,"text":"Activities (MedDRA). The incidence of medical history abnormalities will be summarized by","text_display":" Activities (MedDRA). The incidence of medical history abnormalities will be summarized by","confidence":1,"confidence_rate":1},{"cnt":[[245,2191],[1916,2191],[1916,2243],[245,2243]],"region":{"top_left_x":244,"top_left_y":2191,"width":1673,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c523be5defa54203b4675a6dbb4c78ff","type":"text","conversion_output":true,"text":"system organ class (SOC) and preferred term (PT). Patients are counted only once in each SOC and","text_display":" system organ class (SOC) and preferred term (PT). Patients are counted only once in each SOC and","confidence":1,"confidence_rate":1},{"cnt":[[245,2241],[614,2241],[614,2292],[245,2292]],"region":{"top_left_x":244,"top_left_y":2240,"width":371,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7988720e27754b6bb14f0d2230b82e88","type":"text","conversion_output":true,"text":"only once in each PT.","text_display":" only once in each PT.","confidence":1,"confidence_rate":1},{"cnt":[[1061,2557],[1111,2557],[1111,2600],[1061,2600]],"region":{"top_left_x":1061,"top_left_y":2556,"width":50,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"149580cc84084352990f67e38e9f5703","type":"page_info","conversion_output":false,"text":"32","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-34","page":34,"lines":[{"cnt":[[245,125],[1012,125],[1012,178],[245,178]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30ea8c653a2b4836b96a5ef45b674596","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbb5ebc4809544b9bf4928131f7759ea","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[236,245],[1076,245],[1076,318],[236,318]],"region":{"top_left_x":236,"top_left_y":244,"width":841,"height":74},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a65386faed1b4e018ae866296f259f0b","type":"section_header","conversion_output":false,"children_ids":["1dd05fb92a8a4c6ea19a28f930fff4d0"],"text":"","text_display":""},{"cnt":[[243,251],[1072,251],[1072,312],[243,312]],"region":{"top_left_x":242,"top_left_y":251,"width":831,"height":61},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dd05fb92a8a4c6ea19a28f930fff4d0","type":"text","conversion_output":true,"parent_id":"a65386faed1b4e018ae866296f259f0b","text":"5.5. Prior Medications or Therapy","text_display":"\n\n\\subsection*{5.5. Prior Medications or Therapy}","confidence":0.93701171875,"confidence_rate":0.9982893729470746},{"cnt":[[245,327],[1886,327],[1886,380],[245,380]],"region":{"top_left_x":244,"top_left_y":326,"width":1643,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec38e29535724f91b7a082f3d5442c3a","type":"text","conversion_output":true,"text":"All prior medications or therapy will be coded using the World Health Organization dictionary of","text_display":"\n\nAll prior medications or therapy will be coded using the World Health Organization dictionary of","confidence":1,"confidence_rate":1},{"cnt":[[245,378],[1863,378],[1863,428],[245,428]],"region":{"top_left_x":244,"top_left_y":378,"width":1619,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15758261752a4cf68ed0c6a191f1dd4f","type":"text","conversion_output":true,"text":"medical codes (WHO Drug). The incidence of prior medications or therapy will be summarized","text_display":" medical codes (WHO Drug). The incidence of prior medications or therapy will be summarized","confidence":1,"confidence_rate":1},{"cnt":[[245,425],[1833,425],[1833,477],[245,477]],"region":{"top_left_x":244,"top_left_y":425,"width":1589,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39422644583345e0aa26bf28bb6d44bd","type":"text","conversion_output":true,"text":"using descriptive statistics by therapeutic class and PT. Patients are counted only once in each","text_display":" using descriptive statistics by therapeutic class and PT. Patients are counted only once in each","confidence":1,"confidence_rate":1},{"cnt":[[245,475],[1871,475],[1871,524],[245,524]],"region":{"top_left_x":244,"top_left_y":474,"width":1628,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77852762aeec4280802fce7d15b49539","type":"text","conversion_output":true,"text":"therapeutic class category, and only once in each PT category. Prior medications will include all","text_display":" therapeutic class category, and only once in each PT category. Prior medications will include all","confidence":1,"confidence_rate":1},{"cnt":[[245,520],[1167,520],[1167,576],[245,576]],"region":{"top_left_x":244,"top_left_y":519,"width":923,"height":57},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c2aa2f4ad9b4cfca00c65ed5e5b216e","type":"text","conversion_output":true,"text":"medications taken prior to the \\(1^{\\text {st }}\\) study drug treatment.","text_display":" medications taken prior to the \\(1^{\\text {st }}\\) study drug treatment.","confidence":0.998046875,"confidence_rate":0.9999742761882866},{"cnt":[[245,589],[1605,589],[1605,645],[245,645]],"region":{"top_left_x":244,"top_left_y":588,"width":1361,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e783648c1b04267a1549eb61baca8c3","type":"text","conversion_output":true,"text":"The subset of prior medications will be summarized for the following categories.","text_display":"\nThe subset of prior medications will be summarized for the following categories.","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[370,662],[973,662],[973,715],[370,715]],"region":{"top_left_x":369,"top_left_y":661,"width":605,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1707b44541641d1954729301a8726a5","type":"text","conversion_output":true,"text":"- preventive migraine medication","text_display":"\n- preventive migraine medication","confidence":1,"confidence_rate":1},{"cnt":[[370,735],[750,735],[750,788],[370,788]],"region":{"top_left_x":369,"top_left_y":734,"width":381,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38e0a7c93ebe4bd489524eb80a9100a3","type":"text","conversion_output":true,"text":"- triptans and ergots","text_display":"\n- triptans and ergots","confidence":1,"confidence_rate":1},{"cnt":[[370,808],[1646,808],[1646,862],[370,862]],"region":{"top_left_x":369,"top_left_y":807,"width":1277,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cedf02a084db45f5b069909bc3fc300e","type":"text","conversion_output":true,"text":"- non-steroidal anti-inflammatory drugs (NSAIDs) for migraine/headache","text_display":"\n- non-steroidal anti-inflammatory drugs (NSAIDs) for migraine/headache","confidence":1,"confidence_rate":1},{"cnt":[[370,881],[1285,881],[1285,930],[370,930]],"region":{"top_left_x":369,"top_left_y":880,"width":916,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7689809d9146455eb44f050494919903","type":"text","conversion_output":true,"text":"- NSAIDs for reasons other than migraine/headache","text_display":"\n- NSAIDs for reasons other than migraine/headache","confidence":1,"confidence_rate":1},{"cnt":[[370,950],[952,950],[952,1003],[370,1003]],"region":{"top_left_x":369,"top_left_y":949,"width":583,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88126ad43e264573bde19be11fa5ff82","type":"text","conversion_output":true,"text":"- opioids for migraine/headache","text_display":"\n- opioids for migraine/headache","confidence":1,"confidence_rate":1},{"cnt":[[370,1023],[1265,1023],[1265,1076],[370,1076]],"region":{"top_left_x":369,"top_left_y":1022,"width":897,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6337547a3214448baccf34f1a2f063c7","type":"text","conversion_output":true,"text":"- opioids for reasons other than migraine/headache","text_display":"\n- opioids for reasons other than migraine/headache","confidence":1,"confidence_rate":1},{"cnt":[[370,1096],[531,1096],[531,1141],[370,1141]],"region":{"top_left_x":369,"top_left_y":1095,"width":162,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1af43577b4eb445e846d15d4013d79f8","type":"text","conversion_output":true,"text":"- other","text_display":"\n- other","confidence":1,"confidence_rate":1},{"cnt":[[236,1179],[883,1179],[883,1253],[236,1253]],"region":{"top_left_x":236,"top_left_y":1179,"width":648,"height":74},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ab1be2c864a4ca4991773ccd7ee36fb","type":"section_header","conversion_output":false,"children_ids":["1a8ffe0ed18e4e51ad48e65e4ab662de"],"text":"","text_display":""},{"cnt":[[243,1186],[879,1186],[879,1244],[243,1244]],"region":{"top_left_x":242,"top_left_y":1185,"width":637,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a8ffe0ed18e4e51ad48e65e4ab662de","type":"text","conversion_output":true,"parent_id":"5ab1be2c864a4ca4991773ccd7ee36fb","text":"5.6. Electrocardiography","text_display":"\n\n\\subsection*{5.6. Electrocardiography}","confidence":0.9931640625,"confidence_rate":0.9997634966075137},{"cnt":[[245,1259],[1897,1259],[1897,1313],[245,1313]],"region":{"top_left_x":244,"top_left_y":1258,"width":1654,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92a1ec4f5f4041789e683842c41fee78","type":"text","conversion_output":true,"text":"Electrocardiogram findings (normal, abnormal, and missing) at baseline will be summarized using","text_display":"\n\nElectrocardiogram findings (normal, abnormal, and missing) at baseline will be summarized using","confidence":1,"confidence_rate":1},{"cnt":[[245,1311],[604,1311],[604,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1310,"width":360,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f42daaae2ea4591b8ab40bb385cf315","type":"text","conversion_output":true,"text":"descriptive statistics.","text_display":" descriptive statistics.","confidence":1,"confidence_rate":1},{"cnt":[[236,1394],[922,1394],[922,1467],[236,1467]],"region":{"top_left_x":236,"top_left_y":1394,"width":686,"height":74},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24cf78597ec74f40bdd2d08866428325","type":"section_header","conversion_output":false,"children_ids":["755ff2fc26b041508d34e7f3c1d791ef"],"text":"","text_display":""},{"cnt":[[245,1401],[915,1401],[915,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1400,"width":672,"height":64},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"755ff2fc26b041508d34e7f3c1d791ef","type":"text","conversion_output":true,"parent_id":"24cf78597ec74f40bdd2d08866428325","text":"5.7. Physical Examinations","text_display":"\n\n\\subsection*{5.7. Physical Examinations}","confidence":0.9873046875,"confidence_rate":0.9995879369671402},{"cnt":[[245,1474],[1895,1474],[1895,1528],[245,1528]],"region":{"top_left_x":244,"top_left_y":1473,"width":1651,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7eb9e8f317a14153a8eecf464d2066de","type":"text","conversion_output":true,"text":"Physical examinations results will be listed. Patients with at least 1 abnormal finding (overall) and","text_display":"\n\nPhysical examinations results will be listed. Patients with at least 1 abnormal finding (overall) and","confidence":1,"confidence_rate":1},{"cnt":[[245,1525],[1210,1525],[1210,1579],[245,1579]],"region":{"top_left_x":244,"top_left_y":1525,"width":966,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c24b32012c86462ebd69d21587b7dd9a","type":"text","conversion_output":true,"text":"abnormal findings for each category will be summarized.","text_display":" abnormal findings for each category will be summarized.","confidence":1,"confidence_rate":1},{"cnt":[[236,1611],[851,1611],[851,1678],[236,1678]],"region":{"top_left_x":236,"top_left_y":1611,"width":615,"height":67},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e248b36b45a7450197afb208cd5ab767","type":"section_header","conversion_output":false,"children_ids":["8e18d2453ebb4d29b3e079b22cf0dd6c"],"text":"","text_display":""},{"cnt":[[245,1618],[844,1618],[844,1671],[245,1671]],"region":{"top_left_x":244,"top_left_y":1617,"width":601,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e18d2453ebb4d29b3e079b22cf0dd6c","type":"text","conversion_output":true,"parent_id":"e248b36b45a7450197afb208cd5ab767","text":"5.8. Protocol Violations","text_display":"\n\n\\subsection*{5.8. Protocol Violations}","confidence":0.95849609375,"confidence_rate":0.9985393508264259},{"cnt":[[245,1693],[1871,1693],[1871,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1692,"width":1628,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c57d8e1025ce4a8ba88971364ff2ab8f","type":"text","conversion_output":true,"text":"Patients with at least 1 protocol violation will be summarized for each category using descriptive","text_display":"\n\nPatients with at least 1 protocol violation will be summarized for each category using descriptive","confidence":1,"confidence_rate":1},{"cnt":[[245,1742],[408,1742],[408,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1742,"width":165,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9414ef0fa8da4f42a2ea99df599fb1e1","type":"text","conversion_output":true,"text":"statistics.","text_display":" statistics.","confidence":1,"confidence_rate":1},{"cnt":[[236,1826],[926,1826],[926,1899],[236,1899]],"region":{"top_left_x":236,"top_left_y":1826,"width":690,"height":74},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9a16b2cf5a248619df54c903fcc9adc","type":"section_header","conversion_output":false,"children_ids":["d27d2ce0969b47b582bb169fe0b8e226"],"text":"","text_display":""},{"cnt":[[245,1833],[917,1833],[917,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1832,"width":674,"height":61},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d27d2ce0969b47b582bb169fe0b8e226","type":"text","conversion_output":true,"parent_id":"d9a16b2cf5a248619df54c903fcc9adc","text":"5.9. Childbearing Potential","text_display":"\n\n\\subsection*{5.9. Childbearing Potential}","confidence":0.9912109375,"confidence_rate":0.999724165732907},{"cnt":[[245,1908],[1863,1908],[1863,1962],[245,1962]],"region":{"top_left_x":244,"top_left_y":1907,"width":1619,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8831c3c65534427a8bfdc638ec83df6","type":"text","conversion_output":true,"text":"All patients must be of nonchildbearing potential as defined in protocol Section 4.1. Information","text_display":"\n\nAll patients must be of nonchildbearing potential as defined in protocol Section 4.1. Information","confidence":1,"confidence_rate":1},{"cnt":[[245,1955],[1253,1955],[1253,2009],[245,2009]],"region":{"top_left_x":244,"top_left_y":1955,"width":1009,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1211cd4d61f4b87a1249fb367cbc6ce","type":"text","conversion_output":true,"text":"related to childbearing potential will be collected and listed.","text_display":" related to childbearing potential will be collected and listed.","confidence":1,"confidence_rate":1},{"cnt":[[1061,2557],[1111,2557],[1111,2600],[1061,2600]],"region":{"top_left_x":1061,"top_left_y":2556,"width":50,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a67f5234d604246af013aca36e0d1aa","type":"page_info","conversion_output":false,"text":"33","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-35","page":35,"lines":[{"cnt":[[245,125],[1012,125],[1012,176],[245,176]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7776aa45762f4d3a900f617108a77918","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ec35aab89724d0a981825d46cbb98f0","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[240,369],[241,311],[956,314],[956,372]],"region":{"top_left_x":240,"top_left_y":311,"width":717,"height":61},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"551f1897fba24fac98f85bda77d9066c","type":"section_header","conversion_output":false,"children_ids":["0bb174105a784e5f80c1d30bef852b38"],"text":"","text_display":""},{"cnt":[[245,318],[952,318],[952,365],[245,365]],"region":{"top_left_x":244,"top_left_y":317,"width":708,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bb174105a784e5f80c1d30bef852b38","type":"text","conversion_output":true,"parent_id":"551f1897fba24fac98f85bda77d9066c","text":"6. EFFICACY ANALYSIS","text_display":"\n\n\\section*{6. EFFICACY ANALYSIS}","confidence":1,"confidence_rate":1},{"cnt":[[241,408],[617,408],[617,466],[241,466]],"region":{"top_left_x":240,"top_left_y":408,"width":377,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdfefb158c0b42afa7443f4f6d37de11","type":"section_header","conversion_output":false,"children_ids":["b3fc5a7cf814462ba92f6ed5d25c2f04"],"text":"","text_display":""},{"cnt":[[245,412],[610,412],[610,462],[245,462]],"region":{"top_left_x":244,"top_left_y":412,"width":367,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3fc5a7cf814462ba92f6ed5d25c2f04","type":"text","conversion_output":true,"parent_id":"bdfefb158c0b42afa7443f4f6d37de11","text":"6.1. General","text_display":"\n\n\\subsection*{6.1. General}","confidence":0.9091796875,"confidence_rate":0.9944149179271703},{"cnt":[[245,490],[1914,490],[1914,539],[245,539]],"region":{"top_left_x":244,"top_left_y":489,"width":1671,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1188c1daf3144ec0a8478e5f6136b58d","type":"text","conversion_output":true,"text":"The efficacy data for this study consist of headache related questions responses (e.g., occurrence of","text_display":"\n\nThe efficacy data for this study consist of headache related questions responses (e.g., occurrence of","confidence":0.9985356330871582,"confidence_rate":0.9999861751885265},{"cnt":[[245,537],[1876,537],[1876,587],[245,587]],"region":{"top_left_x":244,"top_left_y":537,"width":1632,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34698c70986f4a0d972f5fd25a185c4b","type":"text","conversion_output":true,"text":"headache, duration of headache in each day, maximum severity of headache, and acute migraine-","text_display":" headache, duration of headache in each day, maximum severity of headache, and acute migraine","confidence":1,"confidence_rate":1},{"cnt":[[245,587],[1629,587],[1629,638],[245,638]],"region":{"top_left_x":244,"top_left_y":586,"width":1385,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28aa533bd8b34de1b9da1781abdfcb1f","type":"text","conversion_output":true,"text":"specific medication use) collected daily using an electronic headache diary device.","text_display":"specific medication use) collected daily using an electronic headache diary device.","confidence":1,"confidence_rate":1},{"cnt":[[245,655],[1893,655],[1893,707],[245,707]],"region":{"top_left_x":244,"top_left_y":655,"width":1649,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41aca4a01f6a4f4db08efcf223a9e1b5","type":"text","conversion_output":true,"text":"In addition, the following questionnaires will be used for the assessments of migraine impairment,","text_display":"\nIn addition, the following questionnaires will be used for the assessments of migraine impairment,","confidence":1,"confidence_rate":1},{"cnt":[[245,705],[1878,705],[1878,754],[245,754]],"region":{"top_left_x":244,"top_left_y":704,"width":1634,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c6e0ae550274c7ca5778eca66564eca","type":"text","conversion_output":true,"text":"quality of life and satisfaction of treatment etc. during the study (See Table 1) for the schedule of","text_display":" quality of life and satisfaction of treatment etc. during the study (See Table 1) for the schedule of","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[524,752],[524,801],[245,801]],"region":{"top_left_x":244,"top_left_y":751,"width":281,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce82308a341344d2ba0e22b7ae25bfa9","type":"text","conversion_output":true,"text":"the assessment).","text_display":" the assessment).","confidence":1,"confidence_rate":1},{"cnt":[[370,825],[1326,825],[1326,879],[370,879]],"region":{"top_left_x":369,"top_left_y":825,"width":957,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38db610c81c64eb1b67f7ed726730e18","type":"text","conversion_output":true,"text":"- migraine disability assessment test (see Appendix C)","text_display":"\n- migraine disability assessment test (see Appendix C)","confidence":1,"confidence_rate":1},{"cnt":[[370,896],[1781,896],[1781,947],[370,947]],"region":{"top_left_x":369,"top_left_y":895,"width":1413,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a25875177504e8182da43f397924a37","type":"text","conversion_output":true,"text":"- migraine-specific quality of life, as measured by the MSQOL questionnaire (see","text_display":"\n- migraine-specific quality of life, as measured by the MSQOL questionnaire (see","confidence":1,"confidence_rate":1},{"cnt":[[430,945],[660,945],[660,999],[430,999]],"region":{"top_left_x":429,"top_left_y":945,"width":231,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"798035cb5ccc4d85b0d557f6939176f4","type":"text","conversion_output":true,"text":"Appendix D)","text_display":" Appendix D)","confidence":1,"confidence_rate":1},{"cnt":[[370,1016],[1714,1016],[1714,1068],[370,1068]],"region":{"top_left_x":369,"top_left_y":1016,"width":1346,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35d74b498dcc4630a59eb46162700ecf","type":"text","conversion_output":true,"text":"- health status, as measured by the EQ-5D-5L questionnaire (see Appendix F)","text_display":"\n- health status, as measured by the EQ-5D-5L questionnaire (see Appendix F)","confidence":1,"confidence_rate":1},{"cnt":[[370,1087],[1884,1087],[1884,1141],[370,1141]],"region":{"top_left_x":369,"top_left_y":1087,"width":1516,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cc43479af00488eb0fbe16a9bddfaa0","type":"text","conversion_output":true,"text":"- patient depression status, as measured by the PHQ-2 and the PHQ-9 (see Appendix G)","text_display":"\n- patient depression status, as measured by the PHQ-2 and the PHQ-9 (see Appendix G)","confidence":1,"confidence_rate":1},{"cnt":[[370,1160],[1734,1160],[1734,1212],[370,1212]],"region":{"top_left_x":369,"top_left_y":1160,"width":1365,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5934ea7248f04c28bae17cbcbc4e75cf","type":"text","conversion_output":true,"text":"- patient work productivity and activity impairment, as measured by the WPAI","text_display":"\n- patient work productivity and activity impairment, as measured by the WPAI","confidence":1,"confidence_rate":1},{"cnt":[[432,1210],[973,1210],[973,1261],[432,1261]],"region":{"top_left_x":431,"top_left_y":1209,"width":543,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b708cac076224bb69739170a477c2581","type":"text","conversion_output":true,"text":"questionnaire (see Appendix H)","text_display":" questionnaire (see Appendix H)","confidence":1,"confidence_rate":1},{"cnt":[[370,1280],[1826,1280],[1826,1332],[370,1332]],"region":{"top_left_x":369,"top_left_y":1280,"width":1458,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd1d5bd133f64ddda0b7d35a4532f8dc","type":"text","conversion_output":true,"text":"- assessment of patient satisfaction, as measured by the PGIC scale (see Appendix I)","text_display":"\n- assessment of patient satisfaction, as measured by the PGIC scale (see Appendix I)","confidence":1,"confidence_rate":1},{"cnt":[[245,1371],[1880,1371],[1880,1420],[245,1420]],"region":{"top_left_x":244,"top_left_y":1370,"width":1636,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa0c85a5a1e948f18cc992b063b5cde4","type":"text","conversion_output":true,"text":"The monthly average number of days or hours of efficacy variables (e.g. migraine days, days of","text_display":"\n\nThe monthly average number of days or hours of efficacy variables (e.g. migraine days, days of","confidence":1,"confidence_rate":1},{"cnt":[[245,1420],[1783,1420],[1783,1470],[245,1470]],"region":{"top_left_x":244,"top_left_y":1420,"width":1540,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54267aaba7bf4208be433b241eb0a026","type":"text","conversion_output":true,"text":"headache with at least moderate severity, days of headache with any severity, total hours of","text_display":" headache with at least moderate severity, days of headache with any severity, total hours of","confidence":1,"confidence_rate":1},{"cnt":[[245,1467],[1895,1467],[1895,1519],[245,1519]],"region":{"top_left_x":244,"top_left_y":1467,"width":1651,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6021191e1944b05aa0b650b6a58b782","type":"text","conversion_output":true,"text":"headache with any severity, total hours of headache with at least moderate severity, 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during the 12-week period after the \\(1^{\\text {st }}\\) dose of study drug will be derived and","text_display":" phonophobia etc.) during the 12-week period after the \\(1^{\\text {st }}\\) dose of study drug will be derived and","confidence":0.9265387700870633,"confidence_rate":0.9993424629241874},{"cnt":[[245,1611],[1296,1611],[1296,1665],[245,1665]],"region":{"top_left_x":244,"top_left_y":1611,"width":1052,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58e822c06ec94045b19143dd4241a3ea","type":"text","conversion_output":true,"text":"normalized to \\(2 8\\) days equivalent using the following formula.","text_display":" normalized to \\(2 8\\) days equivalent using the following 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data separated by each visit of study drug dosing will be used.","confidence":1,"confidence_rate":1},{"cnt":[[363,1979],[1712,1979],[1712,2093],[363,2093]],"region":{"top_left_x":363,"top_left_y":1978,"width":1350,"height":115},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45d0d2ee16c14d5d937d2ee8a7bd1966","type":"math","conversion_output":true,"text":"\\[\n\\frac{\\sum \\text { Days or hours of efficacy variable during the } 4 \\text { week period }}{\\sum \\text { Days with assessments recorded in the eDiary for the } 4 \\text { week period }} \\times 28\n\\]","text_display":"\n\\[\n\\frac{\\sum \\text { Days or hours of efficacy variable during the } 4 \\text { week period }}{\\sum \\text { Days with assessments recorded in the eDiary for the } 4 \\text { week period }} \\times 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Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43178bb382c4438c993333e4188fad59","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[1882,251],[1882,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1639,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"896c4fa6b6f247a1994d0f708c17f8b4","type":"text","conversion_output":true,"text":"where the baseline value is calculated by formula (3) and the postbaseline value in the equation is","text_display":"\nwhere the baseline value is calculated by formula (3) and the postbaseline value in the equation is","confidence":0.55078125,"confidence_rate":0.9942816283117005},{"cnt":[[245,301],[1841,301],[1841,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1598,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2fb17bb6b5c4793a546f7e11671093f","type":"text","conversion_output":true,"text":"calculated by formula (1) for the variables during the 12-week period or by formula (2) for the","text_display":" calculated by formula (1) for the variables during the 12-week period or by formula (2) for the","confidence":0.9878244274295866,"confidence_rate":0.999877504482624},{"cnt":[[245,348],[1482,348],[1482,402],[245,402]],"region":{"top_left_x":244,"top_left_y":348,"width":1239,"height":54},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f894c621f7d496eadf6e4a7a2668e48","type":"text","conversion_output":true,"text":"variables during the 4-week period after each dose for months 1, 2 and 3.","text_display":" variables during the 4-week period after each dose for months 1, 2 and 3.","confidence":0.7930241327806834,"confidence_rate":0.9971054270585551},{"cnt":[[245,417],[1884,417],[1884,471],[245,471]],"region":{"top_left_x":244,"top_left_y":416,"width":1641,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f92ed4d80d2f4518b4381614ca9c2d67","type":"text","conversion_output":true,"text":"The baseline values for calculating the change from baseline of the weekly number of days of the","text_display":"\nThe baseline values for calculating the change from baseline of the weekly number of days of the","confidence":1,"confidence_rate":1},{"cnt":[[245,466],[1663,466],[1663,518],[245,518]],"region":{"top_left_x":244,"top_left_y":466,"width":1419,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"165c2069f9924318a1a2f924421f8b1c","type":"text","conversion_output":true,"text":"efficacy variables will use all data collected in the run-in period and be calculated as","text_display":" efficacy variables will use all data collected in the run-in period and be calculated as","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[357,524],[1837,524],[1837,655],[357,655]],"region":{"top_left_x":356,"top_left_y":524,"width":1481,"height":132},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6a5147122e24092beabf7ba3ad45ab4","type":"math","conversion_output":true,"text":"\\[\n\\frac{\\sum \\text { Days of efficacy variable during the run }- \\text { in period }}{\\sum \\text { Days with assessments recorded in the eDiary for the run }- \\text { in period }} \\times 7\n\\]","text_display":"\n\\[\n\\frac{\\sum \\text { Days of efficacy variable during the run }- \\text { in period }}{\\sum \\text { Days with assessments recorded in the eDiary for the run }- \\text { in period }} \\times 7\n\\]","confidence":0.9839217431192537,"confidence_rate":0.999888220630932},{"cnt":[[1852,567],[1914,567],[1914,621],[1852,621]],"region":{"top_left_x":1851,"top_left_y":567,"width":64,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbf0ad3a7bc24644bb7ba8b50f932040","type":"equation_number","conversion_output":false,"text":"(5)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1846,683],[1846,735],[245,735]],"region":{"top_left_x":244,"top_left_y":683,"width":1602,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29dc885be70c4daf8fb58e978f181531","type":"text","conversion_output":true,"text":"The weekly number of days of efficacy variables (e.g., days of headache with at least moderate","text_display":"\n\nThe weekly number of days of efficacy variables (e.g., days of headache with at least moderate","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1923,730],[1923,784],[245,784]],"region":{"top_left_x":244,"top_left_y":730,"width":1679,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1245761bd71c4ee78e0f930839b82379","type":"text","conversion_output":true,"text":"severity, migraine days) for each week during the 4 -week period after the \\(1^{\\text {st }}\\) dose of study drug will","text_display":" severity, migraine days) for each week during the 4 -week period after the \\(1^{\\text {st }}\\) dose of study drug will","confidence":0.9975595474243164,"confidence_rate":0.9999804527083794},{"cnt":[[245,782],[1532,782],[1532,831],[245,831]],"region":{"top_left_x":244,"top_left_y":782,"width":1288,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0efc3b98281b4ebba8966c6061b64794","type":"text","conversion_output":true,"text":"be derived and normalized to \\(7\\) days equivalent using the following formula.","text_display":" be derived and normalized to \\(7\\) days equivalent using the following formula.","confidence":0.87548828125,"confidence_rate":0.998454991122629},{"cnt":[[354,862],[1818,862],[1818,990],[354,990]],"region":{"top_left_x":354,"top_left_y":861,"width":1464,"height":130},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c3e926f4aa74913adfbff75004d8e76","type":"math","conversion_output":true,"text":"\\[\n\\frac{\\sum \\text { Days of efficacy variable during the } 7 \\text { days period }}{\\sum \\text { Days with assessments recorded in the eDiary for the } 7 \\text { days period }} \\times 7\n\\]","text_display":"\n\\[\n\\frac{\\sum \\text { Days of efficacy variable during the } 7 \\text { days period }}{\\sum \\text { Days with assessments recorded in the eDiary for the } 7 \\text { days period }} \\times 7\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[1839,902],[1901,902],[1901,954],[1839,954]],"region":{"top_left_x":1839,"top_left_y":902,"width":63,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80c699cad7c54966a528859992b4558a","type":"equation_number","conversion_output":false,"text":"(6)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,1018],[1904,1018],[1904,1070],[245,1070]],"region":{"top_left_x":244,"top_left_y":1018,"width":1660,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eccf6842bf964495950d0803e6b78861","type":"text","conversion_output":true,"text":"The FAS will be used for all efficacy analyses. Summaries will be presented by treatment group as","text_display":"\n\nThe FAS will be used for all efficacy analyses. Summaries will be presented by treatment group as","confidence":1,"confidence_rate":1},{"cnt":[[245,1068],[1904,1068],[1904,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1067,"width":1660,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f337a987c5cf401091100b6e12fb833b","type":"text","conversion_output":true,"text":"randomized, unless otherwise noted. Descriptive statistics for all efficacy data will be presented by","text_display":" randomized, unless otherwise noted. Descriptive statistics for all efficacy data will be presented by","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[1343,1117],[1343,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":1099,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2845fd448d0e4417841d024f76b4d1bf","type":"text","conversion_output":true,"text":"month (or week) or visit as appropriate and over 12-week period.","text_display":" month (or week) or visit as appropriate and over 12-week period.","confidence":1,"confidence_rate":1},{"cnt":[[245,1186],[1846,1186],[1846,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1185,"width":1602,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a90c3c420204cf9bba535cd9f3139fc","type":"text","conversion_output":true,"text":"The primary and secondary endpoints analysis listed in Section 4.4 will be repeated for the per-","text_display":"\n\nThe primary and secondary endpoints analysis listed in Section 4.4 will be repeated for the per","confidence":1,"confidence_rate":1},{"cnt":[[245,1233],[606,1233],[606,1287],[245,1287]],"region":{"top_left_x":244,"top_left_y":1233,"width":362,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98fe81353d754a7e9754ed7c7bf489d3","type":"text","conversion_output":true,"text":"protocol analysis set.","text_display":"protocol analysis set.","confidence":1,"confidence_rate":1},{"cnt":[[236,1317],[1334,1317],[1334,1394],[236,1394]],"region":{"top_left_x":236,"top_left_y":1316,"width":1099,"height":79},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c779049e575c4e2aa7e1539ab0afb32f","type":"section_header","conversion_output":false,"children_ids":["f64ebfb51e2943baa84c283c3217798e"],"text":"","text_display":""},{"cnt":[[243,1326],[1328,1326],[1328,1386],[243,1386]],"region":{"top_left_x":242,"top_left_y":1325,"width":1086,"height":61},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f64ebfb51e2943baa84c283c3217798e","type":"text","conversion_output":true,"parent_id":"c779049e575c4e2aa7e1539ab0afb32f","text":"6.2 Primary Efficacy Variable(s) and Analysis","text_display":"\n\n\\subsection*{6.2 Primary Efficacy Variable(s) and Analysis}","confidence":0.90234375,"confidence_rate":0.9979469157873752},{"cnt":[[243,1401],[1910,1401],[1910,1454],[243,1454]],"region":{"top_left_x":242,"top_left_y":1400,"width":1668,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59d7be84a71f45699a772454e15512b9","type":"text","conversion_output":true,"text":"For the purpose of this study, a migraine day is endorsed when at least 1 of the following situations","text_display":"\n\nFor the purpose of this study, a migraine day is endorsed when at least 1 of the following situations","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[245,1454],[359,1454],[359,1497],[245,1497]],"region":{"top_left_x":244,"top_left_y":1454,"width":115,"height":44},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b578e4dfb6ef42468eeed662491ae63f","type":"text","conversion_output":true,"text":"occur:","text_display":" occur:","confidence":1,"confidence_rate":1},{"cnt":[[370,1521],[1914,1521],[1914,1573],[370,1573]],"region":{"top_left_x":369,"top_left_y":1521,"width":1546,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceb439077f2f44e5a423872eea755684","type":"text","conversion_output":true,"text":"- A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache","text_display":"\n- A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache","confidence":0.9548687934875488,"confidence_rate":0.999524017058536},{"cnt":[[432,1568],[1304,1568],[1304,1622],[432,1622]],"region":{"top_left_x":431,"top_left_y":1568,"width":874,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8bac17731ca48bf9b7980ed2acef86d","type":"text","conversion_output":true,"text":"endorsing criteria for migraine with or without aura","text_display":" endorsing criteria for migraine with or without aura","confidence":1,"confidence_rate":1},{"cnt":[[370,1641],[1914,1641],[1914,1691],[370,1691]],"region":{"top_left_x":369,"top_left_y":1641,"width":1546,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b608f46a5bb64c71801b3a3f40873e84","type":"text","conversion_output":true,"text":"- A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache","text_display":"\n- A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache","confidence":0.9785842895507812,"confidence_rate":0.999776845992654},{"cnt":[[432,1689],[1835,1689],[1835,1742],[432,1742]],"region":{"top_left_x":431,"top_left_y":1688,"width":1404,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16a27a3ee06243f68c3b336aceed5b05","type":"text","conversion_output":true,"text":"endorsing criteria for probable migraine, a migraine subtype where only 1 migraine","text_display":" endorsing criteria for probable migraine, a migraine subtype where only 1 migraine","confidence":1,"confidence_rate":1},{"cnt":[[430,1740],[765,1740],[765,1790],[430,1790]],"region":{"top_left_x":429,"top_left_y":1740,"width":336,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1403e3f763de4e2d90af7150f6b2e4b8","type":"text","conversion_output":true,"text":"criterion is missing","text_display":" criterion is missing","confidence":1,"confidence_rate":1},{"cnt":[[370,1811],[1811,1811],[1811,1863],[370,1863]],"region":{"top_left_x":369,"top_left_y":1811,"width":1443,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98c637d497c64650b27509ddca6ebd11","type":"text","conversion_output":true,"text":"- A calendar day (0:00 to 23:59) demonstrating a headache of any duration that was","text_display":"\n- A calendar day (0:00 to 23:59) demonstrating a headache of any duration that was","confidence":0.994140625,"confidence_rate":0.999932455057251},{"cnt":[[430,1861],[1682,1861],[1682,1910],[430,1910]],"region":{"top_left_x":429,"top_left_y":1860,"width":1254,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d1078ac52cd4d0c910eac38e3b2881a","type":"text","conversion_output":true,"text":"treated with migraine specific medications (triptans and ergot compounds)","text_display":" treated with migraine specific medications (triptans and ergot compounds)","confidence":1,"confidence_rate":1},{"cnt":[[245,1929],[1068,1929],[1068,1979],[245,1979]],"region":{"top_left_x":244,"top_left_y":1929,"width":824,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b68f09afeea4085a9f832250c953529","type":"text","conversion_output":true,"text":"The derivation logic is presented in Appendix B.","text_display":"\n\nThe derivation logic is presented in Appendix B.","confidence":1,"confidence_rate":1},{"cnt":[[236,2013],[793,2013],[793,2073],[236,2073]],"region":{"top_left_x":236,"top_left_y":2013,"width":557,"height":61},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9d5ba8e83ae4f2b8e6fb10b86663b65","type":"section_header","conversion_output":false,"children_ids":["30e3d646ef6349c4aba36964d07fb823"],"text":"","text_display":""},{"cnt":[[245,2020],[788,2020],[788,2065],[245,2065]],"region":{"top_left_x":244,"top_left_y":2019,"width":545,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30e3d646ef6349c4aba36964d07fb823","type":"text","conversion_output":true,"parent_id":"a9d5ba8e83ae4f2b8e6fb10b86663b65","text":"6.2.1. Variable Definition","text_display":"\n\n\\subsection*{6.2.1. Variable Definition}","confidence":0.994140625,"confidence_rate":0.9998104499511072},{"cnt":[[245,2086],[1798,2086],[1798,2138],[245,2138]],"region":{"top_left_x":244,"top_left_y":2086,"width":1555,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7ade9b7345344e0a0a4079a7af7560b","type":"text","conversion_output":true,"text":"The primary efficacy variable is the change from baseline in the monthly average number of","text_display":"\n\nThe primary efficacy variable is the change from baseline in the monthly average number of","confidence":1,"confidence_rate":1},{"cnt":[[245,2133],[1904,2133],[1904,2185],[245,2185]],"region":{"top_left_x":244,"top_left_y":2133,"width":1660,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c8127b116da420d9da73b23db90688b","type":"text","conversion_output":true,"text":"migraine days during the 12-week period after the \\(1^{\\text {st }}\\) dose of study drug. The baseline values will","text_display":" migraine days during the 12-week period after the \\(1^{\\text {st }}\\) dose of study drug. The baseline values will","confidence":0.9873106479644775,"confidence_rate":0.9998917808604376},{"cnt":[[245,2185],[1861,2185],[1861,2237],[245,2237]],"region":{"top_left_x":244,"top_left_y":2184,"width":1617,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a206e83afbf4a6683a292ca54e768c7","type":"text","conversion_output":true,"text":"be derived using formula (3). The postbaseline values will be derived using formula (1), and the","text_display":" be derived using formula (3). The postbaseline values will be derived using formula (1), and the","confidence":0.9868335723876953,"confidence_rate":0.9998687821401676},{"cnt":[[245,2234],[1343,2234],[1343,2284],[245,2284]],"region":{"top_left_x":244,"top_left_y":2234,"width":1099,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de0e4a2d69be4f46938d005eeb48196d","type":"text","conversion_output":true,"text":"change is calculated as postbaseline value - baseline value.","text_display":" change is calculated as postbaseline value - baseline value.","confidence":0.9926891257055104,"confidence_rate":0.9998871182222882},{"cnt":[[1061,2557],[1113,2557],[1113,2600],[1061,2600]],"region":{"top_left_x":1061,"top_left_y":2556,"width":52,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"45054ccab9cb471f938f7e96dbc8db2c","type":"page_info","conversion_output":false,"text":"35","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-37","page":37,"lines":[{"cnt":[[245,125],[1012,125],[1012,176],[245,176]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3170c7757d44221a400c8cfd482d801","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acb3c72b0e074e41b9859f36ade82432","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,247],[758,247],[758,307],[241,307]],"region":{"top_left_x":240,"top_left_y":247,"width":519,"height":61},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b634219f25a4d7cbef525e14a5ce567","type":"section_header","conversion_output":false,"children_ids":["c0740abcb7c94fbb91361d9291e7b3cb"],"text":"","text_display":""},{"cnt":[[245,254],[754,254],[754,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":511,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0740abcb7c94fbb91361d9291e7b3cb","type":"text","conversion_output":true,"parent_id":"8b634219f25a4d7cbef525e14a5ce567","text":"6.2.2 Primary Analysis","text_display":"\n\n\\subsection*{6.2.2 Primary Analysis}","confidence":0.87939453125,"confidence_rate":0.9952512503577897},{"cnt":[[245,322],[1076,322],[1076,372],[245,372]],"region":{"top_left_x":244,"top_left_y":322,"width":833,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9de787418ad0457eaf36410fcffd8511","type":"text","conversion_output":true,"text":"The hypothesis testing for the primary analysis is","text_display":"\n\nThe hypothesis testing for the primary analysis is","confidence":1,"confidence_rate":1},{"cnt":[[569,389],[1124,389],[1124,453],[569,453]],"region":{"top_left_x":569,"top_left_y":388,"width":555,"height":66},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71a5729ecce846e8b8bda6fc815041c1","type":"math","conversion_output":true,"text":"\\[\nH_{o}: \\delta_{1}=\\delta_{2} \\quad \\text { vs } \\quad H_{a}: \\delta_{1} \\neq \\delta_{2}\n\\]","text_display":"\n\\[\nH_{o}: \\delta_{1}=\\delta_{2} \\quad \\text { vs } \\quad H_{a}: \\delta_{1} \\neq \\delta_{2}\n\\]","confidence":0.98779296875,"confidence_rate":0.9998193964726684},{"cnt":[[245,477],[1901,477],[1901,535],[245,535]],"region":{"top_left_x":244,"top_left_y":476,"width":1658,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91b3008912024fa181af69af85214c18","type":"text","conversion_output":true,"text":"where \\(\\delta_{1}\\) and \\(\\delta_{2}\\) are the estimates of mean change from baseline in the monthly average number of","text_display":"\nwhere \\(\\delta_{1}\\) and \\(\\delta_{2}\\) are the estimates of mean change from baseline in the monthly average number of","confidence":0.9892578125,"confidence_rate":0.9999100015388481},{"cnt":[[245,537],[1772,537],[1772,591],[245,591]],"region":{"top_left_x":244,"top_left_y":537,"width":1529,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f36fcb9cb6442688a5ed9658e59a6d5","type":"text","conversion_output":true,"text":"migraine days for the TEV-48125 treatment group and the placebo group respectively. The","text_display":" migraine days for the TEV-48125 treatment group and the placebo group respectively. The","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[245,587],[1914,587],[1914,638],[245,638]],"region":{"top_left_x":244,"top_left_y":586,"width":1671,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af920ef7e8114042882794e1f461f50d","type":"text","conversion_output":true,"text":"estimated difference of each TEV-48125 dose vs. placebo will be tested following the pre-specified","text_display":" estimated difference of each TEV-48125 dose vs. placebo will be tested following the pre-specified","confidence":0.99853515625,"confidence_rate":0.9999857678907678},{"cnt":[[245,636],[960,636],[960,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":717,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e4821af42fb496290b5d1949e43ec6b","type":"text","conversion_output":true,"text":"fixed sequence as specified in Section 4.4.","text_display":" fixed sequence as specified in Section 4.4.","confidence":1,"confidence_rate":1},{"cnt":[[245,705],[1906,705],[1906,758],[245,758]],"region":{"top_left_x":244,"top_left_y":704,"width":1662,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f27af06f59b2484dad3e4ebe82f0b7f8","type":"text","conversion_output":true,"text":"An analysis of covariance (ANCOVA) method will be applied for the primary analysis. The model","text_display":"\n\nAn analysis of covariance (ANCOVA) method will be applied for the primary analysis. The model","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[1833,752],[1833,806],[245,806]],"region":{"top_left_x":244,"top_left_y":751,"width":1589,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f61d41e0e8aa45a7ba7650b09890740b","type":"text","conversion_output":true,"text":"will include treatment, sex, region (Table 2), and baseline preventive migraine medication use","text_display":" will include treatment, sex, region (Table 2), and baseline preventive migraine medication use","confidence":1,"confidence_rate":1},{"cnt":[[245,804],[1914,804],[1914,853],[245,853]],"region":{"top_left_x":244,"top_left_y":803,"width":1671,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dec8b1bec4947e38deac98e6de2faea","type":"text","conversion_output":true,"text":"(yes/no) as fixed effects; the baseline number of migraine days and years since onset of migraine as","text_display":" (yes/no) as fixed effects; the baseline number of migraine days and years since onset of migraine as","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[245,851],[1910,851],[1910,902],[245,902]],"region":{"top_left_x":244,"top_left_y":850,"width":1666,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00e803d876d24919bf5c03d0eb497181","type":"text","conversion_output":true,"text":"covariates. The least square (LS) means for the treatment groups, LS mean and corresponding \\(95 \\%\\)","text_display":" covariates. The least square (LS) means for the treatment groups, LS mean and corresponding \\(95 \\%\\)","confidence":0.7431640625,"confidence_rate":0.9970061224575459},{"cnt":[[245,900],[1884,900],[1884,952],[245,952]],"region":{"top_left_x":244,"top_left_y":900,"width":1641,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7195905b1cdf4163a0a7c7b5bf565171","type":"text","conversion_output":true,"text":"confidence intervals for the treatment differences (TEV-48125-placebo), and associated p-value","text_display":" confidence intervals for the treatment differences (TEV-48125-placebo), and associated p-value","confidence":0.4761589106785209,"confidence_rate":0.9925330311617409},{"cnt":[[245,950],[535,950],[535,999],[245,999]],"region":{"top_left_x":244,"top_left_y":949,"width":291,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f38222517b04134aa88191bdd889a63","type":"text","conversion_output":true,"text":"will be provided.","text_display":" will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[245,1018],[1482,1018],[1482,1070],[245,1070]],"region":{"top_left_x":244,"top_left_y":1018,"width":1239,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"762edf63e8db45efb50bf28ed6784e4e","type":"text","conversion_output":true,"text":"The following sample SAS code pertains to the primary efficacy analysis.","text_display":"\n\nThe following sample SAS code pertains to the primary efficacy 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X\\);","confidence":0.962925910949707,"confidence_rate":0.9987414990502363},{"cnt":[[494,1225],[1154,1225],[1154,1274],[494,1274]],"region":{"top_left_x":494,"top_left_y":1224,"width":660,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6977a41e80684649a9b0d59313a3884b","type":"text","conversion_output":true,"parent_id":"ee78afa8b7d141ed8d374592aeeb572e","text":"CLASS TREAT SEX BMU REGION;","text_display":"\n> CLASS TREAT SEX BMU REGION;","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[494,1296],[1534,1296],[1534,1345],[494,1345]],"region":{"top_left_x":494,"top_left_y":1295,"width":1040,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6963303ff5747d2ad6a765132abbb38","type":"text","conversion_output":true,"parent_id":"ee78afa8b7d141ed8d374592aeeb572e","text":"MODEL \\(CHG = BASE\\) YOD BMU SEX TREAT REGION/S;","text_display":"\n> MODEL \\(CHG = BASE\\) YOD BMU SEX TREAT REGION/S;","confidence":0.6720475058732991,"confidence_rate":0.9929282262271405},{"cnt":[[494,1366],[1291,1366],[1291,1414],[494,1414]],"region":{"top_left_x":494,"top_left_y":1366,"width":798,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"004fe575c58a4bfb9951dc23232d0a89","type":"text","conversion_output":true,"parent_id":"ee78afa8b7d141ed8d374592aeeb572e","text":"LSMEANS TREAT/PDIFF CL ALPHA \\(=0.05\\);","text_display":"\n> LSMEANS TREAT/PDIFF CL ALPHA \\(=0.05\\);","confidence":0.9663248062133789,"confidence_rate":0.9992217742710021},{"cnt":[[370,1435],[479,1435],[479,1480],[370,1480]],"region":{"top_left_x":369,"top_left_y":1435,"width":111,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba6835823bd544e69cc79cdd265a9af8","type":"text","conversion_output":true,"parent_id":"ee78afa8b7d141ed8d374592aeeb572e","text":"RUN;","text_display":"\n> 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In case that the Shapiro Wilk's test has a p value \\(\\leq 0.01\\), Wilcoxon rank-sum test","text_display":" normality test. In case that the Shapiro Wilk's test has a p value \\(\\leq 0.01\\), Wilcoxon rank-sum test","confidence":0.9263529777526855,"confidence_rate":0.9993110488639071},{"cnt":[[245,1603],[1807,1603],[1807,1652],[245,1652]],"region":{"top_left_x":244,"top_left_y":1602,"width":1563,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e4853a1c92142488ded624f561188a7","type":"text","conversion_output":true,"text":"will be conducted as the primary analysis using SAS procedure NPAR1WAY for each active","text_display":" will be conducted as the primary analysis using SAS procedure NPAR1WAY for each active","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[245,1650],[1861,1650],[1861,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1650,"width":1617,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"086fb0e61f1d4777a21b6e4c7fe05766","type":"text","conversion_output":true,"text":"treatment group and placebo group. P value based on normal approximation from this procedure","text_display":" treatment group and placebo group. P value based on normal approximation from this procedure","confidence":0.9990234375,"confidence_rate":0.9999905142231666},{"cnt":[[245,1697],[1820,1697],[1820,1749],[245,1749]],"region":{"top_left_x":244,"top_left_y":1697,"width":1576,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68f9e976f5804805a224622c9fc4f5af","type":"text","conversion_output":true,"text":"will be selected for the treatment comparison. The ANCOVA analysis will be performed as a","text_display":" will be selected for the treatment comparison. The ANCOVA analysis will be performed as a","confidence":1,"confidence_rate":1},{"cnt":[[245,1749],[587,1749],[587,1798],[245,1798]],"region":{"top_left_x":244,"top_left_y":1748,"width":343,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b71d46f695e45048eccd0365105a8c5","type":"text","conversion_output":true,"text":"supportive analysis.","text_display":" supportive analysis.","confidence":1,"confidence_rate":1},{"cnt":[[241,1833],[793,1833],[793,1893],[241,1893]],"region":{"top_left_x":240,"top_left_y":1832,"width":553,"height":61},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae518095739e43c7881a1a07465432b6","type":"section_header","conversion_output":false,"children_ids":["aafd4e110c68491da629aa5cad70adff"],"text":"","text_display":""},{"cnt":[[245,1839],[788,1839],[788,1888],[245,1888]],"region":{"top_left_x":244,"top_left_y":1839,"width":545,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aafd4e110c68491da629aa5cad70adff","type":"text","conversion_output":true,"parent_id":"ae518095739e43c7881a1a07465432b6","text":"6.2.3 Sensitivity Analysis","text_display":"\n\n\\subsection*{6.2.3 Sensitivity Analysis}","confidence":0.5654296875,"confidence_rate":0.9817755519032988},{"cnt":[[241,1921],[758,1921],[758,1983],[241,1983]],"region":{"top_left_x":240,"top_left_y":1920,"width":519,"height":64},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92af25d66f9547ccacb2c367ae693d4c","type":"section_header","conversion_output":false,"children_ids":["257fced6eb544baba4e62d5725dc2c7a"],"text":"","text_display":""},{"cnt":[[245,1929],[750,1929],[750,1979],[245,1979]],"region":{"top_left_x":244,"top_left_y":1929,"width":506,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"257fced6eb544baba4e62d5725dc2c7a","type":"text","conversion_output":true,"parent_id":"92af25d66f9547ccacb2c367ae693d4c","text":"6.2.3.1. MMRM Analysis","text_display":"\n\n\\subsection*{6.2.3.1. MMRM Analysis}","confidence":0.9990234375,"confidence_rate":0.9999638140011058},{"cnt":[[245,1996],[1884,1996],[1884,2047],[245,2047]],"region":{"top_left_x":244,"top_left_y":1995,"width":1641,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"341857321193460daf0bd6cac83eb2ed","type":"text","conversion_output":true,"text":"A mixed-effects repeated measures (MMRM) analysis model will be implemented to estimate the","text_display":"\n\nA mixed-effects repeated measures (MMRM) analysis model will be implemented to estimate the","confidence":1,"confidence_rate":1},{"cnt":[[245,2045],[1811,2045],[1811,2095],[245,2095]],"region":{"top_left_x":244,"top_left_y":2045,"width":1568,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27984088178d4fd2961665d5697726be","type":"text","conversion_output":true,"text":"mean change from baseline in the monthly average number of migraine days for the overall 3","text_display":" mean change from baseline in the monthly average number of migraine days for the overall 3","confidence":1,"confidence_rate":1},{"cnt":[[245,2093],[1523,2093],[1523,2144],[245,2144]],"region":{"top_left_x":244,"top_left_y":2092,"width":1280,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d64866badaf0443ea7951ab5d8e6a53b","type":"text","conversion_output":true,"text":"months treatment period and by each month to support the primary analysis.","text_display":" months treatment period and by each month to support the primary analysis.","confidence":1,"confidence_rate":1},{"cnt":[[245,2161],[1876,2161],[1876,2213],[245,2213]],"region":{"top_left_x":244,"top_left_y":2161,"width":1632,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e72a387a2fc4d2d897efee14942dbc3","type":"text","conversion_output":true,"text":"Each patient's monthly number of migraine days during the 4 -week period for month 1 , month 2","text_display":"\nEach patient's monthly number of migraine days during the 4 -week period for month 1 , month 2","confidence":0.6895980834960938,"confidence_rate":0.9964328549442321},{"cnt":[[245,2211],[1914,2211],[1914,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2210,"width":1671,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d8e1c7dea8f40ba9940c0ab54e76aa7","type":"text","conversion_output":true,"text":"and month 3 will be calculated by formula (2) in Section 6.1 based on the e-diary responses for that","text_display":" and month 3 will be calculated by formula (2) in Section 6.1 based on the e-diary responses for that","confidence":0.99072265625,"confidence_rate":0.9999160337385748},{"cnt":[[245,2260],[1910,2260],[1910,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1666,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"480d9963b4ed4b2ea2090e8d8c448556","type":"text","conversion_output":true,"text":"month. If a patient is early terminated or has intermittent missing days and has less than 10 days of","text_display":" month. If a patient is early terminated or has intermittent missing days and has less than 10 days of","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[245,2307],[1747,2307],[1747,2359],[245,2359]],"region":{"top_left_x":244,"top_left_y":2307,"width":1503,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6aae45202df4c889ff192b9afd1e24d","type":"text","conversion_output":true,"text":"e-diary entries for a month, that month's value will be considered as missing as described","text_display":" e-diary entries for a month, that month's value will be considered as missing as described","confidence":1,"confidence_rate":1},{"cnt":[[245,2357],[494,2357],[494,2402],[245,2402]],"region":{"top_left_x":244,"top_left_y":2356,"width":251,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd372e2f211640d194aded14a97c0739","type":"text","conversion_output":true,"text":"in Section 4.5.","text_display":" in Section 4.5.","confidence":1,"confidence_rate":1},{"cnt":[[1061,2557],[1113,2557],[1113,2600],[1061,2600]],"region":{"top_left_x":1061,"top_left_y":2556,"width":52,"height":44},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"902b6e8d60ad469892f4ba1a88d12fc0","type":"page_info","conversion_output":false,"text":"36","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-38","page":38,"lines":[{"cnt":[[245,127],[1012,127],[1012,174],[245,174]],"region":{"top_left_x":244,"top_left_y":126,"width":768,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30e3460dd92a47e0b2b9a44b6d080aee","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,127],[1927,127],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":126,"width":386,"height":44},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99a27872e86c430cab762bbd652fe0fd","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1923,254],[1923,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1679,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"419051d3f982415c90e77baa6adae740","type":"text","conversion_output":true,"text":"The MMRM model will include baseline value, treatment, sex, region, baseline preventive migraine","text_display":"\n\nThe MMRM model will include baseline value, treatment, sex, region, baseline preventive migraine","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1906,301],[1906,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1662,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21716ffbbed64ffa8b0a00ca2f8739f4","type":"text","conversion_output":true,"text":"medication use (yes/no), years since onset of migraines, month and treatment-by-month interaction","text_display":" medication use (yes/no), years since onset of migraines, month and treatment-by-month interaction","confidence":1,"confidence_rate":1},{"cnt":[[245,350],[1785,350],[1785,400],[245,400]],"region":{"top_left_x":244,"top_left_y":350,"width":1542,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69e37ea1d4314eed8efc5b4c370108ea","type":"text","conversion_output":true,"text":"as fixed effects, and patient in the repeated statement as a random effect. The unconstructed","text_display":" as fixed effects, and patient in the repeated statement as a random effect. The unconstructed","confidence":1,"confidence_rate":1},{"cnt":[[245,400],[1876,400],[1876,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1632,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12c779b5b2ce4e3b8b44b513d59a791a","type":"text","conversion_output":true,"text":"covariance structure will be used for the repeated observations within a patient. LS means for the","text_display":" covariance structure will be used for the repeated observations within a patient. LS means for the","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1691,447],[1691,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1447,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15ddd660adb84d6faf404c51ed111c54","type":"text","conversion_output":true,"text":"treatment groups, LS means for the treatment differences (TEV-48125 - placebo), and","text_display":" treatment groups, LS means for the treatment differences (TEV-48125 - placebo), and","confidence":0.83544921875,"confidence_rate":0.9979590660861596},{"cnt":[[245,494],[1876,494],[1876,546],[245,546]],"region":{"top_left_x":244,"top_left_y":494,"width":1632,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35ecb3bb84ef4e38ab1b4c4276a05494","type":"text","conversion_output":true,"text":"corresponding \\(95 \\%\\) confidence intervals and associated p -values will be calculated by month and","text_display":" corresponding \\(95 \\%\\) confidence intervals and associated p -values will be calculated by month and","confidence":0.9654413828575343,"confidence_rate":0.9996773925017222},{"cnt":[[245,546],[784,546],[784,595],[245,595]],"region":{"top_left_x":244,"top_left_y":545,"width":541,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc2ea1b6be244c42a1676bf09e1006f8","type":"text","conversion_output":true,"text":"for the overall treatment period.","text_display":" for the overall treatment period.","confidence":1,"confidence_rate":1},{"cnt":[[245,614],[1216,614],[1216,664],[245,664]],"region":{"top_left_x":244,"top_left_y":614,"width":973,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76fd0c303e3742e794c7a5b59cbe097f","type":"text","conversion_output":true,"text":"The following SAS code pertains to the MMRM analysis.","text_display":"\n\nThe following SAS code pertains to the MMRM analysis.","confidence":1,"confidence_rate":1},{"cnt":[[361,675],[1852,675],[1852,1137],[361,1137]],"region":{"top_left_x":360,"top_left_y":674,"width":1492,"height":463},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"048493415f8745c7b09d97f057188b6b","type":"diagram","conversion_output":false,"children_ids":["a77553ffed274286939254e37001edb0","4f72d4de353a4fa0942dc584487bebfb","3211d80f482e47b59f523dc43eac8d23","ae3b69bdea1f4da889705e072060c3e8","fb7e80ad183f474ebe2c123b899e19fe","67d5578e77c44287b809c4d2205736a1","63581cd3a4cb474ab03cc45432a93fbd"],"text":"","text_display":"","subtype":"algorithm"},{"cnt":[[370,683],[1472,683],[1472,733],[370,733]],"region":{"top_left_x":369,"top_left_y":683,"width":1103,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a77553ffed274286939254e37001edb0","type":"code","conversion_output":true,"parent_id":"048493415f8745c7b09d97f057188b6b","text":"ODS OUTPUT DIFFS =XXX LSMEANS =XXX TESTS3=XXX;","text_display":"\n```\nODS OUTPUT DIFFS =XXX LSMEANS =XXX TESTS3=XXX;","confidence":0.9586991233262141,"confidence_rate":0.999139594986568},{"cnt":[[370,752],[1214,752],[1214,801],[370,801]],"region":{"top_left_x":369,"top_left_y":751,"width":845,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f72d4de353a4fa0942dc584487bebfb","type":"code","conversion_output":true,"parent_id":"048493415f8745c7b09d97f057188b6b","text":"PROC MIXED DATA=XXX METHOD=REML;","text_display":"\nPROC MIXED DATA=XXX METHOD=REML;","confidence":0.99853515625,"confidence_rate":0.9999581175147387},{"cnt":[[494,821],[1497,821],[1497,870],[494,870]],"region":{"top_left_x":494,"top_left_y":820,"width":1004,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3211d80f482e47b59f523dc43eac8d23","type":"code","conversion_output":true,"parent_id":"048493415f8745c7b09d97f057188b6b","text":"CLASS USUBJID MONTH TREAT SEX BMU REGION;","text_display":"\n    CLASS USUBJID MONTH TREAT SEX BMU REGION;","confidence":1,"confidence_rate":1},{"cnt":[[494,894],[1846,894],[1846,939],[494,939]],"region":{"top_left_x":494,"top_left_y":893,"width":1352,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae3b69bdea1f4da889705e072060c3e8","type":"code","conversion_output":true,"parent_id":"048493415f8745c7b09d97f057188b6b","text":"MODEL CHG=BASE YOD BMU SEX TREAT MONTH TREAT*MONTH/S;","text_display":"\n    MODEL CHG=BASE YOD BMU SEX TREAT MONTH TREAT*MONTH/S;","confidence":1,"confidence_rate":1},{"cnt":[[494,941],[1510,941],[1510,988],[494,988]],"region":{"top_left_x":494,"top_left_y":941,"width":1017,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb7e80ad183f474ebe2c123b899e19fe","type":"code","conversion_output":true,"parent_id":"048493415f8745c7b09d97f057188b6b","text":"REPEATED MONTH/SUBJECT=USUBJID TYPE=UN R;","text_display":"\n    REPEATED MONTH/SUBJECT=USUBJID TYPE=UN R;","confidence":1,"confidence_rate":1},{"cnt":[[494,1010],[1605,1010],[1605,1059],[494,1059]],"region":{"top_left_x":494,"top_left_y":1009,"width":1111,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67d5578e77c44287b809c4d2205736a1","type":"code","conversion_output":true,"parent_id":"048493415f8745c7b09d97f057188b6b","text":"LSMEANS TREAT TREAT*MONTH/PDIFF CL ALPHA=0.05;","text_display":"\n    LSMEANS TREAT TREAT*MONTH/PDIFF CL ALPHA=0.05;","confidence":0.99951171875,"confidence_rate":0.9999900326925697},{"cnt":[[370,1079],[477,1079],[477,1128],[370,1128]],"region":{"top_left_x":369,"top_left_y":1078,"width":108,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63581cd3a4cb474ab03cc45432a93fbd","type":"code","conversion_output":true,"parent_id":"048493415f8745c7b09d97f057188b6b","text":"RUN;","text_display":"\nRUN;\n```\n","confidence":1,"confidence_rate":1},{"cnt":[[245,1169],[1880,1169],[1880,1220],[245,1220]],"region":{"top_left_x":244,"top_left_y":1168,"width":1636,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffa97742a4684df4ba66c8f5bfd0cb96","type":"text","conversion_output":true,"text":"The LS means ± SE of monthly change from baseline values estimated by MMRM will be plotted","text_display":"\n\nThe LS means ± SE of monthly change from baseline values estimated by MMRM will be plotted","confidence":0.962959979660809,"confidence_rate":0.9996027796914931},{"cnt":[[245,1216],[844,1216],[844,1270],[245,1270]],"region":{"top_left_x":244,"top_left_y":1216,"width":601,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c0cab2ebdbc401086c3754fea2ead49","type":"text","conversion_output":true,"text":"by month for each treatment group.","text_display":" by month for each treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[236,1302],[1214,1302],[1214,1364],[236,1364]],"region":{"top_left_x":236,"top_left_y":1301,"width":978,"height":64},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c88c8a2be2d144329b6527179e9ee00f","type":"section_header","conversion_output":false,"children_ids":["507ad19406a24c1c8c5f72fe643b0fb3"],"text":"","text_display":""},{"cnt":[[245,1308],[1207,1308],[1207,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1308,"width":964,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"507ad19406a24c1c8c5f72fe643b0fb3","type":"text","conversion_output":true,"parent_id":"c88c8a2be2d144329b6527179e9ee00f","text":"6.2.3.2. Analysis with Multiple Imputation Method","text_display":"\n\n\\subsection*{6.2.3.2. Analysis with Multiple Imputation Method}","confidence":0.677734375,"confidence_rate":0.9928221836258798},{"cnt":[[245,1377],[1912,1377],[1912,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1377,"width":1669,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"055ef50fea4a43aeb7fbdce3270cdf7a","type":"text","conversion_output":true,"text":"Multiple imputation (MI) method will be applied to impute the monthly missing data. The data will","text_display":"\n\nMultiple imputation (MI) method will be applied to impute the monthly missing data. The data will","confidence":1,"confidence_rate":1},{"cnt":[[245,1427],[857,1427],[857,1476],[245,1476]],"region":{"top_left_x":244,"top_left_y":1426,"width":614,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8262d7b03468422b8a1b56d906db47ca","type":"text","conversion_output":true,"text":"be processed by the following steps.","text_display":" be processed by the following steps.","confidence":1,"confidence_rate":1},{"cnt":[[370,1497],[1867,1497],[1867,1549],[370,1549]],"region":{"top_left_x":369,"top_left_y":1497,"width":1498,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ca69076945e49609ed5d14d8832b0e7","type":"text","conversion_output":true,"text":"- If a patient has partial e-diary data for a month, ie, \\(<10\\) days of data, that month value","text_display":"\n- If a patient has partial e-diary data for a month, ie, \\(<10\\) days of data, that month value","confidence":0.9921875,"confidence_rate":0.9999207791233815},{"cnt":[[432,1547],[1313,1547],[1313,1596],[432,1596]],"region":{"top_left_x":431,"top_left_y":1546,"width":882,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc3b814b708f492d8d782a497bfb792f","type":"text","conversion_output":true,"text":"will be considered missing before the MI procedure.","text_display":" will be considered missing before the MI procedure.","confidence":1,"confidence_rate":1},{"cnt":[[370,1618],[1886,1618],[1886,1669],[370,1669]],"region":{"top_left_x":369,"top_left_y":1617,"width":1518,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6db8bfc9937b4a80bce2940cc797f1b5","type":"text","conversion_output":true,"text":"- For the patients in the active treatment group who are early terminated with reasons of","text_display":"\n- For the patients in the active treatment group who are early terminated with reasons of","confidence":1,"confidence_rate":1},{"cnt":[[432,1667],[1921,1667],[1921,1717],[432,1717]],"region":{"top_left_x":431,"top_left_y":1667,"width":1490,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ea3ba983598422eae4e0d6b9cf532fa","type":"text","conversion_output":true,"text":"adverse event or lack of efficacy, they will be assigned to placebo group so their missing","text_display":" adverse event or lack of efficacy, they will be assigned to placebo group so their missing","confidence":1,"confidence_rate":1},{"cnt":[[432,1714],[1558,1714],[1558,1764],[432,1764]],"region":{"top_left_x":431,"top_left_y":1714,"width":1127,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b74b42d5f0849fd9875f91d87fa6cf9","type":"text","conversion_output":true,"text":"values will be imputed using data from the placebo treated patients","text_display":" values will be imputed using data from the placebo treated patients","confidence":1,"confidence_rate":1},{"cnt":[[370,1788],[1474,1788],[1474,1837],[370,1837]],"region":{"top_left_x":369,"top_left_y":1787,"width":1105,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15498d5d6ac04bf2908808032e4061d1","type":"text","conversion_output":true,"text":"- Run SAS PROC MI procedure to create 10 complete datasets.","text_display":"\n- Run SAS PROC MI procedure to create 10 complete datasets.","confidence":1,"confidence_rate":1},{"cnt":[[370,1858],[1901,1858],[1901,1910],[370,1910]],"region":{"top_left_x":369,"top_left_y":1858,"width":1533,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39d94a8cca8e4cda8ffc8010650848f7","type":"text","conversion_output":true,"text":"- Within each imputed data set, for a patient who has partial, say X days \\(( X <10)\\), e-diary","text_display":"\n- Within each imputed data set, for a patient who has partial, say X days \\(( X <10)\\), e-diary","confidence":0.7672360177192559,"confidence_rate":0.9975267941775147},{"cnt":[[430,1908],[1351,1908],[1351,1957],[430,1957]],"region":{"top_left_x":429,"top_left_y":1907,"width":923,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7e870a458554dde99e85496ef385785","type":"text","conversion_output":true,"text":"data in a month, the monthly value will be replaced by","text_display":" data in a month, the monthly value will be replaced by","confidence":0.99951171875,"confidence_rate":0.9999917220597181},{"cnt":[[370,1977],[1420,1977],[1420,2030],[370,2030]],"region":{"top_left_x":369,"top_left_y":1976,"width":1052,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07a8f9c266a44e31b26b223c8ef7da50","type":"text","conversion_output":true,"text":"\\(\\sum(\\) oberseved migraine days \\()+(28-X) *\\) imputed value \\(/ 28\\)","text_display":"\n\\(\\sum(\\) oberseved migraine days \\()+(28-X) *\\) imputed value \\(/ 28\\)","confidence":0.641207176887677,"confidence_rate":0.992620650998398},{"cnt":[[370,2041],[1884,2041],[1884,2099],[370,2099]],"region":{"top_left_x":369,"top_left_y":2041,"width":1516,"height":59},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2123f33ae23e407d9fd4030826494bbd","type":"text","conversion_output":true,"text":"- The monthly average number of migraine days during the 12-week period after the \\(1^{\\text {st }}\\)","text_display":"\n- The monthly average number of migraine days during the 12-week period after the \\(1^{\\text {st }}\\)","confidence":0.94970703125,"confidence_rate":0.9994892222725004},{"cnt":[[430,2097],[1772,2097],[1772,2146],[430,2146]],"region":{"top_left_x":429,"top_left_y":2096,"width":1344,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ec70cc8b65d4de4a25c0f23e5ec7718","type":"text","conversion_output":true,"text":"dose of study drug will be the average of month 1 , month 2 and month 3 values.","text_display":" dose of study drug will be the average of month 1 , month 2 and month 3 values.","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[245,2166],[1882,2166],[1882,2215],[245,2215]],"region":{"top_left_x":244,"top_left_y":2165,"width":1639,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85b65a7566ff490698c4bfaa5702c1e8","type":"text","conversion_output":true,"text":"Each dataset will be analyzed using the same ANCOVA model as described in Section 6.2.2. The","text_display":"\n\nEach dataset will be analyzed using the same ANCOVA model as described in Section 6.2.2. The","confidence":1,"confidence_rate":1},{"cnt":[[245,2213],[1708,2213],[1708,2264],[245,2264]],"region":{"top_left_x":244,"top_left_y":2212,"width":1465,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9853f75d4e314dc982b9a6bf75bb1cd6","type":"text","conversion_output":true,"text":"LS means and standard errors from each analysis will be output to a SAS data set. SAS","text_display":" LS means and standard errors from each analysis will be output to a SAS data set. SAS","confidence":1,"confidence_rate":1},{"cnt":[[245,2264],[1809,2264],[1809,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2264,"width":1565,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9490059856834462bf99c9351a8e2200","type":"text","conversion_output":true,"text":"MIANALYZE procedure will be used to generate the final LS means ( ± SE) for the treatment","text_display":" MIANALYZE procedure will be used to generate the final LS means ( ± SE) for the treatment","confidence":0.9196422490884276,"confidence_rate":0.9991092209767279},{"cnt":[[245,2312],[1854,2312],[1854,2361],[245,2361]],"region":{"top_left_x":244,"top_left_y":2311,"width":1611,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a95f54e5aa84ad4a68d17c3e4f640d9","type":"text","conversion_output":true,"text":"groups and the treatment differences (TEV-48125-placebo) as well as p-values associated with","text_display":" groups and the treatment differences (TEV-48125-placebo) as well as p-values associated with","confidence":0.5159941630795402,"confidence_rate":0.9932019765041886},{"cnt":[[245,2361],[1813,2361],[1813,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2361,"width":1570,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddb2256b4b03472789b8cca5605d7258","type":"text","conversion_output":true,"text":"treatment differences. The \\(95 \\%\\) confidence intervals for the treatment differences will also be","text_display":" treatment differences. The \\(95 \\%\\) confidence intervals for the treatment differences will also be","confidence":0.9088230133056641,"confidence_rate":0.9990631361058159},{"cnt":[[245,2411],[453,2411],[453,2456],[245,2456]],"region":{"top_left_x":244,"top_left_y":2410,"width":210,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd504e18daf24f29a00514ed30150042","type":"text","conversion_output":true,"text":"constructed.","text_display":" constructed.","confidence":1,"confidence_rate":1},{"cnt":[[1057,2557],[1111,2557],[1111,2608],[1057,2608]],"region":{"top_left_x":1057,"top_left_y":2556,"width":54,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2606662f2ad54ebdbb5dfdeaa59c18af","type":"page_info","conversion_output":false,"text":"37","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-39","page":39,"lines":[{"cnt":[[245,125],[1012,125],[1012,176],[245,176]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"199b9298aa8044a48cda43dbea5a8684","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4d91b3113ff430982086e0e229c41c5","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[236,245],[1343,245],[1343,320],[236,320]],"region":{"top_left_x":236,"top_left_y":244,"width":1107,"height":77},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3d26d4e961a49c6814050324d3e1268","type":"section_header","conversion_output":false,"children_ids":["6f341e4d694f49429200574a49cb94a2"],"text":"","text_display":""},{"cnt":[[243,251],[1336,251],[1336,312],[243,312]],"region":{"top_left_x":242,"top_left_y":251,"width":1095,"height":61},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f341e4d694f49429200574a49cb94a2","type":"text","conversion_output":true,"parent_id":"f3d26d4e961a49c6814050324d3e1268","text":"6.3. Secondary Efficacy Variables and Analysis","text_display":"\n\n\\subsection*{6.3. Secondary Efficacy Variables and Analysis}","confidence":0.9067835807800293,"confidence_rate":0.9980831832229897},{"cnt":[[245,327],[1068,327],[1068,380],[245,380]],"region":{"top_left_x":244,"top_left_y":326,"width":824,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b878d376be9488999b802ebd1f21277","type":"text","conversion_output":true,"text":"The secondary efficacy endpoints are as follows:","text_display":"\n\nThe secondary efficacy endpoints are as follows:","confidence":1,"confidence_rate":1},{"cnt":[[370,400],[1921,400],[1921,453],[370,453]],"region":{"top_left_x":369,"top_left_y":399,"width":1552,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b6e83fee2f24fff9dc809cdc682966e","type":"text","conversion_output":true,"text":"- proportion of patients reaching at least \\(50 \\%\\) reduction in the monthly average number of","text_display":"\n- proportion of patients reaching at least \\(50 \\%\\) reduction in the monthly average number of","confidence":1,"confidence_rate":1},{"cnt":[[430,447],[1648,447],[1648,501],[430,501]],"region":{"top_left_x":429,"top_left_y":446,"width":1219,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50783b8a10a342dea54442fb7f02f2e8","type":"text","conversion_output":true,"text":"migraine days during the 12 -week period after the \\(1^{\\text {st }}\\) dose of study drug","text_display":" migraine days during the 12 -week period after the \\(1^{\\text {st }}\\) dose of study drug","confidence":0.95703125,"confidence_rate":0.9995426126133627},{"cnt":[[370,520],[1865,520],[1865,574],[370,574]],"region":{"top_left_x":369,"top_left_y":519,"width":1496,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67a3dd724e954fca80f9f8cdee60fe00","type":"text","conversion_output":true,"text":"- mean change from baseline (28-day run-in period) in the monthly average number of","text_display":"\n- mean change from baseline (28-day run-in period) in the monthly average number of","confidence":0.9951171875,"confidence_rate":0.9999443791335259},{"cnt":[[432,569],[1824,569],[1824,621],[432,621]],"region":{"top_left_x":431,"top_left_y":569,"width":1394,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49eabed6d8f5476cb5cc4b4deeb9de96","type":"text","conversion_output":true,"text":"days of use of any acute headache medications during the 12-week period after the","text_display":" days of use of any acute headache medications during the 12-week period after 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days","confidence":0.99462890625,"confidence_rate":0.9999373790545804},{"cnt":[[432,735],[1446,735],[1446,793],[432,793]],"region":{"top_left_x":431,"top_left_y":734,"width":1015,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bc44ba02e0f43bda7878f2ec300bb83","type":"text","conversion_output":true,"text":"during the 4 -week period after the \\(1^{\\text {st }}\\) dose of the study drug","text_display":" during the 4 -week period after the \\(1^{\\text {st }}\\) dose of the study drug","confidence":0.8908860683441162,"confidence_rate":0.9986416442354877},{"cnt":[[370,810],[1867,810],[1867,862],[370,862]],"region":{"top_left_x":369,"top_left_y":809,"width":1498,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a35b9e72fb674e04acbaa31b49bbcd53","type":"text","conversion_output":true,"text":"- mean change from baseline (28-day run-in period) in the monthly average number of","text_display":"\n- mean change from baseline (28-day run-in period) in the monthly average number of","confidence":0.9990234375,"confidence_rate":0.9999888973383643},{"cnt":[[432,855],[1897,855],[1897,913],[432,913]],"region":{"top_left_x":431,"top_left_y":855,"width":1467,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e860ccc97194143a9b0034426db4650","type":"text","conversion_output":true,"text":"migraine days during the 12-week period after the \\(1^{\\text {st }}\\) dose of study drug in patients not","text_display":" migraine days during the 12-week period after the \\(1^{\\text {st }}\\) dose of study drug in patients 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The baseline values","text_display":" collected through the corresponding headache diary questions (Appendix A). The baseline values","confidence":1,"confidence_rate":1},{"cnt":[[245,1470],[1893,1470],[1893,1523],[245,1523]],"region":{"top_left_x":244,"top_left_y":1469,"width":1649,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07ea06ae788c4588a75de1e7d9441a94","type":"text","conversion_output":true,"text":"and the postbaseline values will be calculated using formula (3) and (1) respectively. The change","text_display":" and the postbaseline values will be calculated using formula (3) and (1) respectively. 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The patient is","text_display":" after the \\(1^{\\text {st }}\\) dose of study drug will be calculated by formula (4) in Section 6.1. The patient is","confidence":1,"confidence_rate":1},{"cnt":[[245,1684],[1906,1684],[1906,1738],[245,1738]],"region":{"top_left_x":244,"top_left_y":1684,"width":1662,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d5b5b7ae01144af863e6ed080c6aaf3","type":"text","conversion_output":true,"text":"considered as a responder if the percent reduction is \\(50 \\%\\) or more. If a patient is early discontinued","text_display":" considered as a responder if the percent reduction is \\(50 \\%\\) or more. If a patient is early discontinued","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1227,1732],[1227,1785],[245,1785]],"region":{"top_left_x":244,"top_left_y":1731,"width":983,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3aa9e960fdf4ede91db111ce86379fc","type":"text","conversion_output":true,"text":"from the study, he/she will be counted as a non-responder.","text_display":" from the study, he/she will be counted as a non-responder.","confidence":1,"confidence_rate":1},{"cnt":[[245,1800],[1921,1800],[1921,1854],[245,1854]],"region":{"top_left_x":244,"top_left_y":1800,"width":1677,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab74c668eca54adf835217bdf520da6a","type":"text","conversion_output":true,"text":"The change from baseline (run-in period) in the number of migraine days during the 4-week period","text_display":"\nThe change from baseline (run-in period) in the number of migraine days during the 4-week period","confidence":1,"confidence_rate":1},{"cnt":[[245,1848],[1850,1848],[1850,1906],[245,1906]],"region":{"top_left_x":244,"top_left_y":1847,"width":1606,"height":59},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bde4e2335cdc4e7e8c1665bc0f7ec403","type":"text","conversion_output":true,"text":"after the \\(1^{\\text {st }}\\) dose of study drug will be derived similar to the primary endpoint using only the \\(1^{\\text {st }}\\)","text_display":" after the \\(1^{\\text {st }}\\) dose of study drug will be derived similar to the primary endpoint using only the \\(1^{\\text {st }}\\)","confidence":0.99951171875,"confidence_rate":0.9999962430801487},{"cnt":[[245,1901],[548,1901],[548,1953],[245,1953]],"region":{"top_left_x":244,"top_left_y":1901,"width":304,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c0adf0d40a04d0380fa16790646d765","type":"text","conversion_output":true,"text":"month diary data.","text_display":" month diary data.","confidence":1,"confidence_rate":1},{"cnt":[[236,1981],[1188,1981],[1188,2050],[236,2050]],"region":{"top_left_x":236,"top_left_y":1980,"width":953,"height":70},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5224ce24df148d3badcf8d76c9968ee","type":"section_header","conversion_output":false,"children_ids":["bee0d794f3084e039ee3ad55cba43370"],"text":"","text_display":""},{"cnt":[[245,1989],[1179,1989],[1179,2043],[245,2043]],"region":{"top_left_x":244,"top_left_y":1989,"width":936,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bee0d794f3084e039ee3ad55cba43370","type":"text","conversion_output":true,"parent_id":"d5224ce24df148d3badcf8d76c9968ee","text":"6.3.1.2 Migraine Disability Assessment (MIDAS)","text_display":"\n\n\\subsection*{6.3.1.2 Migraine Disability Assessment (MIDAS)}","confidence":0.56689453125,"confidence_rate":0.9889326399695065},{"cnt":[[245,2058],[1867,2058],[1867,2112],[245,2112]],"region":{"top_left_x":244,"top_left_y":2058,"width":1623,"height":54},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbc84f893c3d41cfb70a5872c175e3e7","type":"text","conversion_output":true,"text":"The MIDAS questionnaire is a 5-item instrument developed to assess headache-related disability","text_display":"\n\nThe MIDAS questionnaire is a 5-item instrument developed to assess headache-related disability","confidence":0.947265625,"confidence_rate":0.9994529200654353},{"cnt":[[245,2110],[1914,2110],[1914,2159],[245,2159]],"region":{"top_left_x":244,"top_left_y":2109,"width":1671,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e530bb0774704cf49e0d64b7a83b9335","type":"text","conversion_output":true,"text":"based on lost days of activity in 3 domains (work, household work, and nonwork) over the previous","text_display":" based on lost days of activity in 3 domains (work, household work, and nonwork) over the previous","confidence":1,"confidence_rate":1},{"cnt":[[245,2157],[1876,2157],[1876,2209],[245,2209]],"region":{"top_left_x":244,"top_left_y":2157,"width":1632,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea2cdf5b9c5442ad8966e4c94b8f933c","type":"text","conversion_output":true,"text":"3 months. Patients will complete the MIDAS questionnaire at baseline (visit 2 ) and the EOT visit","text_display":" 3 months. Patients will complete the MIDAS questionnaire at baseline (visit 2 ) and the EOT visit","confidence":0.62255859375,"confidence_rate":0.9954534675995617},{"cnt":[[245,2204],[1869,2204],[1869,2258],[245,2258]],"region":{"top_left_x":244,"top_left_y":2204,"width":1626,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f873581e149443d863980de58381b83","type":"text","conversion_output":true,"text":"(visit 5). The total score, ie, the sum of the first 5 questions, is used for grading of disability, with","text_display":" (visit 5). The total score, ie, the sum of the first 5 questions, is used for grading of disability, with","confidence":0.9746332168579102,"confidence_rate":0.999772644728785},{"cnt":[[245,2256],[1897,2256],[1897,2307],[245,2307]],"region":{"top_left_x":244,"top_left_y":2255,"width":1654,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"585e329e2b6a4d47a1448e6f2ec26b8f","type":"text","conversion_output":true,"text":"scores of 0 to 5,6 to 10,11 to 20 , and \\(\\geq 21\\) interpreted as disability grades 1 (little or no disability),","text_display":" scores of 0 to 5,6 to 10,11 to 20 , and \\(\\geq 21\\) interpreted as disability grades 1 (little or no disability),","confidence":0.6433921747762374,"confidence_rate":0.9965606093436785},{"cnt":[[245,2303],[1605,2303],[1605,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2303,"width":1361,"height":54},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89c1cd00b80140bd804d94b2ee8b0f34","type":"text","conversion_output":true,"text":"2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively.","text_display":" 2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively.","confidence":1,"confidence_rate":1},{"cnt":[[1057,2557],[1113,2557],[1113,2608],[1057,2608]],"region":{"top_left_x":1057,"top_left_y":2556,"width":56,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ebe1ae9e95f4ecd9cb97e60b307e3f8","type":"page_info","conversion_output":false,"text":"38","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-40","page":40,"lines":[{"cnt":[[245,125],[1012,125],[1012,176],[245,176]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d73a083e12448c5ab616e5c21c3fb65","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"919274a2b96e45baab07ae873fdc38c0","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[236,245],[1179,245],[1179,307],[236,307]],"region":{"top_left_x":236,"top_left_y":244,"width":944,"height":64},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bbce625bbee4b8a8a04b3aeea61bad8","type":"section_header","conversion_output":false,"children_ids":["5aa83e1a0cdf4ea8b556dbc2cdf4ae93"],"text":"","text_display":""},{"cnt":[[243,249],[1175,249],[1175,303],[243,303]],"region":{"top_left_x":242,"top_left_y":249,"width":934,"height":54},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5aa83e1a0cdf4ea8b556dbc2cdf4ae93","type":"text","conversion_output":true,"parent_id":"2bbce625bbee4b8a8a04b3aeea61bad8","text":"6.3.2 Analysis of Secondary Efficacy Variables","text_display":"\n\n\\subsection*{6.3.2 Analysis of Secondary Efficacy Variables}","confidence":0.640625,"confidence_rate":0.9913064210489928},{"cnt":[[245,322],[1895,322],[1895,372],[245,372]],"region":{"top_left_x":244,"top_left_y":322,"width":1651,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ab6a1767ca84af4ad6a550f1a730c6b","type":"text","conversion_output":true,"text":"An ANCOVA method, which is similar to the primary analysis setup, will be used for the analysis","text_display":"\n\nAn ANCOVA method, which is similar to the primary analysis setup, will be used for the analysis","confidence":1,"confidence_rate":1},{"cnt":[[245,370],[1854,370],[1854,419],[245,419]],"region":{"top_left_x":244,"top_left_y":369,"width":1611,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"200a284f14bd4375a292ac9ad921e6ad","type":"text","conversion_output":true,"text":"of the mean change from baseline in the monthly average number of days of secondary efficacy","text_display":" of the mean change from baseline in the monthly average number of days of secondary efficacy","confidence":1,"confidence_rate":1},{"cnt":[[245,417],[1848,417],[1848,471],[245,471]],"region":{"top_left_x":244,"top_left_y":416,"width":1604,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5080cd96b51545488626ca653f95aa0e","type":"text","conversion_output":true,"text":"variables during the 12-week period derived from headache diary data. The model will include","text_display":" variables during the 12-week period derived from headache diary data. The model will include","confidence":1,"confidence_rate":1},{"cnt":[[245,466],[1871,466],[1871,518],[245,518]],"region":{"top_left_x":244,"top_left_y":466,"width":1628,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"458550ddf89d4d32932e97f513a5e803","type":"text","conversion_output":true,"text":"treatment, sex, region, and baseline preventive migraine medication use (yes/no) as fixed effects;","text_display":" treatment, sex, region, and baseline preventive migraine medication use (yes/no) as fixed effects;","confidence":1,"confidence_rate":1},{"cnt":[[245,516],[1931,516],[1931,565],[245,565]],"region":{"top_left_x":244,"top_left_y":515,"width":1688,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"207660275d374e639b7d88b18a016120","type":"text","conversion_output":true,"text":"the baseline values and years since onset of migraines as covariates. The LS means for the treatment","text_display":" the baseline values and years since onset of migraines as covariates. The LS means for the treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[1800,563],[1800,614],[245,614]],"region":{"top_left_x":244,"top_left_y":562,"width":1557,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab7fe2ce3d6b4c41b1d681212a9c9fbd","type":"text","conversion_output":true,"text":"groups, LS means and \\(95 \\%\\) confidence intervals for the treatment differences (TEV-48125-","text_display":" groups, LS means and \\(95 \\%\\) confidence intervals for the treatment differences (TEV-48125","confidence":0.8234043121337891,"confidence_rate":0.9979567436363767},{"cnt":[[245,612],[1106,612],[1106,664],[245,664]],"region":{"top_left_x":244,"top_left_y":612,"width":863,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4b42857863346ef92efa663391b7a03","type":"text","conversion_output":true,"text":"placebo), and associated p -values will be provided.","text_display":"placebo), and associated p -values will be provided.","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[245,679],[1901,679],[1901,733],[245,733]],"region":{"top_left_x":244,"top_left_y":678,"width":1658,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2e63ab77f4f4b00b8eeae91a8e86f01","type":"text","conversion_output":true,"text":"If a patient has less than 10 days of e-diary data entries after the \\(1^{\\text {st }}\\) dose of study drug, the missing","text_display":"\nIf a patient has less than 10 days of e-diary data entries after the \\(1^{\\text {st }}\\) dose of study drug, the 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period.","text_display":" monthly average number of days of secondary efficacy variables during the 12-week period.","confidence":1,"confidence_rate":1},{"cnt":[[245,849],[1884,849],[1884,900],[245,900]],"region":{"top_left_x":244,"top_left_y":848,"width":1641,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aefaa11179494ee1a04998f6bf6a3d7c","type":"text","conversion_output":true,"text":"Similar to the sensitivity analysis for the primary efficacy variable described in Section 6.2.3.1 an","text_display":"\nSimilar to the sensitivity analysis for the primary efficacy variable described in Section 6.2.3.1 an","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1880,898],[1880,947],[245,947]],"region":{"top_left_x":244,"top_left_y":898,"width":1636,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d424700afb514e2cb27ad36caeec5894","type":"text","conversion_output":true,"text":"MMRM model will be implemented to estimate the mean change from baseline for the following","text_display":" MMRM model will be implemented to estimate the mean change from baseline for the following","confidence":1,"confidence_rate":1},{"cnt":[[245,941],[1519,941],[1519,999],[245,999]],"region":{"top_left_x":244,"top_left_y":941,"width":1275,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"186e215bb88c458c9703424af0095b1f","type":"text","conversion_output":true,"text":"endpoint by month and for overall 3 months after the \\(1^{\\text {st }}\\) dose of study drug.","text_display":" endpoint by month and for overall 3 months after the \\(1^{\\text {st }}\\) dose of study 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medications","confidence":1,"confidence_rate":1},{"cnt":[[245,1134],[1880,1134],[1880,1188],[245,1188]],"region":{"top_left_x":244,"top_left_y":1134,"width":1636,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3daeeaab702548e88b89d2b6d7d091ce","type":"text","conversion_output":true,"text":"LS means for the treatment groups, LS mean and corresponding \\(95 \\%\\) confidence intervals for the","text_display":"\nLS means for the treatment groups, LS mean and corresponding \\(95 \\%\\) confidence intervals for the","confidence":0.85986328125,"confidence_rate":0.9985062466858582},{"cnt":[[245,1182],[1897,1182],[1897,1235],[245,1235]],"region":{"top_left_x":244,"top_left_y":1181,"width":1654,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54282839c4f24588a770491b4ec590ea","type":"text","conversion_output":true,"text":"treatment differences (TEV-48125 - placebo), and associated p-values will be calculated by month","text_display":" treatment differences (TEV-48125 - placebo), and associated p-values will be calculated by month","confidence":0.5507579888217151,"confidence_rate":0.9941118609840931},{"cnt":[[245,1233],[855,1233],[855,1283],[245,1283]],"region":{"top_left_x":244,"top_left_y":1233,"width":612,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c51276b06e84a18b3693ace4586f0ce","type":"text","conversion_output":true,"text":"and for the overall treatment period.","text_display":" and for the overall treatment period.","confidence":1,"confidence_rate":1},{"cnt":[[245,1302],[1910,1302],[1910,1354],[245,1354]],"region":{"top_left_x":244,"top_left_y":1301,"width":1666,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbd1f8f83f7746dda99623b9f3bd50fb","type":"text","conversion_output":true,"text":"The LS means ± SE of e-diary efficacy variables estimated by MMRM will be plotted by month for","text_display":"\n\nThe LS means ± SE of e-diary efficacy variables estimated by MMRM will be plotted by month for","confidence":0.977082952277442,"confidence_rate":0.9997658483728332},{"cnt":[[245,1351],[617,1351],[617,1403],[245,1403]],"region":{"top_left_x":244,"top_left_y":1351,"width":373,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f25c987e8ebc408aaae06350a4e3e806","type":"text","conversion_output":true,"text":"each treatment group.","text_display":" each treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[245,1418],[1871,1418],[1871,1472],[245,1472]],"region":{"top_left_x":244,"top_left_y":1417,"width":1628,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9dbb190f3ef40c09ba0478622cc164e","type":"text","conversion_output":true,"text":"Cochran Mantel-Haenszel test stratified by baseline preventive migraine medication use (yes/no)","text_display":"\nCochran Mantel-Haenszel test stratified by baseline preventive migraine medication use (yes/no)","confidence":1,"confidence_rate":1},{"cnt":[[245,1467],[1912,1467],[1912,1519],[245,1519]],"region":{"top_left_x":244,"top_left_y":1467,"width":1669,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95737b244372435a87a027cd2914f213","type":"text","conversion_output":true,"text":"will be used for analyzing the proportion of patients reaching at least \\(50 \\%\\) reduction in the monthly","text_display":" will be used for analyzing the proportion of patients reaching at least \\(50 \\%\\) reduction in the 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The","text_display":" average number of migraine days during the 12 -week period after the \\(1^{\\text {st }}\\) dose of study drug. The","confidence":0.9345808029174805,"confidence_rate":0.9994316137829896},{"cnt":[[245,1566],[1175,1566],[1175,1618],[245,1618]],"region":{"top_left_x":244,"top_left_y":1566,"width":932,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e922b41c8b514dacad10b6ce91f9da6e","type":"text","conversion_output":true,"text":"SAS Proc FREQ will be used to carry out this analysis.","text_display":" SAS Proc FREQ will be used to carry out this analysis.","confidence":1,"confidence_rate":1},{"cnt":[[245,1635],[1794,1635],[1794,1687],[245,1687]],"region":{"top_left_x":244,"top_left_y":1634,"width":1550,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be4a02d4f1f54c90b0ad5f7c2a10a0da","type":"text","conversion_output":true,"text":"The change from baseline values in the MIDAS total scores will be analyzed using the same","text_display":"\nThe change from baseline values in the MIDAS total scores will be analyzed using the same","confidence":1,"confidence_rate":1},{"cnt":[[245,1684],[904,1684],[904,1729],[245,1729]],"region":{"top_left_x":244,"top_left_y":1684,"width":661,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa4a0bbd3f18458eb6b9dd3bda44b23a","type":"text","conversion_output":true,"text":"ANCOVA method as described above.","text_display":" ANCOVA method as described above.","confidence":1,"confidence_rate":1},{"cnt":[[245,1753],[1893,1753],[1893,1807],[245,1807]],"region":{"top_left_x":244,"top_left_y":1753,"width":1649,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77dace95912a4774a54fe7000ff6f82b","type":"text","conversion_output":true,"text":"Patients not receiving concomitant preventive medication constitute the sub-population who don't","text_display":"\n\nPatients not receiving concomitant preventive medication constitute the sub-population who don't","confidence":1,"confidence_rate":1},{"cnt":[[245,1800],[1897,1800],[1897,1854],[245,1854]],"region":{"top_left_x":244,"top_left_y":1800,"width":1654,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23bbf6ac0ff14381856d693e3384d932","type":"text","conversion_output":true,"text":"take any preventive migraine medications listed in APPENDIX B of the protocol during the study,","text_display":" take any preventive migraine medications listed in APPENDIX B of the protocol during the study,","confidence":1,"confidence_rate":1},{"cnt":[[245,1852],[1240,1852],[1240,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1851,"width":996,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f32a1974ca740abb886301b78977e5d","type":"text","conversion_output":true,"text":"ie, with baseline preventive migraine medication use \\(=\\) No.","text_display":" ie, with baseline preventive migraine medication use \\(=\\) No.","confidence":0.7276718616485596,"confidence_rate":0.9951948383923589},{"cnt":[[245,1921],[1854,1921],[1854,1970],[245,1970]],"region":{"top_left_x":244,"top_left_y":1920,"width":1611,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a02385d80384464abae497b393d729a1","type":"text","conversion_output":true,"text":"For all relevant secondary endpoints, the normality of the residuals from each ANCOVA model","text_display":"\n\nFor all relevant secondary endpoints, the normality of the residuals from each ANCOVA model","confidence":1,"confidence_rate":1},{"cnt":[[245,1968],[1863,1968],[1863,2022],[245,2022]],"region":{"top_left_x":244,"top_left_y":1967,"width":1619,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c3e28da76c74007b5e1d9527c8e1e98","type":"text","conversion_output":true,"text":"will be checked using Shapiro Wilk's normality test. In case that the Shapiro Wilk's test has a p","text_display":" will be checked using Shapiro Wilk's normality test. In case that the Shapiro Wilk's test has a p","confidence":0.9014151096343994,"confidence_rate":0.9989829743209628},{"cnt":[[245,2020],[1861,2020],[1861,2069],[245,2069]],"region":{"top_left_x":244,"top_left_y":2019,"width":1617,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e64c9655ddb94069abf82a81e1ede600","type":"text","conversion_output":true,"text":"value \\(\\leq 0.01\\), Wilcoxon rank-sum test will be conducted as the primary analysis. The ANCOVA","text_display":" value \\(\\leq 0.01\\), Wilcoxon rank-sum test will be conducted as the primary analysis. The ANCOVA","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,2067],[1119,2067],[1119,2118],[245,2118]],"region":{"top_left_x":244,"top_left_y":2066,"width":876,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bb768dfbbab478ba5760f092a590845","type":"text","conversion_output":true,"text":"analysis will be considered as a supportive analysis.","text_display":" analysis will be considered as a supportive analysis.","confidence":1,"confidence_rate":1},{"cnt":[[1057,2557],[1113,2557],[1113,2608],[1057,2608]],"region":{"top_left_x":1057,"top_left_y":2556,"width":56,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b42525a7b0864cbdb2bc9e7953092da4","type":"page_info","conversion_output":false,"text":"39","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-41","page":41,"lines":[{"cnt":[[245,125],[1012,125],[1012,176],[245,176]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a608179a245b463cbf0055b768d61d0f","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64de936934ad4dfc81fa101e9cda7101","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[236,245],[1379,245],[1379,320],[236,320]],"region":{"top_left_x":236,"top_left_y":244,"width":1144,"height":77},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7103318e1238430aa8ed2e6bfc83e59c","type":"section_header","conversion_output":false,"children_ids":["856c2b3be2eb463184d34b2d1b99321c"],"text":"","text_display":""},{"cnt":[[243,251],[1371,251],[1371,312],[243,312]],"region":{"top_left_x":242,"top_left_y":251,"width":1129,"height":61},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"856c2b3be2eb463184d34b2d1b99321c","type":"text","conversion_output":true,"parent_id":"7103318e1238430aa8ed2e6bfc83e59c","text":"6.4. Exploratory Efficacy Variables and Analysis","text_display":"\n\n\\subsection*{6.4. Exploratory Efficacy Variables and Analysis}","confidence":0.78759765625,"confidence_rate":0.9955050776695241},{"cnt":[[245,327],[1354,327],[1354,380],[245,380]],"region":{"top_left_x":244,"top_left_y":326,"width":1110,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10c88610e16944ff817b03f8978becfc","type":"text","conversion_output":true,"text":"The exploratory efficacy endpoints are described in Section 2.2.3.","text_display":"\n\nThe exploratory efficacy endpoints are described in Section 2.2.3.","confidence":1,"confidence_rate":1},{"cnt":[[236,412],[793,412],[793,471],[236,471]],"region":{"top_left_x":236,"top_left_y":412,"width":557,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af80f61cdd8e4711b3cb7fdfb0e575dd","type":"section_header","conversion_output":false,"children_ids":["9125a67938b84e528313b2e3a352bd2e"],"text":"","text_display":""},{"cnt":[[245,417],[788,417],[788,466],[245,466]],"region":{"top_left_x":244,"top_left_y":416,"width":545,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9125a67938b84e528313b2e3a352bd2e","type":"text","conversion_output":true,"parent_id":"af80f61cdd8e4711b3cb7fdfb0e575dd","text":"6.4.1. Variable Definition","text_display":"\n\n\\subsection*{6.4.1. Variable Definition}","confidence":0.99462890625,"confidence_rate":0.9998262870275043},{"cnt":[[236,503],[1025,503],[1025,565],[236,565]],"region":{"top_left_x":236,"top_left_y":502,"width":789,"height":64},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8013189257243d18ee709b0e0f73ef5","type":"section_header","conversion_output":false,"children_ids":["2c8e7990575d46bc8bb3d73b0712956f"],"text":"","text_display":""},{"cnt":[[245,507],[1021,507],[1021,561],[245,561]],"region":{"top_left_x":244,"top_left_y":507,"width":777,"height":54},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c8e7990575d46bc8bb3d73b0712956f","type":"text","conversion_output":true,"parent_id":"a8013189257243d18ee709b0e0f73ef5","text":"6.4.1.1. Electronic Headache Diary Data","text_display":"\n\n\\subsection*{6.4.1.1. Electronic Headache Diary Data}","confidence":0.9912109375,"confidence_rate":0.9997993857138384},{"cnt":[[245,576],[1841,576],[1841,629],[245,629]],"region":{"top_left_x":244,"top_left_y":575,"width":1598,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9584e87e58cc49e0bd2cb2068dc605d7","type":"text","conversion_output":true,"text":"A headache day of at least moderate severity will be defined as a calendar day (00:00 to 23:59)","text_display":"\n\nA headache day of at least moderate severity will be defined as a calendar day (00:00 to 23:59)","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,627],[679,627],[679,677],[245,677]],"region":{"top_left_x":244,"top_left_y":627,"width":435,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5daca8dc78d4823943626a1c3ef888b","type":"text","conversion_output":true,"text":"where the patient reports:","text_display":" where the patient reports:","confidence":1,"confidence_rate":1},{"cnt":[[370,696],[1863,696],[1863,750],[370,750]],"region":{"top_left_x":369,"top_left_y":696,"width":1494,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"598be0d232244f5aac0b35fa36924dbf","type":"text","conversion_output":true,"text":"- a day with headache pain that lasts \\(\\geq 4\\) hours with a peak severity of at least moderate","text_display":"\n- a day with headache pain that lasts \\(\\geq 4\\) hours with a peak severity of at least moderate","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[430,748],[578,748],[578,797],[430,797]],"region":{"top_left_x":429,"top_left_y":747,"width":149,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ec74bb02d794a47b8fd184d4fc1a394","type":"text","conversion_output":true,"text":"severity","text_display":" severity","confidence":1,"confidence_rate":1},{"cnt":[[432,825],[481,825],[481,864],[432,864]],"region":{"top_left_x":431,"top_left_y":825,"width":51,"height":39},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2dc8d1e417546cdbf5347440daca006","type":"text","conversion_output":true,"text":"or","text_display":"\nor","confidence":1,"confidence_rate":1},{"cnt":[[370,887],[1865,887],[1865,939],[370,939]],"region":{"top_left_x":369,"top_left_y":887,"width":1496,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"445fe19853634bfc93bd78ec2daf31bc","type":"text","conversion_output":true,"text":"- a day when the patient used acute migraine-specific medication (triptans or ergots) to","text_display":"\n- a day when the patient used acute migraine-specific medication (triptans or ergots) to","confidence":1,"confidence_rate":1},{"cnt":[[430,937],[1167,937],[1167,986],[430,986]],"region":{"top_left_x":429,"top_left_y":936,"width":738,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48194c38d68f4bd4ac7109df514991e8","type":"text","conversion_output":true,"text":"treat a headache of any severity or duration","text_display":" treat a headache of any severity or duration","confidence":1,"confidence_rate":1},{"cnt":[[243,1005],[1895,1005],[1895,1055],[243,1055]],"region":{"top_left_x":242,"top_left_y":1005,"width":1653,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eabde2d6ed9c4174bc8aa3fe6238ca1f","type":"text","conversion_output":true,"text":"The percent reduction in the monthly average number of migraine days during the 12-week period","text_display":"\n\nThe percent reduction in the monthly average number of migraine days during the 12-week period","confidence":0.99267578125,"confidence_rate":0.9999257484887895},{"cnt":[[245,1053],[1809,1053],[1809,1106],[245,1106]],"region":{"top_left_x":244,"top_left_y":1052,"width":1565,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2471ad41c06f444aaa5308f5a9fc93f5","type":"text","conversion_output":true,"text":"after the \\(1^{\\text {st }}\\) dose of study drug will be calculated by formula (4) in Section 6.1. The patient is","text_display":" after the \\(1^{\\text {st }}\\) dose of study drug will be calculated by formula (4) in Section 6.1. The patient is","confidence":1,"confidence_rate":1},{"cnt":[[245,1102],[1843,1102],[1843,1154],[245,1154]],"region":{"top_left_x":244,"top_left_y":1102,"width":1600,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a060e883450c4bcf84b5d81aeb84dae6","type":"text","conversion_output":true,"text":"considered as a responder reaching \\(50 \\%, 75 \\%\\) or \\(100 \\%\\) reduction if his/her percent reduction is","text_display":" considered as a responder reaching \\(50 \\%, 75 \\%\\) or \\(100 \\%\\) reduction if his/her percent reduction is","confidence":0.9307963366154581,"confidence_rate":0.9993039823007384},{"cnt":[[245,1152],[1923,1152],[1923,1205],[245,1205]],"region":{"top_left_x":244,"top_left_y":1151,"width":1679,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8ad82945bc3431a88c2c28517fb83ea","type":"text","conversion_output":true,"text":"\\(50 \\%\\) or more, \\(75 \\%\\) or more, or \\(100 \\%\\) respectively. Similar definition will be applied to calculate the","text_display":" \\(50 \\%\\) or more, \\(75 \\%\\) or more, or \\(100 \\%\\) respectively. Similar definition will be applied to calculate the","confidence":0.9990236759185791,"confidence_rate":0.9999910385631244},{"cnt":[[245,1199],[1807,1199],[1807,1253],[245,1253]],"region":{"top_left_x":244,"top_left_y":1198,"width":1563,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e0df1b34170480195e8fee560b0713c","type":"text","conversion_output":true,"text":"proportion of patients reaching at least \\(50 \\%\\), \\(75 \\%\\) or \\(100 \\%\\) reduction in the monthly average","text_display":" proportion of patients reaching at least \\(50 \\%\\), \\(75 \\%\\) or \\(100 \\%\\) reduction in the monthly average","confidence":0.9430316844955087,"confidence_rate":0.9994415331698643},{"cnt":[[245,1246],[1897,1246],[1897,1300],[245,1300]],"region":{"top_left_x":244,"top_left_y":1246,"width":1654,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b95491eeecc643538bbe6c81eebc55e9","type":"text","conversion_output":true,"text":"number of headache days of at least moderate severity during the 12-week period after the \\(1^{\\text {st }}\\) dose","text_display":" number of headache days of at least moderate severity during the 12-week period after the \\(1^{\\text {st }}\\) dose","confidence":0.925028947647661,"confidence_rate":0.999339792209361},{"cnt":[[245,1298],[1841,1298],[1841,1349],[245,1349]],"region":{"top_left_x":244,"top_left_y":1297,"width":1598,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e913f6d002884be8aaa2642d277aa03d","type":"text","conversion_output":true,"text":"of study drug. If a patient is early discontinued from the study, he/she will be counted as a non-","text_display":" of study drug. If a patient is early discontinued from the study, he/she will be counted as a non","confidence":1,"confidence_rate":1},{"cnt":[[245,1347],[428,1347],[428,1399],[245,1399]],"region":{"top_left_x":244,"top_left_y":1347,"width":184,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42ee361ed94e456196b142d4a0a35fad","type":"text","conversion_output":true,"text":"responder.","text_display":"responder.","confidence":1,"confidence_rate":1},{"cnt":[[245,1414],[1906,1414],[1906,1467],[245,1467]],"region":{"top_left_x":244,"top_left_y":1413,"width":1662,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf43906b9111408e9f3fc8a015216eb8","type":"text","conversion_output":true,"text":"The percent reduction in the monthly number of migraine days during the 4 -week period after each","text_display":"\nThe percent reduction in the monthly number of migraine days during the 4 -week period after each","confidence":0.6923828125,"confidence_rate":0.996505014310531},{"cnt":[[245,1465],[1884,1465],[1884,1515],[245,1515]],"region":{"top_left_x":244,"top_left_y":1465,"width":1641,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da529511cd874f0b9cee74dec7510fee","type":"text","conversion_output":true,"text":"dose for months 1,2 , and 3 will be calculated by formula ( 4 ) where the postbaseline value will be","text_display":" dose for months 1,2 , and 3 will be calculated by formula ( 4 ) where the postbaseline value will be","confidence":0.8879739982075989,"confidence_rate":0.9989583252209694},{"cnt":[[245,1512],[1888,1512],[1888,1566],[245,1566]],"region":{"top_left_x":244,"top_left_y":1512,"width":1645,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9df2a35de7eb4c0384357d5add11f1b2","type":"text","conversion_output":true,"text":"the number of headache days of at least moderate severity prorated to 28 days for month 1 , month","text_display":" the number of headache days of at least moderate severity prorated to 28 days for month 1 , month","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[245,1560],[1867,1560],[1867,1613],[245,1613]],"region":{"top_left_x":244,"top_left_y":1559,"width":1623,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"073ee659aa434a30a7cb449272003db7","type":"text","conversion_output":true,"text":"2 , and month 3 , respectively. If the patient has \\(50 \\%\\) reduction or more in month 1 , he/she will be","text_display":" 2 , and month 3 , respectively. If the patient has \\(50 \\%\\) reduction or more in month 1 , he/she will be","confidence":0.998046875,"confidence_rate":0.9999826989564276},{"cnt":[[245,1607],[1921,1607],[1921,1661],[245,1661]],"region":{"top_left_x":244,"top_left_y":1607,"width":1677,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"857b9c944f424a5084585efd10b831b8","type":"text","conversion_output":true,"text":"considered responder during the 4 -week period after \\(1^{\\text {st }}\\) dose of study drug. In addition if the patient","text_display":" considered responder during the 4 -week period after \\(1^{\\text {st }}\\) dose of study drug. In addition if the patient","confidence":0.8028304576873779,"confidence_rate":0.9982585678694077},{"cnt":[[245,1659],[1914,1659],[1914,1708],[245,1708]],"region":{"top_left_x":244,"top_left_y":1658,"width":1671,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba37410edc8b4911977d1b8d533c2d55","type":"text","conversion_output":true,"text":"also has \\(50 \\%\\) reduction or more in month 2 and 3 , he/she is a responder for months 2 and 3 , and the","text_display":" also has \\(50 \\%\\) reduction or more in month 2 and 3 , he/she is a responder for months 2 and 3 , and the","confidence":0.960956335067749,"confidence_rate":0.9996681691678799},{"cnt":[[245,1704],[1863,1704],[1863,1760],[245,1760]],"region":{"top_left_x":244,"top_left_y":1703,"width":1619,"height":57},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"140ac0038a0f4826b6f6758236fc4dd2","type":"text","conversion_output":true,"text":"level of effect is sustained throughout the 12 -week period after the \\(1^{\\text {st }}\\) dose of study drug for this","text_display":" level of effect is sustained throughout the 12 -week period after the \\(1^{\\text {st }}\\) dose of study drug for this","confidence":0.5234813690185547,"confidence_rate":0.9947938104056326},{"cnt":[[245,1755],[1794,1755],[1794,1807],[245,1807]],"region":{"top_left_x":244,"top_left_y":1755,"width":1550,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90a146740e55467a87efdce9a63546cf","type":"text","conversion_output":true,"text":"patient. Similar definition will be applied to calculate the proportion of sustained responders","text_display":" patient. Similar definition will be applied to calculate the proportion of sustained responders","confidence":1,"confidence_rate":1},{"cnt":[[245,1805],[1893,1805],[1893,1858],[245,1858]],"region":{"top_left_x":244,"top_left_y":1804,"width":1649,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"417aae13427d4edbbc127e57e7fb83b5","type":"text","conversion_output":true,"text":"reaching at least \\(75 \\%\\) reduction. The proportion of sustained responders reaching at least \\(50 \\%\\) and","text_display":" reaching at least \\(75 \\%\\) reduction. The proportion of sustained responders reaching at least \\(50 \\%\\) and","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[245,1852],[1781,1852],[1781,1906],[245,1906]],"region":{"top_left_x":244,"top_left_y":1851,"width":1538,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c2866565ffc49048e179233c28d1916","type":"text","conversion_output":true,"text":"\\(75 \\%\\) reduction in the number of headache days of at least moderate severity will be derived","text_display":" \\(75 \\%\\) reduction in the number of headache days of at least moderate severity will be derived","confidence":0.60400390625,"confidence_rate":0.9946507984836831},{"cnt":[[245,1901],[415,1901],[415,1953],[245,1953]],"region":{"top_left_x":244,"top_left_y":1901,"width":171,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7eaf669c651042e3b82a95b57c6e7fbe","type":"text","conversion_output":true,"text":"similarly.","text_display":" similarly.","confidence":1,"confidence_rate":1},{"cnt":[[245,1970],[1901,1970],[1901,2022],[245,2022]],"region":{"top_left_x":244,"top_left_y":1970,"width":1658,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79d9868688784145a82f8774bcbb0640","type":"text","conversion_output":true,"text":"The headache day of any severity will be defined as a calendar day (00:00 to 23:59) with headache","text_display":"\nThe headache day of any severity will be defined as a calendar day (00:00 to 23:59) with headache","confidence":0.7815682888031006,"confidence_rate":0.9975867132265235},{"cnt":[[245,2020],[1818,2020],[1818,2073],[245,2073]],"region":{"top_left_x":244,"top_left_y":2019,"width":1574,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0da732df25a4c9a87d08784374e7392","type":"text","conversion_output":true,"text":"pain that lasts \\(\\geq 4\\) hours of any severity or a day when the patient used acute migraine-specific","text_display":" pain that lasts \\(\\geq 4\\) hours of any severity or a day when the patient used acute migraine-specific","confidence":0.9990236759185791,"confidence_rate":0.9999905165401506},{"cnt":[[245,2071],[1545,2071],[1545,2121],[245,2121]],"region":{"top_left_x":244,"top_left_y":2071,"width":1301,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c66820c617b416b9c7b5b2e31f0ec19","type":"text","conversion_output":true,"text":"medication (triptans or ergots) to treat a headache of any severity or duration.","text_display":" medication (triptans or ergots) to treat a headache of any severity or duration.","confidence":1,"confidence_rate":1},{"cnt":[[245,2136],[1893,2136],[1893,2189],[245,2189]],"region":{"top_left_x":244,"top_left_y":2135,"width":1649,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f011a749ef674dd4b4a82c242e9f6e86","type":"text","conversion_output":true,"text":"The change from baseline in the monthly average number of days or hours of exploratory efficacy","text_display":"\nThe change from baseline in the monthly average number of days or hours of exploratory efficacy","confidence":1,"confidence_rate":1},{"cnt":[[245,2187],[1899,2187],[1899,2237],[245,2237]],"region":{"top_left_x":244,"top_left_y":2187,"width":1656,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00749340379d44cd8708cefab6ef0a0f","type":"text","conversion_output":true,"text":"variables (e.g. days with at least moderate severity, days with any severity, total hours of headache","text_display":" variables (e.g. days with at least moderate severity, days with any severity, total hours of headache","confidence":1,"confidence_rate":1},{"cnt":[[245,2234],[1897,2234],[1897,2288],[245,2288]],"region":{"top_left_x":244,"top_left_y":2234,"width":1654,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84a4c9a8e0ee4694b640a42b536cb048","type":"text","conversion_output":true,"text":"with at least moderate severity, total hours of headache with any severity, days of use of migraine-","text_display":" with at least moderate severity, total hours of headache with any severity, days of use of migraine","confidence":1,"confidence_rate":1},{"cnt":[[245,2282],[1916,2282],[1916,2335],[245,2335]],"region":{"top_left_x":244,"top_left_y":2281,"width":1673,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f063164d8a149a68a5e7affca9be9e2","type":"text","conversion_output":true,"text":"specific acute medications, days with nausea or vomiting, days with photophobia and phonophobia","text_display":"specific acute medications, days with nausea or vomiting, days with photophobia and phonophobia","confidence":1,"confidence_rate":1},{"cnt":[[245,2329],[1798,2329],[1798,2383],[245,2383]],"region":{"top_left_x":244,"top_left_y":2328,"width":1555,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e29a3c806f0a42a496fe9d301cbd9aa5","type":"text","conversion_output":true,"text":"etc.) during the 12-week period after the \\(1^{\\text {st }}\\) dose of study drug will be derived similar to the","text_display":" etc.) during the 12-week period after the \\(1^{\\text {st }}\\) dose of study drug will be derived similar to the","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[245,2380],[1794,2380],[1794,2434],[245,2434]],"region":{"top_left_x":244,"top_left_y":2380,"width":1550,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70f786e2ff684074947b4f466b7158f4","type":"text","conversion_output":true,"text":"primary variables using the e-diary data collected through the corresponding headache diary","text_display":" primary variables using the e-diary data collected through the corresponding headache diary","confidence":1,"confidence_rate":1},{"cnt":[[245,2430],[1833,2430],[1833,2481],[245,2481]],"region":{"top_left_x":244,"top_left_y":2429,"width":1589,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86c6ae33edd74ca5b2d8e1f71c7a2ede","type":"text","conversion_output":true,"text":"questions (Appendix A). The baseline values and the postbaseline values will be derived using","text_display":" questions (Appendix A). The baseline values and the postbaseline values will be derived using","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[1057,2557],[1113,2557],[1113,2608],[1057,2608]],"region":{"top_left_x":1057,"top_left_y":2556,"width":56,"height":53},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6d5933b258f419a990260c24ce8e00a","type":"page_info","conversion_output":false,"text":"40","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-42","page":42,"lines":[{"cnt":[[245,125],[1012,125],[1012,174],[245,174]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1009d6ade0a747529ff784775061efad","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"494340595ff644e689bc1b964b51da3f","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[1841,251],[1841,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1598,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2129290c85ec4abcad4b31bd14403725","type":"text","conversion_output":true,"text":"formula (3) and (1) respectively, and the change is calculated as postbaseline value - baseline","text_display":"\nformula (3) and (1) respectively, and the change is calculated as postbaseline value - baseline","confidence":0.89306640625,"confidence_rate":0.998869695897759},{"cnt":[[245,301],[357,301],[357,346],[245,346]],"region":{"top_left_x":244,"top_left_y":300,"width":113,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e26ec626df144c8bb69af2a6259c49ba","type":"text","conversion_output":true,"text":"value.","text_display":" value.","confidence":1,"confidence_rate":1},{"cnt":[[245,370],[1912,370],[1912,421],[245,421]],"region":{"top_left_x":244,"top_left_y":369,"width":1669,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"744c9063fe4946a0bf7d3e167c232357","type":"text","conversion_output":true,"text":"The change from baseline in the monthly number of days or hours of exploratory efficacy variables","text_display":"\n\nThe change from baseline in the monthly number of days or hours of exploratory efficacy variables","confidence":1,"confidence_rate":1},{"cnt":[[245,421],[1846,421],[1846,471],[245,471]],"region":{"top_left_x":244,"top_left_y":421,"width":1602,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9d654611bff416fa3cff21be3506162","type":"text","conversion_output":true,"text":"(e.g. days of headache with at least moderate severity, days of headache with any severity, total","text_display":" (e.g. days of headache with at least moderate severity, days of headache with any severity, total","confidence":1,"confidence_rate":1},{"cnt":[[245,468],[1931,468],[1931,518],[245,518]],"region":{"top_left_x":244,"top_left_y":468,"width":1688,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7208f3f878644bbdb2e0fd46d128a994","type":"text","conversion_output":true,"text":"hours of headache with at least moderate severity, total hours of headache with any severity, days of","text_display":" hours of headache with at least moderate severity, total hours of headache with any severity, days of","confidence":1,"confidence_rate":1},{"cnt":[[245,516],[1882,516],[1882,567],[245,567]],"region":{"top_left_x":244,"top_left_y":515,"width":1639,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0fb154eb52f4cdc9936644146e8b440","type":"text","conversion_output":true,"text":"use of migraine-specific acute medications, days with nausea or vomiting, days with photophobia","text_display":" use of migraine-specific acute medications, days with nausea or vomiting, days with photophobia","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[1919,563],[1919,614],[245,614]],"region":{"top_left_x":244,"top_left_y":562,"width":1675,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95b8e6dea79c4f3c8c1b5c340a3f15cd","type":"text","conversion_output":true,"text":"and phonophobia etc.) during the 4 week period after the each dose of study drug will be calculated","text_display":" and phonophobia etc.) during the 4 week period after the each dose of study drug will be calculated","confidence":1,"confidence_rate":1},{"cnt":[[245,612],[1631,612],[1631,664],[245,664]],"region":{"top_left_x":244,"top_left_y":612,"width":1387,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"306b48dcf82d4688b99bd61eaf38371b","type":"text","conversion_output":true,"text":"using formula ( 2 ) using the month 1 , month 2 and month 3 diary data respectively.","text_display":" using formula ( 2 ) using the month 1 , month 2 and month 3 diary data respectively.","confidence":0.987321138381958,"confidence_rate":0.9998736720958709},{"cnt":[[245,683],[1824,683],[1824,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1581,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16c0b110bbb3497fbfbe8a073a50a1d0","type":"text","conversion_output":true,"text":"The change from baseline in weekly number of headache days of at least moderate severity or","text_display":"\n\nThe change from baseline in weekly number of headache days of at least moderate severity or","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1893,730],[1893,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1649,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae9934bd7e4b4e0a8e8757e3ffc73057","type":"text","conversion_output":true,"text":"migraine days for week 1 (Day 1-7), week 2 (Day 8-14), week 3 (Day15-21) and week 4 (Day 22-","text_display":" migraine days for week 1 (Day 1-7), week 2 (Day 8-14), week 3 (Day15-21) and week 4 (Day 22","confidence":0.99853515625,"confidence_rate":0.9999865513043565},{"cnt":[[245,778],[1835,778],[1835,831],[245,831]],"region":{"top_left_x":244,"top_left_y":777,"width":1591,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"047210dc02144122b6403e9428f90e04","type":"text","conversion_output":true,"text":"28) after the \\(1^{\\text {st }}\\) dose of study drug will be derived using the \\(1^{\\text {st }} 28\\)-day diary data. The baseline","text_display":"28) after the \\(1^{\\text {st }}\\) dose of study drug will be derived using the \\(1^{\\text {st }} 28\\)-day diary data. The baseline","confidence":0.958984375,"confidence_rate":0.9996851586162246},{"cnt":[[245,829],[1790,829],[1790,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":1546,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee11a871606e4ee19867cc919cc69716","type":"text","conversion_output":true,"text":"values and the postbaseline values will be derived using formula (5) and (6) in Section 6.2.1","text_display":" values and the postbaseline values will be derived using formula (5) and (6) in Section 6.2.1","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1618,877],[1618,930],[245,930]],"region":{"top_left_x":244,"top_left_y":876,"width":1374,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"583bea02812f471d9bc630ea52a21045","type":"text","conversion_output":true,"text":"respectively, and the change is calculated as postbaseline value - baseline value.","text_display":" respectively, and the change is calculated as postbaseline value - baseline value.","confidence":0.65478515625,"confidence_rate":0.9951446061459768},{"cnt":[[236,962],[1040,962],[1040,1025],[236,1025]],"region":{"top_left_x":236,"top_left_y":962,"width":804,"height":63},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac8b1052c2e84e2091dc0f0b64a241c7","type":"section_header","conversion_output":false,"children_ids":["5cd28e4764ee43d69b68670304766c7a"],"text":"","text_display":""},{"cnt":[[245,967],[1033,967],[1033,1018],[245,1018]],"region":{"top_left_x":244,"top_left_y":966,"width":790,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cd28e4764ee43d69b68670304766c7a","type":"text","conversion_output":true,"parent_id":"ac8b1052c2e84e2091dc0f0b64a241c7","text":"6.4.1.2 Migraine-Specific Quality of Life","text_display":"\n\n\\subsection*{6.4.1.2 Migraine-Specific Quality of Life}","confidence":0.72216796875,"confidence_rate":0.9929489430584258},{"cnt":[[245,1036],[1910,1036],[1910,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1035,"width":1666,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d38a2aba6e1e435986ec09b3447c34cc","type":"text","conversion_output":true,"text":"The 14-item MSQOL (see Appendix D) questionnaire is designed to measure how migraines affect","text_display":"\n\nThe 14-item MSQOL (see Appendix D) questionnaire is designed to measure how migraines affect","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,1083],[1927,1083],[1927,1137],[245,1137]],"region":{"top_left_x":244,"top_left_y":1082,"width":1684,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df66b5beaaf440bfab5dd467a5f0faca","type":"text","conversion_output":true,"text":"and/or limit daily functioning across three domains: Role Function-Restrictive domain comprising 7","text_display":" and/or limit daily functioning across three domains: Role Function-Restrictive domain comprising 7","confidence":1,"confidence_rate":1},{"cnt":[[245,1130],[1888,1130],[1888,1184],[245,1184]],"region":{"top_left_x":244,"top_left_y":1130,"width":1645,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e54a5079f5e4df2915e80e006411708","type":"text","conversion_output":true,"text":"items assessing how migraines limit one's daily social and work-related activities; Role Function-","text_display":" items assessing how migraines limit one's daily social and work-related activities; Role Function","confidence":1,"confidence_rate":1},{"cnt":[[245,1182],[1796,1182],[1796,1231],[245,1231]],"region":{"top_left_x":244,"top_left_y":1181,"width":1553,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8788dd9bc77c49c380c6f37ce9c30811","type":"text","conversion_output":true,"text":"Preventive domain comprising 4 items assessing how migraines prevent these activities, and","text_display":"Preventive domain comprising 4 items assessing how migraines prevent these activities, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1229],[1893,1229],[1893,1283],[245,1283]],"region":{"top_left_x":244,"top_left_y":1228,"width":1649,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d88e1dc127b442ba802a8b5efa7796b","type":"text","conversion_output":true,"text":"Emotional Function domain comprising 3 items assessing the emotions associated with migraines.","text_display":" Emotional Function domain comprising 3 items assessing the emotions associated with migraines.","confidence":1,"confidence_rate":1},{"cnt":[[245,1280],[1854,1280],[1854,1330],[245,1330]],"region":{"top_left_x":244,"top_left_y":1280,"width":1611,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c133c7805cd442d910ac977f63fff5d","type":"text","conversion_output":true,"text":"Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale","text_display":" Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale","confidence":1,"confidence_rate":1},{"cnt":[[245,1328],[1904,1328],[1904,1379],[245,1379]],"region":{"top_left_x":244,"top_left_y":1327,"width":1660,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c2b10d94bed4b55a9c6d56452df65c5","type":"text","conversion_output":true,"text":"such that higher scores indicate better quality of life. Appendix E provides the scoring instructions","text_display":" such that higher scores indicate better quality of life. Appendix E provides the scoring instructions","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,1375],[1491,1375],[1491,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1375,"width":1248,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"906721fc00314ab692dd00392879ffbe","type":"text","conversion_output":true,"text":"on how to rescale the raw score to the scales that will be used for analysis.","text_display":" on how to rescale the raw score to the scales that will be used for analysis.","confidence":1,"confidence_rate":1},{"cnt":[[236,1461],[1104,1461],[1104,1523],[236,1523]],"region":{"top_left_x":236,"top_left_y":1460,"width":869,"height":64},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19e376f6f9f44809be6cc08236dc0f61","type":"section_header","conversion_output":false,"children_ids":["4e9ce7e868894b889ec1158ef54f0fdf"],"text":"","text_display":""},{"cnt":[[245,1465],[1096,1465],[1096,1519],[245,1519]],"region":{"top_left_x":244,"top_left_y":1465,"width":852,"height":54},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e9ce7e868894b889ec1158ef54f0fdf","type":"text","conversion_output":true,"parent_id":"19e376f6f9f44809be6cc08236dc0f61","text":"6.4.1.3. EuroQol-5 Dimension Questionnaire","text_display":"\n\n\\subsection*{6.4.1.3. EuroQol-5 Dimension Questionnaire}","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[245,1534],[1852,1534],[1852,1588],[245,1588]],"region":{"top_left_x":244,"top_left_y":1533,"width":1608,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebc8467bc9d24a1b9672520bc5cacd29","type":"text","conversion_output":true,"text":"The EQ-5D-5L questionnaire (Appendix F) is a standardized questionnaire that assesses overall","text_display":"\n\nThe EQ-5D-5L questionnaire (Appendix F) is a standardized questionnaire that assesses overall","confidence":1,"confidence_rate":1},{"cnt":[[245,1586],[1777,1586],[1777,1635],[245,1635]],"region":{"top_left_x":244,"top_left_y":1585,"width":1533,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"220b3318a7b14637ba9c9c74766df56a","type":"text","conversion_output":true,"text":"state of health. The EQ-5D-5L consist of 2 parts. In part 1, patients rate their health state in","text_display":" state of health. The EQ-5D-5L consist of 2 parts. In part 1, patients rate their health state in","confidence":1,"confidence_rate":1},{"cnt":[[245,1633],[1880,1633],[1880,1682],[245,1682]],"region":{"top_left_x":244,"top_left_y":1632,"width":1636,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa55e913ad8d409fb356b9521d046e12","type":"text","conversion_output":true,"text":"5 domains: mobility, self-care, usual activities, pain/discomfort, and mood, using a scale of 1 to 5","text_display":" 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood, using a scale of 1 to 5","confidence":1,"confidence_rate":1},{"cnt":[[245,1680],[1897,1680],[1897,1732],[245,1732]],"region":{"top_left_x":244,"top_left_y":1680,"width":1654,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c07c3957b6c4335982f1e32b3b58232","type":"text","conversion_output":true,"text":"where \\(1=\\) no problems, \\(2=\\) slight problems, \\(3=\\) moderate problems, \\(4=\\) severe problems, and \\(5=\\)","text_display":" where \\(1=\\) no problems, \\(2=\\) slight problems, \\(3=\\) moderate problems, \\(4=\\) severe problems, and \\(5=\\)","confidence":0.9951171875,"confidence_rate":0.999953823968252},{"cnt":[[245,1729],[1824,1729],[1824,1781],[245,1781]],"region":{"top_left_x":244,"top_left_y":1729,"width":1581,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"948a425283694cfc88e0d9969c928f8a","type":"text","conversion_output":true,"text":"extreme problems. In part 2, patients rate their health state on a 100 mm visual analog scale; a","text_display":" extreme problems. In part 2, patients rate their health state on a 100 mm visual analog scale; a","confidence":1,"confidence_rate":1},{"cnt":[[245,1779],[1824,1779],[1824,1828],[245,1828]],"region":{"top_left_x":244,"top_left_y":1778,"width":1581,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8531018a73754e34a6a1b7172c14906d","type":"text","conversion_output":true,"text":"rating of 0 represents the worst imaginable health state, and a rating of 100 represents the best","text_display":" rating of 0 represents the worst imaginable health state, and a rating of 100 represents the best","confidence":1,"confidence_rate":1},{"cnt":[[245,1826],[647,1826],[647,1880],[245,1880]],"region":{"top_left_x":244,"top_left_y":1826,"width":403,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18f1bfe837934f54a50e107405c9a4c0","type":"text","conversion_output":true,"text":"imaginable health state.","text_display":" imaginable health state.","confidence":1,"confidence_rate":1},{"cnt":[[236,1912],[971,1912],[971,1974],[236,1974]],"region":{"top_left_x":236,"top_left_y":1912,"width":736,"height":63},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dde0f2abbdbe4255813891f09091ef6d","type":"section_header","conversion_output":false,"children_ids":["4cf4afc950f043968129d182dffb707f"],"text":"","text_display":""},{"cnt":[[245,1916],[965,1916],[965,1968],[245,1968]],"region":{"top_left_x":244,"top_left_y":1916,"width":721,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cf4afc950f043968129d182dffb707f","type":"text","conversion_output":true,"parent_id":"dde0f2abbdbe4255813891f09091ef6d","text":"6.4.1.4. Patient Health Questionnaire","text_display":"\n\n\\subsection*{6.4.1.4. Patient Health Questionnaire}","confidence":0.9985356330871582,"confidence_rate":0.9999651091766528},{"cnt":[[245,1985],[1914,1985],[1914,2035],[245,2035]],"region":{"top_left_x":244,"top_left_y":1985,"width":1671,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0b2a0b160754941beac18617a81f118","type":"text","conversion_output":true,"text":"The PHQ (Appendix G) is a 9-item questionnaire with each item corresponding to 1 criterion of the","text_display":"\n\nThe PHQ (Appendix G) is a 9-item questionnaire with each item corresponding to 1 criterion of the","confidence":0.951108880341053,"confidence_rate":0.9995227164824981},{"cnt":[[245,2028],[1837,2028],[1837,2086],[245,2086]],"region":{"top_left_x":244,"top_left_y":2028,"width":1593,"height":59},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1ebc519f7554dd58576a693503812eb","type":"text","conversion_output":true,"text":"Diagnostic and Statistical Manual for Mental Disorders \\(4{ }^{\\text {th }}\\) edition diagnostic criteria for major","text_display":" Diagnostic and Statistical Manual for Mental Disorders \\(4{ }^{\\text {th }}\\) edition diagnostic criteria for major","confidence":0.9985356330871582,"confidence_rate":0.9999873669750909},{"cnt":[[245,2082],[1882,2082],[1882,2133],[245,2133]],"region":{"top_left_x":244,"top_left_y":2081,"width":1639,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a601d6be2ff84f1bbd44486e76dab4ec","type":"text","conversion_output":true,"text":"depressive disorder. Each of the items is scored on a scale of 0 (\"not at all\"), 1 (\"several days\"), 2","text_display":" depressive disorder. Each of the items is scored on a scale of 0 (\"not at all\"), 1 (\"several days\"), 2","confidence":0.9448771476745605,"confidence_rate":0.9994938748888309},{"cnt":[[245,2131],[1919,2131],[1919,2185],[245,2185]],"region":{"top_left_x":244,"top_left_y":2131,"width":1675,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79e016e70c434fc98c4a84eb517e30a8","type":"text","conversion_output":true,"text":"(\"more than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during","text_display":" (\"more than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[245,2179],[1901,2179],[1901,2230],[245,2230]],"region":{"top_left_x":244,"top_left_y":2178,"width":1658,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"397b6bbb17044932b08e3abdfac97f93","type":"text","conversion_output":true,"text":"the past 2 weeks (Spitzer et al 1999). The PHQ-2 was developed from the PHQ-9 to rapidly screen","text_display":" the past 2 weeks (Spitzer et al 1999). The PHQ-2 was developed from the PHQ-9 to rapidly screen","confidence":1,"confidence_rate":1},{"cnt":[[245,2230],[1861,2230],[1861,2279],[245,2279]],"region":{"top_left_x":244,"top_left_y":2230,"width":1617,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3529b89b258f4ababb43dc721db2e98f","type":"text","conversion_output":true,"text":"for depression and consists of the first 2 questions of the PHQ-9. The PHQ-2 and the PHQ-9 are","text_display":" for depression and consists of the first 2 questions of the PHQ-9. The PHQ-2 and the PHQ-9 are","confidence":1,"confidence_rate":1},{"cnt":[[245,2277],[1910,2277],[1910,2329],[245,2329]],"region":{"top_left_x":244,"top_left_y":2277,"width":1666,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f6fa072c79744b184cb224e7d5e5c10","type":"text","conversion_output":true,"text":"validated measures for detecting and monitoring depression, anxiety, and somatization (Kroenke et","text_display":" validated measures for detecting and monitoring depression, anxiety, and somatization (Kroenke et","confidence":1,"confidence_rate":1},{"cnt":[[245,2325],[402,2325],[402,2378],[245,2378]],"region":{"top_left_x":244,"top_left_y":2324,"width":158,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4ba6bae3e494c0bade6d1289a1d9e14","type":"text","conversion_output":true,"text":"al 2010).","text_display":" al 2010).","confidence":1,"confidence_rate":1},{"cnt":[[1057,2557],[1109,2557],[1109,2608],[1057,2608]],"region":{"top_left_x":1057,"top_left_y":2556,"width":52,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"342a508ecb2a4352b03cb051518c6427","type":"page_info","conversion_output":false,"text":"41","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-43","page":43,"lines":[{"cnt":[[245,125],[1012,125],[1012,174],[245,174]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82a3d50d3c574791a419aa9da144dd40","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"387ae69136194e44ba16357279d95bbd","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[1867,251],[1867,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1623,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7a850451f9e4e6887fbee278e6057a1","type":"text","conversion_output":true,"text":"Patients will complete the PHQ-2 at baseline (visit 2) and the EOT visit (visit 5). If the PHQ-2 is","text_display":"\n\nPatients will complete the PHQ-2 at baseline (visit 2) and the EOT visit (visit 5). If the PHQ-2 is","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1843,301],[1843,352],[245,352]],"region":{"top_left_x":244,"top_left_y":300,"width":1600,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce281bd2c99c48e9b8f7dfe48ab04893","type":"text","conversion_output":true,"text":"positive (ie, the total score of the 2 items is \\(\\geq 3\\) ), the patient will complete questions 3 thought 9","text_display":" positive (ie, the total score of the 2 items is \\(\\geq 3\\) ), the patient will complete questions 3 thought 9","confidence":0.9878287315368652,"confidence_rate":0.9998925852000163},{"cnt":[[245,350],[810,350],[810,400],[245,400]],"region":{"top_left_x":244,"top_left_y":350,"width":566,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efbcaed02af6431a98b1675414d5f730","type":"text","conversion_output":true,"text":"(unique questions) of the PHQ-9.","text_display":" (unique questions) of the PHQ-9.","confidence":1,"confidence_rate":1},{"cnt":[[241,434],[1893,434],[1893,494],[241,494]],"region":{"top_left_x":240,"top_left_y":433,"width":1653,"height":62},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8d933f90ccf493e93b6113700a8ede6","type":"section_header","conversion_output":false,"children_ids":["1584f091fba84aa58b51ed2eb3d54349"],"text":"","text_display":""},{"cnt":[[245,438],[1888,438],[1888,490],[245,490]],"region":{"top_left_x":244,"top_left_y":438,"width":1645,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1584f091fba84aa58b51ed2eb3d54349","type":"text","conversion_output":true,"parent_id":"e8d933f90ccf493e93b6113700a8ede6","text":"6.4.1.5. Work Productivity and Activity Impairment Questionnaire: General Health V2.0","text_display":"\n\n\\subsection*{6.4.1.5. Work Productivity and Activity Impairment Questionnaire: General Health V2.0}","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[245,509],[1888,509],[1888,559],[245,559]],"region":{"top_left_x":244,"top_left_y":509,"width":1645,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b232a4db45db435cbb5df01abeffee6a","type":"text","conversion_output":true,"text":"The generic version of the WPAI: General Health (GH) (Appendix H) questionnaire measures the","text_display":"\n\nThe generic version of the WPAI: General Health (GH) (Appendix H) questionnaire measures the","confidence":1,"confidence_rate":1},{"cnt":[[245,559],[1865,559],[1865,608],[245,608]],"region":{"top_left_x":244,"top_left_y":558,"width":1621,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"420564d286f94d42919b060e8b8963a6","type":"text","conversion_output":true,"text":"overall effect of health on productivity at work and daily activities. The specific health problems","text_display":" overall effect of health on productivity at work and daily activities. The specific health problems","confidence":1,"confidence_rate":1},{"cnt":[[245,606],[1794,606],[1794,655],[245,655]],"region":{"top_left_x":244,"top_left_y":605,"width":1550,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f86b246888c466185e52ce3e6d56760","type":"text","conversion_output":true,"text":"version of the WPAI questionnaire allows investigators to attribute productivity and activity","text_display":" version of the WPAI questionnaire allows investigators to attribute productivity and activity","confidence":1,"confidence_rate":1},{"cnt":[[245,653],[1871,653],[1871,707],[245,707]],"region":{"top_left_x":244,"top_left_y":653,"width":1628,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6be4561698240afb43d8d1d03254bc5","type":"text","conversion_output":true,"text":"impairment issues to specific health conditions. This assessment will be done at baseline (visit 2)","text_display":" impairment issues to specific health conditions. This assessment will be done at baseline (visit 2)","confidence":0.9072265625,"confidence_rate":0.9990642547484215},{"cnt":[[245,705],[700,705],[700,754],[245,754]],"region":{"top_left_x":244,"top_left_y":704,"width":457,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01f397f406dc4b3ebd11b0738a83578c","type":"text","conversion_output":true,"text":"and the EOT visit (visit 5).","text_display":" and the EOT visit (visit 5).","confidence":1,"confidence_rate":1},{"cnt":[[245,773],[1794,773],[1794,823],[245,823]],"region":{"top_left_x":244,"top_left_y":773,"width":1550,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3db59da41d44f54ad102b8734954289","type":"text","conversion_output":true,"text":"The following scores (in percentages) will be derived based on the WPAI:GH questionnaire.","text_display":"\n\nThe following scores (in percentages) will be derived based on the WPAI:GH questionnaire.","confidence":1,"confidence_rate":1},{"cnt":[[370,838],[1321,838],[1321,922],[370,922]],"region":{"top_left_x":369,"top_left_y":837,"width":953,"height":85},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b4d08e65f744335be8017090b0b644f","type":"text","conversion_output":true,"text":"- percent work item missed due to health: \\(\\frac{Q 2}{Q 2+Q 4} \\times 100\\)","text_display":"\n- percent work item missed due to health: \\(\\frac{Q 2}{Q 2+Q 4} \\times 100\\)","confidence":1,"confidence_rate":1},{"cnt":[[370,935],[1420,935],[1420,1016],[370,1016]],"region":{"top_left_x":369,"top_left_y":934,"width":1052,"height":83},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74e0f49ab328487996269d8c0db4f4a3","type":"text","conversion_output":true,"text":"- percent impairment while working due to health: \\(\\frac{ Q 5}{10} \\times 100\\)","text_display":"\n- percent impairment while working due to health: \\(\\frac{ Q 5}{10} \\times 100\\)","confidence":0.9970703125,"confidence_rate":0.9999580867721726},{"cnt":[[370,1031],[1858,1031],[1858,1113],[370,1113]],"region":{"top_left_x":369,"top_left_y":1031,"width":1490,"height":82},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfd4491a9e7f4def8c73fa2fdf4b0ac5","type":"text","conversion_output":true,"text":"- percent overall work impairment due to health: \\(\\left\\{\\frac{Q 2}{Q 2+Q 4}+\\left[\\left(1-\\frac{Q 2}{Q 2+Q 4}\\right) \\times \\frac{Q 5}{10}\\right]\\right\\} \\times 100\\)","text_display":"\n- percent overall work impairment due to health: \\(\\left\\{\\frac{Q 2}{Q 2+Q 4}+\\left[\\left(1-\\frac{Q 2}{Q 2+Q 4}\\right) \\times \\frac{Q 5}{10}\\right]\\right\\} \\times 100\\)","confidence":1,"confidence_rate":1},{"cnt":[[370,1126],[1296,1126],[1296,1205],[370,1205]],"region":{"top_left_x":369,"top_left_y":1125,"width":927,"height":81},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b7c4de4e1c94cec93a1db02eb61ced4","type":"text","conversion_output":true,"text":"- percent activity impairment due to health: \\(\\frac{ Q 6}{10} \\times 100\\)","text_display":"\n- percent activity impairment due to health: \\(\\frac{ Q 6}{10} \\times 100\\)","confidence":0.9800434112548828,"confidence_rate":0.9996899186836172},{"cnt":[[241,1240],[1137,1240],[1137,1300],[241,1300]],"region":{"top_left_x":240,"top_left_y":1239,"width":897,"height":61},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a8d79755122457bb45eff13ceb32342","type":"section_header","conversion_output":false,"children_ids":["83187783cde448d881c5cc03e910092c"],"text":"","text_display":""},{"cnt":[[245,1246],[1132,1246],[1132,1296],[245,1296]],"region":{"top_left_x":244,"top_left_y":1246,"width":889,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83187783cde448d881c5cc03e910092c","type":"text","conversion_output":true,"parent_id":"9a8d79755122457bb45eff13ceb32342","text":"6.4.1.6. Patient's Global Impression of Change","text_display":"\n\n\\subsection*{6.4.1.6. Patient's Global Impression of Change}","confidence":0.97265625,"confidence_rate":0.9994565291452868},{"cnt":[[245,1313],[1843,1313],[1843,1362],[245,1362]],"region":{"top_left_x":244,"top_left_y":1312,"width":1600,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d26eee2228314a0db08f4fc264cdf629","type":"text","conversion_output":true,"text":"The PGIC scale (Appendix I) is a validated generic tool for assessment of overall change in the","text_display":"\n\nThe PGIC scale (Appendix I) is a validated generic tool for assessment of overall change in the","confidence":1,"confidence_rate":1},{"cnt":[[245,1362],[1850,1362],[1850,1412],[245,1412]],"region":{"top_left_x":244,"top_left_y":1362,"width":1606,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"314cf7064606403a814ed251487dcebe","type":"text","conversion_output":true,"text":"severity of illness following treatment. Patients will rate how they feel now compared with how","text_display":" severity of illness following treatment. Patients will rate how they feel now compared with how","confidence":1,"confidence_rate":1},{"cnt":[[245,1409],[1871,1409],[1871,1459],[245,1459]],"region":{"top_left_x":244,"top_left_y":1409,"width":1628,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af32fe28ccaa43ce8504241627213845","type":"text","conversion_output":true,"text":"they felt before receiving study drug on a 7 -point scale where 0 is \"No change\" and 7 is \"A great","text_display":" they felt before receiving study drug on a 7 -point scale where 0 is \"No change\" and 7 is \"A great","confidence":0.85595703125,"confidence_rate":0.9986122575452852},{"cnt":[[245,1457],[458,1457],[458,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1456,"width":214,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6f68b00380649408ed3c5bb4bc48da3","type":"text","conversion_output":true,"text":"deal better\".","text_display":" deal better\".","confidence":1,"confidence_rate":1},{"cnt":[[245,1525],[1919,1525],[1919,1575],[245,1575]],"region":{"top_left_x":244,"top_left_y":1525,"width":1675,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc9af9fb99834d648eabc157225b5ea0","type":"text","conversion_output":true,"text":"Based on the PGIC assessment, a dichotomous scale of \"Yes\" or \"No\" will be derived. A favorable","text_display":"\n\nBased on the PGIC assessment, a dichotomous scale of \"Yes\" or \"No\" will be derived. A favorable","confidence":0.5060768127441406,"confidence_rate":0.9932124718639098},{"cnt":[[245,1577],[1919,1577],[1919,1626],[245,1626]],"region":{"top_left_x":244,"top_left_y":1576,"width":1675,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2387c1de38f42918379f02340fab653","type":"text","conversion_output":true,"text":"change is score of \\(5-7=\\) 'Yes', which means there is significant improvement with the treatment. If","text_display":" change is score of \\(5-7=\\) 'Yes', which means there is significant improvement with the treatment. If","confidence":0.6661738597322255,"confidence_rate":0.9961752144058594},{"cnt":[[245,1624],[1338,1624],[1338,1678],[245,1678]],"region":{"top_left_x":244,"top_left_y":1624,"width":1095,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23d3508f030a4403bccf05d383bfe420","type":"text","conversion_output":true,"text":"the response is \\(1-4=\\) 'No', it is considered no significant change.","text_display":" the response is \\(1-4=\\) 'No', it is considered no significant change.","confidence":0.9690199309616787,"confidence_rate":0.9995748188108945},{"cnt":[[236,1708],[984,1708],[984,1772],[236,1772]],"region":{"top_left_x":236,"top_left_y":1708,"width":748,"height":65},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f503e164752d4b7980cf440610791000","type":"section_header","conversion_output":false,"children_ids":["603f4163e7f94bf7bb514112cf585f11"],"text":"","text_display":""},{"cnt":[[245,1714],[978,1714],[978,1766],[245,1766]],"region":{"top_left_x":244,"top_left_y":1714,"width":734,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"603f4163e7f94bf7bb514112cf585f11","type":"text","conversion_output":true,"parent_id":"f503e164752d4b7980cf440610791000","text":"6.4.2 Exploratory Efficacy Analysis","text_display":"\n\n\\subsection*{6.4.2 Exploratory Efficacy Analysis}","confidence":0.595900297164917,"confidence_rate":0.9871413403615749},{"cnt":[[236,1798],[1025,1798],[1025,1861],[236,1861]],"region":{"top_left_x":236,"top_left_y":1798,"width":789,"height":63},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dba85e7a075405d80d402eb2224ce75","type":"section_header","conversion_output":false,"children_ids":["aea8dbcfb1294c478b08cafab79e636d"],"text":"","text_display":""},{"cnt":[[245,1805],[1021,1805],[1021,1854],[245,1854]],"region":{"top_left_x":244,"top_left_y":1804,"width":777,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aea8dbcfb1294c478b08cafab79e636d","type":"text","conversion_output":true,"parent_id":"3dba85e7a075405d80d402eb2224ce75","text":"6.4.2.1. 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efficacy variables estimated by MMRM will be plotted by week for","text_display":"\nThe LS means ± SE of e-diary efficacy variables estimated by MMRM will be plotted by week for","confidence":0.9673463929283344,"confidence_rate":0.999661295805036},{"cnt":[[245,1405],[614,1405],[614,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1405,"width":371,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1edf6e35b2347cba40383447fe10446","type":"text","conversion_output":true,"text":"each treatment group.","text_display":" each treatment 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SAFETY ANALYSIS","text_display":"\n\n\\section*{7. SAFETY ANALYSIS}","confidence":1,"confidence_rate":1},{"cnt":[[243,408],[614,408],[614,466],[243,466]],"region":{"top_left_x":242,"top_left_y":408,"width":373,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"527497e2e25b4a31a6aa2b3ea0292f1e","type":"section_header","conversion_output":false,"children_ids":["29f3947896034523ad67c05f66c62c9f"],"text":"","text_display":""},{"cnt":[[245,412],[608,412],[608,462],[245,462]],"region":{"top_left_x":244,"top_left_y":412,"width":365,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29f3947896034523ad67c05f66c62c9f","type":"text","conversion_output":true,"parent_id":"527497e2e25b4a31a6aa2b3ea0292f1e","text":"7.1. General","text_display":"\n\n\\subsection*{7.1. General}","confidence":0.9482421875,"confidence_rate":0.9968786851513192},{"cnt":[[245,488],[1927,488],[1927,539],[245,539]],"region":{"top_left_x":244,"top_left_y":487,"width":1684,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a1db3b177d64d38a08a423fa80964ec","type":"text","conversion_output":true,"text":"The safety population will be used for all safety analyses. Summaries will be presented by treatment","text_display":"\n\nThe safety population will be used for all safety analyses. Summaries will be presented by treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1439,537],[1439,587],[245,587]],"region":{"top_left_x":244,"top_left_y":537,"width":1196,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd492dab66364bc4a849da7e48f9b94b","type":"text","conversion_output":true,"text":"group and all TV48125 as actually received unless specified otherwise.","text_display":" group and all TV48125 as actually received unless specified otherwise.","confidence":1,"confidence_rate":1},{"cnt":[[241,623],[1021,623],[1021,690],[241,690]],"region":{"top_left_x":240,"top_left_y":623,"width":781,"height":67},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6611e6be25f14fdeb8a587a5b800443c","type":"section_header","conversion_output":false,"children_ids":["99896adeb689447ea1ce46eec47c117b"],"text":"","text_display":""},{"cnt":[[245,627],[1016,627],[1016,685],[245,685]],"region":{"top_left_x":244,"top_left_y":627,"width":773,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99896adeb689447ea1ce46eec47c117b","type":"text","conversion_output":true,"parent_id":"6611e6be25f14fdeb8a587a5b800443c","text":"7.2. Study Drug Administration","text_display":"\n\n\\subsection*{7.2. Study Drug Administration}","confidence":0.72021484375,"confidence_rate":0.9906665236159788},{"cnt":[[245,705],[1886,705],[1886,754],[245,754]],"region":{"top_left_x":244,"top_left_y":704,"width":1643,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"674deb0245b041aa9fd4bfc5688eca58","type":"text","conversion_output":true,"text":"Following the baseline assessments, eligible patients will be randomly assigned with stratification","text_display":"\n\nFollowing the baseline assessments, eligible patients will be randomly assigned with stratification","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[1824,752],[1824,801],[245,801]],"region":{"top_left_x":244,"top_left_y":751,"width":1581,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e13ac3588f5d4bfab8582af9b2e3dc62","type":"text","conversion_output":true,"text":"based on sex, country, and baseline use of preventive migraine medication (yes, no) to receive","text_display":" based on sex, country, and baseline use of preventive migraine medication (yes, no) to receive","confidence":1,"confidence_rate":1},{"cnt":[[245,801],[1884,801],[1884,853],[245,853]],"region":{"top_left_x":244,"top_left_y":801,"width":1641,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1c85f7b9b974f2c96dfdfaf76e2fec9","type":"text","conversion_output":true,"text":"monthly TEV-48125 at 225 mg , TEV-48125 at 675 mg followed by monthly placebo, or monthly","text_display":" monthly TEV-48125 at 225 mg , TEV-48125 at 675 mg followed by monthly placebo, or monthly","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,851],[393,851],[393,900],[245,900]],"region":{"top_left_x":244,"top_left_y":850,"width":150,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82964704c0794f47863d32e0443a64b4","type":"text","conversion_output":true,"text":"placebo.","text_display":" placebo.","confidence":1,"confidence_rate":1},{"cnt":[[245,920],[1893,920],[1893,969],[245,969]],"region":{"top_left_x":244,"top_left_y":919,"width":1649,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c17ad1f54284ca1869d4859604ca3e3","type":"text","conversion_output":true,"text":"Study drug will be administered by qualified study personnel as sc injections approximately every","text_display":"\n\nStudy drug will be administered by qualified study personnel as sc injections approximately every","confidence":1,"confidence_rate":1},{"cnt":[[245,971],[935,971],[935,1018],[245,1018]],"region":{"top_left_x":244,"top_left_y":971,"width":691,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"354258de5adc466e8bbb25e57be06ef7","type":"text","conversion_output":true,"text":"28 days for a total of 3 doses, as follows:","text_display":" 28 days for a total of 3 doses, as follows:","confidence":1,"confidence_rate":1},{"cnt":[[370,1040],[1897,1040],[1897,1089],[370,1089]],"region":{"top_left_x":369,"top_left_y":1039,"width":1529,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83dedb8e461841abb40f1b6cbb96acd7","type":"text","conversion_output":true,"text":"- Patients randomized to receive monthly TEV-48125225 mg will receive 1 active and 2","text_display":"\n- Patients randomized to receive monthly TEV-48125225 mg will receive 1 active and 2","confidence":0.7500975551083684,"confidence_rate":0.9968450750983763},{"cnt":[[432,1091],[1841,1091],[1841,1141],[432,1141]],"region":{"top_left_x":431,"top_left_y":1091,"width":1411,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fcbe352bab74299a59580bb2e2a8109","type":"text","conversion_output":true,"text":"placebo injections at visit 2 and 1 active injection ( \\(225 mg / 1.5 mL\\) ) at visits 3 and 4 .","text_display":" placebo injections at visit 2 and 1 active injection ( \\(225 mg / 1.5 mL\\) ) at visits 3 and 4 .","confidence":0.9551324980566278,"confidence_rate":0.9995974038118091},{"cnt":[[370,1160],[1790,1160],[1790,1212],[370,1212]],"region":{"top_left_x":369,"top_left_y":1160,"width":1421,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15fd5794b5c544f49863d8a594783c67","type":"text","conversion_output":true,"text":"- Patients randomized to receive TEV-48125 \\(675 mg /\\) placebo/placebo will receive","text_display":"\n- Patients randomized to receive TEV-48125 \\(675 mg /\\) placebo/placebo will receive","confidence":0.8787034302949905,"confidence_rate":0.9985481579477082},{"cnt":[[432,1210],[1876,1210],[1876,1261],[432,1261]],"region":{"top_left_x":431,"top_left_y":1209,"width":1445,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1fc08bc4b3449778deddbd07575cd3f","type":"text","conversion_output":true,"text":"3 active injections ( \\(225 mg / 1.5 mL\\) ) at visit 2 and 1 placebo injection at visits 3 and 4 .","text_display":" 3 active injections ( \\(225 mg / 1.5 mL\\) ) at visit 2 and 1 placebo injection at visits 3 and 4 .","confidence":0.8293353847693652,"confidence_rate":0.9983741002512205},{"cnt":[[370,1280],[1897,1280],[1897,1330],[370,1330]],"region":{"top_left_x":369,"top_left_y":1280,"width":1529,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36247f340b7243f6b8b1b87bb8eec6f4","type":"text","conversion_output":true,"text":"- Patients randomized to receive placebo will receive 3 placebo injections at visit 2 and 1","text_display":"\n- Patients randomized to receive placebo will receive 3 placebo injections at visit 2 and 1","confidence":1,"confidence_rate":1},{"cnt":[[434,1330],[1119,1330],[1119,1379],[434,1379]],"region":{"top_left_x":433,"top_left_y":1329,"width":687,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cac3ab5a602b4e31940ab7da61267e5f","type":"text","conversion_output":true,"text":"single placebo injection at visits 3 and 4.","text_display":" single placebo injection at visits 3 and 4.","confidence":0.98486328125,"confidence_rate":0.9996949975586008},{"cnt":[[245,1394],[1899,1394],[1899,1450],[245,1450]],"region":{"top_left_x":244,"top_left_y":1394,"width":1656,"height":57},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13803a1e2d1f4c388318d1a3469a3176","type":"text","conversion_output":true,"text":"Duration of treatment (days treated) is the number of days on treatment based on the \\(1^{\\text {st }}\\) study drug","text_display":"\nDuration of treatment (days treated) is the number of days on treatment based on the \\(1^{\\text {st }}\\) study drug","confidence":0.969794511795044,"confidence_rate":0.9997422930992137},{"cnt":[[245,1448],[1923,1448],[1923,1497],[245,1497]],"region":{"top_left_x":244,"top_left_y":1448,"width":1679,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ec3059f49dd452a89a734ad1b821c21","type":"text","conversion_output":true,"text":"administration day and end of treatment (EOT) visit day/early withdrawal day (EOT visit day - first","text_display":" administration day and end of treatment (EOT) visit day/early withdrawal day (EOT visit day - first","confidence":1,"confidence_rate":1},{"cnt":[[245,1497],[1876,1497],[1876,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1497,"width":1632,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"772cdd5f0fc84aeb980b174f6b24274f","type":"text","conversion_output":true,"text":"day of study drug +1 ). For subjects who are lost to follow-up, the EOT date is defined as the last","text_display":" day of study drug +1 ). For subjects who are lost to follow-up, the EOT date is defined as the last","confidence":0.9111328125,"confidence_rate":0.9991305967973335},{"cnt":[[245,1547],[849,1547],[849,1594],[245,1594]],"region":{"top_left_x":244,"top_left_y":1546,"width":605,"height":49},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cb3ec0231044c4eadb95ea874aced72","type":"text","conversion_output":true,"text":"study drug administration date +27 .","text_display":" study drug administration date +27 .","confidence":0.8857421875,"confidence_rate":0.9972463130186975},{"cnt":[[245,1616],[1910,1616],[1910,1665],[245,1665]],"region":{"top_left_x":244,"top_left_y":1615,"width":1666,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14964398f01d45bc903de2b6140c1956","type":"text","conversion_output":true,"text":"Number (\\%) of patient receiving 1 dose, 2 doses, and 3 doses will be summarized using descriptive","text_display":"\n\nNumber (\\%) of patient receiving 1 dose, 2 doses, and 3 doses will be summarized using descriptive","confidence":1,"confidence_rate":1},{"cnt":[[245,1663],[1751,1663],[1751,1714],[245,1714]],"region":{"top_left_x":244,"top_left_y":1662,"width":1507,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39a1becc98a240339e7345939497281c","type":"text","conversion_output":true,"text":"statistics by treatment group. Duration of treatment (days) will also be summarized using","text_display":" statistics by treatment group. Duration of treatment (days) will also be summarized using","confidence":1,"confidence_rate":1},{"cnt":[[245,1712],[1021,1712],[1021,1764],[245,1764]],"region":{"top_left_x":244,"top_left_y":1712,"width":777,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba2da6260ed14ec7b39bea6e3e5ed117","type":"text","conversion_output":true,"text":"descriptive statistics for each treatment group.","text_display":" descriptive statistics for each treatment 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period is defined for each patient as the time period from","confidence":1,"confidence_rate":1},{"cnt":[[245,1998],[1884,1998],[1884,2047],[245,2047]],"region":{"top_left_x":244,"top_left_y":1998,"width":1641,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c80f2762f9e841fe80468a5ca53a26df","type":"text","conversion_output":true,"text":"signature of the informed consent form through completion of visit 5 or the early withdrawal visit","text_display":" signature of the informed consent form through completion of visit 5 or the early withdrawal visit","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,2045],[1205,2045],[1205,2095],[245,2095]],"region":{"top_left_x":244,"top_left_y":2045,"width":962,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9bebf1b63524180bb9a26374654d579","type":"text","conversion_output":true,"text":"for patients who withdraw from the study for any reason.","text_display":" for patients who withdraw from the study for any reason.","confidence":1,"confidence_rate":1},{"cnt":[[245,2114],[1446,2114],[1446,2168],[245,2168]],"region":{"top_left_x":244,"top_left_y":2114,"width":1202,"height":54},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d56461e604b7413d964320e509fb0e2c","type":"text","conversion_output":true,"text":"Adverse events will be collected at each visit via adverse event inquiry.","text_display":"\n\nAdverse events will be collected at each visit via adverse event inquiry.","confidence":1,"confidence_rate":1},{"cnt":[[245,2185],[1867,2185],[1867,2237],[245,2237]],"region":{"top_left_x":244,"top_left_y":2184,"width":1623,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"986f718c80d047f4b9780d5d1c15854d","type":"text","conversion_output":true,"text":"The following are considered protocol-defined adverse events of special interest to be sent to the","text_display":"\nThe following are considered protocol-defined adverse events of special interest to be sent to the","confidence":1,"confidence_rate":1},{"cnt":[[245,2234],[1869,2234],[1869,2284],[245,2284]],"region":{"top_left_x":244,"top_left_y":2234,"width":1626,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3711572b3684cf79a2e50aecc3f3d04","type":"text","conversion_output":true,"text":"sponsor's Pharmacovigilance Department for evaluation: ophthalmic related adverse events of at","text_display":" sponsor's Pharmacovigilance Department for evaluation: ophthalmic related adverse events of 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Law events, as well anaphylaxis and","text_display":" total bilirubin \\(\\geq 2 \\times\\) the ULN or INR > 1.5), or Hy's Law events, as well anaphylaxis and","confidence":0.5155777276698404,"confidence_rate":0.9929772520916239},{"cnt":[[245,2378],[1919,2378],[1919,2430],[245,2430]],"region":{"top_left_x":244,"top_left_y":2378,"width":1675,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28036920d1024afc86d329b72e02e582","type":"text","conversion_output":true,"text":"hypersensitivity reactions. Hypersensitivity reactions will be monitored using the diagnostic criteria","text_display":" hypersensitivity reactions. Hypersensitivity reactions will be monitored using the diagnostic criteria","confidence":1,"confidence_rate":1},{"cnt":[[245,2428],[1734,2428],[1734,2477],[245,2477]],"region":{"top_left_x":244,"top_left_y":2427,"width":1490,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf5a5f4750b24b558743ea7dddc77fd8","type":"text","conversion_output":true,"text":"for anaphylaxis as outlined by the 2006 Joint National Institute of Allergy and Infectious","text_display":" for anaphylaxis as outlined by the 2006 Joint National Institute of Allergy and Infectious","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[1057,2557],[1109,2557],[1109,2608],[1057,2608]],"region":{"top_left_x":1057,"top_left_y":2556,"width":52,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d87272f51124d928683b6afa7a95a5b","type":"page_info","conversion_output":false,"text":"45","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-47","page":47,"lines":[{"cnt":[[245,125],[1012,125],[1012,176],[245,176]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d6167e00c754f0eb53e0b92cb0c4463","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5adf3ca0a99400d95e0e6d4fb2833f1","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[1901,251],[1901,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1658,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44aeb5b14ad345aea50e83e6716b8c56","type":"text","conversion_output":true,"text":"Disease/Food Allergy and Anaphylaxis Network Second Symposium on Anaphylaxis (Sampson et","text_display":"\n\nDisease/Food Allergy and Anaphylaxis Network Second Symposium on Anaphylaxis (Sampson et","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1796,301],[1796,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1553,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f34636ced9348bab6324ca29dc735e7","type":"text","conversion_output":true,"text":"al, 2006). In the event of suspected anaphylaxis, vital signs, including oxygen saturation and","text_display":" al, 2006). In the event of suspected anaphylaxis, vital signs, including oxygen saturation and","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[821,348],[821,400],[245,400]],"region":{"top_left_x":244,"top_left_y":348,"width":577,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"099e24740eed45a3a43997ca8b39c2ca","type":"text","conversion_output":true,"text":"respiration rate, will be measured.","text_display":" respiration rate, will be measured.","confidence":1,"confidence_rate":1},{"cnt":[[245,419],[1923,419],[1923,471],[245,471]],"region":{"top_left_x":244,"top_left_y":418,"width":1679,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca910fcc22b345ddb80fcb6d8562e7b7","type":"text","conversion_output":true,"text":"Summaries by treatment group will be presented for treatment emergent adverse events (overall and","text_display":"\n\nSummaries by treatment group will be presented for treatment emergent adverse events (overall and","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[245,468],[1846,468],[1846,518],[245,518]],"region":{"top_left_x":244,"top_left_y":468,"width":1602,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe0965a8fbf04d388dc3911ca953c0f3","type":"text","conversion_output":true,"text":"by severity), treatment emergent adverse events determined by the investigator to be treatment-","text_display":" by severity), treatment emergent adverse events determined by the investigator to be treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,518],[1841,518],[1841,569],[245,569]],"region":{"top_left_x":244,"top_left_y":517,"width":1598,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"839e788b4148473d87ea94cf16dda31a","type":"text","conversion_output":true,"text":"related adverse events (overall and by severity), serious adverse events, adverse events causing","text_display":"related adverse events (overall and by severity), serious adverse events, adverse events causing","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[1775,563],[1775,614],[245,614]],"region":{"top_left_x":244,"top_left_y":562,"width":1531,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18e9bfeeebd74bb8aea93fe6c4ae1404","type":"text","conversion_output":true,"text":"discontinuation from the study, non-serious treatment emergent adverse events and prior to","text_display":" discontinuation from the study, non-serious treatment emergent adverse events and prior to","confidence":1,"confidence_rate":1},{"cnt":[[245,612],[1884,612],[1884,664],[245,664]],"region":{"top_left_x":244,"top_left_y":612,"width":1641,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc8f90be58ee462e9321df9eb647e434","type":"text","conversion_output":true,"text":"treatment adverse events. Additionally, the injection site reactions recorded as adverse events and","text_display":" treatment adverse events. Additionally, the injection site reactions recorded as adverse events and","confidence":1,"confidence_rate":1},{"cnt":[[245,662],[1639,662],[1639,713],[245,713]],"region":{"top_left_x":244,"top_left_y":661,"width":1396,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34c11032d97f40dfa9d2ff74d072ba8e","type":"text","conversion_output":true,"text":"protocol defined adverse events will be summarized by treatment group separately.","text_display":" protocol defined adverse events will be summarized by treatment group separately.","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1858,730],[1858,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1615,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47f435f1b0e747d39821413192cc7954","type":"text","conversion_output":true,"text":"The incidence of adverse event will be summarized using descriptive statistics by SOC, PT, and","text_display":"\nThe incidence of adverse event will be summarized using descriptive statistics by SOC, PT, and","confidence":1,"confidence_rate":1},{"cnt":[[245,780],[1927,780],[1927,831],[245,831]],"region":{"top_left_x":244,"top_left_y":779,"width":1684,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d99ba4b0fa0444978e38e951db8b7507","type":"text","conversion_output":true,"text":"severity of the adverse event. Each patient will be counted only once within a SOC or a PT by using","text_display":" severity of the adverse event. Each patient will be counted only once within a SOC or a PT by using","confidence":0.9990236759185791,"confidence_rate":0.9999906077268363},{"cnt":[[245,829],[1897,829],[1897,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":1654,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55f190f99c57455f82f1cb9f8b2ecce2","type":"text","conversion_output":true,"text":"the adverse events with the highest severity within each category. Treatment-related adverse event","text_display":" the adverse events with the highest severity within each category. Treatment-related adverse event","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1807,877],[1807,930],[245,930]],"region":{"top_left_x":244,"top_left_y":876,"width":1563,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a72f00246a0c4e269a3de9aa413e7273","type":"text","conversion_output":true,"text":"summaries will include adverse events related to study drug and adverse events with missing","text_display":" summaries will include adverse events related to study drug and adverse events with missing","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1923,924],[1923,978],[245,978]],"region":{"top_left_x":244,"top_left_y":923,"width":1679,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05ccb570e5384a128bd1c4e21c511a80","type":"text","conversion_output":true,"text":"relationship to study drug. Adverse events with the missing flag indicating serious will be excluded","text_display":" relationship to study drug. Adverse events with the missing flag indicating serious will be excluded","confidence":1,"confidence_rate":1},{"cnt":[[245,973],[1867,973],[1867,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":973,"width":1623,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ed8f118085a40be8fb6963747fb2057","type":"text","conversion_output":true,"text":"from the summary of serious adverse events but included in the summary of non-serious adverse","text_display":" from the summary of serious adverse events but included in the summary of non-serious adverse","confidence":1,"confidence_rate":1},{"cnt":[[245,1027],[372,1027],[372,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1026,"width":128,"height":42},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4597a41d4c9840908522638151fc0034","type":"text","conversion_output":true,"text":"events.","text_display":" events.","confidence":1,"confidence_rate":1},{"cnt":[[245,1091],[1904,1091],[1904,1145],[245,1145]],"region":{"top_left_x":244,"top_left_y":1091,"width":1660,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1092c3db6f4455ca0725e86c4ba201d","type":"text","conversion_output":true,"text":"Listings for deaths, serious adverse events, adverse events leading to discontinuation, injection site","text_display":"\n\nListings for deaths, serious adverse events, adverse events leading to discontinuation, injection site","confidence":1,"confidence_rate":1},{"cnt":[[245,1143],[1807,1143],[1807,1192],[245,1192]],"region":{"top_left_x":244,"top_left_y":1142,"width":1563,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2bde35ff31d459988fca87a278f5755","type":"text","conversion_output":true,"text":"related adverse event, and protocol defined adverse events will be presented. All information","text_display":" related adverse event, and protocol defined adverse events will be presented. All information","confidence":1,"confidence_rate":1},{"cnt":[[245,1190],[1841,1190],[1841,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1190,"width":1598,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bb252778e7b4fee8a70d3ed4fdf75a4","type":"text","conversion_output":true,"text":"pertaining to adverse events noted during the study will be listed by subject, detailing verbatim","text_display":" pertaining to adverse events noted during the study will be listed by subject, detailing verbatim","confidence":1,"confidence_rate":1},{"cnt":[[245,1237],[1871,1237],[1871,1291],[245,1291]],"region":{"top_left_x":244,"top_left_y":1237,"width":1628,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca8977e014d44cc19092d219986a6022","type":"text","conversion_output":true,"text":"given by the investigator, PT, SOC, date of onset, date of resolution, severity, and relationship to","text_display":" given by the investigator, PT, SOC, date of onset, date of resolution, severity, and relationship to","confidence":0.9833984375,"confidence_rate":0.999840575443913},{"cnt":[[245,1285],[1919,1285],[1919,1336],[245,1336]],"region":{"top_left_x":244,"top_left_y":1284,"width":1675,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"250b40c2d1cc4b4c8414b40c430f1a6b","type":"text","conversion_output":true,"text":"treatment. The onset of adverse events will also be shown relative (in number of days) to the \\(1^{\\text {st }}\\) day","text_display":" treatment. The onset of adverse events will also be shown relative (in number of days) to the \\(1^{\\text {st }}\\) day","confidence":0.98974609375,"confidence_rate":0.9999148231343057},{"cnt":[[245,1334],[1858,1334],[1858,1386],[245,1386]],"region":{"top_left_x":244,"top_left_y":1334,"width":1615,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66d1e1f87e0e4f5ab86fd5dbb2489a32","type":"text","conversion_output":true,"text":"of treatment. In addition, MedDRA dictionary terms for adverse event descriptions, and adverse","text_display":" of treatment. In addition, MedDRA dictionary terms for adverse event descriptions, and adverse","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[245,1384],[1575,1384],[1575,1437],[245,1437]],"region":{"top_left_x":244,"top_left_y":1383,"width":1331,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b74ba5b278e407b906f88e4e93a0e13","type":"text","conversion_output":true,"text":"event preferred terms by patient number and treatment group will be presented.","text_display":" event preferred terms by patient number and treatment group will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[236,1470],[995,1470],[995,1540],[236,1540]],"region":{"top_left_x":236,"top_left_y":1469,"width":759,"height":72},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de328acf3100430b9365de596853960c","type":"section_header","conversion_output":false,"children_ids":["710ca4f576b547c18f362787d4436a8c"],"text":"","text_display":""},{"cnt":[[245,1474],[988,1474],[988,1536],[245,1536]],"region":{"top_left_x":244,"top_left_y":1473,"width":745,"height":64},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"710ca4f576b547c18f362787d4436a8c","type":"text","conversion_output":true,"parent_id":"de328acf3100430b9365de596853960c","text":"7.4. Injection Site Assessments","text_display":"\n\n\\subsection*{7.4. Injection Site Assessments}","confidence":0.84423828125,"confidence_rate":0.9953076961817021},{"cnt":[[245,1551],[1871,1551],[1871,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1551,"width":1628,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7a42abbfac3493886151c7d78f1f474","type":"text","conversion_output":true,"text":"Injection site assessments will be performed immediately and 1 hour after administration of each","text_display":"\n\nInjection site assessments will be performed immediately and 1 hour after administration of each","confidence":1,"confidence_rate":1},{"cnt":[[245,1601],[1790,1601],[1790,1652],[245,1652]],"region":{"top_left_x":244,"top_left_y":1600,"width":1546,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fbd62718af5425cb58fedca077b950f","type":"text","conversion_output":true,"text":"dose of study drug (Table 1). The injection site(s) will be assessed for erythema, induration,","text_display":" dose of study drug (Table 1). The injection site(s) will be assessed for erythema, induration,","confidence":1,"confidence_rate":1},{"cnt":[[245,1646],[1678,1646],[1678,1699],[245,1699]],"region":{"top_left_x":244,"top_left_y":1645,"width":1434,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ff7ff4e13154674bc7332bc0fea5b12","type":"text","conversion_output":true,"text":"ecchymosis, and pain, and severity will be graded according to the following criteria:","text_display":" ecchymosis, and pain, and severity will be graded according to the following criteria:","confidence":1,"confidence_rate":1},{"cnt":[[370,1719],[1888,1719],[1888,1772],[370,1772]],"region":{"top_left_x":369,"top_left_y":1718,"width":1520,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa61805804e14a9ab80d1740020b82fe","type":"text","conversion_output":true,"text":"- Injection-site erythema, injection-site induration, and injection-site ecchymosis will be","text_display":"\n- Injection-site erythema, injection-site induration, and injection-site ecchymosis will be","confidence":1,"confidence_rate":1},{"cnt":[[432,1770],[1880,1770],[1880,1820],[432,1820]],"region":{"top_left_x":431,"top_left_y":1770,"width":1449,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d4d61eb1fee4ce1a058627bedee8e3d","type":"text","conversion_output":true,"text":"graded according to measurements: absent, 5 mm to \\(\\leq 50 mm\\) (mild), \\(>50\\) to \\(\\leq 100 mm\\)","text_display":" graded according to measurements: absent, 5 mm to \\(\\leq 50 mm\\) (mild), \\(>50\\) to \\(\\leq 100 mm\\)","confidence":0.9980475902557373,"confidence_rate":0.9999800581765897},{"cnt":[[434,1818],[1033,1818],[1033,1867],[434,1867]],"region":{"top_left_x":433,"top_left_y":1817,"width":601,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac3530d5e80647d0962f2463b45e785f","type":"text","conversion_output":true,"text":"(moderate), and \\(>100 mm\\) (severe).","text_display":" (moderate), and \\(>100 mm\\) (severe).","confidence":0.99853515625,"confidence_rate":0.9999659094722},{"cnt":[[245,1886],[1302,1886],[1302,1938],[245,1938]],"region":{"top_left_x":244,"top_left_y":1886,"width":1058,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86d36946daf84a6689043b5a47ebe336","type":"text","conversion_output":true,"text":"Injection-site pain will be measured as summarized in Table 3.","text_display":"\n\nInjection-site pain will be measured as summarized in Table 3.","confidence":0.9990234375,"confidence_rate":0.9999851964785456},{"cnt":[[245,1955],[1783,1955],[1783,2007],[245,2007]],"region":{"top_left_x":244,"top_left_y":1955,"width":1540,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4b2ff5ea4f14cc3bba2d5219b796b27","type":"text","conversion_output":true,"text":"If a patient has severe injection site induration, erythema, and/or ecchymosis and/or grade 3","text_display":"\nIf a patient has severe injection site induration, erythema, and/or ecchymosis and/or grade 3","confidence":1,"confidence_rate":1},{"cnt":[[245,2007],[1833,2007],[1833,2056],[245,2056]],"region":{"top_left_x":244,"top_left_y":2006,"width":1589,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13abaa8028294ef48f69c8a4d1d8b4b2","type":"text","conversion_output":true,"text":"(severe) or grade 4 (worst possible) injection site pain at 1 hour after completion of study drug","text_display":" (severe) or grade 4 (worst possible) injection site pain at 1 hour after completion of study drug","confidence":1,"confidence_rate":1},{"cnt":[[245,2054],[1893,2054],[1893,2103],[245,2103]],"region":{"top_left_x":244,"top_left_y":2053,"width":1649,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5898e93c5404be5af090900a5166362","type":"text","conversion_output":true,"text":"administration, the patient will be reassessed at 3 hours after study drug administration and hourly","text_display":" administration, the patient will be reassessed at 3 hours after study drug administration and hourly","confidence":1,"confidence_rate":1},{"cnt":[[245,2101],[1311,2101],[1311,2155],[245,2155]],"region":{"top_left_x":244,"top_left_y":2101,"width":1067,"height":54},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"debb2014ec7b4e5ca1b5a67d3b30a74b","type":"text","conversion_output":true,"text":"thereafter until the reaction/pain is of moderate or less severity.","text_display":" thereafter until the reaction/pain is of moderate or less severity.","confidence":1,"confidence_rate":1},{"cnt":[[245,2170],[1790,2170],[1790,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2169,"width":1546,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3169ef3f97044bc68fa3c3e8c7f48920","type":"text","conversion_output":true,"text":"Number (\\%) of patients having injections and their post injection assessments for erythema,","text_display":"\nNumber (\\%) of patients having injections and their post injection assessments for erythema,","confidence":1,"confidence_rate":1},{"cnt":[[245,2221],[1850,2221],[1850,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2221,"width":1606,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"699d35b42e4e49699ccf329544cb0337","type":"text","conversion_output":true,"text":"induration, ecchymosis, and pain of each grade will be summarized by visits and timepoints for","text_display":" induration, ecchymosis, and pain of each grade will be summarized by visits and timepoints for","confidence":1,"confidence_rate":1},{"cnt":[[245,2269],[617,2269],[617,2322],[245,2322]],"region":{"top_left_x":244,"top_left_y":2268,"width":373,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c6b024875704d0eb046b6a972e85114","type":"text","conversion_output":true,"text":"each treatment group.","text_display":" each treatment 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Urinalysis \\\\\n\\hline \\begin{tabular}{l}\n- calcium \\\\\n- phosphorus \\\\\n- sodium \\\\\n- potassium \\\\\n- chloride \\\\\n- carbon dioxide \\\\\n- magnesium \\\\\n- glucose \\\\\n- blood urea nitrogen \\\\\n- creatinine \\\\\n- ALT \\\\\n- AST \\\\\n- total bilirubin \\\\\n- direct bilirubin \\\\\n- lactate dehydrogenase \\\\\n- GGT \\\\\n- ALP \\\\\n- albumin \\\\\n- creatine phosphokinase \\\\\n- total protein\n\\end{tabular} & \\begin{tabular}{l}\n- hemoglobin \\\\\n- hematocrit \\\\\n- RBC count \\\\\n- RBC indices \\\\\n- mean corpuscular volume \\\\\n- mean corpuscular hemoglobin concentration \\\\\n- RBC distribution width \\\\\n- platelet count \\\\\n- WBC count and differential count (absolute values and percentages) \\\\\n- neutrophils \\\\\n- lymphocytes \\\\\n- eosinophils \\\\\n- monocytes \\\\\n- basophils\n\\end{tabular} & \\begin{tabular}{l}\n- prothrombin time \\\\\n- partial thromboplastin time \\\\\n- INR\n\\end{tabular} & \\begin{tabular}{l}\n- color and appearance \\\\\n- specific gravity \\\\\n- pH \\\\\n- blood (hemoglobin) \\\\\n- glucose \\\\\n- albumin \\\\\n- protein \\\\\n- ketones \\\\\n- leukocyte esterase \\\\\n- nitrite \\\\\n- direct bilirubin \\\\\n- microscopic \\\\\n- bacteria \\\\\n- RBCs \\\\\n- WBCs \\\\\n- casts \\\\\n- crystals\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4: Clinical Laboratory Test}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Serum Chemistry & Hematology & Coagulation & Urinalysis \\\\\n\\hline \\begin{tabular}{l}\n- calcium \\\\\n- phosphorus \\\\\n- sodium \\\\\n- potassium \\\\\n- chloride \\\\\n- carbon dioxide \\\\\n- magnesium \\\\\n- glucose \\\\\n- blood urea nitrogen \\\\\n- creatinine \\\\\n- ALT \\\\\n- AST \\\\\n- total bilirubin \\\\\n- direct bilirubin \\\\\n- lactate dehydrogenase \\\\\n- GGT \\\\\n- ALP \\\\\n- albumin \\\\\n- creatine phosphokinase \\\\\n- total protein\n\\end{tabular} & 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calcium \\\\\n- phosphorus \\\\\n- sodium \\\\\n- potassium \\\\\n- chloride \\\\\n- carbon dioxide \\\\\n- magnesium \\\\\n- glucose \\\\\n- blood urea nitrogen \\\\\n- creatinine \\\\\n- ALT \\\\\n- AST \\\\\n- total bilirubin \\\\\n- direct bilirubin \\\\\n- lactate dehydrogenase \\\\\n- GGT \\\\\n- ALP \\\\\n- albumin \\\\\n- creatine phosphokinase \\\\\n- total protein\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- calcium \\\\\n- phosphorus \\\\\n- sodium \\\\\n- potassium \\\\\n- chloride \\\\\n- carbon dioxide \\\\\n- magnesium \\\\\n- glucose \\\\\n- blood urea nitrogen \\\\\n- creatinine \\\\\n- ALT \\\\\n- AST \\\\\n- total bilirubin \\\\\n- direct bilirubin \\\\\n- lactate dehydrogenase \\\\\n- GGT \\\\\n- ALP \\\\\n- albumin \\\\\n- creatine phosphokinase \\\\\n- total 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RBCs","confidence":0.99853515625,"confidence_rate":0.9998667436355548},{"cnt":[[1628,1336],[1795,1336],[1795,1372],[1628,1372]],"region":{"top_left_x":1628,"top_left_y":1335,"width":168,"height":38},"line":81,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"337cc7c1f3d04e10b52b9845063c9e5e","type":"text","conversion_output":false,"parent_id":"2880409342d0481f9767f518188d2c7d","text":"- WBCs","text_display":"\n- WBCs","confidence":1,"confidence_rate":1},{"cnt":[[1631,1388],[1771,1388],[1771,1420],[1631,1420]],"region":{"top_left_x":1630,"top_left_y":1387,"width":142,"height":34},"line":82,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"55bb517d2b5045f09984fa3a9b6a1f9f","type":"text","conversion_output":false,"parent_id":"2880409342d0481f9767f518188d2c7d","text":"- casts","text_display":"\n- casts","confidence":1,"confidence_rate":1},{"cnt":[[1631,1435],[1810,1435],[1810,1476],[1631,1476]],"region":{"top_left_x":1630,"top_left_y":1435,"width":181,"height":42},"line":83,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e64f8b63653142bfb9967bd644c54494","type":"text","conversion_output":false,"parent_id":"2880409342d0481f9767f518188d2c7d","text":"- crystals","text_display":"\n- crystals","confidence":1,"confidence_rate":1},{"cnt":[[245,1637],[1910,1637],[1910,1680],[245,1680]],"region":{"top_left_x":244,"top_left_y":1637,"width":1666,"height":44},"line":84,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb92a8ff34004c609b8610678be3217f","type":"text","conversion_output":true,"text":"ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma- glutamyl","text_display":"\n\nALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma- glutamyl","confidence":1,"confidence_rate":1},{"cnt":[[245,1676],[1613,1676],[1613,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1675,"width":1370,"height":46},"line":85,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37f5e5b060774f63bbe6e0d96dd8f91d","type":"text","conversion_output":true,"text":"transpeptidase; INR=international normalized ratio; RBC=red blood cell; WBC=white blood cell.","text_display":" transpeptidase; INR=international normalized ratio; RBC=red blood cell; WBC=white blood cell.","confidence":0.9868226051330566,"confidence_rate":0.9998646521493562},{"cnt":[[245,1738],[1815,1738],[1815,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1738,"width":1572,"height":52},"line":86,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5494b7ba0fc43a9b65fc95331318fd3","type":"text","conversion_output":true,"text":"Laboratory tests results and changes from baseline for chemistry, hematology, urinalysis, and","text_display":"\nLaboratory tests results and changes from baseline for chemistry, hematology, urinalysis, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1788],[1921,1788],[1921,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1787,"width":1677,"height":55},"line":87,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96269eecf5e8400d9037a009ca6f4c12","type":"text","conversion_output":true,"text":"coagulation laboratory tests will be summarized by visits for each treatment group using descriptive","text_display":" coagulation laboratory tests will be summarized by visits for each treatment group using descriptive","confidence":1,"confidence_rate":1},{"cnt":[[245,1835],[1790,1835],[1790,1886],[245,1886]],"region":{"top_left_x":244,"top_left_y":1834,"width":1546,"height":53},"line":88,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17c250079f6d434da01dfb135699694b","type":"text","conversion_output":true,"text":"statistics. Shifts (below, within, and above the normal range) from baseline to each visit and","text_display":" statistics. Shifts (below, within, and above the normal range) from baseline to each visit and","confidence":1,"confidence_rate":1},{"cnt":[[245,1886],[1921,1886],[1921,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1886,"width":1677,"height":50},"line":89,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ced09aec4234811895b7a9ce956138b","type":"text","conversion_output":true,"text":"endpoint will be summarized using patient counts. Listings of all individual patients' laboratory test","text_display":" endpoint will be summarized using patient counts. Listings of all individual patients' laboratory test","confidence":0.99658203125,"confidence_rate":0.9999680021628804},{"cnt":[[245,1934],[668,1934],[668,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1933,"width":425,"height":51},"line":90,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64bd691290c14712850468f0edceeb98","type":"text","conversion_output":true,"text":"results will be presented.","text_display":" results will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[245,2002],[1807,2002],[1807,2054],[245,2054]],"region":{"top_left_x":244,"top_left_y":2002,"width":1563,"height":52},"line":91,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e305d5d9e47e4a309eed4aec800d46ae","type":"text","conversion_output":true,"text":"The incidence of potentially clinically significant abnormal results will be summarized using","text_display":"\n\nThe incidence of potentially clinically significant abnormal results will be summarized using","confidence":1,"confidence_rate":1},{"cnt":[[245,2052],[1835,2052],[1835,2103],[245,2103]],"region":{"top_left_x":244,"top_left_y":2051,"width":1591,"height":53},"line":92,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5efcd1fc19d46aa9e7055a6b137f98b","type":"text","conversion_output":true,"text":"descriptive statistics with the criteria specified in Table 5. The potentially clinically significant","text_display":" descriptive statistics with the criteria specified in Table 5. The potentially clinically significant","confidence":0.9941432476043701,"confidence_rate":0.9999445867199885},{"cnt":[[245,2101],[1904,2101],[1904,2151],[245,2151]],"region":{"top_left_x":244,"top_left_y":2101,"width":1660,"height":50},"line":93,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"929ce49d28df4ea1afb4b72713af56bc","type":"text","conversion_output":true,"text":"abnormal laboratory values will include all postbaseline values (including scheduled, unscheduled,","text_display":" abnormal laboratory values will include all postbaseline values (including scheduled, unscheduled,","confidence":1,"confidence_rate":1},{"cnt":[[245,2148],[1904,2148],[1904,2202],[245,2202]],"region":{"top_left_x":244,"top_left_y":2148,"width":1660,"height":55},"line":94,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"495ed2f5cb90426d8ed6e997f3eb0934","type":"text","conversion_output":true,"text":"and early termination visits) for the summaries. Listings of patients who have potentially clinically","text_display":" and early termination visits) for the summaries. Listings of patients who have potentially clinically","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,2196],[1162,2196],[1162,2249],[245,2249]],"region":{"top_left_x":244,"top_left_y":2195,"width":919,"height":55},"line":95,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f65d2b60190742a8b5a561f64750fb49","type":"text","conversion_output":true,"text":"significant abnormal laboratory data will be presented.","text_display":" significant abnormal laboratory data will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[1057,2557],[1113,2557],[1113,2608],[1057,2608]],"region":{"top_left_x":1057,"top_left_y":2556,"width":56,"height":53},"line":96,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d67a92b510b94f4cb3232a130125d149","type":"page_info","conversion_output":false,"text":"48","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-50","page":50,"lines":[{"cnt":[[245,129],[1012,129],[1012,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":768,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dde9997aed844289a1baa1d9beebd135","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,129],[1927,129],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":128,"width":386,"height":42},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bbe9410faab4e2bb7daa1b8c653737b","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1646,254],[1646,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1402,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65af3c90f9d645a88fcdac52a6849dc8","type":"figure_label","conversion_output":false,"text":"Table 5: Criteria for Potentially Clinically Significant Laboratory 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Test & Criterion value \\\\\n\\hline Serum chemistry & \\\\\n\\hline ALT & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline AST & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline ALP & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline GGT & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline LDH & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline BUN & \\(\\geq 10.71 mmol / L\\) \\\\\n\\hline Creatinine & \\(\\geq 177 \\mu mol / L\\) \\\\\n\\hline Uric acid Men & \\(\\geq 625 \\mu mol / L\\) \\\\\n\\hline Women & \\(\\geq 506 \\mu mol / L\\) \\\\\n\\hline Bilirubin (total) & \\(\\geq 34.2 \\mu mol / L\\) \\\\\n\\hline Hematology & \\\\\n\\hline Hematocrit Men & \\(<0.37 L / L\\) \\\\\n\\hline Women & \\(<0.32 L / L\\) \\\\\n\\hline Hemoglobin Men & \\(\\leq 115 g / L\\) \\\\\n\\hline Women & \\(\\leq 95 g / L\\) \\\\\n\\hline WBC counts & \\begin{tabular}{l}\n\\(\\leq 3 \\times 10^{9} / L\\) \\\\\n\\(\\geq 20 \\times 10^{9} / L\\)\n\\end{tabular} \\\\\n\\hline Eosinophils & \\(\\geq 10 \\%\\) \\\\\n\\hline ANC & \\(\\leq 1 \\times 10^{9} / L\\) \\\\\n\\hline Platelet counts & \\begin{tabular}{l}\n\\(\\leq 75 \\times 10^{9} / L\\) \\\\\n\\(\\geq 700 \\times 10^{9} / L\\)\n\\end{tabular} \\\\\n\\hline Urinalysis & \\\\\n\\hline HGB & \\(\\geq 2\\) unit increase from baseline \\\\\n\\hline Glucose & \\(\\geq 2\\) unit increase from baseline \\\\\n\\hline Ketones & \\(\\geq 2\\) unit increase from baseline \\\\\n\\hline Total protein & \\(\\geq 2\\) unit increase from baseline \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 5: Criteria for Potentially Clinically Significant Laboratory Values}\n\\begin{tabular}{|l|l|}\n\\hline Test & Criterion value \\\\\n\\hline Serum chemistry & \\\\\n\\hline ALT & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline AST & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline ALP & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline GGT & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline LDH & \\(\\geq 3 \\times\\) ULN \\\\\n\\hline BUN & \\(\\geq 10.71 mmol / 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AST=aspartate","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,2209],[1725,2209],[1725,2249],[245,2249]],"region":{"top_left_x":244,"top_left_y":2208,"width":1482,"height":42},"line":88,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"985af9b7ee874e06832613b231145882","type":"text","conversion_output":true,"text":"aminotransferase; BUN=blood urea nitrogen; GGT=gamma- glutamyl transpeptidase; HGB=hemoglobin;","text_display":" aminotransferase; BUN=blood urea nitrogen; GGT=gamma- glutamyl transpeptidase; HGB=hemoglobin;","confidence":1,"confidence_rate":1},{"cnt":[[245,2247],[1869,2247],[1869,2290],[245,2290]],"region":{"top_left_x":244,"top_left_y":2247,"width":1626,"height":44},"line":89,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cacfc465634a4285a7bf92bcb7ac0da1","type":"text","conversion_output":true,"text":"INR=international normalized ratio; LDH=lactate dehydrogenase; RBC=red blood cell; ULN=upper limit of normal","text_display":" INR=international normalized ratio; LDH=lactate dehydrogenase; RBC=red blood cell; ULN=upper limit of normal","confidence":1,"confidence_rate":1},{"cnt":[[245,2288],[672,2288],[672,2331],[245,2331]],"region":{"top_left_x":244,"top_left_y":2288,"width":429,"height":44},"line":90,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"abfc58fcb4924b70bf14686e5e9d3a79","type":"text","conversion_output":true,"text":"range; \\(WBC =\\) white blood cell","text_display":" range; \\(WBC =\\) white blood cell","confidence":0.9239380003418773,"confidence_rate":0.9979735864976625},{"cnt":[[245,2350],[1916,2350],[1916,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2350,"width":1673,"height":50},"line":91,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63cbc769923c4ac489f55737c4a101c8","type":"text","conversion_output":true,"text":"Serum \\(\\beta\\)-HCG tests will be performed for all women of childbearing potential at screening (visit 1),","text_display":"\n\nSerum \\(\\beta\\)-HCG tests will be performed for all women of childbearing potential at screening (visit 1),","confidence":0.9425184200517833,"confidence_rate":0.9994520037600995},{"cnt":[[245,2398],[1901,2398],[1901,2449],[245,2449]],"region":{"top_left_x":244,"top_left_y":2397,"width":1658,"height":53},"line":92,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da2f293da5c441cd9aa6e6b63be093d0","type":"text","conversion_output":true,"text":"and urine \\(\\beta\\)-HCG tests will be performed for women of childbearing potential at visits 2 through 5.","text_display":" and urine \\(\\beta\\)-HCG tests will be performed for women of childbearing potential at visits 2 through 5.","confidence":0.9113901006057858,"confidence_rate":0.9991491304339121},{"cnt":[[245,2447],[995,2447],[995,2499],[245,2499]],"region":{"top_left_x":244,"top_left_y":2447,"width":751,"height":52},"line":93,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfe38a8ae7534bd79849706ceccb0b8e","type":"text","conversion_output":true,"text":"Positive pregnancy test results will be listed.","text_display":" Positive pregnancy test results will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[1057,2557],[1111,2557],[1111,2608],[1057,2608]],"region":{"top_left_x":1057,"top_left_y":2556,"width":54,"height":53},"line":94,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4705a5079174c8abc030dd270d41bd2","type":"page_info","conversion_output":false,"text":"49","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-51","page":51,"lines":[{"cnt":[[245,125],[1012,125],[1012,176],[245,176]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b84553b671cd45f49754e92bf943f689","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0f2d0f5065845e287300d5d03f394eb","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,249],[672,249],[672,316],[241,316]],"region":{"top_left_x":240,"top_left_y":249,"width":433,"height":67},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f33e7716b85e4b6b9618608f04df6403","type":"section_header","conversion_output":false,"children_ids":["2884705356154600b948fb0d393df19d"],"text":"","text_display":""},{"cnt":[[245,254],[668,254],[668,312],[245,312]],"region":{"top_left_x":244,"top_left_y":253,"width":425,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2884705356154600b948fb0d393df19d","type":"text","conversion_output":true,"parent_id":"f33e7716b85e4b6b9618608f04df6403","text":"7.7. Vital Signs","text_display":"\n\n\\subsection*{7.7. Vital Signs}","confidence":0.994140625,"confidence_rate":0.9997202006516653},{"cnt":[[245,327],[1919,327],[1919,380],[245,380]],"region":{"top_left_x":244,"top_left_y":326,"width":1675,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdf1a952de8b42e193da6610d6665585","type":"text","conversion_output":true,"text":"Vital signs (pulse, systolic and diastolic blood pressure, body temperature, and respiratory rate) will","text_display":"\n\nVital signs (pulse, systolic and diastolic blood pressure, body temperature, and respiratory rate) will","confidence":1,"confidence_rate":1},{"cnt":[[245,378],[1914,378],[1914,428],[245,428]],"region":{"top_left_x":244,"top_left_y":378,"width":1671,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59b8123915d04357be122c50b15da6d7","type":"text","conversion_output":true,"text":"be measured before other assessments (eg, blood draws and administration of questionnaires) at the","text_display":" be measured before other assessments (eg, blood draws and administration of questionnaires) at the","confidence":1,"confidence_rate":1},{"cnt":[[245,425],[771,425],[771,477],[245,477]],"region":{"top_left_x":244,"top_left_y":425,"width":528,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4d86d9c6c5f487fa33806d8a3735316","type":"text","conversion_output":true,"text":"time points detailed in Table 1.","text_display":" time points detailed in Table 1.","confidence":0.99951171875,"confidence_rate":0.9999864334115239},{"cnt":[[245,494],[1895,494],[1895,546],[245,546]],"region":{"top_left_x":244,"top_left_y":494,"width":1651,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a64fe1347315407f8dcd3b6157463b3f","type":"text","conversion_output":true,"text":"For any abnormal vital sign finding, the measurement should be repeated as soon as possible. Any","text_display":"\nFor any abnormal vital sign finding, the measurement should be repeated as soon as possible. Any","confidence":1,"confidence_rate":1},{"cnt":[[245,544],[1923,544],[1923,595],[245,595]],"region":{"top_left_x":244,"top_left_y":543,"width":1679,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"005bd2114de7481f8a6c57f4efd7de17","type":"text","conversion_output":true,"text":"vital sign value that is judged by the investigator as a clinically significant change (worsening) from","text_display":" vital sign value that is judged by the investigator as a clinically significant change (worsening) from","confidence":1,"confidence_rate":1},{"cnt":[[245,593],[1137,593],[1137,640],[245,640]],"region":{"top_left_x":244,"top_left_y":592,"width":893,"height":49},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9392ba2a26e4bf5807649f87877ed34","type":"text","conversion_output":true,"text":"a baseline value will be considered an adverse event.","text_display":" a baseline value will be considered an adverse event.","confidence":1,"confidence_rate":1},{"cnt":[[245,662],[1884,662],[1884,715],[245,715]],"region":{"top_left_x":244,"top_left_y":661,"width":1641,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ded69d73baf481cb1a14801fe084311","type":"text","conversion_output":true,"text":"Vital signs values and changes from baseline to each visit and endpoint will be summarized using","text_display":"\n\nVital signs values and changes from baseline to each visit and endpoint will be summarized using","confidence":1,"confidence_rate":1},{"cnt":[[245,711],[1854,711],[1854,763],[245,763]],"region":{"top_left_x":244,"top_left_y":711,"width":1611,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9527747553f44ed28c2568c8135f680b","type":"text","conversion_output":true,"text":"descriptive statistics. The incidence of potentially clinically significant abnormal values will be","text_display":" descriptive statistics. The incidence of potentially clinically significant abnormal values will be","confidence":0.9990234375,"confidence_rate":0.9999906054321309},{"cnt":[[245,761],[1300,761],[1300,810],[245,810]],"region":{"top_left_x":244,"top_left_y":760,"width":1056,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0564f41c63f64377be3c5cb09aa92b23","type":"text","conversion_output":true,"text":"summarized for selected vital signs using descriptive statistics.","text_display":" summarized for selected vital signs using descriptive statistics.","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[1921,829],[1921,881],[245,881]],"region":{"top_left_x":244,"top_left_y":829,"width":1677,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3e9372443884b749e9d990b957045b9","type":"text","conversion_output":true,"text":"Table 6 specifies the criteria for identifying vital signs as potentially clinically significant abnormal.","text_display":"\n\nTable 6 specifies the criteria for identifying vital signs as potentially clinically significant abnormal.","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1912,877],[1912,930],[245,930]],"region":{"top_left_x":244,"top_left_y":876,"width":1669,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15bb83b706fd441ba2c91a4f8f5fbd5a","type":"text","conversion_output":true,"text":"Note that in order to be identified as potentially clinically significant abnormal, a value would need","text_display":" Note that in order to be identified as potentially clinically significant abnormal, a value would need","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1921,924],[1921,978],[245,978]],"region":{"top_left_x":244,"top_left_y":923,"width":1677,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b4e513a57b7440eae6aad5c76ca53c4","type":"text","conversion_output":true,"text":"to meet both conditions below: i.e., have a value beyond the criterion value and a change of at least","text_display":" to meet both conditions below: i.e., have a value beyond the criterion value and a change of at least","confidence":0.991706371307373,"confidence_rate":0.9999214350469642},{"cnt":[[245,975],[1888,975],[1888,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1645,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cbe2af497a6446b9e93222f019127ff","type":"text","conversion_output":true,"text":"the magnitude specified in the change from baseline column. The potentially clinically significant","text_display":" the magnitude specified in the change from baseline column. The potentially clinically significant","confidence":0.99853515625,"confidence_rate":0.9999857678907678},{"cnt":[[245,1023],[1901,1023],[1901,1074],[245,1074]],"region":{"top_left_x":244,"top_left_y":1022,"width":1658,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0e5a4d8f5dd483d9f6fd7a9546b21e2","type":"text","conversion_output":true,"text":"abnormal vital signs values will include all postbaseline values (including scheduled, unscheduled,","text_display":" abnormal vital signs values will include all postbaseline values (including scheduled, unscheduled,","confidence":1,"confidence_rate":1},{"cnt":[[245,1072],[1044,1072],[1044,1124],[245,1124]],"region":{"top_left_x":244,"top_left_y":1072,"width":801,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88d09258a4254290adb9c6d32889f916","type":"text","conversion_output":true,"text":"and early termination visits) for the summaries.","text_display":" and early termination visits) for the summaries.","confidence":1,"confidence_rate":1},{"cnt":[[243,1160],[1506,1160],[1506,1218],[243,1218]],"region":{"top_left_x":242,"top_left_y":1160,"width":1265,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"650abb09ce5240a5a169cb4393b81588","type":"figure_label","conversion_output":false,"text":"Table 6: Criteria for Potentially Clinically Significant Vital Signs","text_display":"","confidence":0.9907269477844238,"confidence_rate":0.9998723873949391},{"cnt":[[226,1222],[1888,1222],[1888,1826],[226,1826]],"region":{"top_left_x":225,"top_left_y":1222,"width":1664,"height":605},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4262212612264d5d99ab9ee9b696600e","type":"table","conversion_output":true,"children_ids":["a48bde8bb75443cb9bb66f2c89c563e2","f7f2ed33ba95421ab2c13bdf10fb79cd","a0c53b3a420647ad9658050a77b8ddf2","f6966cdcc0ca4375a91d653dc909cab1","22c21cf30cc843d29648ab30fc63a3b4","2dc275eb57934277bf5abacf00f7f68d","b79c7cb8f2a644c0b98749153ba4489e","737a896e2e354130b0db9f37d2fd1dbc","2ac947de3e384ef6a817525db7e266c1","72b2841bdb4b4889b4e146f4bf8a062f","10b57826839748e0ad49b6b0dcc06ce8","a548936b26774b43b5b3dab9079722d4","a7469b3476cc4a609e5ec8ccbbc6b9c6","8012593c948c4c0b9394c2eca041855b","8860ce7e7d2d49a0a093e9ee10d38c9c","af8e7edef19d44efa395095bb02f4c8a","e07ad8a992d04bada596c7ff8f8cc2d3","e2165bba88be486f84fc06cc161933ac","7998dce831704888902a33f9c6b06867","daa2ac268761472db634b75bdff20f48","d37e89d36afa427fb81572b7447bb0c6","1f8744648e2c44ddbe7a9a2edc6fde95","84fb5c7baea94bbbba6891f93ad9bcbe","77daedbaa84b4888aca5792de2e9caae","8d21af689bbb4c15b854e7c71302f594","27c5e57b52df412d8c053b777713c7c7","979da02ce2de41128e708aabcb1f6c39","c29149ae143c4d7097822968da9b35ca","655e8aa2be4c43c0bc056dea81433206","b0811bd18de1437dbc1f82a223a3256f","0948f60cf1c043f7b75c86de21b1b8d6","783d305792c24974969c963f8fcef884","5aa458f0d935488da5a58e4a3266a9dc","1163e07ed018457b9677ba7761649faa","259b750c31ee4658a217f66d46b46f1b"],"selected_labels":["650abb09ce5240a5a169cb4393b81588"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline 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Electrocardiography}","confidence":0.9990234375,"confidence_rate":0.9999663095451973},{"cnt":[[245,2050],[1916,2050],[1916,2103],[245,2103]],"region":{"top_left_x":244,"top_left_y":2049,"width":1673,"height":55},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"faa0d661ff534dd5bfb6205449098420","type":"text","conversion_output":true,"text":"Twelve-lead ECGs will be conducted before other assessments (eg, blood draws and administration","text_display":"\n\nTwelve-lead ECGs will be conducted before other assessments (eg, blood draws and administration","confidence":0.962890625,"confidence_rate":0.9996219169814367},{"cnt":[[245,2099],[1184,2099],[1184,2151],[245,2151]],"region":{"top_left_x":244,"top_left_y":2099,"width":940,"height":52},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5063011e5a754137a369022627692b5a","type":"text","conversion_output":true,"text":"of questionnaires) at the time points detailed in Table 1.","text_display":" of questionnaires) at the time points detailed in Table 1.","confidence":0.9887795448303223,"confidence_rate":0.9998180185065246},{"cnt":[[245,2168],[1867,2168],[1867,2221],[245,2221]],"region":{"top_left_x":244,"top_left_y":2167,"width":1623,"height":55},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ada8b25f0c64b28977bbf034707c2d0","type":"text","conversion_output":true,"text":"The ECGs will be performed in triplicate, with approximately 1 minute between recordings. The","text_display":"\nThe ECGs will be performed in triplicate, with approximately 1 minute between recordings. The","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,2217],[1437,2217],[1437,2267],[245,2267]],"region":{"top_left_x":244,"top_left_y":2217,"width":1194,"height":50},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d904e4b20b6043ddaab2e01c38b31f19","type":"text","conversion_output":true,"text":"average of the recorded measurements will be calculated for each visit.","text_display":" average of the recorded measurements will be calculated for each visit.","confidence":1,"confidence_rate":1},{"cnt":[[245,2286],[1850,2286],[1850,2340],[245,2340]],"region":{"top_left_x":244,"top_left_y":2285,"width":1606,"height":55},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d0ac7f77bd64d54b29cb4e77051061c","type":"text","conversion_output":true,"text":"Any ECG finding that is judged by the investigator as a potentially clinically significant change","text_display":"\n\nAny ECG finding that is judged by the investigator as a potentially clinically significant change","confidence":1,"confidence_rate":1},{"cnt":[[245,2338],[1639,2338],[1639,2387],[245,2387]],"region":{"top_left_x":244,"top_left_y":2337,"width":1396,"height":50},"line":66,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8451148a248c45059c82c95b9207faf1","type":"text","conversion_output":true,"text":"(worsening) compared with the baseline value will be considered an adverse event.","text_display":" (worsening) compared with the baseline value will be considered an adverse event.","confidence":1,"confidence_rate":1},{"cnt":[[1061,2557],[1113,2557],[1113,2600],[1061,2600]],"region":{"top_left_x":1061,"top_left_y":2556,"width":52,"height":44},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a4a0d0467054e6aa41bb4d67435004b","type":"page_info","conversion_output":false,"text":"50","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"27095da8-d3cb-46c8-acc8-b1f7518b8cec-52","page":52,"lines":[{"cnt":[[245,125],[1012,125],[1012,174],[245,174]],"region":{"top_left_x":244,"top_left_y":124,"width":768,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e63a5be307b146338816a285e37550ff","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan with Amendment 02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1543,125],[1927,125],[1927,170],[1543,170]],"region":{"top_left_x":1542,"top_left_y":124,"width":386,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66f3080de93b45c3a2af493c0e5717c4","type":"page_info","conversion_output":false,"text":"TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[1811,251],[1811,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1568,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bfb7ccb31b3418e876bf26ce68ec529","type":"text","conversion_output":true,"text":"Shifts (normal and abnormal) from baseline to the endpoint will be summarized using patient","text_display":"\n\nShifts (normal and abnormal) from baseline to the endpoint will be summarized using patient","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1828,301],[1828,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1585,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2850f5cd5f6e4780bc89030712c16376","type":"text","conversion_output":true,"text":"counts and percentages. ECG variables results and changes from baseline to EOT/EOS will be","text_display":" counts and percentages. ECG variables results and changes from baseline to EOT/EOS will be","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[915,348],[915,400],[245,400]],"region":{"top_left_x":244,"top_left_y":348,"width":672,"height":52},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcd601fab74f4285b6610c092fe99d0c","type":"text","conversion_output":true,"text":"summarized using descriptive statistics.","text_display":" summarized using descriptive statistics.","confidence":1,"confidence_rate":1},{"cnt":[[241,436],[920,436],[920,501],[241,501]],"region":{"top_left_x":240,"top_left_y":436,"width":680,"height":65},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71a8f89163f64e90906822eac774394e","type":"section_header","conversion_output":false,"children_ids":["30219291b0994f7d894ced7e9c233732"],"text":"","text_display":""},{"cnt":[[245,443],[913,443],[913,496],[245,496]],"region":{"top_left_x":244,"top_left_y":442,"width":670,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30219291b0994f7d894ced7e9c233732","type":"text","conversion_output":true,"parent_id":"71a8f89163f64e90906822eac774394e","text":"7.9. Physical Examinations","text_display":"\n\n\\subsection*{7.9. Physical Examinations}","confidence":0.8837890625,"confidence_rate":0.9960228697534778},{"cnt":[[245,516],[1904,516],[1904,565],[245,565]],"region":{"top_left_x":244,"top_left_y":515,"width":1660,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e220d3f561f411eaff260df420b39d3","type":"text","conversion_output":true,"text":"Physical examinations, including height (to be obtained at the screening visit only) and weight will","text_display":"\n\nPhysical examinations, including height (to be obtained at the screening visit only) and weight will","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[1106,563],[1106,614],[245,614]],"region":{"top_left_x":244,"top_left_y":562,"width":863,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dc0ccec23eb4d65ac7febac53704651","type":"text","conversion_output":true,"text":"be performed at the time points detailed in Table 1.","text_display":" be performed at the time points detailed in Table 1.","confidence":1,"confidence_rate":1},{"cnt":[[245,632],[1858,632],[1858,685],[245,685]],"region":{"top_left_x":244,"top_left_y":631,"width":1615,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e62111cf97ed413389472126cce1d77a","type":"text","conversion_output":true,"text":"A complete physical examination will include the following organ systems: general appearance;","text_display":"\nA complete physical examination will include the following organ systems: general appearance;","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1871,683],[1871,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1628,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bfb62a9ae3d458289d012bb0e95c106","type":"text","conversion_output":true,"text":"head, eyes, ears, nose, and throat; chest and lungs; heart; abdomen; musculoskeletal; skin; lymph","text_display":" head, eyes, ears, nose, and throat; chest and lungs; heart; abdomen; musculoskeletal; skin; lymph","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1876,730],[1876,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1632,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d83c967dc9804eab8278d220ef92ae19","type":"text","conversion_output":true,"text":"nodes; and neurological. Any physical examination finding that is judged by the investigator as a","text_display":" nodes; and neurological. Any physical examination finding that is judged by the investigator as a","confidence":1,"confidence_rate":1},{"cnt":[[245,780],[1790,780],[1790,831],[245,831]],"region":{"top_left_x":244,"top_left_y":779,"width":1546,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12d5e8890dd14afc9706e4dfa0836f17","type":"text","conversion_output":true,"text":"potentially clinically significant change (worsening) compared with a baseline value will be","text_display":" potentially clinically significant change (worsening) compared with a baseline value will be","confidence":0.99853515625,"confidence_rate":0.9999848875607663},{"cnt":[[245,829],[733,829],[733,874],[245,874]],"region":{"top_left_x":244,"top_left_y":829,"width":489,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa5c175b26024fb8a08f166f76366e13","type":"text","conversion_output":true,"text":"considered an adverse event.","text_display":" considered an adverse event.","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1171,898],[1171,950],[245,950]],"region":{"top_left_x":244,"top_left_y":898,"width":927,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7dc052b14484707b67a53b2c10b8ac0","type":"text","conversion_output":true,"text":"Abnormal physical examination findings will be listed.","text_display":"\n\nAbnormal physical examination findings will be listed.","confidence":0.9858465194702148,"confidence_rate":0.9997584258572544},{"cnt":[[241,984],[1502,984],[1502,1051],[241,1051]],"region":{"top_left_x":240,"top_left_y":983,"width":1262,"height":68},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dafc2e849644f899197dc451a327b53","type":"section_header","conversion_output":false,"children_ids":["4a7e938f29a24ddd894f3c3554a159d6"],"text":"","text_display":""},{"cnt":[[245,988],[1497,988],[1497,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":988,"width":1254,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a7e938f29a24ddd894f3c3554a159d6","type":"text","conversion_output":true,"parent_id":"8dafc2e849644f899197dc451a327b53","text":"7.10. Electronic Columbia-Suicide Severity Rating Scale","text_display":"\n\n\\subsection*{7.10. Electronic Columbia-Suicide Severity Rating Scale}","confidence":0.994140625,"confidence_rate":0.9999020613214891},{"cnt":[[245,1066],[1914,1066],[1914,1115],[245,1115]],"region":{"top_left_x":244,"top_left_y":1065,"width":1671,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"560bcec18232499aa50d8e926913e239","type":"text","conversion_output":true,"text":"The electronic columbia-suicide severity rating scale (eC-SSRS) will be used to assess the patient's","text_display":"\n\nThe electronic columbia-suicide severity rating scale (eC-SSRS) will be used to assess the patient's","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[245,1113],[1732,1113],[1732,1164],[245,1164]],"region":{"top_left_x":244,"top_left_y":1112,"width":1488,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad5bd7b0fee744f189e852127ae77db5","type":"text","conversion_output":true,"text":"suicidal ideation (severity and intensity) and behavior (Posner et al 2011). The eC-SSRS","text_display":" suicidal ideation (severity and intensity) and behavior (Posner et al 2011). The eC-SSRS","confidence":1,"confidence_rate":1},{"cnt":[[247,1162],[1867,1162],[1867,1212],[247,1212]],"region":{"top_left_x":247,"top_left_y":1162,"width":1620,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f41ab4b29044d6da0aca9decd039f95","type":"text","conversion_output":true,"text":"'Baseline/Screening version' will be completed by the patient at visit 2, and the eC-SSRS 'Since","text_display":" 'Baseline/Screening version' will be completed by the patient at visit 2, and the eC-SSRS 'Since","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1910,1212],[1910,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1666,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f78b3b18071b46b0bdfc9824d7275de9","type":"text","conversion_output":true,"text":"Last Visit version' will be completed by the patient at all other time points, as described in Table 1.","text_display":" Last Visit version' will be completed by the patient at all other time points, as described in Table 1.","confidence":1,"confidence_rate":1},{"cnt":[[245,1280],[1901,1280],[1901,1330],[245,1330]],"region":{"top_left_x":244,"top_left_y":1280,"width":1658,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a13b8c09a5a42f3aa9d22fe81c119e3","type":"text","conversion_output":true,"text":"Any positive findings on the eC-SSRS 'Since Last Visit version' require evaluation by a physician","text_display":"\n\nAny positive findings on the eC-SSRS 'Since Last Visit version' require evaluation by a physician","confidence":1,"confidence_rate":1},{"cnt":[[245,1328],[763,1328],[763,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1327,"width":519,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81ceedf7d0b240c9bb1fb84cab956543","type":"text","conversion_output":true,"text":"or doctoral-level psychologist.","text_display":" or doctoral-level psychologist.","confidence":1,"confidence_rate":1},{"cnt":[[245,1396],[1027,1396],[1027,1450],[245,1450]],"region":{"top_left_x":244,"top_left_y":1396,"width":783,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c851dc70cbae400db6381b960a021886","type":"text","conversion_output":true,"text":"Patients having positive findings will be listed.","text_display":"\nPatients having positive findings will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[243,1487],[1214,1487],[1214,1549],[243,1549]],"region":{"top_left_x":242,"top_left_y":1486,"width":972,"height":64},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"383ae7c30cf44b80834ebcd65ed9735c","type":"section_header","conversion_output":false,"children_ids":["c0f096e38287491580bc1fec5526e984"],"text":"","text_display":""},{"cnt":[[245,1491],[1207,1491],[1207,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1491,"width":964,"height":59},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0f096e38287491580bc1fec5526e984","type":"text","conversion_output":true,"parent_id":"383ae7c30cf44b80834ebcd65ed9735c","text":"7.11. Concomitant Therapy or Medication","text_display":"\n\n\\subsection*{7.11. Concomitant Therapy or Medication}","confidence":0.99951171875,"confidence_rate":0.9999889000502842},{"cnt":[[245,1564],[1811,1564],[1811,1613],[245,1613]],"region":{"top_left_x":244,"top_left_y":1564,"width":1568,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c344c1d5a464a3e82aceb56a090282f","type":"text","conversion_output":true,"text":"All concomitant medications will be coded using the WHO dictionary of medical codes. The","text_display":"\n\nAll concomitant medications will be coded using the WHO dictionary of medical codes. The","confidence":1,"confidence_rate":1},{"cnt":[[245,1611],[1876,1611],[1876,1665],[245,1665]],"region":{"top_left_x":244,"top_left_y":1611,"width":1632,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5a1956176104ee4abd2c16960eddddb","type":"text","conversion_output":true,"text":"concomitant medication will include all medications taken after the \\(1^{\\text {st }}\\) study drug administration.","text_display":" concomitant medication will include all medications taken after the \\(1^{\\text {st }}\\) study drug administration.","confidence":0.9931697845458984,"confidence_rate":0.9999419199228416},{"cnt":[[245,1684],[1807,1684],[1807,1734],[245,1734]],"region":{"top_left_x":244,"top_left_y":1684,"width":1563,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce662a89276640d19dcea293c3836a93","type":"text","conversion_output":true,"text":"The incidence of concomitant medications will be summarized using descriptive statistics by","text_display":"\n\nThe incidence of concomitant medications will be summarized using descriptive statistics by","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1811,1732],[1811,1781],[245,1781]],"region":{"top_left_x":244,"top_left_y":1731,"width":1568,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9d9a57506bb4a59a9fbe061458065ab","type":"text","conversion_output":true,"text":"therapeutic class and preferred term. Patients are counted only once in each therapeutic class","text_display":" therapeutic class and preferred term. Patients are counted only once in each therapeutic class","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[245,1781],[1197,1781],[1197,1833],[245,1833]],"region":{"top_left_x":244,"top_left_y":1781,"width":953,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3e6826385444fa2a400398d5f19a085","type":"text","conversion_output":true,"text":"category, and only once in each preferred term category.","text_display":" category, and only once in each preferred term category.","confidence":1,"confidence_rate":1},{"cnt":[[245,1850],[1880,1850],[1880,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1849,"width":1636,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce98a784a7e145f789c9beb1a98665f4","type":"text","conversion_output":true,"text":"The subset of concomitant pain medication and medication or therapy for migraine/headache will","text_display":"\nThe subset of concomitant pain medication and medication or therapy for migraine/headache will","confidence":1,"confidence_rate":1},{"cnt":[[245,1899],[1160,1899],[1160,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1899,"width":917,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee3c16e271d841ae9d1d35c19b5dab4f","type":"text","conversion_output":true,"text":"be summarized by the following indication categories.","text_display":" be summarized by the following indication categories.","confidence":1,"confidence_rate":1},{"cnt":[[370,1972],[1141,1972],[1141,2022],[370,2022]],"region":{"top_left_x":369,"top_left_y":1972,"width":772,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f25c44ebbac44b23a275c65ef3ca2ace","type":"text","conversion_output":true,"text":"- migraine/headache preventive medication","text_display":"\n- migraine/headache preventive 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& The following questions are referring to yesterday (00:00-23:59) AT THE TIME WHEN YOUR HEADCAHE REACHED THE WORST SEVERITY \\\\\n\\hline B1 & Was it worse on one side of the head than on the other, and/or limited to one side of the head? \\\\\n\\hline B2 & Was it pounding, pulsating, or throbbing? \\\\\n\\hline B3 & Was it made worse by routine activities such as walking or climbing stairs? \\\\\n\\hline B4 & Did you have nausea, or get sick to your stomach? \\\\\n\\hline B5 & Did light bother you more than when you didn't have a headache (did you experience photophobia)? \\\\\n\\hline B6 & Did sounds bother you more than when you didn't have a headache (did you experience phonophobia)? \\\\\n\\hline & The following questions are referring to yesterday (00:00-23:59) \\\\\n\\hline B7 & Did you experience something like seeing spots, stars, lines, flashing lights, zigzag lines, or \"heat waves\" around the time of your headache? 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(This is different from \"light bothers you\") \\\\\n\\hline B10 & Did you have feelings such as numbness or tingling in any part of your body or face, similar to what you may have felt when you have a headache? \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & The following questions are referring to yesterday (00:00-23:59) AT THE TIME WHEN YOUR HEADCAHE REACHED THE WORST SEVERITY \\\\\n\\hline B1 & Was it worse on one side of the head than on the other, and/or limited to one side of the head? \\\\\n\\hline B2 & Was it pounding, pulsating, or throbbing? \\\\\n\\hline B3 & Was it made worse by routine activities such as walking or climbing stairs? \\\\\n\\hline B4 & Did you have nausea, or get sick to your stomach? \\\\\n\\hline B5 & Did light bother you more than when you didn't have a headache (did you experience photophobia)? \\\\\n\\hline B6 & Did sounds bother you more than when you didn't have a headache (did you experience phonophobia)? \\\\\n\\hline & The following questions are referring to yesterday (00:00-23:59) \\\\\n\\hline B7 & Did you experience something like seeing spots, stars, lines, flashing lights, zigzag lines, or \"heat waves\" around the time of your headache? 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(This is different from \"light bothers you\")","text_display":"Did you experience something like seeing spots, stars, lines, flashing lights, zigzag lines, or \"heat waves\" similar to those you may have seen when you have a headache? 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