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enrolled","text_display":"\nNumber of Patients Planned: A total of 768 patients ( 256 patients per treatment group) are planned to be enrolled","confidence":0.99951171875,"confidence_rate":0.9999960928036482},{"cnt":[[247,1143],[1777,1143],[1777,1184],[247,1184]],"region":{"top_left_x":247,"top_left_y":1142,"width":1530,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7bced380daa1400d92c55a47be0f0d29","type":"text","conversion_output":true,"text":"in this study to have 675 completers ( 225 completers per treatment group); a \\(12 \\%\\) drop-out rate is anticipated.","text_display":" in this study to have 675 completers ( 225 completers per treatment group); a \\(12 \\%\\) drop-out rate is anticipated.","confidence":0.9614805998280644,"confidence_rate":0.9996858022413154},{"cnt":[[245,1190],[1201,1190],[1201,1231],[245,1231]],"region":{"top_left_x":244,"top_left_y":1190,"width":957,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"62fdb3ee50a9423ba7dc06aab17e3347","type":"text","conversion_output":true,"text":"Patients will be randomized \\(1: 1: 1\\) to the following treatment groups:","text_display":" Patients will be randomized \\(1: 1: 1\\) to the following treatment groups:","confidence":0.9775390625,"confidence_rate":0.9997011364280354},{"cnt":[[309,1263],[1321,1263],[1321,1302],[309,1302]],"region":{"top_left_x":309,"top_left_y":1263,"width":1013,"height":39},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea090e78c59f4f7c920b24d4d46af055","type":"text","conversion_output":true,"text":"- monthly subcutaneous (sc) administration of TEV-48125 at 225 mg","text_display":"\n- monthly subcutaneous (sc) administration of TEV-48125 at 225 mg","confidence":0.9482421875,"confidence_rate":0.9992517541980298},{"cnt":[[309,1332],[1429,1332],[1429,1371],[309,1371]],"region":{"top_left_x":309,"top_left_y":1332,"width":1120,"height":39},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1987fd76bc784658947f34264a271f9d","type":"text","conversion_output":true,"text":"- sc administration of TEV-48125 at 675 mg followed by monthly sc placebo","text_display":"\n- sc administration of TEV-48125 at 675 mg followed by monthly sc placebo","confidence":0.99951171875,"confidence_rate":0.999994115673962},{"cnt":[[309,1401],[896,1401],[896,1442],[309,1442]],"region":{"top_left_x":309,"top_left_y":1400,"width":587,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dfda7f611bcb47afba918600389c2df1","type":"text","conversion_output":true,"text":"- monthly sc administration of placebo","text_display":"\n- monthly sc administration of placebo","confidence":1,"confidence_rate":1},{"cnt":[[247,1470],[1575,1470],[1575,1510],[247,1510]],"region":{"top_left_x":247,"top_left_y":1469,"width":1328,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6fbc966589a14026bd7ee1065699869b","type":"text","conversion_output":true,"text":"(Note: For this study, monthly dosing refers to dosing approximately every 4 weeks [28 days].)","text_display":"\n(Note: For this study, monthly dosing refers to dosing approximately every 4 weeks [28 days].)","confidence":0.8926303386688232,"confidence_rate":0.998887063516181},{"cnt":[[247,1538],[1768,1538],[1768,1579],[247,1579]],"region":{"top_left_x":247,"top_left_y":1538,"width":1522,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"402c3a0d54b44bc7856358baccfe55fc","type":"text","conversion_output":true,"text":"Study Population: The study population will be composed of female and male patients, aged 18 to 70 years,","text_display":"\nStudy Population: The study population will be composed of female and male patients, aged 18 to 70 years,","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[247,1581],[1850,1581],[1850,1626],[247,1626]],"region":{"top_left_x":247,"top_left_y":1581,"width":1603,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c34f7e979a194cce91b254defd70c11a","type":"text","conversion_output":true,"text":"inclusive, with a history of migraine (as defined by International Classification of Headache Disorders, \\(3{ }^{\\text {rd }}\\) revision","text_display":" inclusive, with a history of migraine (as defined by International Classification of Headache Disorders, \\(3{ }^{\\text {rd }}\\) revision","confidence":0.71533203125,"confidence_rate":0.997557670092104},{"cnt":[[249,1637],[1755,1637],[1755,1678],[249,1678]],"region":{"top_left_x":249,"top_left_y":1637,"width":1507,"height":41},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d23604672474e2d8f56177b20d57f48","type":"text","conversion_output":true,"text":"[ICHD-3] criteria [Classification Committee of the IHS, 2013]) for at least 12 months prior to screening and","text_display":" [ICHD-3] criteria [Classification Committee of the IHS, 2013]) for at least 12 months prior to screening and","confidence":0.998046875,"confidence_rate":0.9999831463934391},{"cnt":[[247,1684],[1811,1684],[1811,1725],[247,1725]],"region":{"top_left_x":247,"top_left_y":1684,"width":1565,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b353637f3ab4be38aee8d6fbd17e0f7","type":"text","conversion_output":true,"text":"episodic migraine (EM) prospectively documented via a review of headache data recorded daily in an electronic","text_display":" episodic migraine (EM) prospectively documented via a review of headache data recorded daily in an electronic","confidence":1,"confidence_rate":1},{"cnt":[[249,1732],[1068,1732],[1068,1772],[249,1772]],"region":{"top_left_x":249,"top_left_y":1731,"width":819,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73ef1b31b60c418cb0208d1201dd4266","type":"text","conversion_output":true,"text":"daily headache diary device during a 28-day run-in period.","text_display":" daily headache diary device during a 28-day run-in period.","confidence":0.9873046875,"confidence_rate":0.9997972176015594},{"cnt":[[247,1805],[1833,1805],[1833,1846],[247,1846]],"region":{"top_left_x":247,"top_left_y":1804,"width":1586,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b90669739fb4aa68ee972a175280dfe","type":"text","conversion_output":true,"text":"Because headache consortium guidelines recommend preventive therapies for patients with EM occurring on 4 or","text_display":"\n\nBecause headache consortium guidelines recommend preventive therapies for patients with EM occurring on 4 or","confidence":1,"confidence_rate":1},{"cnt":[[247,1852],[1837,1852],[1837,1893],[247,1893]],"region":{"top_left_x":247,"top_left_y":1851,"width":1590,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3cac541080814035b9472d272927b70b","type":"text","conversion_output":true,"text":"more days per month due to the frequency of headaches and high degree of disability, patients using no more than","text_display":" more days per month due to the frequency of headaches and high degree of disability, patients using no more than","confidence":1,"confidence_rate":1},{"cnt":[[249,1899],[1725,1899],[1725,1940],[249,1940]],"region":{"top_left_x":249,"top_left_y":1899,"width":1477,"height":42},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77e9f032abdf484897cca02a7ab19875","type":"text","conversion_output":true,"text":"1 preventive medication at the time of study enrollment will be allowed to remain on the medication if the","text_display":" 1 preventive medication at the time of study enrollment will be allowed to remain on the medication if the","confidence":1,"confidence_rate":1},{"cnt":[[247,1946],[1854,1946],[1854,1987],[247,1987]],"region":{"top_left_x":247,"top_left_y":1946,"width":1608,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"adf83d472fae4b4d859087651aa77007","type":"text","conversion_output":true,"text":"medication has at least moderate evidence of efficacy for migraine (Silberstein et al 2012). Patients on concomitant","text_display":" medication has at least moderate evidence of efficacy for migraine (Silberstein et al 2012). Patients on concomitant","confidence":0.99951171875,"confidence_rate":0.9999959636403931},{"cnt":[[245,1998],[1809,1998],[1809,2039],[245,2039]],"region":{"top_left_x":244,"top_left_y":1998,"width":1565,"height":41},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"669fdf0611ca43ab9e6d229907b2a647","type":"text","conversion_output":true,"text":"preventive medications must be on a stable dose for at least 2 months of consecutive use prior to study entry (ie,","text_display":" preventive medications must be on a stable dose for at least 2 months of consecutive use prior to study entry (ie,","confidence":1,"confidence_rate":1},{"cnt":[[247,2045],[1871,2045],[1871,2086],[247,2086]],"region":{"top_left_x":247,"top_left_y":2045,"width":1625,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c3d535cdfa064a6f970f4bbb899f895d","type":"text","conversion_output":true,"text":"before the run-in period), without anticipated changes during the study. A list of preventive medications is presented","text_display":" before the run-in period), without anticipated changes during the study. A list of preventive medications is presented","confidence":0.9990234375,"confidence_rate":0.9999920566197779},{"cnt":[[247,2093],[1858,2093],[1858,2136],[247,2136]],"region":{"top_left_x":247,"top_left_y":2092,"width":1612,"height":44},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc1ee5659164424ca68b539fb7724b9e","type":"text","conversion_output":true,"text":"in Appendix A. The total number of patients receiving concomitant preventive medication during the study will not","text_display":" in Appendix A. The total number of patients receiving concomitant preventive medication during the study will not","confidence":1,"confidence_rate":1},{"cnt":[[247,2144],[1588,2144],[1588,2185],[247,2185]],"region":{"top_left_x":247,"top_left_y":2144,"width":1341,"height":41},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d2452cf6c12c49f39b1df30f62ec9c35","type":"text","conversion_output":true,"text":"exceed \\(30 \\%\\) of the total sample size of the study. This subset will be randomized independently.","text_display":" exceed \\(30 \\%\\) of the total sample size of the study. This subset will be randomized independently.","confidence":0.99658203125,"confidence_rate":0.9999667595490823},{"cnt":[[1048,2539],[1074,2539],[1074,2578],[1048,2578]],"region":{"top_left_x":1048,"top_left_y":2539,"width":27,"height":40},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c9b643afb4e4b3c834f71b208093e73","type":"page_info","conversion_output":false,"text":"8","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-010","page":10,"lines":[{"cnt":[[1109,127],[1880,127],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":126,"width":772,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f2ab20281b04891a18f327b280d5250","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f3524a7d70f49879ea1bbe59a7ce483","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8c3c863242e4ba583bd78cb94e97cad","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,260],[1278,260],[1278,303],[245,303]],"region":{"top_left_x":244,"top_left_y":259,"width":1035,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3863522322f0404c85b0ee5642682bbe","type":"text","conversion_output":true,"text":"Primary Objectives: The primary objectives of this study are as follows:","text_display":"\n\nPrimary Objectives: The primary objectives of this study are as follows:","confidence":0.99951171875,"confidence_rate":0.9999936571565041},{"cnt":[[372,331],[1871,331],[1871,372],[372,372]],"region":{"top_left_x":371,"top_left_y":330,"width":1501,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7f83d230786415791705e4aee17335e","type":"text","conversion_output":true,"text":"- to demonstrate the efficacy 2 dose regimens of TEV-48125, as assessed by the decrease in the monthly","text_display":"\n- to demonstrate the efficacy 2 dose regimens of TEV-48125, as assessed by the decrease in the monthly","confidence":1,"confidence_rate":1},{"cnt":[[434,374],[1863,374],[1863,421],[434,421]],"region":{"top_left_x":433,"top_left_y":373,"width":1430,"height":49},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"adea896038944fa090d6a1f7c7be0389","type":"text","conversion_output":true,"text":"average number of migraine days during 12-week period after the \\(1^{\\text {st }}\\) dose of study drug relative to the","text_display":" average number of migraine days during 12-week period after the \\(1^{\\text {st }}\\) dose of study drug relative to 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average","text_display":"\n- to demonstrate the efficacy of TEV-48125, as assessed by the reduction in the monthly average","confidence":1,"confidence_rate":1},{"cnt":[[434,898],[1858,898],[1858,947],[434,947]],"region":{"top_left_x":433,"top_left_y":898,"width":1426,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57e27c066bff4e148515334b309dad77","type":"text","conversion_output":true,"text":"number of days of use of any acute headache medications during the 12-week period after the \\(1^{\\text {st }}\\) dose","text_display":" number of days of use of any acute headache medications during the 12-week period after the \\(1^{\\text {st }}\\) 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number of migraine","confidence":1,"confidence_rate":1},{"cnt":[[434,1066],[1714,1066],[1714,1111],[434,1111]],"region":{"top_left_x":433,"top_left_y":1065,"width":1282,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a7f548b2c9d4181ba6e7167f6cde0d7","type":"text","conversion_output":true,"text":"days during the 4-week period after the \\(1^{\\text {st }}\\) dose of study drug relative to the baseline period","text_display":" days during the 4-week period after the \\(1^{\\text {st }}\\) dose of study drug relative to the baseline period","confidence":0.7950217723846436,"confidence_rate":0.9979898670808137},{"cnt":[[370,1139],[1764,1139],[1764,1182],[370,1182]],"region":{"top_left_x":369,"top_left_y":1138,"width":1395,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6186e03d1dbd4fc4a40db63ba8b43294","type":"text","conversion_output":true,"text":"- to demonstrate the efficacy of TEV-48125, as 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A computer-generated master","text_display":" bioanalytical analyses), and patients will be blinded to treatment assignment. 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Each patient will undergo randomization in a \\(1: 1: 1\\) ratio within the stratum to which he or she belongs to","text_display":" no). Each patient will undergo randomization in a \\(1: 1: 1\\) ratio within the stratum to which he or she belongs to","confidence":0.937044620513916,"confidence_rate":0.999449097757776},{"cnt":[[245,571],[1846,571],[1846,617],[245,617]],"region":{"top_left_x":244,"top_left_y":571,"width":1602,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"52b591e61a2d4f2cbbd012e9815fb5a1","type":"text","conversion_output":true,"text":"receive 1 of the 2 TEV- 48125 dose regimens or placebo, as assigned by the IRT. The IRT will manage initial drug","text_display":" receive 1 of the 2 TEV- 48125 dose regimens or placebo, as assigned by the IRT. The IRT will manage initial drug","confidence":0.95263671875,"confidence_rate":0.9996149817136797},{"cnt":[[245,619],[1863,619],[1863,664],[245,664]],"region":{"top_left_x":244,"top_left_y":618,"width":1619,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20b2d0b6d8694031a473c8ca9025f1bb","type":"text","conversion_output":true,"text":"supply, maintenance of adequate study drug supplies on site, and study randomization centrally. At the time of each","text_display":" supply, maintenance of adequate study drug supplies on site, and study randomization centrally. At the time of each","confidence":1,"confidence_rate":1},{"cnt":[[245,666],[1798,666],[1798,711],[245,711]],"region":{"top_left_x":244,"top_left_y":666,"width":1555,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0bd7c4e8594b44debc5caf3970b9ae2b","type":"text","conversion_output":true,"text":"study visit, the IRT will be queried, and site personnel will retrieve and administer a \\(1.5- mL\\) volume from each","text_display":" study visit, the IRT will be queried, and site personnel will retrieve and administer a \\(1.5- mL\\) volume from each","confidence":1,"confidence_rate":1},{"cnt":[[245,718],[1018,718],[1018,763],[245,763]],"region":{"top_left_x":244,"top_left_y":717,"width":775,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cdb276dbb490428aae54e1d8e3dcc2f6","type":"text","conversion_output":true,"text":"syringe contained in the appropriately numbered kit(s).","text_display":" syringe contained in the appropriately numbered kit(s).","confidence":1,"confidence_rate":1},{"cnt":[[245,786],[1854,786],[1854,831],[245,831]],"region":{"top_left_x":244,"top_left_y":786,"width":1611,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30668845df0a4ece85cfda6608197271","type":"text","conversion_output":true,"text":"The total number of patients receiving concomitant preventive medication during the study will not exceed \\(30 \\%\\) of","text_display":"\n\nThe total number of patients receiving concomitant preventive medication during the study will not exceed \\(30 \\%\\) of","confidence":1,"confidence_rate":1},{"cnt":[[245,834],[718,834],[718,879],[245,879]],"region":{"top_left_x":244,"top_left_y":833,"width":474,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a6b267cd28541129481eaf665026791","type":"text","conversion_output":true,"text":"the total sample size of the study.","text_display":" the total sample size of the study.","confidence":1,"confidence_rate":1},{"cnt":[[245,902],[1867,902],[1867,950],[245,950]],"region":{"top_left_x":244,"top_left_y":902,"width":1623,"height":48},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6799da77547b49d58d33373441b4ee5b","type":"text","conversion_output":true,"text":"Study Drug Dose, Mode of Administration, and Administration Rate: Prefilled syringes (active or placebo) will","text_display":"\n\nStudy Drug Dose, Mode of Administration, and Administration Rate: Prefilled syringes (active or placebo) will","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1854,954],[1854,999],[245,999]],"region":{"top_left_x":244,"top_left_y":953,"width":1611,"height":47},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"319bc53707984766994b8f594e20a3ad","type":"text","conversion_output":true,"text":"be contained in uniquely numbered kits and stored (refrigerated at \\(2^{\\circ} C\\) to \\(8^{\\circ} C\\) ) on site. Active syringes will contain","text_display":" be contained in uniquely numbered kits and stored (refrigerated at \\(2^{\\circ} C\\) to \\(8^{\\circ} C\\) ) on site. Active syringes will contain","confidence":0.9931747913360596,"confidence_rate":0.9999537266995157},{"cnt":[[247,1001],[1820,1001],[1820,1046],[247,1046]],"region":{"top_left_x":247,"top_left_y":1001,"width":1573,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8cf35672c52433fbb50870ffc9ef236","type":"text","conversion_output":true,"text":"\\(150 mg / mL\\) of TEV-48125, and placebo syringes will contain the same vehicle and excipients as those for active","text_display":" \\(150 mg / mL\\) of TEV-48125, and placebo syringes will contain the same vehicle and excipients as those for active","confidence":1,"confidence_rate":1},{"cnt":[[245,1051],[965,1051],[965,1094],[245,1094]],"region":{"top_left_x":244,"top_left_y":1050,"width":721,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b801a9ade114c6aacd09308f2fa4a64","type":"text","conversion_output":true,"text":"injections. Each kit will contain 1 prefilled syringe.","text_display":" injections. Each kit will contain 1 prefilled syringe.","confidence":1,"confidence_rate":1},{"cnt":[[245,1121],[1876,1121],[1876,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1121,"width":1632,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"52ba09707ec14ecfb4c83d33b3a7a0a4","type":"text","conversion_output":true,"text":"Study drug will be administered by qualified study personnel as sc injections approximately every 4 weeks ( 28 days)","text_display":"\n\nStudy drug will be administered by qualified study personnel as sc injections approximately every 4 weeks ( 28 days)","confidence":0.9980475902557373,"confidence_rate":0.999984611786269},{"cnt":[[245,1169],[707,1169],[707,1210],[245,1210]],"region":{"top_left_x":244,"top_left_y":1168,"width":463,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"667ffbcadbb64b19b8963e62d3953f02","type":"text","conversion_output":true,"text":"for a total of 3 doses, as follows:","text_display":" for a total of 3 doses, as follows:","confidence":1,"confidence_rate":1},{"cnt":[[370,1237],[1846,1237],[1846,1283],[370,1283]],"region":{"top_left_x":369,"top_left_y":1237,"width":1477,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a2e4dd9567149ff9611de35611a42e6","type":"text","conversion_output":true,"text":"- Patients randomized to receive TEV-48125 at 225 mg will receive 225 mg of TEV-48125 as 1 active","text_display":"\n- Patients randomized to receive TEV-48125 at 225 mg will receive 225 mg of TEV-48125 as 1 active","confidence":1,"confidence_rate":1},{"cnt":[[432,1285],[1852,1285],[1852,1332],[432,1332]],"region":{"top_left_x":431,"top_left_y":1284,"width":1421,"height":49},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05be8c638abb4670a3598dbfd01b1e07","type":"text","conversion_output":true,"text":"injection ( \\(225 mg / 1.5 mL\\) ) and two \\(1.5- mL\\) placebo injections at visit 2 and 225 mg of TEV- 48125 as","text_display":" injection ( \\(225 mg / 1.5 mL\\) ) and two \\(1.5- mL\\) placebo injections at visit 2 and 225 mg of TEV- 48125 as","confidence":0.5466534094147587,"confidence_rate":0.9953292343731315},{"cnt":[[434,1336],[1162,1336],[1162,1381],[434,1381]],"region":{"top_left_x":433,"top_left_y":1336,"width":730,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"adf4d06df7f74f91b704c666e6f1ee3a","type":"text","conversion_output":true,"text":"1 active injection ( \\(225 mg / 1.5 mL\\) ) at visits 3 and 4 .","text_display":" 1 active injection ( \\(225 mg / 1.5 mL\\) ) at visits 3 and 4 .","confidence":0.930325296940282,"confidence_rate":0.9990111608357909},{"cnt":[[370,1405],[1811,1405],[1811,1450],[370,1450]],"region":{"top_left_x":369,"top_left_y":1405,"width":1443,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1fed6d2b0f14fa99a84d14ee38e64ef","type":"text","conversion_output":true,"text":"- Patients randomized to receive TEV-48125 \\(675 mg /\\) placebo will receive 675 mg of TEV-48125 as","text_display":"\n- Patients randomized to receive TEV-48125 \\(675 mg /\\) placebo will receive 675 mg of TEV-48125 as","confidence":0.9741894925246015,"confidence_rate":0.9997601256238584},{"cnt":[[432,1452],[1850,1452],[1850,1497],[432,1497]],"region":{"top_left_x":431,"top_left_y":1452,"width":1419,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"211bf44cf0734220a309321c767a87fb","type":"text","conversion_output":true,"text":"3 active injections ( \\(225 mg / 1.5 mL\\) ) at visit 2 and placebo as single \\(1.5- mL\\) injection at visits 3 and 4 .","text_display":" 3 active injections ( \\(225 mg / 1.5 mL\\) ) at visit 2 and placebo as single \\(1.5- mL\\) injection at visits 3 and 4 .","confidence":0.9661734955154595,"confidence_rate":0.999741297687913},{"cnt":[[370,1525],[1796,1525],[1796,1571],[370,1571]],"region":{"top_left_x":369,"top_left_y":1525,"width":1428,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa28ad135c164cee8360706e03942e1f","type":"text","conversion_output":true,"text":"- Patients randomized to receive placebo will receive three \\(1.5- mL\\) placebo injections at visit 2 and","text_display":"\n- Patients randomized to receive placebo will receive three \\(1.5- mL\\) placebo injections at visit 2 and","confidence":1,"confidence_rate":1},{"cnt":[[434,1573],[1119,1573],[1119,1618],[434,1618]],"region":{"top_left_x":433,"top_left_y":1572,"width":687,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31911a302e1a461bb2b2d4ff13ed64fa","type":"text","conversion_output":true,"text":"single \\(1.5- mL\\) placebo injection at visits 3 and 4 .","text_display":" single \\(1.5- mL\\) placebo injection at visits 3 and 4 .","confidence":0.7744140625,"confidence_rate":0.9962475202155257},{"cnt":[[245,1644],[1760,1644],[1760,1687],[245,1687]],"region":{"top_left_x":244,"top_left_y":1643,"width":1516,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c40b8b6d4794b8fbf0a490fd549420d","type":"text","conversion_output":true,"text":"The recommended sc injection sites follow the National Institutes of Health Patient Education Guidelines of","text_display":"\n\nThe recommended sc injection sites follow the National Institutes of Health Patient Education Guidelines of","confidence":0.99951171875,"confidence_rate":0.9999956392907748},{"cnt":[[245,1691],[1867,1691],[1867,1738],[245,1738]],"region":{"top_left_x":244,"top_left_y":1690,"width":1623,"height":49},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"848dd208d0c24a88b62106b6245f7991","type":"text","conversion_output":true,"text":"June 2012, which are available in Appendix C and at http://www.cc.nih.gov/ccc/patient_education/pepubs/subq.pdf.","text_display":" June 2012, which are available in Appendix C and at http://www.cc.nih.gov/ccc/patient_education/pepubs/subq.pdf.","confidence":1,"confidence_rate":1},{"cnt":[[245,1740],[1867,1740],[1867,1785],[245,1785]],"region":{"top_left_x":244,"top_left_y":1740,"width":1623,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa00bf2c9a4c476a962fc7ee8e03a057","type":"text","conversion_output":true,"text":"The suggested sites of injection are back of upper arms, lower abdomen/belly/waistline, and front of thighs. Each of","text_display":" The suggested sites of injection are back of upper arms, lower abdomen/belly/waistline, and front of thighs. Each of","confidence":1,"confidence_rate":1},{"cnt":[[245,1788],[1841,1788],[1841,1833],[245,1833]],"region":{"top_left_x":244,"top_left_y":1787,"width":1598,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83d1c535344c4154b25cb69144e76e47","type":"text","conversion_output":true,"text":"the injections at visit 2 should be given in a different location (eg, not in precisely the same place), and study staff","text_display":" the injections at visit 2 should be given in a different location (eg, not in precisely the same place), and study staff","confidence":1,"confidence_rate":1},{"cnt":[[245,1839],[1863,1839],[1863,1882],[245,1882]],"region":{"top_left_x":244,"top_left_y":1839,"width":1619,"height":44},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"baa3dfeb958747e487ea9eb7ad1192d7","type":"text","conversion_output":true,"text":"member(s) responsible for administration of injections should inspect previous injection sites to ensure that they are","text_display":" member(s) responsible for administration of injections should inspect previous injection sites to ensure that they are","confidence":1,"confidence_rate":1},{"cnt":[[245,1886],[1317,1886],[1317,1931],[245,1931]],"region":{"top_left_x":244,"top_left_y":1886,"width":1073,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a20442ca8da47c88a2bd841fc35655b","type":"text","conversion_output":true,"text":"free of bruising and tenderness and that proper rotation of sites is performed.","text_display":" free of bruising and tenderness and that proper rotation of sites is performed.","confidence":0.9990234375,"confidence_rate":0.9999883686432659},{"cnt":[[245,1955],[1807,1955],[1807,2000],[245,2000]],"region":{"top_left_x":244,"top_left_y":1955,"width":1563,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37b4bb82a88a46f9a5271f9bb94a0947","type":"text","conversion_output":true,"text":"The total number of sc injections and their locations will be recorded for each dosing visit (visits 2, 3, and 4). A","text_display":"\n\nThe total number of sc injections and their locations will be recorded for each dosing visit (visits 2, 3, and 4). A","confidence":0.9483852386474609,"confidence_rate":0.999562124908584},{"cnt":[[247,2002],[1815,2002],[1815,2047],[247,2047]],"region":{"top_left_x":247,"top_left_y":2002,"width":1569,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b9d2cd46c574ace985d39db0dc07bae","type":"text","conversion_output":true,"text":"\\(1.5- mL\\) volume from each syringe in each visit's kit(s) must be injected sc for dosing to be considered complete.","text_display":" \\(1.5- mL\\) volume from each syringe in each visit's kit(s) must be injected sc for dosing to be considered complete.","confidence":1,"confidence_rate":1},{"cnt":[[245,2075],[788,2075],[788,2116],[245,2116]],"region":{"top_left_x":244,"top_left_y":2075,"width":545,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"feafc7afaf8a49e19adddb259149915b","type":"text","conversion_output":true,"text":"Investigational Product: TEV-48125","text_display":"\n\nInvestigational Product: TEV-48125","confidence":0.99951171875,"confidence_rate":0.9999874769887185},{"cnt":[[245,2133],[552,2133],[552,2181],[245,2181]],"region":{"top_left_x":244,"top_left_y":2133,"width":309,"height":48},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4fbf6ee7501e4509b1f2622a4f962095","type":"text","conversion_output":true,"text":"Reference Therapy:","text_display":"\nReference Therapy:","confidence":1,"confidence_rate":1},{"cnt":[[309,2191],[1240,2191],[1240,2237],[309,2237]],"region":{"top_left_x":309,"top_left_y":2191,"width":931,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f332f6358cf451190536211175b90ec","type":"text","conversion_output":true,"text":"Placebo: Same vehicle and excipients as those for active injection","text_display":"\nPlacebo: Same vehicle and excipients as those for active injection","confidence":1,"confidence_rate":1},{"cnt":[[309,2252],[810,2252],[810,2297],[309,2297]],"region":{"top_left_x":309,"top_left_y":2251,"width":501,"height":46},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30a524c5f75044a5862fd697b3aa7a03","type":"text","conversion_output":true,"text":"Comparison Drug: Not applicable","text_display":"\nComparison Drug: Not applicable","confidence":1,"confidence_rate":1},{"cnt":[[245,2310],[1841,2307],[1841,2355],[245,2357]],"region":{"top_left_x":244,"top_left_y":2307,"width":1598,"height":50},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e1adb43a1724872aab988aaf63a3c58","type":"text","conversion_output":true,"text":"Duration of Patient Participation: Patient participation will last for approximately 4 months (including a 28 -day","text_display":"\nDuration of Patient Participation: Patient participation will last for approximately 4 months (including a 28 -day","confidence":0.73095703125,"confidence_rate":0.9974959355989703},{"cnt":[[245,2359],[1820,2359],[1820,2404],[245,2404]],"region":{"top_left_x":244,"top_left_y":2358,"width":1576,"height":47},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41106cbc6bed4884898d38017f894e95","type":"text","conversion_output":true,"text":"run-in period and a 12-week, double-blind treatment period); after which, patients may enter into a double-blind,","text_display":" run-in period and a 12-week, double-blind treatment period); after which, patients may enter into a double-blind,","confidence":0.99853515625,"confidence_rate":0.999987577045958},{"cnt":[[245,2406],[1824,2406],[1824,2451],[245,2451]],"region":{"top_left_x":244,"top_left_y":2406,"width":1581,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6dadf932d76d45aabb3ea0cec174af8d","type":"text","conversion_output":true,"text":"long-term safety and efficacy study. Patients who do not enroll in the double-blind, long-term safety and efficacy","text_display":" long-term safety and efficacy study. Patients who do not enroll in the double-blind, long-term safety and efficacy","confidence":1,"confidence_rate":1},{"cnt":[[245,2454],[1790,2454],[1790,2499],[245,2499]],"region":{"top_left_x":244,"top_left_y":2453,"width":1546,"height":46},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fbacb60bebd54bdab60713caab752801","type":"text","conversion_output":true,"text":"study for any reason will be offered to enter the long-term safety extension for the purpose of evaluating ADA","text_display":" study for any reason will be offered to enter the long-term safety extension for the purpose of evaluating ADA","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9dbc4a665565441585454c752f47118a","type":"page_info","conversion_output":false,"text":"14","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-016","page":16,"lines":[{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"894f34e93dd24193b237e2c3a95b975b","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1109,127],[1880,127],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":126,"width":772,"height":49},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dd25082935848239f19b29f86b92791","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,168],[1880,168],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":167,"width":493,"height":59},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"256073ca90a04333a0d98a85e8c493c3","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1824,254],[1824,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1581,"height":50},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3bf80e79718e40bd8bb3e83ae0c742c8","type":"text","conversion_output":true,"text":"approximately 7.5 months ( 225 days [the approximate equivalent of 5 half-lives]) after receiving the last dose of","text_display":"\napproximately 7.5 months ( 225 days [the approximate equivalent of 5 half-lives]) after receiving the last dose of","confidence":0.9951171875,"confidence_rate":0.9999617603219619},{"cnt":[[245,305],[1725,305],[1725,352],[245,352]],"region":{"top_left_x":244,"top_left_y":305,"width":1482,"height":48},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6df9cf6e514b40a39fe04e0d6b38726c","type":"text","conversion_output":true,"text":"study drug in this study. Thus, patient participation for these patients will last approximately 10.5 months.","text_display":" study drug in this study. Thus, patient participation for these patients will last approximately 10.5 months.","confidence":1,"confidence_rate":1},{"cnt":[[245,374],[1723,374],[1723,419],[245,419]],"region":{"top_left_x":244,"top_left_y":373,"width":1480,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8deded2ce66f4a3b9eb8fbb025f33f14","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 (visit 5).","text_display":"\n\nThe end of the study is defined as the date the last patient attends the EOT/early withdrawal visit (visit 5).","confidence":0.99609375,"confidence_rate":0.9999659666720065},{"cnt":[[245,443],[1747,443],[1747,492],[245,492]],"region":{"top_left_x":244,"top_left_y":442,"width":1503,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db183ddd0dba40ac9c7f5625f4eec95d","type":"text","conversion_output":true,"text":"Criteria for Inclusion: Patients may be included in the study only if they meet all of the following criteria:","text_display":"\nCriteria for Inclusion: Patients may be included in the study only if they meet all of the following criteria:","confidence":1,"confidence_rate":1},{"cnt":[[370,516],[1669,516],[1669,561],[370,561]],"region":{"top_left_x":369,"top_left_y":515,"width":1301,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39f2aca7f9fd43cdaaea7ac42444deb0","type":"text","conversion_output":true,"text":"a. Males or females aged 18 to 70 years, inclusive, with migraine onset at \\(\\leq 50\\) years of age","text_display":"\na. Males or females aged 18 to 70 years, inclusive, with migraine onset at \\(\\leq 50\\) years of age","confidence":1,"confidence_rate":1},{"cnt":[[370,584],[1205,584],[1205,629],[370,629]],"region":{"top_left_x":369,"top_left_y":584,"width":837,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c388d7ea0db94c22a4b9f2b6ada5aa2d","type":"text","conversion_output":true,"text":"b. Patient signs and dates the informed consent document","text_display":"\nb. Patient signs and dates the informed consent document","confidence":1,"confidence_rate":1},{"cnt":[[370,653],[1755,653],[1755,698],[370,698]],"region":{"top_left_x":369,"top_left_y":653,"width":1387,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05716d9364a644bb854e2f7c981030a0","type":"text","conversion_output":true,"text":"c. Patient has history of migraine (according to ICHD-3 criteria [Classification Committee of the","text_display":"\nc. Patient has history of migraine (according to ICHD-3 criteria [Classification Committee of the","confidence":1,"confidence_rate":1},{"cnt":[[432,700],[1841,700],[1841,748],[432,748]],"region":{"top_left_x":431,"top_left_y":700,"width":1411,"height":48},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"729b0836c2fb45e084ddd9cfc2e64673","type":"text","conversion_output":true,"text":"IHS, 2013]) or clinical judgement suggests a migraine diagnosis (not better accounted for by another","text_display":" IHS, 2013]) or clinical judgement suggests a migraine diagnosis (not better accounted for by another","confidence":1,"confidence_rate":1},{"cnt":[[434,752],[1190,752],[1190,797],[434,797]],"region":{"top_left_x":433,"top_left_y":751,"width":758,"height":47},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca44dffc50714eb0aff2276394e28c0b","type":"text","conversion_output":true,"text":"ICHD-3 diagnosis) for \\(\\geq 12\\) months prior to screening.","text_display":" ICHD-3 diagnosis) for \\(\\geq 12\\) months prior to screening.","confidence":1,"confidence_rate":1},{"cnt":[[370,821],[1863,821],[1863,866],[370,866]],"region":{"top_left_x":369,"top_left_y":820,"width":1494,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a96b98d74f04357aa6e26cea64a6e79","type":"text","conversion_output":true,"text":"d. Patient fulfills the following criteria for EM in prospectively collected baseline information during the","text_display":"\nd. Patient fulfills the following criteria for EM in prospectively collected baseline information during the","confidence":1,"confidence_rate":1},{"cnt":[[434,868],[737,868],[737,913],[434,913]],"region":{"top_left_x":433,"top_left_y":867,"width":304,"height":47},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ec826d986434110a2efdba0493cc170","type":"text","conversion_output":true,"text":"28-day run-in period:","text_display":" 28-day run-in period:","confidence":1,"confidence_rate":1},{"cnt":[[434,932],[1057,932],[1057,978],[434,978]],"region":{"top_left_x":433,"top_left_y":932,"width":625,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d311020b6cce4d72b0bf28a191ede4f4","type":"text","conversion_output":true,"text":"- headache occurring on \\(\\geq 6\\) and \\(\\leq 14\\) days","text_display":"\n- headache occurring on \\(\\geq 6\\) and \\(\\leq 14\\) days","confidence":1,"confidence_rate":1},{"cnt":[[432,993],[1098,993],[1098,1042],[432,1042]],"region":{"top_left_x":431,"top_left_y":992,"width":667,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"700fb398def74e139ece16325e89a3ec","type":"text","conversion_output":true,"text":"- on \\(\\geq 4\\) days, fulfilling any of the following:","text_display":"\n- on \\(\\geq 4\\) days, fulfilling any of the following:","confidence":0.9834136962890625,"confidence_rate":0.9996903183942882},{"cnt":[[494,1057],[1687,1057],[1687,1104],[494,1104]],"region":{"top_left_x":494,"top_left_y":1057,"width":1193,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a08855adfcc64eabbadb7679d219a6ba","type":"text","conversion_output":true,"text":"- ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura (Appendix D)","text_display":"\n- ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura (Appendix D)","confidence":0.9582134605906845,"confidence_rate":0.9995094915243417},{"cnt":[[496,1121],[1489,1121],[1489,1167],[496,1167]],"region":{"top_left_x":496,"top_left_y":1121,"width":993,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e32d4d4f3bd4691a3d79b8f622b43c0","type":"text","conversion_output":true,"text":"- ICHD-3 criteria B and C for 1.2 Migraine with aura (Appendix D)","text_display":"\n- ICHD-3 criteria B and C for 1.2 Migraine with aura (Appendix D)","confidence":0.902504617581144,"confidence_rate":0.998535623641877},{"cnt":[[496,1186],[1714,1186],[1714,1231],[496,1231]],"region":{"top_left_x":496,"top_left_y":1185,"width":1219,"height":47},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b7972a3374845d8ae8acb1bdb36cd03","type":"text","conversion_output":true,"text":"- Probable migraine (a migraine subtype where only 1 migraine criterion is missing)","text_display":"\n- Probable migraine (a migraine subtype where only 1 migraine criterion is missing)","confidence":1,"confidence_rate":1},{"cnt":[[494,1250],[1635,1250],[1635,1291],[494,1291]],"region":{"top_left_x":494,"top_left_y":1250,"width":1141,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26ee7d01755c428e801a69ab6a35c38a","type":"text","conversion_output":true,"text":"- The patient used a triptan or ergot derivative to treat an established headache","text_display":"\n- The patient used a triptan or ergot derivative to treat an established headache","confidence":1,"confidence_rate":1},{"cnt":[[370,1319],[1869,1319],[1869,1364],[370,1364]],"region":{"top_left_x":369,"top_left_y":1319,"width":1501,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1cc181ea829948cf89d5287663627781","type":"text","conversion_output":true,"text":"e. Not using preventive medications (presented in Appendix B) (ie, at least 5 half-lives have passed since","text_display":"\ne. 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Body mass index of 17.5 to \\(37.5 kg / m ^{2}\\) and a total body weight between 45 and 120 kg , inclusive","text_display":"\nf. Body mass index of 17.5 to \\(37.5 kg / m ^{2}\\) and a total body weight between 45 and 120 kg , inclusive","confidence":1,"confidence_rate":1},{"cnt":[[370,1603],[1291,1603],[1291,1646],[370,1646]],"region":{"top_left_x":369,"top_left_y":1602,"width":923,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7515ae631f5c404badd4650d0a2ee823","type":"text","conversion_output":true,"text":"g. All patients must be of nonchildbearing potential, defined as:","text_display":"\ng. 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Section 5.2) with their partners during the entire study period and for 7.5 months after the last dose","confidence":1,"confidence_rate":1},{"cnt":[[494,2144],[698,2144],[698,2189],[494,2189]],"region":{"top_left_x":494,"top_left_y":2144,"width":205,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29ba04e6cac8432297061aaf7a8ef076","type":"text","conversion_output":true,"text":"of study drug.","text_display":" of study drug.","confidence":1,"confidence_rate":1},{"cnt":[[432,2213],[1796,2213],[1796,2258],[432,2258]],"region":{"top_left_x":431,"top_left_y":2212,"width":1366,"height":47},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99c5e96237cb46d4971e17f8899623ff","type":"text","conversion_output":true,"text":"- Sexual abstinence is only considered a highly effective method if defined as refraining from","text_display":"\n- Sexual abstinence is only considered a highly effective method if defined as 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The reliability of sexual abstinence needs to be","text_display":" heterosexual intercourse in the defined period. 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Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods),","text_display":" subject. 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Female patients of childbearing potential must have negative a serum beta-human chorionic","text_display":"\nh. 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The patient demonstrated compliance with the electronic headache diary during the run-in period by","text_display":"\ni. 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The patient is in good health as determined by a medical and psychiatric history, medical examination,","text_display":"\nj. 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The patient must be willing and able to comply with study restrictions, to remain at the clinic for the","text_display":"\nk. 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Patient has received onabotulinumtoxinA (Botox \\({ }^{\\circledR}\\), Allergan, Inc.) for migraine or for any medical or","text_display":"\na. 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Patient is using medications containing opioids (including codeine) or barbiturates (including","text_display":"\nb. 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Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the following","text_display":"\nc. 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Patient has used an intervention/device (eg, scheduled nerve blocks and transcranial magnetic","text_display":"\nd. 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Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in","text_display":"\nf. 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criteria.","text_display":" preventive treatments and therapeutic failures of migraine preventives are described in the exclusion criteria.","confidence":1,"confidence_rate":1},{"cnt":[[245,722],[1828,722],[1828,763],[245,763]],"region":{"top_left_x":244,"top_left_y":721,"width":1585,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26b0fc85bbe9436fa2f22a0d11af3756","type":"text","conversion_output":true,"text":"Concomitant (Current) Therapy: Up to \\(30 \\%\\) of patients will be allowed to remain on stable doses of no more than","text_display":"\n\nConcomitant (Current) Therapy: Up to \\(30 \\%\\) of patients will be allowed to remain on stable doses of no more 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in Appendix A. Patients on","text_display":" evidence of efficacy as defined by guidelines (Silberstein et al 2012) and presented in Appendix A. Patients on","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[245,868],[1751,868],[1751,913],[245,913]],"region":{"top_left_x":244,"top_left_y":867,"width":1507,"height":47},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"895fd755673e4b538972d4286d7bcf45","type":"text","conversion_output":true,"text":"preventive medication must be on a stable dose for at least 2 months of consecutive use prior to study entry.","text_display":" preventive medication must be on a stable dose for at least 2 months of consecutive use prior to study entry.","confidence":0.99951171875,"confidence_rate":0.999995825645481},{"cnt":[[245,915],[1800,915],[1800,960],[245,960]],"region":{"top_left_x":244,"top_left_y":915,"width":1557,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e32ac7403f894bc7be31778049999416","type":"text","conversion_output":true,"text":"Alternatively, patients must have discontinued the preventive medication at least 5 half-lives prior to screening.","text_display":" Alternatively, patients must have discontinued the preventive medication at least 5 half-lives prior to screening.","confidence":0.99951171875,"confidence_rate":0.9999959967252418},{"cnt":[[245,984],[1515,984],[1515,1029],[245,1029]],"region":{"top_left_x":244,"top_left_y":983,"width":1271,"height":47},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"022089b872da47278352355a4e2e07c9","type":"text","conversion_output":true,"text":"Patients will be allowed to use acute medications to treat acute migraine attacks as needed.","text_display":"\n\nPatients will be allowed to use acute medications to treat acute migraine attacks as needed.","confidence":1,"confidence_rate":1},{"cnt":[[245,1053],[1858,1053],[1858,1098],[245,1098]],"region":{"top_left_x":244,"top_left_y":1052,"width":1615,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da827f274b1e4939a89c83e0f7a52771","type":"text","conversion_output":true,"text":"All concomitant medications taken during the study must be recorded with indication, daily dose, and start and stop","text_display":"\nAll concomitant medications taken during the study must be recorded with indication, daily dose, and start and stop","confidence":1,"confidence_rate":1},{"cnt":[[245,1102],[1710,1102],[1710,1145],[245,1145]],"region":{"top_left_x":244,"top_left_y":1102,"width":1467,"height":44},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f65d8c087619440a837c36c7eeb4ac2c","type":"text","conversion_output":true,"text":"dates of administration. All patients will be questioned about concomitant medication at each clinic visit.","text_display":" dates of administration. 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For the proportion of","text_display":" endpoint will be performed for the continuous secondary and exploratory efficacy endpoints. For the proportion of","confidence":1,"confidence_rate":1},{"cnt":[[245,670],[1783,670],[1783,711],[245,711]],"region":{"top_left_x":244,"top_left_y":670,"width":1540,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b438f6c3261d4da4a9228d3b017ff328","type":"text","conversion_output":true,"text":"responders, defined as \\(50 \\%\\) or more reduction from baseline in the monthly average number of migraine days,","text_display":" responders, defined as \\(50 \\%\\) or more reduction from baseline in the monthly average number of migraine days,","confidence":0.99609375,"confidence_rate":0.9999656681391664},{"cnt":[[245,718],[862,718],[862,754],[245,754]],"region":{"top_left_x":244,"top_left_y":717,"width":618,"height":38},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1ea5caed03f418295c4348c942c9ffd","type":"text","conversion_output":true,"text":"Cochran-Mantel-Haenszel test will be used.","text_display":" Cochran-Mantel-Haenszel test will be used.","confidence":1,"confidence_rate":1},{"cnt":[[245,786],[1833,786],[1833,829],[245,829]],"region":{"top_left_x":244,"top_left_y":786,"width":1589,"height":44},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14603967d4984dc6b79727aab3ad0b4f","type":"text","conversion_output":true,"text":"Multiple Comparisons and Multiplicity: A fixed-sequence (hierarchical) testing procedure will be implemented to","text_display":"\n\nMultiple Comparisons and Multiplicity: A fixed-sequence (hierarchical) testing procedure will be implemented to","confidence":1,"confidence_rate":1},{"cnt":[[247,838],[1760,838],[1760,879],[247,879]],"region":{"top_left_x":247,"top_left_y":837,"width":1513,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0fd633554cf47d6904a71b28238fd5a","type":"text","conversion_output":true,"text":"control the type 1 error rate at 0.05 . The sequence of comparisons will be described in detail in the statistical","text_display":" control the type 1 error rate at 0.05 . The sequence of comparisons will be described in detail in the statistical","confidence":0.99951171875,"confidence_rate":0.9999960928036482},{"cnt":[[245,885],[440,885],[440,926],[245,926]],"region":{"top_left_x":244,"top_left_y":885,"width":197,"height":41},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9faa3616ea141b6ba3bdde4bebde43a","type":"text","conversion_output":true,"text":"analysis plan.","text_display":" analysis plan.","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1833,954],[1833,995],[245,995]],"region":{"top_left_x":244,"top_left_y":953,"width":1589,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a069521bd3e245f8a3e82740c41c4e46","type":"text","conversion_output":true,"text":"Safety and Tolerability Analyses: All adverse events will be coded using the Medical Dictionary for Regulatory","text_display":"\n\nSafety and Tolerability Analyses: All adverse events will be coded using the Medical Dictionary for Regulatory","confidence":1,"confidence_rate":1},{"cnt":[[245,1001],[1796,1001],[1796,1044],[245,1044]],"region":{"top_left_x":244,"top_left_y":1001,"width":1553,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2884e840bb44cce935769d5c6610d05","type":"text","conversion_output":true,"text":"Activities. Each patient will be counted only once in each preferred term or system organ class category for the","text_display":" Activities. Each patient will be counted only once in each preferred term or system organ class category for the","confidence":1,"confidence_rate":1},{"cnt":[[245,1053],[1794,1053],[1794,1094],[245,1094]],"region":{"top_left_x":244,"top_left_y":1052,"width":1550,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20ce232136f9479eaf5dce6dcb09d5d8","type":"text","conversion_output":true,"text":"analyses of safety. Summaries will be presented for all adverse events (overall and by severity), adverse events","text_display":" analyses of safety. 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Patient listings of","text_display":" and by severity), serious adverse events, and adverse events causing withdrawal from the study. Patient listings of","confidence":1,"confidence_rate":1},{"cnt":[[245,1199],[1399,1199],[1399,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1198,"width":1155,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c418457c4e3944a5a7c48590865a9f21","type":"text","conversion_output":true,"text":"serious adverse events and adverse events leading to withdrawal will be presented.","text_display":" serious adverse events and adverse events leading to withdrawal will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[245,1268],[1235,1268],[1235,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1267,"width":992,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2796a56eb32d476ba09f949f99b71660","type":"text","conversion_output":true,"text":"Local tolerability findings will be listed and summarized descriptively.","text_display":"\n\nLocal tolerability findings will be listed and summarized descriptively.","confidence":1,"confidence_rate":1},{"cnt":[[247,1336],[1764,1336],[1764,1377],[247,1377]],"region":{"top_left_x":247,"top_left_y":1336,"width":1517,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92199bb2fdaa4309ba62aee159dcbb40","type":"text","conversion_output":true,"text":"Changes in laboratory and vital signs measurement data will be summarized descriptively. All values will be","text_display":"\nChanges in laboratory and vital signs measurement data will be summarized descriptively. All values will be","confidence":1,"confidence_rate":1},{"cnt":[[247,1386],[1798,1386],[1798,1429],[247,1429]],"region":{"top_left_x":247,"top_left_y":1385,"width":1552,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6aa1c70f6b7d4d09ba90c699ce1cb058","type":"text","conversion_output":true,"text":"compared with prespecified boundaries to identify potentially clinically significant changes or values, and such","text_display":" compared with prespecified boundaries to identify potentially clinically significant changes or values, and such","confidence":1,"confidence_rate":1},{"cnt":[[245,1435],[535,1435],[535,1467],[245,1467]],"region":{"top_left_x":244,"top_left_y":1435,"width":291,"height":33},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be619c212b9b46e29e7c3558c448d13c","type":"text","conversion_output":true,"text":"values will be listed.","text_display":" values will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[245,1504],[1704,1504],[1704,1545],[245,1545]],"region":{"top_left_x":244,"top_left_y":1503,"width":1460,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ddbc177a1f74b2089f36b9d388318b2","type":"text","conversion_output":true,"text":"The use of concomitant medications will be summarized by therapeutic class using descriptive statistics.","text_display":"\n\nThe use of concomitant medications will be summarized by therapeutic class using descriptive statistics.","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[245,1551],[1695,1551],[1695,1592],[245,1592]],"region":{"top_left_x":244,"top_left_y":1551,"width":1452,"height":41},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d97354c6dbb4ea280340f2a701b72b2","type":"text","conversion_output":true,"text":"Concomitant medications will include all medications taken while the patient is treated with study drug.","text_display":" Concomitant medications will include all medications taken while the patient is treated with study drug.","confidence":0.9990234375,"confidence_rate":0.9999910363736797},{"cnt":[[247,1622],[1846,1622],[1846,1663],[247,1663]],"region":{"top_left_x":247,"top_left_y":1622,"width":1599,"height":41},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56cf767684f94d9cad1faf2e14d3e096","type":"text","conversion_output":true,"text":"Safety data will be summarized descriptively overall and by treatment group. For continuous variables, descriptive","text_display":"\n\nSafety data will be summarized descriptively overall and by treatment group. For continuous variables, descriptive","confidence":1,"confidence_rate":1},{"cnt":[[247,1671],[1794,1671],[1794,1710],[247,1710]],"region":{"top_left_x":247,"top_left_y":1671,"width":1547,"height":40},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9322d15f1b734b7a9e7871842aa505d3","type":"text","conversion_output":true,"text":"statistics ( n , mean, SD, median, minimum, and maximum) will be provided for actual values and changes from","text_display":" statistics ( n , mean, SD, median, minimum, and maximum) will be provided for actual values and changes from","confidence":0.99267578125,"confidence_rate":0.9999382273489243},{"cnt":[[245,1719],[1841,1719],[1841,1760],[245,1760]],"region":{"top_left_x":244,"top_left_y":1718,"width":1598,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8373eafaedf4ed492a3561aa19c9135","type":"text","conversion_output":true,"text":"baseline to each time point. For categorical variables, patient counts and percentages will be provided. Descriptive","text_display":" baseline to each time point. For categorical variables, patient counts and percentages will be provided. Descriptive","confidence":1,"confidence_rate":1},{"cnt":[[247,1766],[1876,1766],[1876,1809],[247,1809]],"region":{"top_left_x":247,"top_left_y":1766,"width":1629,"height":43},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d849d0c552574de29a63f712d9fc48ad","type":"text","conversion_output":true,"text":"summaries of serious adverse events, patient withdrawals due to adverse events, and potentially clinically significant","text_display":" summaries of serious adverse events, patient withdrawals due to adverse events, and potentially clinically significant","confidence":1,"confidence_rate":1},{"cnt":[[245,1815],[1659,1815],[1659,1858],[245,1858]],"region":{"top_left_x":244,"top_left_y":1815,"width":1415,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce0d4762f1f841639e187503068ec9fc","type":"text","conversion_output":true,"text":"abnormal values (clinical laboratory or vital signs) based on predefined criteria will also be provided.","text_display":" abnormal values (clinical laboratory or vital signs) based on predefined criteria will also be provided.","confidence":1,"confidence_rate":1},{"cnt":[[245,1886],[1747,1886],[1747,1927],[245,1927]],"region":{"top_left_x":244,"top_left_y":1886,"width":1503,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"817b2539c59d455c8ad3d5d09e5dcba2","type":"text","conversion_output":true,"text":"If any patient dies during the study, a listing of deaths will be provided, and all relevant information will be","text_display":"\n\nIf any patient dies during the study, a listing of deaths will be provided, and all relevant information will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1934],[1218,1934],[1218,1974],[245,1974]],"region":{"top_left_x":244,"top_left_y":1933,"width":975,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77e4554d8fd64f58a0a8bcb0e1e8624d","type":"text","conversion_output":true,"text":"discussed in the patient narrative included in the clinical study report.","text_display":" discussed in the patient narrative included in the clinical study report.","confidence":1,"confidence_rate":1},{"cnt":[[245,2002],[1738,2002],[1738,2043],[245,2043]],"region":{"top_left_x":244,"top_left_y":2002,"width":1495,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37ceaed32b0f4e29b8053cbd1db0a880","type":"text","conversion_output":true,"text":"Pharmacokinetic Analysis: Pharmacokinetic plasma concentration results (TEV-48125) will be tabulated","text_display":"\n\nPharmacokinetic Analysis: Pharmacokinetic plasma concentration results (TEV-48125) will be tabulated","confidence":1,"confidence_rate":1},{"cnt":[[245,2052],[1222,2050],[1223,2093],[245,2095]],"region":{"top_left_x":244,"top_left_y":2049,"width":979,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35ca5ea0460e49a0856fc893b233273a","type":"text","conversion_output":true,"text":"descriptively at each planned sampling time point by treatment group.","text_display":" descriptively at each planned sampling time point by treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[245,2123],[1785,2123],[1785,2163],[245,2163]],"region":{"top_left_x":244,"top_left_y":2122,"width":1542,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ce1953566ca4b949da88bab52ae1cd0","type":"text","conversion_output":true,"text":"Pharmacokinetic/Pharmacodynamic Analysis: The pharmacokinetic/pharmacodynamic relationship will be","text_display":"\n\nPharmacokinetic/Pharmacodynamic Analysis: The pharmacokinetic/pharmacodynamic relationship will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2170],[1687,2170],[1687,2211],[245,2211]],"region":{"top_left_x":244,"top_left_y":2169,"width":1443,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6941deaf41c84771ae757d76d142d6ff","type":"text","conversion_output":true,"text":"estimated by compartmental techniques. The pharmacokinetic parameters will be based on TEV-48125","text_display":" estimated by compartmental techniques. The pharmacokinetic parameters will be based on TEV-48125","confidence":1,"confidence_rate":1},{"cnt":[[245,2217],[1214,2217],[1214,2260],[245,2260]],"region":{"top_left_x":244,"top_left_y":2217,"width":970,"height":44},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"266abba9275f47feab4472fda323f5d1","type":"text","conversion_output":true,"text":"measurements. The pharmacodynamic will be the efficacy responses.","text_display":" measurements. The pharmacodynamic will be the efficacy responses.","confidence":1,"confidence_rate":1},{"cnt":[[245,2288],[1777,2288],[1777,2329],[245,2329]],"region":{"top_left_x":244,"top_left_y":2288,"width":1533,"height":41},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ad7f94a09e144d78868a8fabb110be4","type":"text","conversion_output":true,"text":"The pharmacokinetic/pharmacodynamic relationship will be estimated using the most appropriate model after","text_display":"\n\nThe pharmacokinetic/pharmacodynamic relationship will be estimated using the most appropriate model after","confidence":1,"confidence_rate":1},{"cnt":[[247,2338],[1519,2338],[1519,2378],[247,2378]],"region":{"top_left_x":247,"top_left_y":2337,"width":1272,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e048b9de565f4f36b91a60832f86a02a","type":"text","conversion_output":true,"text":"comparing different candidate models for their quality of fit. Covariates that may affect the","text_display":" comparing different candidate models for their quality of fit. Covariates that may affect the","confidence":1,"confidence_rate":1},{"cnt":[[245,2385],[1790,2385],[1790,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2384,"width":1546,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db498e130df048a2990f0d23db9775db","type":"text","conversion_output":true,"text":"pharmacokinetic/pharmacodynamic relationship will be tested for inclusion in the model. This analysis will be","text_display":" pharmacokinetic/pharmacodynamic relationship will be tested for inclusion in the model. This analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2436],[526,2436],[526,2477],[245,2477]],"region":{"top_left_x":244,"top_left_y":2436,"width":283,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fa806d5034a841e18d400f470156009a","type":"text","conversion_output":true,"text":"reported separately.","text_display":" reported separately.","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df4ac15fd95c445ebda73183a8d6394c","type":"page_info","conversion_output":false,"text":"20","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-022","page":22,"lines":[{"cnt":[[1109,127],[1880,127],[1880,176],[1109,176]],"region":{"top_left_x":1108,"top_left_y":126,"width":772,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"def4c27e03c0484c8f3c66b098f91985","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a703bbe6114f4949823fe4c7000b4bcc","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"849785ec37e2461f8c1dd340a31c2168","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,260],[1699,260],[1699,303],[245,303]],"region":{"top_left_x":244,"top_left_y":259,"width":1456,"height":44},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83a741502b7f438ca27e194da0210669","type":"text","conversion_output":true,"text":"Immunogenicity Analysis: Summary of immunogenicity results will be provided, and the incidence of","text_display":"\n\nImmunogenicity Analysis: Summary of immunogenicity results will be provided, and the incidence of","confidence":1,"confidence_rate":1},{"cnt":[[245,305],[1828,305],[1828,354],[245,354]],"region":{"top_left_x":244,"top_left_y":305,"width":1585,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"587679350ec44f469fa04639db3ff8cf","type":"text","conversion_output":true,"text":"immunogenicity will be calculated. The impact of immunogenicity on the pharmacokinetic profile, drug efficacy,","text_display":" immunogenicity will be calculated. The impact of immunogenicity on the pharmacokinetic profile, drug efficacy,","confidence":1,"confidence_rate":1},{"cnt":[[245,357],[1442,357],[1442,402],[245,402]],"region":{"top_left_x":244,"top_left_y":356,"width":1198,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1914e53fe4745dab47d2d13290c65b7","type":"text","conversion_output":true,"text":"and clinical safety will be evaluated. This impact analysis will be reported separately.","text_display":" and clinical safety will be evaluated. This impact analysis will be reported separately.","confidence":1,"confidence_rate":1},{"cnt":[[245,425],[1846,425],[1846,471],[245,471]],"region":{"top_left_x":244,"top_left_y":425,"width":1602,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8484cc57e1c422db6d97ec3dc3d34ac","type":"text","conversion_output":true,"text":"Biomarker Analysis: Biomarker analysis will include logistic regression, receiver operating characteristic curves,","text_display":"\n\nBiomarker Analysis: Biomarker analysis will include logistic regression, receiver operating characteristic curves,","confidence":1,"confidence_rate":1},{"cnt":[[245,473],[1076,473],[1076,518],[245,518]],"region":{"top_left_x":244,"top_left_y":472,"width":833,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"86210088116a48968831d6a1bdd43b1c","type":"text","conversion_output":true,"text":"and summary statistics. Results will be reported separately.","text_display":" and summary statistics. 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Abbreviation & Term \\\\\n\\hline \\(\\beta\\)-HCG & beta-human chorionic gonadotropin \\\\\n\\hline ADA & antidrug antibody \\\\\n\\hline ALP & alkaline phosphatase \\\\\n\\hline ALT & alanine aminotransferase \\\\\n\\hline AST & aspartate aminotransferase \\\\\n\\hline BP & blood pressure \\\\\n\\hline CBC & complete blood count \\\\\n\\hline CDMS & clinical data management system \\\\\n\\hline CFR & Code of Federal Regulations (US) \\\\\n\\hline CGRP & calcitonin gene-related peptide \\\\\n\\hline CM & chronic migraine \\\\\n\\hline \\(C _{\\text {max }}\\) & maximum observed plasma drug concentration \\\\\n\\hline CRF & case report form (refers to any media used to collect study data [ie, paper or electronic]) \\\\\n\\hline CRO & contract research organization \\\\\n\\hline DNA & deoxyribonucleic acid \\\\\n\\hline ECG & electrocardiography/electrocardiogram \\\\\n\\hline EDTA & ethylenediaminetetraacetic acid \\\\\n\\hline EM & episodic migraine \\\\\n\\hline EOT & end of 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The 2 most common forms of migraine,","text_display":" (such as nausea, photophobia, or phonophobia). The 2 most common forms of migraine,","confidence":1,"confidence_rate":1},{"cnt":[[245,587],[1790,587],[1790,638],[245,638]],"region":{"top_left_x":244,"top_left_y":586,"width":1546,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6223db61f01848ae97bf4b14d7c4b67a","type":"text","conversion_output":true,"text":"migraine without aura and migraine with aura, occur on less than 15 days per month and are","text_display":" migraine without aura and migraine with aura, occur on less than 15 days per month and are","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,636],[1846,636],[1846,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1602,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bba65c2d93a940af8b5c872327de20e8","type":"text","conversion_output":true,"text":"referred to as episodic forms of migraine (ie, EM) (Lipton et al 2007). However, approximately","text_display":" referred to as episodic forms of migraine (ie, EM) (Lipton et al 2007). However, approximately","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1867,683],[1867,735],[245,735]],"region":{"top_left_x":244,"top_left_y":683,"width":1623,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"953e30a7cbe5443689f895687010ff43","type":"text","conversion_output":true,"text":"3\\% of individuals with EM evolve, in any given year, to a significantly more disabling condition","text_display":" 3\\% of individuals with EM evolve, in any given year, to a significantly more disabling condition","confidence":0.99072265625,"confidence_rate":0.9999077206309377},{"cnt":[[245,730],[1820,730],[1820,784],[245,784]],"region":{"top_left_x":244,"top_left_y":730,"width":1576,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcf6f99b90fa4caca394a02151c4582c","type":"text","conversion_output":true,"text":"called CM (Bigal et al 2008, Lipton et al 2007,Scher et al 2003). Individuals with CM present","text_display":" called CM (Bigal et al 2008, Lipton et al 2007,Scher et al 2003). Individuals with CM present","confidence":0.932161808013916,"confidence_rate":0.9992834316984214},{"cnt":[[245,780],[1880,780],[1880,831],[245,831]],"region":{"top_left_x":244,"top_left_y":779,"width":1636,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20317e28e2d9419ab24539fba0aafcc1","type":"text","conversion_output":true,"text":"with headaches of any severity on 15 or more days per month and have full-blown migraine on at","text_display":" with headaches of any severity on 15 or more days per month and have full-blown migraine on at","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[1833,829],[1833,881],[245,881]],"region":{"top_left_x":244,"top_left_y":829,"width":1589,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e409dfddf5bf45ec8f32510490d6b5bc","type":"text","conversion_output":true,"text":"least 8 days per month (Classification Committee of the International Headache Society [IHS],","text_display":" least 8 days per month (Classification Committee of the International Headache Society [IHS],","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1848,877],[1848,930],[245,930]],"region":{"top_left_x":244,"top_left_y":876,"width":1604,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2255588f2408477eaabcd09bdcd873f3","type":"text","conversion_output":true,"text":"2013). A sizable proportion of individuals with CM experiences daily headaches and, therefore,","text_display":" 2013). A sizable proportion of individuals with CM experiences daily headaches and, therefore,","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1149,924],[1149,978],[245,978]],"region":{"top_left_x":244,"top_left_y":923,"width":906,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1046b84f2cc645fdb8d3fe88a319ac30","type":"text","conversion_output":true,"text":"faces considerable disability (Bigal and Lipton 2008).","text_display":" faces considerable disability (Bigal and Lipton 2008).","confidence":1,"confidence_rate":1},{"cnt":[[245,997],[1867,997],[1867,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":996,"width":1623,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc0dfa92c83542a0a9f2de64ed210abf","type":"text","conversion_output":true,"text":"The pathophysiology of migraine involves central and peripheral events. Activation of structures","text_display":"\n\nThe pathophysiology of migraine involves central and peripheral events. 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Chronic dysfunction in these structures predisposes migraineurs not only to","text_display":" migraine attacks. Chronic dysfunction in these structures predisposes migraineurs not only to","confidence":1,"confidence_rate":1},{"cnt":[[245,1143],[1714,1143],[1714,1192],[245,1192]],"region":{"top_left_x":244,"top_left_y":1142,"width":1471,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99a9858188264f77855e493080242be9","type":"text","conversion_output":true,"text":"migraine attacks, but to increased headache frequency (Goadsby and Hargreaves 2008).","text_display":" migraine attacks, but to increased headache frequency (Goadsby and Hargreaves 2008).","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":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d74e0897a2141bf9069627739d86c12","type":"text","conversion_output":true,"text":"Furthermore, the activation of these structures is also associated with inflammation and protein","text_display":" Furthermore, the activation of these structures is also associated with inflammation and protein","confidence":1,"confidence_rate":1},{"cnt":[[245,1240],[1876,1240],[1876,1291],[245,1291]],"region":{"top_left_x":244,"top_left_y":1239,"width":1632,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c6124055f8045cb9180007a5bf5713c","type":"text","conversion_output":true,"text":"extravasation at the level of the meningeal blood vessels, muscles and other structures innervated","text_display":" extravasation at the level of the meningeal blood vessels, muscles and other structures innervated","confidence":1,"confidence_rate":1},{"cnt":[[245,1285],[1876,1285],[1876,1338],[245,1338]],"region":{"top_left_x":244,"top_left_y":1284,"width":1632,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36bafc7e22f14ca0be1ad08b24d2c0d6","type":"text","conversion_output":true,"text":"by the trigeminal nerve. This combination of peripheral insults (inflammation and plasma protein","text_display":" by the trigeminal nerve. This combination of peripheral insults (inflammation and plasma protein","confidence":1,"confidence_rate":1},{"cnt":[[245,1336],[1809,1336],[1809,1386],[245,1386]],"region":{"top_left_x":244,"top_left_y":1336,"width":1565,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"426efc4f5f1b4271a1b8306afa0ee3b4","type":"text","conversion_output":true,"text":"extravasation) with impairment of the inhibitory pain mechanisms at the level of brainstem is","text_display":" extravasation) with impairment of the inhibitory pain mechanisms at the level of brainstem is","confidence":1,"confidence_rate":1},{"cnt":[[245,1384],[1171,1384],[1171,1437],[245,1437]],"region":{"top_left_x":244,"top_left_y":1383,"width":927,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"385bfd58522c4d949d87d29dc47b148b","type":"text","conversion_output":true,"text":"paramount to frequent migraines (Goadsby et al 2002).","text_display":" paramount to frequent migraines (Goadsby et al 2002).","confidence":1,"confidence_rate":1},{"cnt":[[245,1452],[1824,1452],[1824,1506],[245,1506]],"region":{"top_left_x":244,"top_left_y":1452,"width":1581,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0acc2dfac9d04332b6db4027e22a1da8","type":"text","conversion_output":true,"text":"Calcitonin gene-related peptide (CGRP) is a well-studied neuropeptide found at the centers of","text_display":"\nCalcitonin gene-related peptide (CGRP) is a well-studied neuropeptide found at the centers of","confidence":0.7548828125,"confidence_rate":0.9971347986995789},{"cnt":[[245,1504],[1848,1504],[1848,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1503,"width":1604,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f6a3d22dfb54f2985d41c7edce833aa","type":"text","conversion_output":true,"text":"the migraine processes, both centrally and peripherally (Eftekhari and Edvinsson 2010). Its role","text_display":" the migraine processes, both centrally and peripherally (Eftekhari and Edvinsson 2010). Its role","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,1551],[1811,1551],[1811,1603],[245,1603]],"region":{"top_left_x":244,"top_left_y":1551,"width":1568,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78bdf6f106234a5f994c205d4238dddb","type":"text","conversion_output":true,"text":"in migraine pathophysiology was suggested more than 20 years ago (Edvinsson and Goadsby","text_display":" in migraine pathophysiology was suggested more than 20 years ago (Edvinsson and Goadsby","confidence":0.98876953125,"confidence_rate":0.9998811227862585},{"cnt":[[247,1598],[1826,1598],[1826,1652],[247,1652]],"region":{"top_left_x":247,"top_left_y":1598,"width":1580,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1388759089834f719ebce0ca935ada45","type":"text","conversion_output":true,"text":"1990, Goadsby et al 1990). Jugular levels of CGRP are increased during migraine attacks, and","text_display":" 1990, Goadsby et al 1990). Jugular levels of CGRP are increased during migraine attacks, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1650],[1846,1650],[1846,1699],[245,1699]],"region":{"top_left_x":244,"top_left_y":1650,"width":1602,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b231996192994041ad265ffc93f76ada","type":"text","conversion_output":true,"text":"intravenous (iv) CGRP administration induces migraine-like headache in most individuals with","text_display":" intravenous (iv) CGRP administration induces migraine-like headache in most individuals with","confidence":1,"confidence_rate":1},{"cnt":[[245,1697],[1798,1697],[1798,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1697,"width":1555,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c69a7d73c04a442ca24dd0913b84d8b1","type":"text","conversion_output":true,"text":"migraine (Ashina et al 2000, Hansen et al 2010). Calcitonin gene-related peptide is therefore","text_display":" migraine (Ashina et al 2000, Hansen et al 2010). Calcitonin gene-related peptide is therefore","confidence":0.982452392578125,"confidence_rate":0.9998193694605184},{"cnt":[[245,1745],[1659,1745],[1659,1798],[245,1798]],"region":{"top_left_x":244,"top_left_y":1744,"width":1415,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08071f7de02f47e98131db9f45d13e0d","type":"text","conversion_output":true,"text":"involved in the pathophysiology of migraine at all levels, peripherally (vasodilation,","text_display":" involved in the pathophysiology of migraine at all levels, peripherally (vasodilation,","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[245,1794],[1880,1794],[1880,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1793,"width":1636,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a80c1636797041d58dd40036828a0473","type":"text","conversion_output":true,"text":"inflammation and protein extravasation), at the trigeminal ganglion, and inside the brain (Ho et al","text_display":" inflammation and protein extravasation), at the trigeminal ganglion, and inside the brain (Ho et al","confidence":1,"confidence_rate":1},{"cnt":[[245,1841],[1858,1841],[1858,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1841,"width":1615,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47f11d6fa47f474e84d3b3a7808d024c","type":"text","conversion_output":true,"text":"2010). Inhibition of CGRP has demonstrated efficacy in the treatment of EM (Hewitt et al 2011,","text_display":" 2010). Inhibition of CGRP has demonstrated efficacy in the treatment of EM (Hewitt et al 2011,","confidence":1,"confidence_rate":1},{"cnt":[[245,1891],[814,1891],[814,1940],[245,1940]],"region":{"top_left_x":244,"top_left_y":1890,"width":571,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7071c80aacb4c1085a463322337006e","type":"text","conversion_output":true,"text":"Ho et al 2008, Olesen et al 2004).","text_display":" Ho et al 2008, Olesen et al 2004).","confidence":0.9931671619415283,"confidence_rate":0.9998242131758835},{"cnt":[[245,1962],[1867,1962],[1867,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1961,"width":1623,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2820d3963a504069b989dcfda6dde042","type":"text","conversion_output":true,"text":"The goals of migraine treatment are to relieve pain, restore function, reduce headache frequency,","text_display":"\n\nThe goals of migraine treatment are to relieve pain, restore function, reduce headache frequency,","confidence":1,"confidence_rate":1},{"cnt":[[245,2011],[1803,2011],[1803,2060],[245,2060]],"region":{"top_left_x":244,"top_left_y":2010,"width":1559,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a667813397e14f2eb077d73550b5b828","type":"text","conversion_output":true,"text":"and to prevent progression of EM to CM. Pharmacological interventions for the treatment of","text_display":" and to prevent progression of EM to CM. Pharmacological interventions for the treatment of","confidence":1,"confidence_rate":1},{"cnt":[[245,2058],[1854,2058],[1854,2108],[245,2108]],"region":{"top_left_x":244,"top_left_y":2058,"width":1611,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e0f419b3d05460fa3dcd58fdc02ec7d","type":"text","conversion_output":true,"text":"migraine include acute (symptomatic) treatments and daily preventive medications. The latter is","text_display":" migraine include acute (symptomatic) treatments and daily preventive medications. The latter is","confidence":1,"confidence_rate":1},{"cnt":[[245,2105],[1826,2105],[1826,2159],[245,2159]],"region":{"top_left_x":244,"top_left_y":2105,"width":1583,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cce1eaa58764432eb5cc172a23896518","type":"text","conversion_output":true,"text":"indicated for patients with CM and may be appropriate patients with EM who have significant","text_display":" indicated for patients with CM and may be appropriate patients with EM who have significant","confidence":1,"confidence_rate":1},{"cnt":[[245,2157],[1682,2157],[1682,2206],[245,2206]],"region":{"top_left_x":244,"top_left_y":2157,"width":1439,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f49b4ee44bda419aaf22e03b8a5749a6","type":"text","conversion_output":true,"text":"disability with migraine attacks (>3 days per month with headache-related disability),","text_display":" disability with migraine attacks (>3 days per month with headache-related disability),","confidence":0.61865234375,"confidence_rate":0.9947368463721216},{"cnt":[[245,2204],[1807,2204],[1807,2254],[245,2254]],"region":{"top_left_x":244,"top_left_y":2204,"width":1563,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6d26f94af5844558c3239c31e11bb88","type":"text","conversion_output":true,"text":"contraindications to triptans or other vasoactive medications, significant adverse effects from","text_display":" contraindications to triptans or other vasoactive medications, significant adverse effects from","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,2252],[1837,2252],[1837,2305],[245,2305]],"region":{"top_left_x":244,"top_left_y":2251,"width":1593,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"184259d3c47c42baac179b2099bdc22f","type":"text","conversion_output":true,"text":"triptans, and patients with severe or prolonged attacks (Lipton and Silberstein 2015). Currently","text_display":" triptans, and patients with severe or prolonged attacks (Lipton and Silberstein 2015). Currently","confidence":1,"confidence_rate":1},{"cnt":[[245,2303],[1732,2303],[1732,2353],[245,2353]],"region":{"top_left_x":244,"top_left_y":2303,"width":1488,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9815b7bebe014582bc88330dc8be2fa2","type":"text","conversion_output":true,"text":"available drug therapies for preventive treatment of migraine include antiepileptic drugs,","text_display":" available drug therapies for preventive treatment of migraine include antiepileptic drugs,","confidence":1,"confidence_rate":1},{"cnt":[[245,2350],[1818,2350],[1818,2402],[245,2402]],"region":{"top_left_x":244,"top_left_y":2350,"width":1574,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37e3498061874299ae46f1734e73202a","type":"text","conversion_output":true,"text":"beta-blockers, triptans, antidepressants, angiotensin receptor blockers, angiotensin-converting","text_display":" beta-blockers, triptans, antidepressants, angiotensin receptor blockers, angiotensin-converting","confidence":1,"confidence_rate":1},{"cnt":[[245,2398],[1571,2398],[1571,2449],[245,2449]],"region":{"top_left_x":244,"top_left_y":2397,"width":1327,"height":53},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aef93fb4cab7457bb546df403a9e157a","type":"text","conversion_output":true,"text":"enzyme inhibitors, serotonergic agents, calcium channel blockers, nonsteroidal","text_display":" enzyme inhibitors, serotonergic agents, calcium channel blockers, nonsteroidal","confidence":1,"confidence_rate":1},{"cnt":[[245,2447],[1833,2447],[1833,2499],[245,2499]],"region":{"top_left_x":244,"top_left_y":2447,"width":1589,"height":52},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0d833364bc74ccb8942af5fd4ded9fb","type":"text","conversion_output":true,"text":"anti-inflammatory drugs, opioids, and direct vascular smooth muscle relaxants. Although there","text_display":" anti-inflammatory drugs, opioids, and direct vascular smooth muscle relaxants. Although there","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"017ce123e66b4072a09def703294e6a0","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":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-035","page":35,"lines":[{"cnt":[[1109,127],[1880,127],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":126,"width":772,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c85903cc7e304db3baf70cac527e03a1","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44bbb36b15b44727ad93999384aaf376","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4be06872929a45f0865bedc06135bfcd","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1833,254],[1833,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1589,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2db5a164e07a40c1b60418466c3ff8a0","type":"text","conversion_output":true,"text":"are more than 40 medications within these classes of drugs that are used with varying response","text_display":"\nare more than 40 medications within these classes of drugs that are used with varying response","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[245,303],[1669,303],[1669,350],[245,350]],"region":{"top_left_x":244,"top_left_y":302,"width":1426,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44e915a5bf214c59881721319d1b35f1","type":"text","conversion_output":true,"text":"rates to prevent migraine, only 5 marketed drugs are approved by the Food and Drug","text_display":" rates to prevent migraine, only 5 marketed drugs are approved by the Food and Drug","confidence":1,"confidence_rate":1},{"cnt":[[245,350],[1828,350],[1828,400],[245,400]],"region":{"top_left_x":244,"top_left_y":350,"width":1585,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29a310019bd74ccdabe4ccbe9819bf96","type":"text","conversion_output":true,"text":"Administration (FDA) in the United States (US) for the preventive treatment of migraine; 4 of","text_display":" Administration (FDA) in the United States (US) for the preventive treatment of migraine; 4 of","confidence":1,"confidence_rate":1},{"cnt":[[245,400],[1794,400],[1794,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1550,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61e9424a6dee41368f6c76c7751ec188","type":"text","conversion_output":true,"text":"them are approved for the prophylaxis of migraine: propranolol, timolol maleate, divalproex","text_display":" them are approved for the prophylaxis of migraine: propranolol, timolol maleate, divalproex","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1781,447],[1781,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1538,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"391a64d7369d468c93dfb5b9222fdd62","type":"text","conversion_output":true,"text":"sodium, and topiramate. The clinical trials (Brandes et al 2004, Klapper 1997, Mathew et al","text_display":" sodium, and topiramate. The clinical trials (Brandes et al 2004, Klapper 1997, Mathew et al","confidence":1,"confidence_rate":1},{"cnt":[[247,494],[1865,494],[1865,546],[247,546]],"region":{"top_left_x":247,"top_left_y":494,"width":1618,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd3599c8528a4ae4811e8935cb877038","type":"text","conversion_output":true,"text":"1995, Nadelmann et al 1986, Silberstein et al 2004) that supported registration of these drugs for","text_display":" 1995, Nadelmann et al 1986, Silberstein et al 2004) that supported registration of these drugs for","confidence":1,"confidence_rate":1},{"cnt":[[245,546],[1828,546],[1828,595],[245,595]],"region":{"top_left_x":244,"top_left_y":545,"width":1585,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2791035b8a194403a75a3406b73b7e4c","type":"text","conversion_output":true,"text":"this indication were conducted before the establishment of CM as a single entity and generally","text_display":" this indication were conducted before the establishment of CM as a single entity and generally","confidence":1,"confidence_rate":1},{"cnt":[[245,593],[1671,593],[1671,642],[245,642]],"region":{"top_left_x":244,"top_left_y":592,"width":1428,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba334a2f521b4eb7bc38aec95d7f762e","type":"text","conversion_output":true,"text":"included patients with headaches on less than 15 days per month. Only 1 medication,","text_display":" included patients with headaches on less than 15 days per month. Only 1 medication,","confidence":1,"confidence_rate":1},{"cnt":[[245,642],[1712,639],[1712,690],[245,694]],"region":{"top_left_x":244,"top_left_y":638,"width":1469,"height":56},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e57c008a35144d7cb261868a95e57f5a","type":"text","conversion_output":true,"text":"onabotulinumtoxinA, is approved for prophylaxis of CM (Lipton and Silberstein 2015).","text_display":" onabotulinumtoxinA, is approved for prophylaxis of CM (Lipton and Silberstein 2015).","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[245,709],[1678,709],[1678,758],[245,758]],"region":{"top_left_x":244,"top_left_y":708,"width":1434,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c39141ca7b8a41489251f7f1cf1f96b5","type":"text","conversion_output":true,"text":"TEV-48125 (also known as PF-04427429, RN307, or LBR-101) is a fully humanized","text_display":"\nTEV-48125 (also known as PF-04427429, RN307, or LBR-101) is a fully humanized","confidence":1,"confidence_rate":1},{"cnt":[[245,761],[1760,761],[1760,810],[245,810]],"region":{"top_left_x":244,"top_left_y":760,"width":1516,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11216a450d3841a4b639d30e5d787b19","type":"text","conversion_output":true,"text":"immunoglobulin G (IgG) 2a/kappa monoclonal antibody derived from a murine precursor.","text_display":" immunoglobulin G (IgG) 2a/kappa monoclonal antibody derived from a murine precursor.","confidence":0.7341889911331236,"confidence_rate":0.9965342353780927},{"cnt":[[245,808],[1721,808],[1721,857],[245,857]],"region":{"top_left_x":244,"top_left_y":807,"width":1477,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57bcef3de2534e508d249dc3fb4bd1a3","type":"text","conversion_output":true,"text":"TEV-48125 is a potent, selective CGRP binder and blocks both CGRP isoforms ( \\(\\alpha\\) - and","text_display":" TEV-48125 is a potent, selective CGRP binder and blocks both CGRP isoforms ( \\(\\alpha\\) - and","confidence":0.9428987503051758,"confidence_rate":0.9993611131764041},{"cnt":[[245,855],[1811,855],[1811,907],[245,907]],"region":{"top_left_x":244,"top_left_y":855,"width":1568,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad331c9a8716457291dce04035310e7c","type":"text","conversion_output":true,"text":"\\(\\beta\\)-CGRP) from binding to the CGRP receptor. TEV-48125 is specific for CGRP and does not","text_display":" \\(\\beta\\)-CGRP) from binding to the CGRP receptor. TEV-48125 is specific for CGRP and does not","confidence":0.99609375,"confidence_rate":0.9999569910422619},{"cnt":[[245,907],[1852,907],[1852,956],[245,956]],"region":{"top_left_x":244,"top_left_y":906,"width":1608,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3eee5bd15884db78713fc115ebbaedc","type":"text","conversion_output":true,"text":"bind to the closely related family members amylin, calcitonin, or adrenomedullin peptides. Two","text_display":" bind to the closely related family members amylin, calcitonin, or adrenomedullin peptides. Two","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1762,954],[1762,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":953,"width":1518,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf60457ee9e346efbbf2470e3b239e52","type":"text","conversion_output":true,"text":"mutations were introduced into the constant region of the TEV-48125 heavy chain to limit","text_display":" mutations were introduced into the constant region of the TEV-48125 heavy chain to limit","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[245,1003],[1721,1003],[1721,1051],[245,1051]],"region":{"top_left_x":244,"top_left_y":1003,"width":1477,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3ac72126d264bdca3174439e9a11980","type":"text","conversion_output":true,"text":"antibody effector functions. This loss of function prevents TEV-48125 from stimulating","text_display":" antibody effector functions. This loss of function prevents TEV-48125 from stimulating","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[245,1053],[1850,1053],[1850,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1052,"width":1606,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a1f086b53084970b446e29f6d112906","type":"text","conversion_output":true,"text":"antibody-dependent cell mediated cytotoxicity and triggering complement-mediated lysis; these","text_display":" antibody-dependent cell mediated cytotoxicity and triggering complement-mediated lysis; these","confidence":1,"confidence_rate":1},{"cnt":[[245,1100],[1764,1100],[1764,1149],[245,1149]],"region":{"top_left_x":244,"top_left_y":1100,"width":1520,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f569e67cb4014e11bc950323974d5322","type":"text","conversion_output":true,"text":"activities can lead to unwanted consequences such as cell lysis, opsonization, and cytokine","text_display":" activities can lead to unwanted consequences such as cell lysis, opsonization, and cytokine","confidence":1,"confidence_rate":1},{"cnt":[[245,1147],[1326,1147],[1326,1197],[245,1197]],"region":{"top_left_x":244,"top_left_y":1147,"width":1082,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a8c5e35999a48d3b2591ccdc3e54576","type":"text","conversion_output":true,"text":"release and inflammation (Armour et al 1999, Zeller et al 2008).","text_display":" release and inflammation (Armour et al 1999, Zeller et al 2008).","confidence":1,"confidence_rate":1},{"cnt":[[245,1216],[1863,1216],[1863,1268],[245,1268]],"region":{"top_left_x":244,"top_left_y":1216,"width":1619,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63f4535e82594bdfbf6bdb670aef91b3","type":"text","conversion_output":true,"text":"The pharmacokinetics and tolerability of TEV-48125 (iv doses ranging from 0.2 to 2000 mg and","text_display":"\n\nThe pharmacokinetics and tolerability of TEV-48125 (iv doses ranging from 0.2 to 2000 mg and","confidence":0.99658203125,"confidence_rate":0.9999673926902055},{"cnt":[[245,1268],[1772,1268],[1772,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1267,"width":1529,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bb2a4121fde42bcb704cfe66aaa2c3c","type":"text","conversion_output":true,"text":"subcutaneous [sc] doses of 225 mg and 900 mg ) has been well-characterized in the Phase 1","text_display":" subcutaneous [sc] doses of 225 mg and 900 mg ) has been well-characterized in the Phase 1","confidence":1,"confidence_rate":1},{"cnt":[[245,1315],[1734,1315],[1734,1364],[245,1364]],"region":{"top_left_x":244,"top_left_y":1314,"width":1490,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a104312f49e54267829b226209069dfc","type":"text","conversion_output":true,"text":"development program (see Section 1.3.2.1). Furthermore, the safety and effectiveness of","text_display":" development program (see Section 1.3.2.1). Furthermore, the safety and effectiveness of","confidence":1,"confidence_rate":1},{"cnt":[[245,1362],[1813,1362],[1813,1412],[245,1412]],"region":{"top_left_x":244,"top_left_y":1362,"width":1570,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da6a2602f7014de1abbf3f190a253694","type":"text","conversion_output":true,"text":"TEV-48125 has been demonstrated in a randomized double-blind, placebo controlled Phase 2","text_display":" TEV-48125 has been demonstrated in a randomized double-blind, placebo controlled Phase 2","confidence":1,"confidence_rate":1},{"cnt":[[245,1412],[1850,1412],[1850,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1411,"width":1606,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9423203b9aa84e7db406d09f09d9ab52","type":"text","conversion_output":true,"text":"study of 2 sc dosing regimens of TEV-48125 (monthly TEV-48125 at 900 mg or TEV-48125 at","text_display":" study of 2 sc dosing regimens of TEV-48125 (monthly TEV-48125 at 900 mg or TEV-48125 at","confidence":0.9970703125,"confidence_rate":0.9999712358310027},{"cnt":[[245,1461],[1798,1461],[1798,1510],[245,1510]],"region":{"top_left_x":244,"top_left_y":1460,"width":1555,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fa4a9f456f94ade9f8fd087df219b71","type":"text","conversion_output":true,"text":"675 mg followed by monthly TEV-48125 at 225 mg ) in patients with CM and a randomized,","text_display":" 675 mg followed by monthly TEV-48125 at 225 mg ) in patients with CM and a randomized,","confidence":0.9960966110229492,"confidence_rate":0.9999596809460038},{"cnt":[[245,1508],[1865,1508],[1865,1560],[245,1560]],"region":{"top_left_x":244,"top_left_y":1508,"width":1621,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0394612979b542be9f30f76f641060d5","type":"text","conversion_output":true,"text":"double-blind, placebo-controlled Phase 2 study of 2 sc dosing regimens of TEV-48125 (monthly","text_display":" double-blind, placebo-controlled Phase 2 study of 2 sc dosing regimens of TEV-48125 (monthly","confidence":0.8473162651062012,"confidence_rate":0.9984233274983444},{"cnt":[[245,1558],[1725,1558],[1725,1607],[245,1607]],"region":{"top_left_x":244,"top_left_y":1557,"width":1482,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35d5f33aa5d245a0a4a52fafa66c3d01","type":"text","conversion_output":true,"text":"TEV-48125 at 675 or 225 mg ) in patients with EM (see Section 1.3.2.2). The acceptable","text_display":" TEV-48125 at 675 or 225 mg ) in patients with EM (see Section 1.3.2.2). The acceptable","confidence":1,"confidence_rate":1},{"cnt":[[245,1607],[1725,1607],[1725,1656],[245,1656]],"region":{"top_left_x":244,"top_left_y":1607,"width":1482,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25ccb4bfeb7f4213bda2609bb42fc680","type":"text","conversion_output":true,"text":"tolerability, long terminal elimination half-life ( \\(t _{1 / 2}\\), approximately 45 days) and ability to","text_display":" tolerability, long terminal elimination half-life ( \\(t _{1 / 2}\\), approximately 45 days) and ability to","confidence":0.8001075048787243,"confidence_rate":0.9980957540203025},{"cnt":[[245,1656],[1841,1656],[1841,1706],[245,1706]],"region":{"top_left_x":244,"top_left_y":1656,"width":1598,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ba5429435cd4c11bc1bb4b53286f7ef","type":"text","conversion_output":true,"text":"administer sc make TEV-48125 an attractive therapeutic candidate for the preventive treatment","text_display":" administer sc make TEV-48125 an attractive therapeutic candidate for the preventive treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1706],[518,1706],[518,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1705,"width":274,"height":42},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de2d4489f07d49b38071c70c2a304f51","type":"text","conversion_output":true,"text":"of CM and EM .","text_display":" of CM and EM .","confidence":0.759394645690918,"confidence_rate":0.9911607916777051},{"cnt":[[243,1792],[1467,1792],[1467,1858],[243,1858]],"region":{"top_left_x":242,"top_left_y":1791,"width":1226,"height":68},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc1ff54f60f24a2cb6792c98b23341a7","type":"section_header","conversion_output":false,"children_ids":["d31d30997d004308b9e6c581c47ff9af"],"text":"","text_display":""},{"cnt":[[247,1796],[1459,1796],[1459,1852],[247,1852]],"region":{"top_left_x":247,"top_left_y":1796,"width":1212,"height":56},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d31d30997d004308b9e6c581c47ff9af","type":"text","conversion_output":true,"parent_id":"fc1ff54f60f24a2cb6792c98b23341a7","text":"1.2 Name and Description of Investigational Product","text_display":"\n\n\\subsection*{1.2 Name and Description of Investigational Product}","confidence":0.86083984375,"confidence_rate":0.9973277410760364},{"cnt":[[245,1869],[1815,1869],[1815,1921],[245,1921]],"region":{"top_left_x":244,"top_left_y":1869,"width":1572,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bfd5ec4556642689d7295b36f8b0a23","type":"text","conversion_output":true,"text":"TEV-48125 (formerly LBR-101, PF-04427429, or RN307) is a fully humanized IgG2a/kappa","text_display":"\n\nTEV-48125 (formerly LBR-101, PF-04427429, or RN307) is a fully humanized IgG2a/kappa","confidence":1,"confidence_rate":1},{"cnt":[[245,1921],[1764,1921],[1764,1970],[245,1970]],"region":{"top_left_x":244,"top_left_y":1920,"width":1520,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fb4ab91f6eb490390e9e22e48182867","type":"text","conversion_output":true,"text":"monoclonal antibody derived from a murine precursor. TEV-48125 is being developed for","text_display":" monoclonal antibody derived from a murine precursor. TEV-48125 is being developed for","confidence":1,"confidence_rate":1},{"cnt":[[245,1968],[1869,1968],[1869,2017],[245,2017]],"region":{"top_left_x":244,"top_left_y":1967,"width":1626,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a748bf9e5de4547880f3748bd3e5590","type":"text","conversion_output":true,"text":"administration by the sc route. A more detailed description of the product is given in Section 3.9.","text_display":" administration by the sc route. A more detailed description of the product is given in Section 3.9.","confidence":1,"confidence_rate":1},{"cnt":[[243,2054],[1418,2054],[1418,2121],[243,2121]],"region":{"top_left_x":242,"top_left_y":2053,"width":1176,"height":68},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3676e1157c5641d38c16918a8ab1f4a4","type":"section_header","conversion_output":false,"children_ids":["f9bd0fa59726452f93ab000d7ec19cde"],"text":"","text_display":""},{"cnt":[[249,2058],[1412,2058],[1412,2116],[249,2116]],"region":{"top_left_x":249,"top_left_y":2058,"width":1163,"height":59},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9bd0fa59726452f93ab000d7ec19cde","type":"text","conversion_output":true,"parent_id":"3676e1157c5641d38c16918a8ab1f4a4","text":"1.3 Findings from Nonclinical and Clinical Studies","text_display":"\n\n\\subsection*{1.3 Findings from Nonclinical and Clinical Studies}","confidence":0.57177734375,"confidence_rate":0.9898877376544052},{"cnt":[[245,2153],[786,2153],[786,2202],[245,2202]],"region":{"top_left_x":244,"top_left_y":2152,"width":543,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45979f78583b499082a4c0f5766d923b","type":"section_header","conversion_output":false,"children_ids":["7e78a91000d54d8794cb20ffc06259d8"],"text":"","text_display":""},{"cnt":[[249,2157],[782,2157],[782,2198],[249,2198]],"region":{"top_left_x":249,"top_left_y":2157,"width":534,"height":41},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e78a91000d54d8794cb20ffc06259d8","type":"text","conversion_output":true,"parent_id":"45979f78583b499082a4c0f5766d923b","text":"1.3.1. Nonclinical Studies","text_display":"\n\n\\subsection*{1.3.1. 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prevented an increase in blood flow in rat paw skin and the middle meningeal artery after","confidence":1,"confidence_rate":1},{"cnt":[[245,2322],[1813,2322],[1813,2372],[245,2372]],"region":{"top_left_x":244,"top_left_y":2322,"width":1570,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd3801a99a1b409dacd9f3e27f4c0907","type":"text","conversion_output":true,"text":"electrical stimulation and produced a dose-dependent inhibition of the capsaicin-induced skin","text_display":" electrical stimulation and produced a dose-dependent inhibition of the capsaicin-induced skin","confidence":1,"confidence_rate":1},{"cnt":[[245,2372],[896,2372],[896,2421],[245,2421]],"region":{"top_left_x":244,"top_left_y":2371,"width":652,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b35d6d1ef7046d1b0874618921828d3","type":"text","conversion_output":true,"text":"flare response in cynomolgus monkey.","text_display":" flare response in cynomolgus monkey.","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"faa3b4783ce54af5b2fb7b9f7934f68f","type":"page_info","conversion_output":false,"text":"34","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-036","page":36,"lines":[{"cnt":[[1109,125],[1880,125],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2adf9f57c6bd4e53bb382639c66dbebf","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic 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Dawley rats and cynomolgus monkeys and a separate cardiovascular safety","confidence":1,"confidence_rate":1},{"cnt":[[245,351],[1846,349],[1846,400],[245,402]],"region":{"top_left_x":244,"top_left_y":348,"width":1602,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9253082a1a174301ad7cb0590d1f3551","type":"text","conversion_output":true,"text":"pharmacology study in male cynomolgus monkeys. There were no treatment-related changes in","text_display":" pharmacology study in male cynomolgus monkeys. There were no treatment-related changes in","confidence":1,"confidence_rate":1},{"cnt":[[245,400],[1861,400],[1861,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1617,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bd60fdd536842e79d1f16dcac722e2e","type":"text","conversion_output":true,"text":"electrocardiograms (ECGs) and heart rates in the 1- and 3-month toxicity studies, and a single iv","text_display":" electrocardiograms (ECGs) and heart rates in the 1- and 3-month toxicity studies, and a single iv","confidence":0.5374037884175777,"confidence_rate":0.9939302065371315},{"cnt":[[245,447],[1863,447],[1863,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1619,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d598d26177246ffbf53f4da254d3e31","type":"text","conversion_output":true,"text":"dose of TEV-48125 at \\(100 mg / kg\\) did not result in changes in cardiovascular parameters or body","text_display":" dose of TEV-48125 at \\(100 mg / kg\\) did not result in changes in cardiovascular parameters or body","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1695,494],[1695,546],[245,546]],"region":{"top_left_x":244,"top_left_y":494,"width":1452,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78e2e0f1548b4b778df1f8d91e486699","type":"text","conversion_output":true,"text":"temperature in monkeys. Additionally, no target organ toxicity was identified. In these","text_display":" temperature in monkeys. Additionally, no target organ toxicity was identified. In these","confidence":1,"confidence_rate":1},{"cnt":[[245,544],[1695,544],[1695,593],[245,593]],"region":{"top_left_x":244,"top_left_y":543,"width":1452,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d160c05e56d447ef8b42e5e20de3ad37","type":"text","conversion_output":true,"text":"referenced studies, the no-observed-adverse-effect level (NOAEL) ranged from 100 to","text_display":" referenced studies, the no-observed-adverse-effect level (NOAEL) ranged from 100 to","confidence":1,"confidence_rate":1},{"cnt":[[245,593],[1826,593],[1826,642],[245,642]],"region":{"top_left_x":244,"top_left_y":592,"width":1583,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d884b6726ff48c5bf3723d9feee0431","type":"text","conversion_output":true,"text":"\\(300 mg / kg\\) dosed either iv or sc. In a 3 -month monkey study, perivascular inflammation of the","text_display":" \\(300 mg / kg\\) dosed either iv or sc. In a 3 -month monkey study, perivascular inflammation of the","confidence":0.8801701068878174,"confidence_rate":0.998785118691215},{"cnt":[[245,640],[1740,640],[1740,692],[245,692]],"region":{"top_left_x":244,"top_left_y":640,"width":1497,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"553cfc803e924424bd6d00146a6a36df","type":"text","conversion_output":true,"text":"ciliary artery was observed in a few animals at doses \\(\\geq 100 mg / kg\\). The inflammation was","text_display":" ciliary artery was observed in a few animals at doses \\(\\geq 100 mg / kg\\). The inflammation was","confidence":1,"confidence_rate":1},{"cnt":[[245,690],[1704,690],[1704,741],[245,741]],"region":{"top_left_x":244,"top_left_y":689,"width":1460,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59fb9e93eb7940eb82055d7ab3fc123a","type":"text","conversion_output":true,"text":"suspected to be the result of immune complex formation/deposition from the monkeys'","text_display":" suspected to be the result of immune complex formation/deposition from the monkeys'","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[245,739],[1880,739],[1880,788],[245,788]],"region":{"top_left_x":244,"top_left_y":739,"width":1636,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56816c9b745d41ec93d9f2154c8fbfdd","type":"text","conversion_output":true,"text":"immunogenic response to the drug (TEV-48125). In the pivotal 6 -month chronic toxicity study in","text_display":" immunogenic response to the drug (TEV-48125). In the pivotal 6 -month chronic toxicity study in","confidence":0.56591796875,"confidence_rate":0.9944880030042207},{"cnt":[[245,786],[1852,786],[1852,836],[245,836]],"region":{"top_left_x":244,"top_left_y":786,"width":1608,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30d68cbad911421f84ef37a29d33a5ee","type":"text","conversion_output":true,"text":"monkeys following once-weekly sc dosing at dosage levels of up to \\(300 mg / kg /\\) week, achieving","text_display":" monkeys following once-weekly sc dosing at dosage levels of up to \\(300 mg / kg /\\) week, achieving","confidence":0.7670955657958984,"confidence_rate":0.9974780056942046},{"cnt":[[245,836],[1811,836],[1811,887],[245,887]],"region":{"top_left_x":244,"top_left_y":835,"width":1568,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b86e1bc2f22459bb769eb04c9a3d74a","type":"text","conversion_output":true,"text":"high exposure throughout the study, no microscopic findings were noted in any of the organs,","text_display":" high exposure throughout the study, no microscopic findings were noted in any of the organs,","confidence":1,"confidence_rate":1},{"cnt":[[245,885],[1757,885],[1757,935],[245,935]],"region":{"top_left_x":244,"top_left_y":885,"width":1514,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08616c5814d242f99827466d6f4fdc62","type":"text","conversion_output":true,"text":"including the ciliary vessels of the eyes, and the NOAEL of the chronic toxicity study was","text_display":" including the ciliary vessels of the eyes, and the NOAEL of the chronic toxicity study was","confidence":1,"confidence_rate":1},{"cnt":[[245,932],[1869,932],[1869,982],[245,982]],"region":{"top_left_x":244,"top_left_y":932,"width":1626,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d1778abbb2b4e48a66b564d58027a38","type":"text","conversion_output":true,"text":"determined to be the highest dose tested, \\(300 mg / kg /\\) week. Thus, it is believed that in view of the","text_display":" determined to be the highest dose tested, \\(300 mg / kg /\\) week. Thus, it is believed that in view of the","confidence":0.9912292957305908,"confidence_rate":0.9999213477960848},{"cnt":[[245,980],[1867,980],[1867,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":979,"width":1623,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb205dfbbe30462fb285a73cf8929d37","type":"text","conversion_output":true,"text":"low frequency (ie, observed in very few animals) and minimal severity, the finding (perivascular","text_display":" low frequency (ie, observed in very few animals) and minimal severity, the finding (perivascular","confidence":1,"confidence_rate":1},{"cnt":[[245,1031],[1768,1031],[1768,1081],[245,1081]],"region":{"top_left_x":244,"top_left_y":1031,"width":1525,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86f47b17f1c04dd0b2d2f173e85898f7","type":"text","conversion_output":true,"text":"inflammation) that was only recorded in the 3-month toxicity study, and had been resolved","text_display":" inflammation) that was only recorded in the 3-month toxicity study, and had been resolved","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[245,1079],[1111,1079],[1111,1128],[245,1128]],"region":{"top_left_x":244,"top_left_y":1078,"width":867,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34f69b031542407e84e57b7054bd5227","type":"text","conversion_output":true,"text":"during the recovery period, is an incidental finding.","text_display":" during the recovery period, is an incidental finding.","confidence":1,"confidence_rate":1},{"cnt":[[245,1147],[1820,1147],[1820,1199],[245,1199]],"region":{"top_left_x":244,"top_left_y":1147,"width":1576,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aecc1e4bcf5742f6b388673e42b205e9","type":"text","conversion_output":true,"text":"The pharmacokinetics of TEV-48125 in animals (rats and monkeys) is typical of a humanized","text_display":"\n\nThe pharmacokinetics of TEV-48125 in animals (rats and monkeys) is typical of a humanized","confidence":1,"confidence_rate":1},{"cnt":[[245,1197],[1858,1197],[1858,1248],[245,1248]],"region":{"top_left_x":244,"top_left_y":1196,"width":1615,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c73b53d629a41bda9ea434dd42b91c4","type":"text","conversion_output":true,"text":"IgG2 molecule, with low mean plasma clearance, low volume of distribution at steady state, and","text_display":" IgG2 molecule, with low mean plasma clearance, low volume of distribution at steady state, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1246],[1850,1246],[1850,1296],[245,1296]],"region":{"top_left_x":244,"top_left_y":1246,"width":1606,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d618ed597be4e689a789a4d98646dac","type":"text","conversion_output":true,"text":"a long \\(t _{1 / 2}\\). Exposure as defined by the maximum observed plasma drug concentration ( \\(C _{\\max }\\) ) and","text_display":" a long \\(t _{1 / 2}\\). Exposure as defined by the maximum observed plasma drug concentration ( \\(C _{\\max }\\) ) and","confidence":0.42269292407928205,"confidence_rate":0.993397972004921},{"cnt":[[245,1296],[1803,1296],[1803,1345],[245,1345]],"region":{"top_left_x":244,"top_left_y":1295,"width":1559,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9a2af21b47d46eea0ffcd990ba6196c","type":"text","conversion_output":true,"text":"the area under the plasma concentration-time curve increased linearly across doses following","text_display":" the area under the plasma concentration-time curve increased linearly across doses following","confidence":1,"confidence_rate":1},{"cnt":[[245,1343],[1811,1343],[1811,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1342,"width":1568,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e66686f025a45079cfbd272903fc56b","type":"text","conversion_output":true,"text":"single and repeated once-weekly dosing. No gender differences in exposure were observed in","text_display":" single and repeated once-weekly dosing. No gender differences in exposure were observed in","confidence":1,"confidence_rate":1},{"cnt":[[245,1392],[526,1392],[526,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1392,"width":283,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2d4a56d2cff4e28bcc9b2abacb209de","type":"text","conversion_output":true,"text":"rats or monkeys.","text_display":" rats or monkeys.","confidence":1,"confidence_rate":1},{"cnt":[[245,1461],[1807,1461],[1807,1510],[245,1510]],"region":{"top_left_x":244,"top_left_y":1460,"width":1563,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74bb668d25644786a1b29e30ecc6aa4a","type":"text","conversion_output":true,"text":"Additionally, pivotal reproductive and developmental toxicity studies in rabbits and rats with","text_display":"\n\nAdditionally, pivotal reproductive and developmental toxicity studies in rabbits and rats with","confidence":1,"confidence_rate":1},{"cnt":[[245,1508],[1824,1508],[1824,1560],[245,1560]],"region":{"top_left_x":244,"top_left_y":1508,"width":1581,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e36eaa07dbba42b9b8ad87df5a74c1ae","type":"text","conversion_output":true,"text":"TEV-48125 were conducted and completed. Preliminary data suggest that weekly dosing with","text_display":" TEV-48125 were conducted and completed. Preliminary data suggest that weekly dosing with","confidence":1,"confidence_rate":1},{"cnt":[[245,1558],[1792,1558],[1792,1607],[245,1607]],"region":{"top_left_x":244,"top_left_y":1557,"width":1548,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3646b800e9354d34958464e8310316ce","type":"text","conversion_output":true,"text":"TEV-48125 was well tolerated and did not induce any obvious maternal toxicity at any dose","text_display":" TEV-48125 was well tolerated and did not induce any obvious maternal toxicity at any dose","confidence":0.9990236759185791,"confidence_rate":0.9999896085540316},{"cnt":[[245,1607],[1622,1607],[1622,1656],[245,1656]],"region":{"top_left_x":244,"top_left_y":1607,"width":1379,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f9aebb5621240f28bc4bb0b41597a24","type":"text","conversion_output":true,"text":"level. No apparent evidence of embryo-fetal toxicity was noted in any dose group.","text_display":" level. No apparent evidence of embryo-fetal toxicity was noted in any dose group.","confidence":1,"confidence_rate":1},{"cnt":[[245,1676],[1792,1676],[1792,1725],[245,1725]],"region":{"top_left_x":244,"top_left_y":1675,"width":1548,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8bb0c64dce1404caf5ceb1e912c243e","type":"text","conversion_output":true,"text":"Overall, no toxicological concerns were identified following up to 6 months of dosing to the","text_display":"\n\nOverall, no toxicological concerns were identified following up to 6 months of dosing to the","confidence":1,"confidence_rate":1},{"cnt":[[245,1723],[621,1723],[621,1777],[245,1777]],"region":{"top_left_x":244,"top_left_y":1723,"width":377,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7209a9acb484f98b32be74b3310f5fb","type":"text","conversion_output":true,"text":"experimental animals.","text_display":" experimental animals.","confidence":1,"confidence_rate":1},{"cnt":[[245,1796],[1381,1796],[1381,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1796,"width":1138,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4455ce83af814bc5af835ac08063a56d","type":"text","conversion_output":true,"text":"Further details may be found in the current Investigator's Brochure.","text_display":"\n\nFurther details may be found in the current Investigator's Brochure.","confidence":1,"confidence_rate":1},{"cnt":[[243,1882],[724,1882],[724,1931],[243,1931]],"region":{"top_left_x":242,"top_left_y":1882,"width":483,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b32a8bcaf956439cbdebca565e09f545","type":"section_header","conversion_output":false,"children_ids":["7594497e750c4f95877eaaa43ba22fc3"],"text":"","text_display":""},{"cnt":[[249,1886],[720,1886],[720,1927],[249,1927]],"region":{"top_left_x":249,"top_left_y":1886,"width":471,"height":42},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7594497e750c4f95877eaaa43ba22fc3","type":"text","conversion_output":true,"parent_id":"b32a8bcaf956439cbdebca565e09f545","text":"1.3.2 Clinical Studies","text_display":"\n\n\\subsection*{1.3.2 Clinical Studies}","confidence":0.9765625,"confidence_rate":0.999121995796739},{"cnt":[[245,1955],[1656,1955],[1656,2002],[245,2002]],"region":{"top_left_x":244,"top_left_y":1955,"width":1413,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92595ebf6932479cb5285501e99f9d98","type":"text","conversion_output":true,"text":"To date, TEV-48125 has been studied in 6 Phase 1 studies in healthy volunteers and","text_display":"\n\nTo date, TEV-48125 has been studied in 6 Phase 1 studies in healthy volunteers and","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[245,2002],[1745,2002],[1745,2052],[245,2052]],"region":{"top_left_x":244,"top_left_y":2002,"width":1501,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff014d5f30a047e6808bfdf7db345298","type":"text","conversion_output":true,"text":"2 Phase 2b studies in migraine patients. In total, 484 subjects ( 118 healthy volunteers and","text_display":" 2 Phase 2b studies in migraine patients. In total, 484 subjects ( 118 healthy volunteers and","confidence":1,"confidence_rate":1},{"cnt":[[245,2050],[1738,2050],[1738,2099],[245,2099]],"region":{"top_left_x":244,"top_left_y":2049,"width":1495,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6da80e26717446f8a3b6f9416bb0c782","type":"text","conversion_output":true,"text":"366 migraine patients) received at least 1 dose of TEV-48125 via iv or sc administration.","text_display":" 366 migraine patients) received at least 1 dose of TEV-48125 via iv or sc administration.","confidence":0.9741454124450684,"confidence_rate":0.9997271758442032},{"cnt":[[245,2118],[1876,2118],[1876,2170],[245,2170]],"region":{"top_left_x":244,"top_left_y":2118,"width":1632,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a20cabd4a2fd4ccc8052c056e5fe0a4f","type":"text","conversion_output":true,"text":"A brief summary of clinical pharmacology and clinical safety and efficacy studies of TEV-48125","text_display":"\n\nA brief summary of clinical pharmacology and clinical safety and efficacy studies of TEV-48125","confidence":0.9716796875,"confidence_rate":0.9997098494912892},{"cnt":[[245,2170],[1528,2170],[1528,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":1284,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb10ed1299de4ce6a07e7e2cbf80f475","type":"text","conversion_output":true,"text":"follows. Further details may be found in the current Investigator's Brochure.","text_display":" follows. Further details may be found in the current Investigator's Brochure.","confidence":0.9833984375,"confidence_rate":0.9997958633645617},{"cnt":[[243,2256],[990,2256],[990,2314],[243,2314]],"region":{"top_left_x":242,"top_left_y":2255,"width":749,"height":59},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd64164a49f045ceadfa1599cd9f2a24","type":"section_header","conversion_output":false,"children_ids":["1717a7deab68417bbe8ce749a1273eb9"],"text":"","text_display":""},{"cnt":[[249,2260],[986,2260],[986,2310],[249,2310]],"region":{"top_left_x":249,"top_left_y":2260,"width":738,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1717a7deab68417bbe8ce749a1273eb9","type":"text","conversion_output":true,"parent_id":"dd64164a49f045ceadfa1599cd9f2a24","text":"1.3.2.1 Clinical Pharmacology Studies","text_display":"\n\n\\subsection*{1.3.2.1 Clinical Pharmacology Studies}","confidence":0.990234375,"confidence_rate":0.9997663696422919},{"cnt":[[245,2329],[1878,2329],[1878,2378],[245,2378]],"region":{"top_left_x":244,"top_left_y":2328,"width":1634,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c70ff15df1a1463dadc77fa8af4e1213","type":"text","conversion_output":true,"text":"A total of 118 subjects received at least 1 dose of TEV-48125 across 6 completed Phase 1 studies","text_display":"\n\nA total of 118 subjects received at least 1 dose of TEV-48125 across 6 completed Phase 1 studies","confidence":0.988306999206543,"confidence_rate":0.9998959177925186},{"cnt":[[245,2376],[1687,2376],[1687,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2376,"width":1443,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc4d91ce30d14df3ac11d3f6c29779cc","type":"text","conversion_output":true,"text":"at doses ranging from 0.2 through 2000 mg . Studies included 2 single-dose-escalation","text_display":" at doses ranging from 0.2 through 2000 mg . Studies included 2 single-dose-escalation","confidence":1,"confidence_rate":1},{"cnt":[[245,2426],[1708,2426],[1708,2477],[245,2477]],"region":{"top_left_x":244,"top_left_y":2425,"width":1465,"height":53},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"187d7541253345c382bd2f5234c474af","type":"text","conversion_output":true,"text":"pharmacokinetic and pharmacodynamic studies in healthy men (Studies B0141001 and","text_display":" pharmacokinetic and pharmacodynamic studies in healthy men (Studies B0141001 and","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fb0048aa9fab4adc891cd6b04b982654","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":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-037","page":37,"lines":[{"cnt":[[1109,125],[1880,125],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"211c5e9dd9644d18b500eeef239a72ef","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb5697be7d0a4395881c49a09d0453df","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,174],[1880,174],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":174,"width":493,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31ed97809adc4a3cab8f0d67b323d8e3","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1738,254],[1738,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1495,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d410d08ae55044b9b8075214e17e6427","type":"text","conversion_output":true,"text":"B0141002); a 2-cohort, placebo-controlled, cross-over study to examine the acute effects","text_display":"\n\nB0141002); a 2-cohort, placebo-controlled, cross-over study to examine the acute effects","confidence":0.96875,"confidence_rate":0.9996586744119921},{"cnt":[[245,301],[1830,301],[1830,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1587,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82f080702b774408ab47fd0d9fd46930","type":"text","conversion_output":true,"text":"administration of TEV-48125 on capsaicin flare response in healthy men (Study B0141006); a","text_display":" administration of TEV-48125 on capsaicin flare response in healthy men (Study B0141006); a","confidence":1,"confidence_rate":1},{"cnt":[[245,348],[1850,348],[1850,402],[245,402]],"region":{"top_left_x":244,"top_left_y":348,"width":1606,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b2b55cc209f4938b6f6a7082fc2521f","type":"text","conversion_output":true,"text":"parallel-group, repeat-dose study of TEV-48125 in healthy men and women (Study B0141007);","text_display":" parallel-group, repeat-dose study of TEV-48125 in healthy men and women (Study B0141007);","confidence":1,"confidence_rate":1},{"cnt":[[245,400],[1760,400],[1760,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1516,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03c2596c993e4b8ead089b996fe87b1d","type":"text","conversion_output":true,"text":"a single-dose study evaluating the safety, tolerability, and pharmacokinetics of doses up to","text_display":" a single-dose study evaluating the safety, tolerability, and pharmacokinetics of doses up to","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1729,447],[1729,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1486,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7207c20087b24d1aa951b6c9d4a3d930","type":"text","conversion_output":true,"text":"2000 mg administered to healthy women (Study LBR-101-008); and a single-dose study","text_display":" 2000 mg administered to healthy women (Study LBR-101-008); and a single-dose study","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1798,494],[1798,546],[245,546]],"region":{"top_left_x":244,"top_left_y":494,"width":1555,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7cdde41f78f04512ab86f327a0de3638","type":"text","conversion_output":true,"text":"comparing the safety, tolerability, absolute bioavailability, and pharmacokinetics if sc and iv","text_display":" comparing the safety, tolerability, absolute bioavailability, and pharmacokinetics if sc and iv","confidence":1,"confidence_rate":1},{"cnt":[[245,546],[1304,546],[1304,595],[245,595]],"region":{"top_left_x":244,"top_left_y":545,"width":1061,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"328c14c2a8d54c02b437dbf14272fb78","type":"text","conversion_output":true,"text":"TEV-48125 in healthy men and women (Study LBR-101-011).","text_display":" TEV-48125 in healthy men and women (Study LBR-101-011).","confidence":1,"confidence_rate":1},{"cnt":[[245,614],[1687,614],[1687,664],[245,664]],"region":{"top_left_x":244,"top_left_y":614,"width":1443,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"463fb30fcb8a4498be95c7115670ebc1","type":"text","conversion_output":true,"text":"Based on noncompartmental analysis, TEV-48125 exposure increases with dose in an","text_display":"\n\nBased on noncompartmental analysis, TEV-48125 exposure increases with dose in an","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[245,662],[1824,662],[1824,711],[245,711]],"region":{"top_left_x":244,"top_left_y":661,"width":1581,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c9cfe9ba57346a1aed5dd2cdf0511be","type":"text","conversion_output":true,"text":"approximately dose-proportional manner from 225 to 900 mg following sc administration and","text_display":" approximately dose-proportional manner from 225 to 900 mg following sc administration and","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,711],[1850,709],[1850,763],[245,765]],"region":{"top_left_x":244,"top_left_y":708,"width":1606,"height":57},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c1b9aa70c8f4a93b93b1c6f1f11a9d5","type":"text","conversion_output":true,"text":"over the dose range from 100 to 2000 mg following iv infusion. The \\(C _{\\text {max }}\\) occurred near the end","text_display":" over the dose range from 100 to 2000 mg following iv infusion. The \\(C _{\\text {max }}\\) occurred near the end","confidence":0.98974609375,"confidence_rate":0.9999168837792848},{"cnt":[[245,761],[1833,761],[1833,810],[245,810]],"region":{"top_left_x":244,"top_left_y":760,"width":1589,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53c374d9e2ff4e5188431937366fc962","type":"text","conversion_output":true,"text":"of the iv infusion (median time to \\(C _{\\text {max }}\\left[ t _{\\text {max }}\\right]\\) of 1 to 5 hours after the start of the infusion), and","text_display":" of the iv infusion (median time to \\(C _{\\text {max }}\\left[ t _{\\text {max }}\\right]\\) of 1 to 5 hours after the start of the infusion), and","confidence":0.994140625,"confidence_rate":0.999958905680136},{"cnt":[[245,808],[1863,808],[1863,862],[245,862]],"region":{"top_left_x":244,"top_left_y":807,"width":1619,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db27fad554f64f14a9d26f741843fa6d","type":"text","conversion_output":true,"text":"\\(C _{\\text {max }}\\) was prolonged as indicated by the delayed \\(t _{\\text {max }}\\) (median \\(t _{\\text {max }} 96\\) to 108 hours postdose) after","text_display":" \\(C _{\\text {max }}\\) was prolonged as indicated by the delayed \\(t _{\\text {max }}\\) (median \\(t _{\\text {max }} 96\\) to 108 hours postdose) after","confidence":0.9941432476043701,"confidence_rate":0.9999616087733626},{"cnt":[[245,855],[1848,855],[1848,907],[245,907]],"region":{"top_left_x":244,"top_left_y":855,"width":1604,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c81ac41a18d42ec8cfec199f72e2a33","type":"text","conversion_output":true,"text":"sc administration. The mean \\(\\frac{t}{1}_{1 / 2}\\) following sc administration was similar to that observed after iv","text_display":" sc administration. The mean \\(\\frac{t}{1}_{1 / 2}\\) following sc administration was similar to that observed after iv","confidence":0.6208024565176995,"confidence_rate":0.9960017760052207},{"cnt":[[245,904],[1708,904],[1708,956],[245,956]],"region":{"top_left_x":244,"top_left_y":904,"width":1465,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44f883ba4f76465bb8f3b25f8a694b6c","type":"text","conversion_output":true,"text":"administration for each dose level. The \\(t _{1 / 2}\\) ranged from approximately 642 to 770 hours","text_display":" administration for each dose level. The \\(t _{1 / 2}\\) ranged from approximately 642 to 770 hours","confidence":0.7994227409362793,"confidence_rate":0.9979852271095143},{"cnt":[[245,954],[1830,954],[1830,1005],[245,1005]],"region":{"top_left_x":244,"top_left_y":953,"width":1587,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3184c65efb604c189837dcf0b72fcd4a","type":"text","conversion_output":true,"text":"(approximately 27 to 32 days) at the \\(225- mg\\) dose level, and the \\(t _{\\frac{1}{2}}\\) ranged from approximately","text_display":" (approximately 27 to 32 days) at the \\(225- mg\\) dose level, and the \\(t _{\\frac{1}{2}}\\) ranged from approximately","confidence":0.7611943036317825,"confidence_rate":0.9978705000856358},{"cnt":[[245,1001],[1682,1001],[1682,1053],[245,1053]],"region":{"top_left_x":244,"top_left_y":1001,"width":1439,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06a9f140f3904651b8de2adce4c3b338","type":"text","conversion_output":true,"text":"1140 to 1200 hours (approximately 48 to 50 days) at the \\(900- mg\\) dose level. Absolute","text_display":" 1140 to 1200 hours (approximately 48 to 50 days) at the \\(900- mg\\) dose level. Absolute","confidence":1,"confidence_rate":1},{"cnt":[[245,1051],[1156,1051],[1156,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1050,"width":912,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95812e05509248d48d0e3e10a1608a7f","type":"text","conversion_output":true,"text":"bioavailability of the sc dose was approximately \\(55 \\%\\).","text_display":" bioavailability of the sc dose was approximately \\(55 \\%\\).","confidence":0.99951171875,"confidence_rate":0.999992122603638},{"cnt":[[245,1119],[1811,1119],[1811,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1119,"width":1568,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc6b23999f134f2cbac531f56f26f301","type":"text","conversion_output":true,"text":"TEV-48125 was well tolerated with favorable safety profile. The treatment-emergent adverse","text_display":"\nTEV-48125 was well tolerated with favorable safety profile. The treatment-emergent adverse","confidence":0.99365234375,"confidence_rate":0.9999329718435114},{"cnt":[[245,1169],[1755,1169],[1755,1218],[245,1218]],"region":{"top_left_x":244,"top_left_y":1168,"width":1512,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5f4c7e47e924ab3b4005746a4dc3ea9","type":"text","conversion_output":true,"text":"events reported in the Phase 1 studies were predominantly mild to moderate in severity. A","text_display":" events reported in the Phase 1 studies were predominantly mild to moderate in severity. A","confidence":1,"confidence_rate":1},{"cnt":[[245,1216],[1768,1216],[1768,1268],[245,1268]],"region":{"top_left_x":244,"top_left_y":1216,"width":1525,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0919b9ad8314479886fb749a5e16768f","type":"text","conversion_output":true,"text":"specific \"pattern of adverse events\" that could be associated with a dose or a dose range of","text_display":" specific \"pattern of adverse events\" that could be associated with a dose or a dose range of","confidence":1,"confidence_rate":1},{"cnt":[[245,1265],[1790,1265],[1790,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1265,"width":1546,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a89af6963b254f638dc91f9515ea5fe4","type":"text","conversion_output":true,"text":"TEV-48125 has not been identified, nor has a maximally tolerated dose been identified. The","text_display":" TEV-48125 has not been identified, nor has a maximally tolerated dose been identified. The","confidence":0.7022936344146729,"confidence_rate":0.9962868720375679},{"cnt":[[245,1315],[1783,1315],[1783,1364],[245,1364]],"region":{"top_left_x":244,"top_left_y":1314,"width":1540,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"544785b09e724f6caa527d6f9a017515","type":"text","conversion_output":true,"text":"most common treatment-emergent adverse events reported were headache, nasopharyngitis,","text_display":" most common treatment-emergent adverse events reported were headache, nasopharyngitis,","confidence":1,"confidence_rate":1},{"cnt":[[245,1364],[1775,1364],[1775,1414],[245,1414]],"region":{"top_left_x":244,"top_left_y":1364,"width":1531,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b76073cb0ea64fc7bfc1af0bb21e9992","type":"text","conversion_output":true,"text":"gastroenteritis, and back pain. There were no deaths. One serious adverse event reported as","text_display":" gastroenteritis, and back pain. There were no deaths. One serious adverse event reported as","confidence":1,"confidence_rate":1},{"cnt":[[245,1409],[1865,1409],[1865,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1409,"width":1621,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6957bb06aa3542fdaf591a3d86cd4967","type":"text","conversion_output":true,"text":"\"thoracic aortic aneurysm aggravated\" in an individual receiving a single iv \\(300- mg\\) TEV-48125","text_display":" \"thoracic aortic aneurysm aggravated\" in an individual receiving a single iv \\(300- mg\\) TEV-48125","confidence":0.5763034179600481,"confidence_rate":0.9947147759190017},{"cnt":[[245,1461],[492,1461],[492,1506],[245,1506]],"region":{"top_left_x":244,"top_left_y":1460,"width":248,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68b9527011124cf58a0badcd35996a9e","type":"text","conversion_output":true,"text":"dose resolved.","text_display":" dose resolved.","confidence":1,"confidence_rate":1},{"cnt":[[245,1530],[1824,1530],[1824,1583],[245,1583]],"region":{"top_left_x":244,"top_left_y":1529,"width":1581,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f04bd9fe8476465d9271b440a77c7ac9","type":"text","conversion_output":true,"text":"TEV-48125 does not appear to be associated with any clinically relevant patterns of change in","text_display":"\n\nTEV-48125 does not appear to be associated with any clinically relevant patterns of change in","confidence":1,"confidence_rate":1},{"cnt":[[245,1577],[1699,1577],[1699,1629],[245,1629]],"region":{"top_left_x":244,"top_left_y":1576,"width":1456,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d05e6be69ff547bd84290c7d5f804878","type":"text","conversion_output":true,"text":"vital signs (systolic and diastolic blood pressure, temperature and heart rate) or cardiac","text_display":" vital signs (systolic and diastolic blood pressure, temperature and heart rate) or cardiac","confidence":1,"confidence_rate":1},{"cnt":[[245,1629],[1830,1629],[1830,1678],[245,1678]],"region":{"top_left_x":244,"top_left_y":1628,"width":1587,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89b48807b3ff4df598309d8f6311a465","type":"text","conversion_output":true,"text":"conduction and repolarization (P-R interval, QT interval corrected for heart rate using Bazett's","text_display":" conduction and repolarization (P-R interval, QT interval corrected for heart rate using Bazett's","confidence":1,"confidence_rate":1},{"cnt":[[245,1676],[1803,1676],[1803,1725],[245,1725]],"region":{"top_left_x":244,"top_left_y":1675,"width":1559,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5edfd58c9e6404eb7342f04d15a5c40","type":"text","conversion_output":true,"text":"and Fridericia's formulas) measured by frequent 12-lead ECGs. No changes in liver function","text_display":" and Fridericia's formulas) measured by frequent 12-lead ECGs. No changes in liver function","confidence":0.9883177129086107,"confidence_rate":0.9998763122693525},{"cnt":[[245,1723],[1798,1723],[1798,1775],[245,1775]],"region":{"top_left_x":244,"top_left_y":1723,"width":1555,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9a59eaed7d8467a8c7b884301ffef7d","type":"text","conversion_output":true,"text":"tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, and","text_display":" tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1772],[1830,1772],[1830,1824],[245,1824]],"region":{"top_left_x":244,"top_left_y":1772,"width":1587,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b458ed2712e4d25a4ab6c40a12e07fc","type":"text","conversion_output":true,"text":"alkaline phosphatase [ALP]) or differences between TEV-48125 and placebo in hematological","text_display":" alkaline phosphatase [ALP]) or differences between TEV-48125 and placebo in hematological","confidence":0.99853515625,"confidence_rate":0.9999844052526365},{"cnt":[[245,1822],[1861,1822],[1861,1871],[245,1871]],"region":{"top_left_x":244,"top_left_y":1821,"width":1617,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f66f1305e97f4d178858d9d9f0cc892b","type":"text","conversion_output":true,"text":"parameters, tests assessing renal function, electrolytes, or urinalysis has been observed in any of","text_display":" parameters, tests assessing renal function, electrolytes, or urinalysis has been observed in any of","confidence":1,"confidence_rate":1},{"cnt":[[245,1869],[578,1869],[578,1914],[245,1914]],"region":{"top_left_x":244,"top_left_y":1869,"width":334,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31f127445ff2420ead083898e0484335","type":"text","conversion_output":true,"text":"the Phase 1 studies.","text_display":" the Phase 1 studies.","confidence":1,"confidence_rate":1},{"cnt":[[241,1955],[1081,1955],[1081,2013],[241,2013]],"region":{"top_left_x":240,"top_left_y":1955,"width":841,"height":59},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d671199dc03c40bcbcec058740ba9523","type":"section_header","conversion_output":false,"children_ids":["974a8547cc8840c2b2aec84c20d43e89"],"text":"","text_display":""},{"cnt":[[245,1962],[1076,1962],[1076,2009],[245,2009]],"region":{"top_left_x":244,"top_left_y":1961,"width":833,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"974a8547cc8840c2b2aec84c20d43e89","type":"text","conversion_output":true,"parent_id":"d671199dc03c40bcbcec058740ba9523","text":"1.3.2.2 Clinical Safety and Efficacy Studies","text_display":"\n\n\\subsection*{1.3.2.2 Clinical Safety and Efficacy Studies}","confidence":0.939453125,"confidence_rate":0.9987261721117832},{"cnt":[[245,2028],[1742,2028],[1742,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2028,"width":1499,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5410d3d6caff48c18060bf51638f863b","type":"text","conversion_output":true,"text":"The safety, tolerability, and efficacy of TEV-48125 was evaluated in migraine patients in","text_display":"\n\nThe safety, tolerability, and efficacy of TEV-48125 was evaluated in migraine patients in","confidence":0.98828125,"confidence_rate":0.9998746040781297},{"cnt":[[245,2080],[1592,2080],[1592,2129],[245,2129]],"region":{"top_left_x":244,"top_left_y":2079,"width":1348,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e46c44cc4b2d4be490459881adf4866e","type":"text","conversion_output":true,"text":"2 Phase 2b studies. The first study was a multicenter, randomized, double-blind,","text_display":" 2 Phase 2b studies. The first study was a multicenter, randomized, double-blind,","confidence":1,"confidence_rate":1},{"cnt":[[245,2127],[1725,2127],[1725,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2126,"width":1482,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad73ea6762a34e79bdbcafed03af75fa","type":"text","conversion_output":true,"text":"placebo-controlled, parallel-group study comparing the efficacy, safety, tolerability, and","text_display":" placebo-controlled, parallel-group study comparing the efficacy, safety, tolerability, and","confidence":1,"confidence_rate":1},{"cnt":[[245,2174],[1622,2174],[1622,2226],[245,2226]],"region":{"top_left_x":244,"top_left_y":2174,"width":1379,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9133ef8ff885434193193e114ce4df20","type":"text","conversion_output":true,"text":"pharmacokinetics of 2 doses of TEV-48125 with placebo in 264 patients with CM","text_display":" pharmacokinetics of 2 doses of TEV-48125 with placebo in 264 patients with CM","confidence":0.73095703125,"confidence_rate":0.996444963683853},{"cnt":[[245,2224],[1783,2224],[1783,2275],[245,2275]],"region":{"top_left_x":244,"top_left_y":2223,"width":1540,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a80da98d960f47d68d13c8aa8b974b8a","type":"text","conversion_output":true,"text":"(Study LBR-101-021). Following a 28-day run-in period, participants were randomized and","text_display":" (Study LBR-101-021). Following a 28-day run-in period, participants were randomized and","confidence":0.91748046875,"confidence_rate":0.9990643077425478},{"cnt":[[245,2269],[1841,2269],[1841,2322],[245,2322]],"region":{"top_left_x":244,"top_left_y":2268,"width":1598,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"469f11462c134cd5a6013f0085daa3dd","type":"text","conversion_output":true,"text":"treated sc once monthly for 3 months. One active group received a \\(1^{\\text {st }}\\) dose of 675 mg followed","text_display":" treated sc once monthly for 3 months. One active group received a \\(1^{\\text {st }}\\) dose of 675 mg followed","confidence":0.9941456306260079,"confidence_rate":0.9999514757775617},{"cnt":[[245,2320],[1858,2320],[1858,2374],[245,2374]],"region":{"top_left_x":244,"top_left_y":2320,"width":1615,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a7c65c461b9452fbcef532009dcdc83","type":"text","conversion_output":true,"text":"by 225 mg on the subsequent 2 months. The other active group received 900 mg per month. The","text_display":" by 225 mg on the subsequent 2 months. The other active group received 900 mg per month. 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Both doses were also superior to placebo for the secondary","text_display":"\nalso positive at 2 and 1 months. Both doses were also superior to placebo for the secondary","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,301],[1863,301],[1863,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1619,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eda603815d3a4c8bb57c48f1b9048c6b","type":"text","conversion_output":true,"text":"endpoint (decrease in the number of days with moderate or severe headache at 3 months). At the","text_display":" endpoint (decrease in the number of days with moderate or severe headache at 3 months). At the","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,350],[1798,350],[1798,397],[245,397]],"region":{"top_left_x":244,"top_left_y":350,"width":1555,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3dfe5842fe14b3cbc4c3306934f533c","type":"text","conversion_output":true,"text":"doses tested, TEV-48125 was well tolerated, and no serious treatment-related adverse events","text_display":" doses tested, TEV-48125 was well tolerated, and no serious treatment-related adverse events","confidence":0.9956073760986328,"confidence_rate":0.9999541437616456},{"cnt":[[245,400],[1835,400],[1835,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1591,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"787512a1985141a6826554d764ba2d68","type":"text","conversion_output":true,"text":"were reported. Most adverse events were mild to moderate. No safety signals were observed in","text_display":" were reported. Most adverse events were mild to moderate. No safety signals were observed in","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1446,447],[1446,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1202,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed5cda56007b4dac969e144625e42337","type":"text","conversion_output":true,"text":"the clinical laboratory tests, vital signs, physical examination, or ECGs.","text_display":" the clinical laboratory tests, vital signs, physical examination, or ECGs.","confidence":1,"confidence_rate":1},{"cnt":[[245,518],[1644,518],[1644,565],[245,565]],"region":{"top_left_x":244,"top_left_y":517,"width":1400,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e95ef7caec8549f0a5ba1f1b5d14f766","type":"text","conversion_output":true,"text":"The second study was a multicenter, randomized, double-blind, placebo-controlled,","text_display":"\n\nThe second study was a multicenter, randomized, double-blind, placebo-controlled,","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[1876,563],[1876,614],[245,614]],"region":{"top_left_x":244,"top_left_y":562,"width":1632,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10c9ebe5b69f4fa3aa1e33f3eb7735b6","type":"text","conversion_output":true,"text":"parallel-group study comparing the efficacy, safety, tolerability, and pharmacokinetics of 2 doses","text_display":" parallel-group study comparing the efficacy, safety, tolerability, and pharmacokinetics of 2 doses","confidence":1,"confidence_rate":1},{"cnt":[[245,614],[1867,614],[1867,664],[245,664]],"region":{"top_left_x":244,"top_left_y":614,"width":1623,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"017d8a69315142c7a3ea507a57b4f53a","type":"text","conversion_output":true,"text":"of TEV-48125 with placebo in 297 patients with EM (Study LBR-101-022). Following a 28-day","text_display":" of TEV-48125 with placebo in 297 patients with EM (Study LBR-101-022). Following a 28-day","confidence":0.98291015625,"confidence_rate":0.9998223089794392},{"cnt":[[245,662],[1785,662],[1785,711],[245,711]],"region":{"top_left_x":244,"top_left_y":661,"width":1542,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7cdd256d62641358af2167f21c93965","type":"text","conversion_output":true,"text":"run-in period, participants were randomized and treated sc once monthly for 3 months. Two","text_display":" run-in period, participants were randomized and treated sc once monthly for 3 months. Two","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,711],[1798,711],[1798,761],[245,761]],"region":{"top_left_x":244,"top_left_y":711,"width":1555,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4c5fd5705234fc89af810c3b3b9b47d","type":"text","conversion_output":true,"text":"active doses were tested, 225 mg given monthly for 3 months and 675 mg given monthly for","text_display":" active doses were tested, 225 mg given monthly for 3 months and 675 mg given monthly for","confidence":1,"confidence_rate":1},{"cnt":[[245,761],[1850,761],[1850,810],[245,810]],"region":{"top_left_x":244,"top_left_y":760,"width":1606,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e64a07cc13d84f65b116ee095e78cdb6","type":"text","conversion_output":true,"text":"3 months. The mean change in number of migraine days at month 3 relative to baseline for both","text_display":" 3 months. The mean change in number of migraine days at month 3 relative to baseline for both","confidence":1,"confidence_rate":1},{"cnt":[[245,808],[1833,808],[1833,857],[245,857]],"region":{"top_left_x":244,"top_left_y":807,"width":1589,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ac636b5f2414203bb46ef880cb80f16","type":"text","conversion_output":true,"text":"TEV-48125 dose arms was significantly different from placebo at 3 (primary endpoint), 2, and","text_display":" TEV-48125 dose arms was significantly different from placebo at 3 (primary endpoint), 2, and","confidence":0.5595399009829407,"confidence_rate":0.9942104202032979},{"cnt":[[247,855],[1846,855],[1846,907],[247,907]],"region":{"top_left_x":247,"top_left_y":855,"width":1599,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"364073e8b9ee4da3838e8c308dd88da3","type":"text","conversion_output":true,"text":"1 months. Secondary and exploratory endpoints were also positive for the duration of the study.","text_display":" 1 months. Secondary and exploratory endpoints were also positive for the duration of the study.","confidence":1,"confidence_rate":1},{"cnt":[[245,907],[1828,907],[1828,956],[245,956]],"region":{"top_left_x":244,"top_left_y":906,"width":1585,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30454fd298c64863a0bc7664198c3900","type":"text","conversion_output":true,"text":"Both doses were well tolerated, and no serious treatment-related adverse events were reported.","text_display":" Both doses were well tolerated, and no serious treatment-related adverse events were reported.","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1871,954],[1871,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":953,"width":1628,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed1ba252100c447589818cfe99f5ac1b","type":"text","conversion_output":true,"text":"Most adverse events were mild to moderate and the lowest dose had a numerically lower number","text_display":" Most adverse events were mild to moderate and the lowest dose had a numerically lower number","confidence":1,"confidence_rate":1},{"cnt":[[245,1001],[1876,1001],[1876,1053],[245,1053]],"region":{"top_left_x":244,"top_left_y":1001,"width":1632,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7daa83086ef4bae873697fa2e479b6d","type":"text","conversion_output":true,"text":"of adverse events relatively to placebo. No safety signals were observed in the clinical laboratory","text_display":" of adverse events relatively to placebo. 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Risks of TEV-48125","text_display":"\n\n\\subsection*{1.4.1.1. Risks of TEV-48125}","confidence":0.9765737056732178,"confidence_rate":0.9992594914345908},{"cnt":[[245,1515],[1704,1515],[1704,1566],[245,1566]],"region":{"top_left_x":244,"top_left_y":1514,"width":1460,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1be5a78e2e2d4fc8b8296a354b0236c7","type":"text","conversion_output":true,"text":"Identified risks (adverse drug reactions) of TEV-48125 include injection site erythema,","text_display":"\n\nIdentified risks (adverse drug reactions) of TEV-48125 include injection site erythema,","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[245,1564],[1760,1564],[1760,1613],[245,1613]],"region":{"top_left_x":244,"top_left_y":1564,"width":1516,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"227d7346d95b4d4bbde78e41f87b0408","type":"text","conversion_output":true,"text":"administration site pain, injection site pain, injection site pruritus, injection site dermatitis,","text_display":" administration site pain, injection site pain, injection site pruritus, injection site dermatitis,","confidence":1,"confidence_rate":1},{"cnt":[[245,1611],[1837,1611],[1837,1663],[245,1663]],"region":{"top_left_x":244,"top_left_y":1611,"width":1593,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"688f277d00754659956b7dee9144eeef","type":"text","conversion_output":true,"text":"infusion-related reaction, and drug hypersensitivity. None of the identified risks are considered","text_display":" infusion-related reaction, and drug hypersensitivity. None of the identified risks are considered","confidence":1,"confidence_rate":1},{"cnt":[[245,1663],[513,1663],[513,1712],[245,1712]],"region":{"top_left_x":244,"top_left_y":1662,"width":270,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0587445046c64adf8d382e2b83886ea8","type":"text","conversion_output":true,"text":"important risks.","text_display":" important risks.","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1704,1732],[1704,1781],[245,1781]],"region":{"top_left_x":244,"top_left_y":1731,"width":1460,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"476d02e0636940f5ada8be2a048081de","type":"text","conversion_output":true,"text":"Potential risks for TEV-48125 are perivascular inflammation; development of antidrug","text_display":"\n\nPotential risks for TEV-48125 are perivascular inflammation; development of antidrug","confidence":1,"confidence_rate":1},{"cnt":[[245,1779],[1727,1779],[1727,1828],[245,1828]],"region":{"top_left_x":244,"top_left_y":1778,"width":1484,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49cf1b76250b48b3a46b28af818a231e","type":"text","conversion_output":true,"text":"antibodies (ADAs); liver enzyme elevations; and cardiovascular consequences of CGRP","text_display":" antibodies (ADAs); liver enzyme elevations; and cardiovascular consequences of CGRP","confidence":1,"confidence_rate":1},{"cnt":[[245,1826],[1807,1826],[1807,1880],[245,1880]],"region":{"top_left_x":244,"top_left_y":1826,"width":1563,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69de11f4199f467caed910affd03bc46","type":"text","conversion_output":true,"text":"inhibition, including effects on blood pressure, heart rate, or other cardiovascular parameters.","text_display":" inhibition, including effects on blood pressure, heart rate, or other cardiovascular parameters.","confidence":1,"confidence_rate":1},{"cnt":[[245,1895],[1863,1895],[1863,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1894,"width":1619,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b5bdf8385a7455cb64cf1c48e1cdc28","type":"text","conversion_output":true,"text":"As described in Section 1.3.2.2, sc TEV-48125 has generally been well tolerated over the ranges","text_display":"\nAs described in Section 1.3.2.2, sc TEV-48125 has generally been well tolerated over the ranges","confidence":1,"confidence_rate":1},{"cnt":[[245,1946],[1790,1946],[1790,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1946,"width":1546,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b49532594e734b3f990831df77a1331f","type":"text","conversion_output":true,"text":"of doses evaluated (single doses of 0.02 to 2000 mg in healthy volunteers, multiple doses of","text_display":" of doses evaluated (single doses of 0.02 to 2000 mg in healthy volunteers, multiple doses of","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[245,1994],[1828,1994],[1828,2047],[245,2047]],"region":{"top_left_x":244,"top_left_y":1993,"width":1585,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30bc658973874c548a51bef05bc64df0","type":"text","conversion_output":true,"text":"30 to 300 mg in healthy volunteers, and multiple doses of 225 to 900 mg in migraine patients).","text_display":" 30 to 300 mg in healthy volunteers, and multiple doses of 225 to 900 mg in migraine patients).","confidence":1,"confidence_rate":1},{"cnt":[[245,2041],[1830,2041],[1830,2093],[245,2093]],"region":{"top_left_x":244,"top_left_y":2041,"width":1587,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13a6e10eae2f4924bf2871750eaf455a","type":"text","conversion_output":true,"text":"The most common treatment-emergent adverse events were mild to moderate transient general","text_display":" The most common treatment-emergent adverse events were mild to moderate transient general","confidence":1,"confidence_rate":1},{"cnt":[[245,2093],[1818,2093],[1818,2142],[245,2142]],"region":{"top_left_x":244,"top_left_y":2092,"width":1574,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e77586a951cc4b3c8d608d00e3d487ac","type":"text","conversion_output":true,"text":"administration site disorders/reactions. Other commonly reported treatment-emergent adverse","text_display":" administration site disorders/reactions. 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Benefits of TEV-48125","text_display":"\n\n\\subsection*{1.4.1.2. Benefits of TEV-48125}","confidence":0.9719187701120973,"confidence_rate":0.9991865296791711},{"cnt":[[245,2299],[1717,2299],[1717,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2298,"width":1473,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4094f24418dc40cc8685b0fd27f39d65","type":"text","conversion_output":true,"text":"As described in Section 1.3.2.2, results from Phase 2 clinical studies have demonstrated","text_display":"\n\nAs described in Section 1.3.2.2, results from Phase 2 clinical studies have demonstrated","confidence":1,"confidence_rate":1},{"cnt":[[245,2346],[1682,2346],[1682,2398],[245,2398]],"region":{"top_left_x":244,"top_left_y":2346,"width":1439,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c0d58925d274d01a6387bc749789e8c","type":"text","conversion_output":true,"text":"statistically significant reductions in mean headache hours after 1,2 , and 3 months of","text_display":" statistically significant reductions in mean headache hours after 1,2 , and 3 months of","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[245,2398],[1798,2398],[1798,2447],[245,2447]],"region":{"top_left_x":244,"top_left_y":2397,"width":1555,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"978b905b614f42b7b23397fc97117899","type":"text","conversion_output":true,"text":"TEV-48125 treatment in patients with CM and statistically significant reductions in monthly","text_display":" TEV-48125 treatment in patients with CM and statistically significant reductions in monthly","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"417488db575c44b582c1f9f682eff6be","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":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-039","page":39,"lines":[{"cnt":[[1109,125],[1880,125],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e6cb63d89124913b2d3e9107ab0a0cc","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a95534074fd74dd1b2da17eeb0ba1aad","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,174],[1880,174],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":174,"width":493,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cb0715887e4438799a71c2ec80a0624","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[1863,251],[1863,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1619,"height":52},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c201d1212994747ae7228ba2b832278","type":"text","conversion_output":true,"text":"migraine days after 1, 2, and 3 months of TEV-48125 treatment in patients with EM. Results for","text_display":"\nmigraine days after 1, 2, and 3 months of TEV-48125 treatment in patients with EM. Results for","confidence":0.9678976004943252,"confidence_rate":0.9996801591804305},{"cnt":[[245,301],[1783,301],[1783,354],[245,354]],"region":{"top_left_x":244,"top_left_y":300,"width":1540,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7fd0730cf35d48138c8438b573f89065","type":"text","conversion_output":true,"text":"several secondary/exploratory endpoints also showed TEV-48125 to be superior to placebo.","text_display":" several secondary/exploratory endpoints also showed TEV-48125 to be superior to placebo.","confidence":0.99462890625,"confidence_rate":0.9999420923226003},{"cnt":[[241,385],[1371,385],[1371,449],[241,449]],"region":{"top_left_x":240,"top_left_y":384,"width":1131,"height":66},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7f1196e8cd1454586cf8f7a9caaa15c","type":"section_header","conversion_output":false,"children_ids":["614669b6d2914679965ade3d7b78beb2"],"text":"","text_display":""},{"cnt":[[245,391],[1364,391],[1364,445],[245,445]],"region":{"top_left_x":244,"top_left_y":391,"width":1121,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"614669b6d2914679965ade3d7b78beb2","type":"text","conversion_output":true,"parent_id":"a7f1196e8cd1454586cf8f7a9caaa15c","text":"1.4.2. Overall Risk and Benefit Assessment for This Study","text_display":"\n\n\\subsection*{1.4.2. Overall Risk and Benefit Assessment for This Study}","confidence":0.6953125,"confidence_rate":0.9941559514334748},{"cnt":[[245,460],[1828,460],[1828,509],[245,509]],"region":{"top_left_x":244,"top_left_y":459,"width":1585,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d0bf717751742e688ba2e0fdc5d5ce3","type":"text","conversion_output":true,"text":"Based on the current safety profile and the demonstrated efficacy of the sc TEV-48125 dosage","text_display":"\n\nBased on the current safety profile and the demonstrated efficacy of the sc TEV-48125 dosage","confidence":1,"confidence_rate":1},{"cnt":[[245,507],[1442,507],[1442,559],[245,559]],"region":{"top_left_x":244,"top_left_y":507,"width":1198,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abd969311e2847969df9e324de6b6203","type":"text","conversion_output":true,"text":"form, the overall risk and benefit assessment for this study is favorable.","text_display":" form, the overall risk and benefit assessment for this study is favorable.","confidence":1,"confidence_rate":1},{"cnt":[[241,593],[1096,593],[1096,664],[241,664]],"region":{"top_left_x":240,"top_left_y":592,"width":856,"height":72},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4587fb8affa34c3095e802218e396f07","type":"section_header","conversion_output":false,"children_ids":["b59ff5fa68b94f0aa25a79013b305e30"],"text":"","text_display":""},{"cnt":[[245,602],[1089,602],[1089,660],[245,660]],"region":{"top_left_x":244,"top_left_y":601,"width":846,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b59ff5fa68b94f0aa25a79013b305e30","type":"text","conversion_output":true,"parent_id":"4587fb8affa34c3095e802218e396f07","text":"1.5. Selection of Drugs and Dosages","text_display":"\n\n\\subsection*{1.5. Selection of Drugs and Dosages}","confidence":0.94384765625,"confidence_rate":0.9985562804933783},{"cnt":[[245,675],[1566,675],[1566,726],[245,726]],"region":{"top_left_x":244,"top_left_y":674,"width":1323,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d835ace55c24851b90d23c67f4226c1","type":"text","conversion_output":true,"text":"A detailed description of study drug administration is presented in Section 5.1.","text_display":"\n\nA detailed description of study drug administration is presented in Section 5.1.","confidence":1,"confidence_rate":1},{"cnt":[[241,761],[1141,761],[1141,823],[241,823]],"region":{"top_left_x":240,"top_left_y":760,"width":901,"height":63},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f67b92089ed3471481b4b157855e4634","type":"section_header","conversion_output":false,"children_ids":["538196d5ca53414e921a744c32d52e65"],"text":"","text_display":""},{"cnt":[[245,765],[1137,765],[1137,816],[245,816]],"region":{"top_left_x":244,"top_left_y":764,"width":893,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"538196d5ca53414e921a744c32d52e65","type":"text","conversion_output":true,"parent_id":"f67b92089ed3471481b4b157855e4634","text":"1.5.1. Justification for Dosage of Active Drug","text_display":"\n\n\\subsection*{1.5.1. Justification for Dosage of Active Drug}","confidence":0.91259765625,"confidence_rate":0.9982082702303612},{"cnt":[[245,834],[1779,834],[1779,885],[245,885]],"region":{"top_left_x":244,"top_left_y":833,"width":1535,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f50449d817164f73b2af7f221d0a1a18","type":"text","conversion_output":true,"text":"The TEV-48125 doses and dosing regimens to be evaluated in this double-blind study were","text_display":"\n\nThe TEV-48125 doses and dosing regimens to be evaluated in this double-blind study were","confidence":0.998046875,"confidence_rate":0.9999787498471376},{"cnt":[[245,885],[1532,885],[1532,935],[245,935]],"region":{"top_left_x":244,"top_left_y":885,"width":1288,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1309abee911b465ab611a145f6b2a05c","type":"text","conversion_output":true,"text":"selected on the basis of animal pharmacodynamic and pharmacokinetic data,","text_display":" selected on the basis of animal pharmacodynamic and pharmacokinetic data,","confidence":1,"confidence_rate":1},{"cnt":[[245,932],[1828,932],[1828,982],[245,982]],"region":{"top_left_x":244,"top_left_y":932,"width":1585,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43c50c6ba52a426782f3663e06760324","type":"text","conversion_output":true,"text":"6 pharmacokinetic/safety studies in healthy volunteers, 2 safety/efficacy study in patients with","text_display":" 6 pharmacokinetic/safety studies in healthy volunteers, 2 safety/efficacy study in patients with","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,980],[1878,980],[1878,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":979,"width":1634,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf38530a9b1d4b2c9086dccde215eb71","type":"text","conversion_output":true,"text":"migraine, and population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling and","text_display":" migraine, and population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling and","confidence":1,"confidence_rate":1},{"cnt":[[245,1031],[455,1031],[455,1074],[245,1074]],"region":{"top_left_x":244,"top_left_y":1031,"width":212,"height":44},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d58cecc91704296bb3fde1ca2c8f9fb","type":"text","conversion_output":true,"text":"simulations.","text_display":" simulations.","confidence":1,"confidence_rate":1},{"cnt":[[245,1096],[1848,1096],[1848,1149],[245,1149]],"region":{"top_left_x":244,"top_left_y":1095,"width":1604,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5e77ee7febd4c419bd0fb31ad4b858a","type":"text","conversion_output":true,"text":"The pharmacodynamics of TEV-48125 were examined in animal models by characterization of","text_display":"\n\nThe pharmacodynamics of TEV-48125 were examined in animal models by characterization of","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[245,1147],[1783,1147],[1783,1197],[245,1197]],"region":{"top_left_x":244,"top_left_y":1147,"width":1540,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"282d5e57a10c4e5cb961b5aae6d7ec0e","type":"text","conversion_output":true,"text":"the ability of TEV-48125 to block CGRP functions in vivo (see Section 1.3.1). Specifically,","text_display":" the ability of TEV-48125 to block CGRP functions in vivo (see Section 1.3.1). Specifically,","confidence":0.9980475902557373,"confidence_rate":0.9999796427261641},{"cnt":[[245,1195],[1618,1195],[1618,1246],[245,1246]],"region":{"top_left_x":244,"top_left_y":1194,"width":1374,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d737244a2bff41458477b493661306fe","type":"text","conversion_output":true,"text":"neurogenic vasodilation by capsaicin application on the skin was used to induce a","text_display":" neurogenic vasodilation by capsaicin application on the skin was used to induce a","confidence":0.9990234375,"confidence_rate":0.9999886391383975},{"cnt":[[245,1244],[1826,1244],[1826,1296],[245,1296]],"region":{"top_left_x":244,"top_left_y":1243,"width":1583,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f2d3a3609114147a0a124ba4f5758d8","type":"text","conversion_output":true,"text":"CGRP-mediated increase in vasodilatation or skin blood flow in cynomolgus monkeys. In this","text_display":" CGRP-mediated increase in vasodilatation or skin blood flow in cynomolgus monkeys. In this","confidence":0.984375,"confidence_rate":0.9998342415608363},{"cnt":[[245,1293],[1876,1293],[1876,1343],[245,1343]],"region":{"top_left_x":244,"top_left_y":1293,"width":1632,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75e60edeebc14abf988c94033ea1e3d1","type":"text","conversion_output":true,"text":"study, TEV-48125 (dosed as a single iv bolus at 1,10 , or \\(100 mg / kg\\) ) produced a dose-dependent","text_display":" study, TEV-48125 (dosed as a single iv bolus at 1,10 , or \\(100 mg / kg\\) ) produced a dose-dependent","confidence":0.9965834617614746,"confidence_rate":0.9999691681515914},{"cnt":[[245,1341],[1755,1341],[1755,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1340,"width":1512,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba810de37e4742a98f52312be929edc2","type":"text","conversion_output":true,"text":"inhibition of the capsaicin-induced skin flare response. The magnitude and duration of the","text_display":" inhibition of the capsaicin-induced skin flare response. The magnitude and duration of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1388],[1779,1388],[1779,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1387,"width":1535,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3400088f6e634a89b4b88ac3e691539c","type":"text","conversion_output":true,"text":"inhibition produced by TEV-48125 were dose-dependent, with the 10 and \\(100 mg / kg\\) doses","text_display":" inhibition produced by TEV-48125 were dose-dependent, with the 10 and \\(100 mg / kg\\) doses","confidence":0.8740234375,"confidence_rate":0.9986677388694158},{"cnt":[[245,1439],[1850,1439],[1850,1489],[245,1489]],"region":{"top_left_x":244,"top_left_y":1439,"width":1606,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"401c9398b2ea4b548aa1281fcdd73e39","type":"text","conversion_output":true,"text":"showing inhibition out to 56 days postdose. Based on body surface area conversion, these doses","text_display":" showing inhibition out to 56 days postdose. Based on body surface area conversion, these doses","confidence":1,"confidence_rate":1},{"cnt":[[245,1487],[1846,1487],[1846,1540],[245,1540]],"region":{"top_left_x":244,"top_left_y":1486,"width":1602,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c521ebd92e0249ddbe1eebf9321d0d05","type":"text","conversion_output":true,"text":"are equivalent to single doses of approximately 225 and 2000 mg , respectively, in patients with","text_display":" are equivalent to single doses of approximately 225 and 2000 mg , respectively, in patients with","confidence":1,"confidence_rate":1},{"cnt":[[245,1538],[1833,1538],[1833,1588],[245,1588]],"region":{"top_left_x":244,"top_left_y":1538,"width":1589,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc7a6d60cda14d97bd08ef9b3f4dca04","type":"text","conversion_output":true,"text":"migraine. Therefore, the \\(225- mg\\) dose was considered to be a reasonable and pragmatic choice","text_display":" migraine. Therefore, the \\(225- mg\\) dose was considered to be a reasonable and pragmatic choice","confidence":1,"confidence_rate":1},{"cnt":[[245,1586],[1106,1586],[1106,1635],[245,1635]],"region":{"top_left_x":244,"top_left_y":1585,"width":863,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a9e01ce37014aa4917765c66b408b64","type":"text","conversion_output":true,"text":"for the lowest dose with potential for effectiveness.","text_display":" for the lowest dose with potential for effectiveness.","confidence":1,"confidence_rate":1},{"cnt":[[245,1654],[1876,1654],[1876,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1654,"width":1632,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f3380d735814d3d91c866498f758495","type":"text","conversion_output":true,"text":"Based on data from the pharmacokinetic and pharmacodynamic studies in animal models and the","text_display":"\n\nBased on data from the pharmacokinetic and pharmacodynamic studies in animal models and the","confidence":1,"confidence_rate":1},{"cnt":[[245,1702],[1732,1702],[1732,1755],[245,1755]],"region":{"top_left_x":244,"top_left_y":1701,"width":1488,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fada058eb06146b9844d90b477b68220","type":"text","conversion_output":true,"text":"pharmacokinetics, safety, and tolerability of TEV-48125 from Phase 1 studies in healthy","text_display":" pharmacokinetics, safety, and tolerability of TEV-48125 from Phase 1 studies in healthy","confidence":0.8671875,"confidence_rate":0.9985011237796746},{"cnt":[[245,1749],[1858,1749],[1858,1803],[245,1803]],"region":{"top_left_x":244,"top_left_y":1748,"width":1615,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3537cf6ed90049b8aa4da21f2c691f2d","type":"text","conversion_output":true,"text":"volunteers, 2 dose regimens were selected for sc administration in the Phase 2b study in patients","text_display":" volunteers, 2 dose regimens were selected for sc administration in the Phase 2b study in patients","confidence":0.99365234375,"confidence_rate":0.9999393552838918},{"cnt":[[245,1800],[1676,1800],[1676,1850],[245,1850]],"region":{"top_left_x":244,"top_left_y":1800,"width":1432,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a831e32ffcd94859b85a414305ad1af4","type":"text","conversion_output":true,"text":"with EM for a treatment period of 3 months. The 2 active arms were 225 and 675 mg","text_display":" with EM for a treatment period of 3 months. The 2 active arms were 225 and 675 mg","confidence":0.994140625,"confidence_rate":0.9999387872018195},{"cnt":[[245,1848],[1833,1848],[1833,1899],[245,1899]],"region":{"top_left_x":244,"top_left_y":1847,"width":1589,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"096b699836e04e31a12290e6392d63c4","type":"text","conversion_output":true,"text":"administered monthly. The results of the Phase 2b study demonstrated that both dose regimens","text_display":" administered monthly. The results of the Phase 2b study demonstrated that both dose regimens","confidence":1,"confidence_rate":1},{"cnt":[[245,1895],[1833,1895],[1833,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1894,"width":1589,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ef6a753da924261abfb1ddcf69abf81","type":"text","conversion_output":true,"text":"are effective, safe, and well tolerated by EM patients. The mean change in number of migraine","text_display":" are effective, safe, and well tolerated by EM patients. 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Classification of Headache","text_display":" inclusive, with a history of migraine (as defined by International Classification of Headache","confidence":1,"confidence_rate":1},{"cnt":[[245,1927],[1878,1927],[1878,1983],[245,1983]],"region":{"top_left_x":244,"top_left_y":1927,"width":1634,"height":57},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff51bd0f33d345d3b84ea0faed1308d1","type":"text","conversion_output":true,"text":"Disorders, \\(3{ }^{\\text {rd }}\\) revision [ICHD-3] criteria [Classification Committee of the IHS, 2013]) for at least","text_display":" Disorders, \\(3{ }^{\\text {rd }}\\) revision [ICHD-3] criteria [Classification Committee of the IHS, 2013]) for at 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recorded daily during a 28-day run-in period in an electronic headache diary device.","confidence":0.65478515625,"confidence_rate":0.9952534567572214},{"cnt":[[245,2101],[1850,2101],[1850,2151],[245,2151]],"region":{"top_left_x":244,"top_left_y":2101,"width":1606,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9254488590e046c784a005d7987198e4","type":"text","conversion_output":true,"text":"Because headache consortium guidelines recommend preventive therapies for patients with EM","text_display":"\n\nBecause headache consortium guidelines recommend preventive therapies for patients with EM","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[245,2148],[1811,2148],[1811,2198],[245,2198]],"region":{"top_left_x":244,"top_left_y":2148,"width":1568,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3438b2e77dad430ab12d7e414b11dbf6","type":"text","conversion_output":true,"text":"occurring on 4 or more days per month due to the frequency of headaches and high degree of","text_display":" occurring on 4 or more days per month due to the frequency of headaches and high degree of","confidence":0.9951171875,"confidence_rate":0.9999500545904081},{"cnt":[[245,2196],[1833,2196],[1833,2245],[245,2245]],"region":{"top_left_x":244,"top_left_y":2195,"width":1589,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0d4ce17533e40519d147d2e8ebd7e99","type":"text","conversion_output":true,"text":"disability, patients using no more than 1 preventive medication at the time of study enrollment","text_display":" disability, patients using no more than 1 preventive medication at the time of study enrollment","confidence":0.9980475902557373,"confidence_rate":0.999981026217086},{"cnt":[[245,2245],[1850,2245],[1850,2290],[245,2290]],"region":{"top_left_x":244,"top_left_y":2245,"width":1606,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe3eef91436b40309c0748170ea3ef00","type":"text","conversion_output":true,"text":"will be allowed to remain on the medication if the medication has at least moderate evidence of","text_display":" will be allowed to remain on the medication if the medication has at least moderate evidence of","confidence":1,"confidence_rate":1},{"cnt":[[245,2295],[1837,2295],[1837,2344],[245,2344]],"region":{"top_left_x":244,"top_left_y":2294,"width":1593,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f8d1ebda56349acbb7756b1e974817c","type":"text","conversion_output":true,"text":"efficacy for migraine (Silberstein et al 2012). Patients must be on a stable dose and regimen of","text_display":" efficacy for migraine (Silberstein et al 2012). Patients must be on a stable dose and regimen of","confidence":1,"confidence_rate":1},{"cnt":[[245,2342],[1863,2342],[1863,2391],[245,2391]],"region":{"top_left_x":244,"top_left_y":2341,"width":1619,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5740754d36eb470398d026711c7cd668","type":"text","conversion_output":true,"text":"the preventive medication for at least 2 months prior to study entry (ie, before the run-in period),","text_display":" the preventive medication for at least 2 months prior to study entry (ie, before the run-in period),","confidence":1,"confidence_rate":1},{"cnt":[[245,2393],[1785,2393],[1785,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2393,"width":1542,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89b48544e70b4138a962de4a2425e6f3","type":"text","conversion_output":true,"text":"and they cannot change the dose and regimen during the study. The total number of patients","text_display":" and they cannot change the dose and regimen during the study. The total number of patients","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d69bcafbd93049a19d664c742d0da911","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":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-041","page":41,"lines":[{"cnt":[[1109,125],[1880,125],[1880,176],[1109,176]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef031195c40d4d07ac385b606255b6d3","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a47c2a4507a4090ad1256e034e05198","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,174],[1880,174],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":174,"width":493,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f6e9f64d53d4494ac4e03c1573821bb","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[1833,251],[1833,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1589,"height":52},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fa64cc5883d48829edff55a510756a7","type":"text","conversion_output":true,"text":"receiving concomitant preventive medication during the study will not exceed \\(30 \\%\\) of the total","text_display":"\nreceiving concomitant preventive medication during the study will not exceed \\(30 \\%\\) of the total","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,301],[664,301],[664,352],[245,352]],"region":{"top_left_x":244,"top_left_y":300,"width":420,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce3f01cc1a0a4430aa8430a1b403d588","type":"text","conversion_output":true,"text":"sample size of the study.","text_display":" sample size of the study.","confidence":1,"confidence_rate":1},{"cnt":[[245,370],[1863,370],[1863,421],[245,421]],"region":{"top_left_x":244,"top_left_y":369,"width":1619,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d030b97439414c6987c1635d9ff4987d","type":"text","conversion_output":true,"text":"Episodic migraine is a highly prevalent condition and a significant cause of disability, especially","text_display":"\nEpisodic migraine is a highly prevalent condition and a significant cause of disability, especially","confidence":1,"confidence_rate":1},{"cnt":[[245,419],[1841,419],[1841,471],[245,471]],"region":{"top_left_x":244,"top_left_y":418,"width":1598,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06d1654d71504d7584533f8e6ec2e509","type":"text","conversion_output":true,"text":"in patients with high frequency EM. Furthermore, \\(3 \\%\\) to \\(6 \\%\\) of patients with EM evolve in any","text_display":" in patients with high frequency EM. Furthermore, \\(3 \\%\\) to \\(6 \\%\\) of patients with EM evolve in any","confidence":0.951171875,"confidence_rate":0.9995093311824641},{"cnt":[[245,468],[1777,468],[1777,518],[245,518]],"region":{"top_left_x":244,"top_left_y":468,"width":1533,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d19904c29196401fa5b58499377ded73","type":"text","conversion_output":true,"text":"given year to CM, which is significantly more disabling (Scher et al 2003). Risk factors for","text_display":" given year to CM, which is significantly more disabling (Scher et al 2003). Risk factors for","confidence":1,"confidence_rate":1},{"cnt":[[245,516],[1813,516],[1813,569],[245,569]],"region":{"top_left_x":244,"top_left_y":515,"width":1570,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a3e00c5a4264c7f935d03ecbb6ea02a","type":"text","conversion_output":true,"text":"evolution from EM to CM include high headache frequency and the use of specific classes of","text_display":" evolution from EM to CM include high headache frequency and the use of specific classes of","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[1433,563],[1433,614],[245,614]],"region":{"top_left_x":244,"top_left_y":562,"width":1190,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"187fa1251fd746678707913830441c5a","type":"text","conversion_output":true,"text":"acute medication, including barbiturates and opiates (Bigal et al 2008).","text_display":" acute medication, including barbiturates and opiates (Bigal et al 2008).","confidence":0.99951171875,"confidence_rate":0.9999936571565041},{"cnt":[[245,632],[1751,632],[1751,685],[245,685]],"region":{"top_left_x":244,"top_left_y":631,"width":1507,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c26fe50741474b4bb749c7788031bbcf","type":"text","conversion_output":true,"text":"Aside from limiting migraine-associated disability, it is expected that effective preventive","text_display":"\nAside from limiting migraine-associated disability, it is expected that effective preventive","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1837,683],[1837,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1593,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df8c545dc57e481699fa291e0b8c1e52","type":"text","conversion_output":true,"text":"migraine medications should decrease the likelihood that a patient with EM will evolve to CM.","text_display":" migraine medications should decrease the likelihood that a patient with EM will evolve to CM.","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1772,730],[1772,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1529,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f20216b243749739c6d754e246fb1a4","type":"text","conversion_output":true,"text":"However, available preventive medications have variable response rates and are associated","text_display":" However, available preventive medications have variable response rates and are associated","confidence":1,"confidence_rate":1},{"cnt":[[245,778],[1798,778],[1798,831],[245,831]],"region":{"top_left_x":244,"top_left_y":777,"width":1555,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb6635b996c248f2b4dbbf52d0b257db","type":"text","conversion_output":true,"text":"adverse effects. In addition, only 4 are approved for preventive treatment of EM (Lipton and","text_display":" adverse effects. In addition, only 4 are approved for preventive treatment of EM (Lipton and","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[935,829],[935,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":691,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70c12c62c0c1405a8d359374cdb8406b","type":"text","conversion_output":true,"text":"Silberstein 2015, Shamiliyan et al 2013).","text_display":" Silberstein 2015, Shamiliyan et al 2013).","confidence":0.99951171875,"confidence_rate":0.9999893826542317},{"cnt":[[243,915],[1072,915],[1072,982],[243,982]],"region":{"top_left_x":242,"top_left_y":915,"width":831,"height":67},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fe1456013a046b292ef35c827094a12","type":"section_header","conversion_output":false,"children_ids":["84a018f8fdf545a5a26998b8a2878c67"],"text":"","text_display":""},{"cnt":[[247,920],[1068,920],[1068,978],[247,978]],"region":{"top_left_x":247,"top_left_y":919,"width":821,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84a018f8fdf545a5a26998b8a2878c67","type":"text","conversion_output":true,"parent_id":"0fe1456013a046b292ef35c827094a12","text":"1.8. Location and Timing of Study","text_display":"\n\n\\subsection*{1.8. Location and Timing of Study}","confidence":0.99853515625,"confidence_rate":0.9999614239629561},{"cnt":[[245,993],[1858,993],[1858,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":992,"width":1615,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ed68f77374348418fbf21aa14c5bb87","type":"text","conversion_output":true,"text":"This study is planned to be conducted in approximately 15 countries, including North and South","text_display":"\n\nThis study is planned to be conducted in approximately 15 countries, including North and South","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1044],[1837,1044],[1837,1094],[245,1094]],"region":{"top_left_x":244,"top_left_y":1044,"width":1593,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7dfc7d9d34704e489d12488bd51dee15","type":"text","conversion_output":true,"text":"America, the European Union, and Asia Pacific, at approximately 140 centers. It is expected to","text_display":" America, the European Union, and Asia Pacific, at approximately 140 centers. It is expected to","confidence":1,"confidence_rate":1},{"cnt":[[245,1091],[1841,1091],[1841,1143],[245,1143]],"region":{"top_left_x":244,"top_left_y":1091,"width":1598,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be27310fb88345388cbdbf1171b59728","type":"text","conversion_output":true,"text":"start in in 1Q 2016 and have a duration of approximately 21 months. Additional centers will be","text_display":" start in in 1Q 2016 and have a duration of approximately 21 months. Additional centers will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1141],[1858,1141],[1858,1192],[245,1192]],"region":{"top_left_x":244,"top_left_y":1140,"width":1615,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aaa591629a9743c596479e7dc9c3b8e1","type":"text","conversion_output":true,"text":"added, if needed. Expected duration of the study may also be extended dependent on enrollment","text_display":" added, if needed. Expected duration of the study may also be extended dependent on enrollment","confidence":1,"confidence_rate":1},{"cnt":[[245,1190],[649,1190],[649,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1190,"width":405,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cb82b1081f74dd9af520f5faa424d8e","type":"text","conversion_output":true,"text":"speed and other factors.","text_display":" speed and other factors.","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d22c46250552475e8a344d9233d667a1","type":"page_info","conversion_output":false,"text":"40","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-042","page":42,"lines":[{"cnt":[[1109,127],[1880,127],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":126,"width":772,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55d25ff0d2a3421fab8643cd796e5289","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0ad0da1c006482c8e2dbb752b706699","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d10cb7be61754d7f8d008a7af4cb9a74","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,314],[1652,314],[1652,370],[241,370]],"region":{"top_left_x":240,"top_left_y":313,"width":1413,"height":57},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"159ed098f07b477da054da5f0e11c446","type":"section_header","conversion_output":false,"children_ids":["39ee24a8e980451e961025b1ca80c181"],"text":"","text_display":""},{"cnt":[[245,318],[1646,318],[1646,365],[245,365]],"region":{"top_left_x":244,"top_left_y":317,"width":1402,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39ee24a8e980451e961025b1ca80c181","type":"text","conversion_output":true,"parent_id":"159ed098f07b477da054da5f0e11c446","text":"2. 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Biomarker Endpoints}","confidence":0.822265625,"confidence_rate":0.9940874937842209},{"cnt":[[243,318],[926,318],[926,372],[243,372]],"region":{"top_left_x":242,"top_left_y":317,"width":684,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b16b44a5779745448fceeafb1c55d25b","type":"text","conversion_output":true,"text":"The biomarker endpoints are as follows:","text_display":"\n\nThe biomarker endpoints are as follows:","confidence":1,"confidence_rate":1},{"cnt":[[367,391],[1813,391],[1813,445],[367,445]],"region":{"top_left_x":367,"top_left_y":391,"width":1447,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65d2528ac53241b281a159dde901dca8","type":"text","conversion_output":true,"text":"- exploratory correlation of specific genetic polymorphisms and headache response,","text_display":"\n- exploratory correlation of specific genetic polymorphisms and headache 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treatment,","confidence":1,"confidence_rate":1},{"cnt":[[430,563],[1815,563],[1815,612],[430,612]],"region":{"top_left_x":429,"top_left_y":562,"width":1387,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cef6fba7463749aa86a51612103fb86f","type":"text","conversion_output":true,"text":"migraine onset/severity, and response status (ie, responders versus nonresponders)","text_display":" migraine onset/severity, and response status (ie, responders versus nonresponders)","confidence":1,"confidence_rate":1},{"cnt":[[367,632],[1760,632],[1760,685],[367,685]],"region":{"top_left_x":367,"top_left_y":631,"width":1393,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ebabbc1a48d45f69191ad290e29a770","type":"text","conversion_output":true,"text":"- correlation of exploratory biofluid biomarkers with TEV-48125 concentrations","text_display":"\n- correlation of exploratory biofluid biomarkers with TEV-48125 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General Design and Study Schema}","confidence":0.943359375,"confidence_rate":0.9985788651263212},{"cnt":[[245,490],[1803,490],[1803,539],[245,539]],"region":{"top_left_x":244,"top_left_y":489,"width":1559,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cd076e199a046a9b76eea671e6cd451","type":"text","conversion_output":true,"text":"This is a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group","text_display":"\n\nThis is a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group","confidence":0.82421875,"confidence_rate":0.9980090020834419},{"cnt":[[245,537],[1837,537],[1837,587],[245,587]],"region":{"top_left_x":244,"top_left_y":537,"width":1593,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8020387b4a844cafbdc70c2762b955ee","type":"text","conversion_output":true,"text":"study to compare the safety, tolerability, and efficacy of 2 dose regimens of sc TEV-48125 and","text_display":" study to compare the safety, tolerability, and efficacy of 2 dose regimens of sc TEV-48125 and","confidence":0.95849609375,"confidence_rate":0.9995845001490504},{"cnt":[[245,587],[1852,587],[1852,638],[245,638]],"region":{"top_left_x":244,"top_left_y":586,"width":1608,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"949ace183fc541f5ae0f8219bd4bc810","type":"text","conversion_output":true,"text":"placebo in adults with EM. The study consists of a screening visit, a 28 -day run-in period, and a","text_display":" placebo in adults with EM. The study consists of a screening visit, a 28 -day run-in period, and a","confidence":0.81298828125,"confidence_rate":0.9980487120562032},{"cnt":[[245,636],[1811,636],[1811,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1568,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c7ec9b28d9e464b9463d793b66fda71","type":"text","conversion_output":true,"text":"12-week (84-day) treatment period, including a final evaluation at week 12 (end-of-treatment","text_display":" 12-week (84-day) treatment period, including a final evaluation at week 12 (end-of-treatment","confidence":0.9550051689147949,"confidence_rate":0.9995397207006341},{"cnt":[[245,683],[1594,683],[1594,735],[245,735]],"region":{"top_left_x":244,"top_left_y":683,"width":1351,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a71f87e39f0944869c14ccccffa59796","type":"text","conversion_output":true,"text":"[EOT] visit, approximately 4 weeks [28 days] after the final dose of study drug).","text_display":" [EOT] visit, approximately 4 weeks [28 days] after the final dose of study drug).","confidence":0.9707307815551758,"confidence_rate":0.999666279201799},{"cnt":[[245,752],[1738,752],[1738,804],[245,804]],"region":{"top_left_x":244,"top_left_y":751,"width":1495,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d327b0540af46829b2ce55eac32bb88","type":"text","conversion_output":true,"text":"The study population will be composed of female and male patients, aged 18 to 70 years,","text_display":"\nThe study population will be composed of female and male patients, aged 18 to 70 years,","confidence":1,"confidence_rate":1},{"cnt":[[245,801],[1880,801],[1880,853],[245,853]],"region":{"top_left_x":244,"top_left_y":801,"width":1636,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45e02bdcf2044522b092f43e0ba6215d","type":"text","conversion_output":true,"text":"inclusive, with a history of migraine (as defined by ICHD-3 criteria [Classification Committee of","text_display":" inclusive, with a history of migraine (as defined by ICHD-3 criteria [Classification Committee of","confidence":1,"confidence_rate":1},{"cnt":[[245,851],[1876,851],[1876,900],[245,900]],"region":{"top_left_x":244,"top_left_y":850,"width":1632,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"caf1d4166a334cd2a01ca6db2708eab4","type":"text","conversion_output":true,"text":"the IHS, 2013]) for at least 12 months prior to screening and EM prospectively documented via a","text_display":" the IHS, 2013]) for at least 12 months prior to screening and EM prospectively documented via a","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1846,898],[1846,950],[245,950]],"region":{"top_left_x":244,"top_left_y":898,"width":1602,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b9b2c962aac4e0d812d9237d767da47","type":"text","conversion_output":true,"text":"review of headache data recorded daily during a 28 -day run-in period in an electronic headache","text_display":" review of headache data recorded daily during a 28 -day run-in period in an electronic headache","confidence":0.611328125,"confidence_rate":0.9952335178976319},{"cnt":[[245,947],[466,947],[466,999],[245,999]],"region":{"top_left_x":244,"top_left_y":947,"width":223,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06bca4143d40417f87dbf2e170bd0eef","type":"text","conversion_output":true,"text":"diary device.","text_display":" diary 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efficacy","text_display":" allowed to remain on the medication if the medication has at least moderate evidence of efficacy","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1745,1113],[1745,1164],[245,1164]],"region":{"top_left_x":244,"top_left_y":1112,"width":1501,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4916657346514cdfb3f798b4410456bd","type":"text","conversion_output":true,"text":"for migraine (Silberstein et al 2012). Patients should not be using concomitant preventive","text_display":" for migraine (Silberstein et al 2012). Patients should not be using concomitant preventive","confidence":1,"confidence_rate":1},{"cnt":[[245,1162],[1835,1162],[1835,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1162,"width":1591,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8f210884c6249d1ad08626150c669dd","type":"text","conversion_output":true,"text":"migraine medications (presented in Appendix B) at the time of the screening visit, and will not","text_display":" migraine medications (presented in Appendix B) at the time of the screening visit, and will not","confidence":1,"confidence_rate":1},{"cnt":[[245,1212],[1687,1212],[1687,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1443,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fa4fd41ad4740f9992355fb31326d5a","type":"text","conversion_output":true,"text":"be allowed to initiate these medications after study start. A small subgroup of patients","text_display":" be allowed to initiate these medications after study start. A small subgroup of patients","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1760,1259],[1760,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1258,"width":1516,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"086e67a383844152bf5d06d46a4dfedf","type":"text","conversion_output":true,"text":"(approximately \\(30 \\%\\) ) will be allowed to use concomitant migraine preventive medications","text_display":" (approximately \\(30 \\%\\) ) will be allowed to use concomitant migraine preventive medications","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[245,1308],[1813,1308],[1813,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1308,"width":1570,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"103b4cee74fe42c485f929619a0251e4","type":"text","conversion_output":true,"text":"(presented in Appendix A), and no changes in these medications will be allowed until the last","text_display":" (presented in Appendix A), and no changes in these medications will be allowed until the last","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[245,1358],[1846,1358],[1846,1407],[245,1407]],"region":{"top_left_x":244,"top_left_y":1357,"width":1602,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f015a6b9af048b8ae0294e3f70754a4","type":"text","conversion_output":true,"text":"study assessments are complete. Patients will be allowed to use acute medications to treat acute","text_display":" study assessments are complete. Patients will be allowed to use acute medications to treat acute","confidence":1,"confidence_rate":1},{"cnt":[[245,1405],[711,1405],[711,1454],[245,1454]],"region":{"top_left_x":244,"top_left_y":1405,"width":468,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51b6e1fc1b234de5bb347b4da95b9012","type":"text","conversion_output":true,"text":"migraine attacks as needed.","text_display":" migraine attacks as needed.","confidence":1,"confidence_rate":1},{"cnt":[[245,1474],[1734,1474],[1734,1525],[245,1525]],"region":{"top_left_x":244,"top_left_y":1473,"width":1490,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2ac0abb324348e78ba446800f1e8482","type":"text","conversion_output":true,"text":"After completing the informed consent process (screening visit [visit 1]), patients will be","text_display":"\n\nAfter completing the informed consent process (screening visit [visit 1]), patients will be","confidence":0.99853515625,"confidence_rate":0.9999847301407262},{"cnt":[[245,1523],[1869,1523],[1869,1575],[245,1575]],"region":{"top_left_x":244,"top_left_y":1523,"width":1626,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acdeb741923745d98516715acd68beaf","type":"text","conversion_output":true,"text":"screened for eligibility. Eligible patients will enter a 28 -day run-in period. Headache information","text_display":" screened for eligibility. Eligible patients will enter a 28 -day run-in period. Headache information","confidence":0.888671875,"confidence_rate":0.9989077524362586},{"cnt":[[245,1573],[1858,1573],[1858,1622],[245,1622]],"region":{"top_left_x":244,"top_left_y":1572,"width":1615,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a32c047a7b594103832ab07d60e410f5","type":"text","conversion_output":true,"text":"will be captured daily throughout study participation using the electronic headache diary device.","text_display":" will be captured daily throughout study participation using the electronic headache diary device.","confidence":1,"confidence_rate":1},{"cnt":[[245,1620],[1835,1620],[1835,1671],[245,1671]],"region":{"top_left_x":244,"top_left_y":1619,"width":1591,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b76b7f4938df48058f88a982caef318e","type":"text","conversion_output":true,"text":"After completing the run-in period, patients will be asked to return to the study center on day 0","text_display":" After completing the run-in period, patients will be asked to return to the study center on day 0","confidence":1,"confidence_rate":1},{"cnt":[[245,1669],[1747,1669],[1747,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1669,"width":1503,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"577cb00a7b9a4b8ab602884a82320f81","type":"text","conversion_output":true,"text":"(visit 2). Patients who have confirmed EM with headache of any type on 6 to 14 days and","text_display":" (visit 2). Patients who have confirmed EM with headache of any type on 6 to 14 days and","confidence":1,"confidence_rate":1},{"cnt":[[245,1719],[1833,1719],[1833,1768],[245,1768]],"region":{"top_left_x":244,"top_left_y":1718,"width":1589,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8889f87ea5242cba00c42e9e9e495f0","type":"text","conversion_output":true,"text":"migraine on at least 4 days and meet all other eligibility criteria (including electronic headache","text_display":" migraine on at least 4 days and meet all other eligibility criteria (including electronic headache","confidence":1,"confidence_rate":1},{"cnt":[[245,1766],[1742,1766],[1742,1818],[245,1818]],"region":{"top_left_x":244,"top_left_y":1766,"width":1499,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5e701dd32d746869480ee51d0bd8b76","type":"text","conversion_output":true,"text":"diary compliance criteria during the 28 -day run-in period) will be randomly assigned in a","text_display":" diary compliance criteria during the 28 -day run-in period) will be randomly assigned in a","confidence":0.55419921875,"confidence_rate":0.9939953346177988},{"cnt":[[247,1815],[879,1815],[879,1867],[247,1867]],"region":{"top_left_x":247,"top_left_y":1815,"width":632,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fe86a39f2ed443c96ee37b25d9bc61a","type":"text","conversion_output":true,"text":"1:1:1 ratio to 1 of 3 treatment groups:","text_display":" 1:1:1 ratio to 1 of 3 treatment groups:","confidence":1,"confidence_rate":1},{"cnt":[[370,1886],[1311,1886],[1311,1938],[370,1938]],"region":{"top_left_x":369,"top_left_y":1886,"width":942,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad07841264ad482c844476538142842c","type":"text","conversion_output":true,"text":"- monthly sc administration of TEV-48125 at 225 mg","text_display":"\n- monthly sc administration of TEV-48125 at 225 mg","confidence":0.99951171875,"confidence_rate":0.9999912786005654},{"cnt":[[370,1959],[1863,1959],[1863,2011],[370,2011]],"region":{"top_left_x":369,"top_left_y":1959,"width":1494,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca316298bc6a4585a0e3b05b8dbbeabb","type":"text","conversion_output":true,"text":"- sc administration of 675 mg of TEV-48125 at visit 2 followed by monthly sc placebo","text_display":"\n- sc administration of 675 mg of TEV-48125 at visit 2 followed by monthly sc placebo","confidence":0.9956073760986328,"confidence_rate":0.9999546164956433},{"cnt":[[370,2032],[1061,2032],[1061,2082],[370,2082]],"region":{"top_left_x":369,"top_left_y":2032,"width":693,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d31546eb9afb4e69ad7028ed9cefd935","type":"text","conversion_output":true,"text":"- monthly sc administration of placebo","text_display":"\n- monthly sc administration of placebo","confidence":1,"confidence_rate":1},{"cnt":[[245,2101],[1841,2101],[1841,2153],[245,2153]],"region":{"top_left_x":244,"top_left_y":2101,"width":1598,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"752ab5000c3e425b8db4fa901081521d","type":"text","conversion_output":true,"text":"(Note: For this study, monthly dosing refers to dosing approximately every 4 weeks [28 days].)","text_display":"\n(Note: For this study, monthly dosing refers to dosing approximately every 4 weeks [28 days].)","confidence":0.7288155555725098,"confidence_rate":0.9969034846219571},{"cnt":[[245,2170],[1747,2170],[1747,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":1503,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"327da0aca06048219d7c64c64559a46e","type":"text","conversion_output":true,"text":"Randomization will be performed using electronic interactive response technology (IRT).","text_display":"\nRandomization will be performed using electronic interactive response technology (IRT).","confidence":1,"confidence_rate":1},{"cnt":[[245,2217],[1867,2217],[1867,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2217,"width":1623,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7330744e0b9d4d14b1765d9d6f0bf5dd","type":"text","conversion_output":true,"text":"Patients will be stratified based on gender, country, and baseline preventive migraine medication","text_display":" Patients will be stratified based on gender, country, and baseline preventive migraine medication","confidence":1,"confidence_rate":1},{"cnt":[[245,2269],[1712,2269],[1712,2318],[245,2318]],"region":{"top_left_x":244,"top_left_y":2268,"width":1469,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0a4df3ef87d450b96d681e6862fd294","type":"text","conversion_output":true,"text":"use (yes, no) to ensure balance for the covariates (treatment group, preventive migraine","text_display":" use (yes, no) to ensure balance for the covariates (treatment group, preventive migraine","confidence":1,"confidence_rate":1},{"cnt":[[245,2316],[1749,2316],[1749,2365],[245,2365]],"region":{"top_left_x":244,"top_left_y":2316,"width":1505,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0769b34b2c7a4617b7cb1b27a0105b74","type":"text","conversion_output":true,"text":"medication use, country, and gender). The total number of patients receiving concomitant","text_display":" medication use, country, and gender). The total number of patients receiving concomitant","confidence":1,"confidence_rate":1},{"cnt":[[245,2363],[1869,2363],[1869,2417],[245,2417]],"region":{"top_left_x":244,"top_left_y":2363,"width":1626,"height":54},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0837968ed96a4836b81c803c53e30adf","type":"text","conversion_output":true,"text":"preventive medication during the study will not exceed \\(30 \\%\\) of the total sample size of the study.","text_display":" preventive medication during the study will not exceed \\(30 \\%\\) of the total sample size of the study.","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46f88cb21a0f42c6a295b19765509e12","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":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-050","page":50,"lines":[{"cnt":[[1109,125],[1880,125],[1880,176],[1109,176]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59e451403e0244e7b7313f333870ed05","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e76448fef6484c0abe4277dddf7d80ce","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,174],[1880,174],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":174,"width":493,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2ab6f61cf794ebbb25a872dedea9e6c","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1854,254],[1854,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1611,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"387dd8228afa427fa20ab1012277036a","type":"text","conversion_output":true,"text":"Blinded treatment will be administered sc once monthly (ie, approximately every 4 weeks) for a","text_display":"\n\nBlinded treatment will be administered sc once monthly (ie, approximately every 4 weeks) for a","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1850,301],[1850,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1606,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5b5979e734a48f18bbb24a467fccaf9","type":"text","conversion_output":true,"text":"total of 3 doses. First treatment administration will occur at visit 2 (day 0 ), and additional doses","text_display":" total of 3 doses. First treatment administration will occur at visit 2 (day 0 ), and additional doses","confidence":0.9761524200439453,"confidence_rate":0.9997901390961922},{"cnt":[[245,348],[1854,348],[1854,397],[245,397]],"region":{"top_left_x":244,"top_left_y":348,"width":1611,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32edd31176424b1995626e772e6e48be","type":"text","conversion_output":true,"text":"will be administered at visits 3 and 4 . Final study assessments will be performed at visit 5 (EOT","text_display":" will be administered at visits 3 and 4 . Final study assessments will be performed at visit 5 (EOT","confidence":0.99072265625,"confidence_rate":0.999916783406143},{"cnt":[[245,391],[1729,391],[1729,449],[245,449]],"region":{"top_left_x":244,"top_left_y":391,"width":1486,"height":59},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c5703a90b5245ceb8f24708cd41ce38","type":"text","conversion_output":true,"text":"visit), approximately 4 weeks after administration of the \\(3^{\\text {rd }}\\) and final dose of study drug.","text_display":" visit), approximately 4 weeks after administration of the \\(3^{\\text {rd }}\\) and final dose of study drug.","confidence":0.7629261016845703,"confidence_rate":0.9976291823406598},{"cnt":[[245,468],[1876,468],[1876,518],[245,518]],"region":{"top_left_x":244,"top_left_y":468,"width":1632,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a258d080935940a0bd5ab7924ecc5bf1","type":"text","conversion_output":true,"text":"Headache information will be captured daily during the entire study using an electronic headache","text_display":"\n\nHeadache information will be captured daily during the entire study using an electronic headache","confidence":1,"confidence_rate":1},{"cnt":[[245,516],[1846,516],[1846,567],[245,567]],"region":{"top_left_x":244,"top_left_y":515,"width":1602,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf7a0c1b9e614e0587c0dbe687238e28","type":"text","conversion_output":true,"text":"diary device. Assessments of migraine-related disability and change in quality of life (using the","text_display":" diary device. Assessments of migraine-related disability and change in quality of life (using the","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[1811,563],[1811,614],[245,614]],"region":{"top_left_x":244,"top_left_y":562,"width":1568,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9408044900f84aac98969de6d44d0ce4","type":"text","conversion_output":true,"text":"MIDAS questionnaire, PHQ-2/PHQ-9, MSQOL questionnaire, EQ-5D-5L questionnaire, and","text_display":" MIDAS questionnaire, PHQ-2/PHQ-9, MSQOL questionnaire, EQ-5D-5L questionnaire, and","confidence":1,"confidence_rate":1},{"cnt":[[245,612],[1796,612],[1796,664],[245,664]],"region":{"top_left_x":244,"top_left_y":612,"width":1553,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d35982a82ad4774abd8451d2eaa799c","type":"text","conversion_output":true,"text":"PGIC scale, and WPAI questionnaire); safety evaluations; blood draws for pharmacokinetic,","text_display":" PGIC scale, and WPAI questionnaire); safety evaluations; blood draws for pharmacokinetic,","confidence":1,"confidence_rate":1},{"cnt":[[245,662],[1790,662],[1790,711],[245,711]],"region":{"top_left_x":244,"top_left_y":661,"width":1546,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77e9d36df57a467d898e46728282682a","type":"text","conversion_output":true,"text":"immunogenicity, and biomarker analysis; and urine sampling for biomarker analysis will be","text_display":" immunogenicity, and biomarker analysis; and urine sampling for biomarker analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[245,709],[1850,709],[1850,763],[245,763]],"region":{"top_left_x":244,"top_left_y":708,"width":1606,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d29dca41519d4de08bebaf20ef9be427","type":"text","conversion_output":true,"text":"performed throughout the study according to the schedule of assessments (Table 1). In addition,","text_display":" performed throughout the study according to the schedule of assessments (Table 1). In addition,","confidence":1,"confidence_rate":1},{"cnt":[[245,761],[1826,761],[1826,810],[245,810]],"region":{"top_left_x":244,"top_left_y":760,"width":1583,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dd15b5e41164568969815998c949aab","type":"text","conversion_output":true,"text":"patients who consent to pharmacogenomic assessment will provide a blood sample for testing.","text_display":" patients who consent to pharmacogenomic assessment will provide a blood sample for testing.","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[1846,829],[1846,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":1602,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"108ab249cb95486680475e5bcffa0a4a","type":"text","conversion_output":true,"text":"Upon completion of the final study assessments patients who complete all scheduled visits may","text_display":"\n\nUpon completion of the final study assessments patients who complete all scheduled visits may","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1725,877],[1725,930],[245,930]],"region":{"top_left_x":244,"top_left_y":876,"width":1482,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cfb55e53cc643cdbbc7e20e5daed5f6","type":"text","conversion_output":true,"text":"be eligible to enter a long-term safety and efficacy study (Study TV48125-CNS-30051),","text_display":" be eligible to enter a long-term safety and efficacy study (Study TV48125-CNS-30051),","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1760,924],[1760,978],[245,978]],"region":{"top_left_x":244,"top_left_y":923,"width":1516,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"101ea0e9a38446e6b1785311b20fdf00","type":"text","conversion_output":true,"text":"consisting of a 12 -month double-blind treatment period and a 6.5 -month follow-up period.","text_display":" consisting of a 12 -month double-blind treatment period and a 6.5 -month follow-up period.","confidence":0.96923828125,"confidence_rate":0.9996906934586185},{"cnt":[[245,975],[1734,975],[1734,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1490,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8bbb0ca7b13459aabe190b51a30934a","type":"text","conversion_output":true,"text":"Patients receiving active study drug in the current study will continue receiving the same","text_display":" Patients receiving active study drug in the current study will continue receiving the same","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[1790,1023],[1790,1074],[245,1074]],"region":{"top_left_x":244,"top_left_y":1022,"width":1546,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3da5097fc08543eda6954438684ca2e5","type":"text","conversion_output":true,"text":"treatment (ie, monthly sc TEV-48125 at 225 mg or quarterly sc TEV-48125 at 675 mg ), and","text_display":" treatment (ie, monthly sc TEV-48125 at 225 mg or quarterly sc TEV-48125 at 675 mg ), and","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,1072],[1751,1072],[1751,1124],[245,1124]],"region":{"top_left_x":244,"top_left_y":1072,"width":1507,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"def803ab4d0d454594e6229cd126bd19","type":"text","conversion_output":true,"text":"patients receiving placebo in the current study will be randomized in a \\(1: 1\\) ratio to receive","text_display":" patients receiving placebo in the current study will be randomized in a \\(1: 1\\) ratio to receive","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,1121],[1815,1121],[1815,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1121,"width":1572,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e3b09fce70f45aea0734e89b00cbdad","type":"text","conversion_output":true,"text":"monthly sc TEV-48125 at 225 mg or quarterly sc TEV-48125 at 675 mg during the long-term","text_display":" monthly sc TEV-48125 at 225 mg or quarterly sc TEV-48125 at 675 mg during the long-term","confidence":1,"confidence_rate":1},{"cnt":[[245,1169],[1818,1169],[1818,1220],[245,1220]],"region":{"top_left_x":244,"top_left_y":1168,"width":1574,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87831dad3cf04765bee8f0f861fd0d35","type":"text","conversion_output":true,"text":"safety and efficacy study. This long-term safety and efficacy study is beyond the scope of this","text_display":" safety and efficacy study. This long-term safety and efficacy study is beyond the scope of this","confidence":1,"confidence_rate":1},{"cnt":[[245,1216],[1751,1216],[1751,1270],[245,1270]],"region":{"top_left_x":244,"top_left_y":1216,"width":1507,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b79490b653ef4a5ebc6b8bd17cfa6449","type":"text","conversion_output":true,"text":"protocol. A separate protocol will be issued. Patients who withdraw from the study before","text_display":" protocol. A separate protocol will be issued. Patients who withdraw from the study before","confidence":1,"confidence_rate":1},{"cnt":[[245,1268],[1704,1268],[1704,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1267,"width":1460,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a0674ab9fc14c1a8d6b251b04533aab","type":"text","conversion_output":true,"text":"completing the 12-week evaluation period will have EOT visit (visit 5) procedures and","text_display":" completing the 12-week evaluation period will have EOT visit (visit 5) procedures and","confidence":0.7516911845237928,"confidence_rate":0.9968335826153912},{"cnt":[[245,1315],[1725,1315],[1725,1364],[245,1364]],"region":{"top_left_x":244,"top_left_y":1314,"width":1482,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fae214988a84c08a5b97a463468ae40","type":"text","conversion_output":true,"text":"assessments performed on the last day they receive the study drug or as soon as possible","text_display":" assessments performed on the last day they receive the study drug or as soon as possible","confidence":1,"confidence_rate":1},{"cnt":[[245,1362],[1880,1362],[1880,1416],[245,1416]],"region":{"top_left_x":244,"top_left_y":1362,"width":1636,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c82e1bdf81f46eeb6acab5f7e202700","type":"text","conversion_output":true,"text":"thereafter. Those patients who do not enter the long-term safety and efficacy study for any reason","text_display":" thereafter. Those patients who do not enter the long-term safety and efficacy study for any reason","confidence":1,"confidence_rate":1},{"cnt":[[245,1412],[1742,1412],[1742,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1411,"width":1499,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a46290b66899420980968d1214911a00","type":"text","conversion_output":true,"text":"will be offered to enter the long term safety extension for the purpose of evaluating ADA","text_display":" will be offered to enter the long term safety extension for the purpose of evaluating ADA","confidence":1,"confidence_rate":1},{"cnt":[[245,1461],[1704,1461],[1704,1510],[245,1510]],"region":{"top_left_x":244,"top_left_y":1460,"width":1460,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a0126cbc87844b3989b68eca22547a0","type":"text","conversion_output":true,"text":"approximately 7.5 months ( 225 days [the approximate equivalent of 5 half-lives]) after","text_display":" approximately 7.5 months ( 225 days [the approximate equivalent of 5 half-lives]) after","confidence":0.9990236759185791,"confidence_rate":0.9999903287497746},{"cnt":[[245,1504],[1293,1504],[1293,1560],[245,1560]],"region":{"top_left_x":244,"top_left_y":1503,"width":1050,"height":57},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a3cb23486864d8a90ddcb764af791c8","type":"text","conversion_output":true,"text":"administration of the last ( \\(3^{\\text {rd }}\\) ) dose of study drug in this study.","text_display":" administration of the last ( \\(3^{\\text {rd }}\\) ) dose of study drug in this study.","confidence":0.63720703125,"confidence_rate":0.9948919467652263},{"cnt":[[245,1577],[1824,1577],[1824,1629],[245,1629]],"region":{"top_left_x":244,"top_left_y":1576,"width":1581,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddf1e18fe8234ae0b30979398c97b483","type":"text","conversion_output":true,"text":"The assessments and procedures performed during each study visit are detailed in Table 1 and","text_display":"\nThe assessments and procedures performed during each study visit are detailed in Table 1 and","confidence":1,"confidence_rate":1},{"cnt":[[245,1626],[1197,1626],[1197,1678],[245,1678]],"region":{"top_left_x":244,"top_left_y":1626,"width":953,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e29065922bf8481b90c096dff85715e4","type":"text","conversion_output":true,"text":"Section 3.14. The study schema is presented in Figure 1.","text_display":" Section 3.14. The study schema is presented in Figure 1.","confidence":1,"confidence_rate":1},{"cnt":[[245,1697],[1867,1697],[1867,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1697,"width":1623,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4032dc7cd8184165b157999d0794b023","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":"\n\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":[[245,1745],[393,1745],[393,1794],[245,1794]],"region":{"top_left_x":244,"top_left_y":1744,"width":150,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08c4616a848f4d8c8a59765bf8e8c7b0","type":"text","conversion_output":true,"text":"(visit 5).","text_display":" (visit 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Duration of Patient Participation and Justification}","confidence":0.9990236759185791,"confidence_rate":0.9999842452693294},{"cnt":[[245,778],[1772,778],[1772,831],[245,831]],"region":{"top_left_x":244,"top_left_y":777,"width":1529,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9a69cf5679d448cbb6220ab197b7b41","type":"text","conversion_output":true,"text":"This study will consist of a screening visit, a 28 -day run-in period, and a 12-week ( 84 -day)","text_display":"\n\nThis study will consist of a screening visit, a 28 -day run-in period, and a 12-week ( 84 -day)","confidence":0.4479688271726445,"confidence_rate":0.9924528537126625},{"cnt":[[245,829],[1880,829],[1880,883],[245,883]],"region":{"top_left_x":244,"top_left_y":829,"width":1636,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43d0ccd12f9d4f7c88aab48300cb83ac","type":"text","conversion_output":true,"text":"double-blind treatment period. Patients are expected to participate in this study for approximately","text_display":" double-blind treatment period. Patients are expected to participate in this study for approximately","confidence":1,"confidence_rate":1},{"cnt":[[247,879],[1818,879],[1818,930],[247,930]],"region":{"top_left_x":247,"top_left_y":878,"width":1571,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"426e9bd6f1e84cb49405f933927900ba","type":"text","conversion_output":true,"text":"16 weeks. Patients completing this study may enroll in the double-blind, long-term safety and","text_display":" 16 weeks. Patients completing this study may enroll in the double-blind, long-term safety and","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1800,924],[1800,978],[245,978]],"region":{"top_left_x":244,"top_left_y":923,"width":1557,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba2cb05269c64b70bf884392dedd5181","type":"text","conversion_output":true,"text":"efficacy study (Study TV48125-CNS-30051). Those patients who do not enter the long-term","text_display":" efficacy study (Study TV48125-CNS-30051). Those patients who do not enter the long-term","confidence":1,"confidence_rate":1},{"cnt":[[245,973],[1830,973],[1830,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":973,"width":1587,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c27445cadc54f89bd0b09cb1dc3ff8e","type":"text","conversion_output":true,"text":"safety and efficacy study for any reason will be offered to enter the long-term safety extension","text_display":" safety and efficacy study for any reason will be offered to enter the long-term safety extension","confidence":1,"confidence_rate":1},{"cnt":[[245,1023],[1863,1023],[1863,1074],[245,1074]],"region":{"top_left_x":244,"top_left_y":1022,"width":1619,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db17226d93794c06ad11cffaa54d320a","type":"text","conversion_output":true,"text":"for the purpose of evaluating ADA approximately 7.5 months ( 225 days) after administration of","text_display":" for the purpose of evaluating ADA approximately 7.5 months ( 225 days) after administration of","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[245,1066],[1820,1066],[1820,1124],[245,1124]],"region":{"top_left_x":244,"top_left_y":1065,"width":1576,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07ce1fc8618f4730bae0749bb3b635c7","type":"text","conversion_output":true,"text":"the last \\(\\left(3^{\\text {rd }}\\right)\\) dose of study drug in this study. Thus, patient participation for these patients will","text_display":" the last \\(\\left(3^{\\text {rd }}\\right)\\) dose of study drug in this study. Thus, patient participation for these patients will","confidence":0.9965834617614746,"confidence_rate":0.9999714805072476},{"cnt":[[245,1121],[793,1121],[793,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1121,"width":549,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f0cd23f1a7b425d801831d0ec77b24f","type":"text","conversion_output":true,"text":"last approximately 10.5 months.","text_display":" last approximately 10.5 months.","confidence":1,"confidence_rate":1},{"cnt":[[245,1188],[1222,1188],[1222,1244],[245,1244]],"region":{"top_left_x":244,"top_left_y":1188,"width":979,"height":56},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c05d224ab36a447b8c2c0987028b9e6d","type":"text","conversion_output":true,"text":"See Section 12.4 for the definition of the end of the study.","text_display":"\nSee Section 12.4 for the definition of the end of the study.","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1721,1259],[1721,1311],[245,1311]],"region":{"top_left_x":244,"top_left_y":1258,"width":1477,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"702200138ba44fef8e985436e5c4f744","type":"text","conversion_output":true,"text":"The durations of the run-in and double-blind treatment periods align with Classification","text_display":"\nThe durations of the run-in and double-blind treatment periods align with Classification","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1818,1306],[1818,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1306,"width":1574,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf033a90f30b4043956aae4821b828d5","type":"text","conversion_output":true,"text":"Committee of the IHS guidelines for controlled trials for the preventive treatment of migraine","text_display":" Committee of the IHS guidelines for controlled trials for the preventive treatment of migraine","confidence":1,"confidence_rate":1},{"cnt":[[245,1354],[690,1354],[690,1407],[245,1407]],"region":{"top_left_x":244,"top_left_y":1353,"width":446,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d233be30bcc44fdf9db63577f2a239c9","type":"text","conversion_output":true,"text":"(Tfelt-Hansen et al 2012).","text_display":" (Tfelt-Hansen et al 2012).","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[245,1427],[1794,1427],[1794,1480],[245,1480]],"region":{"top_left_x":244,"top_left_y":1426,"width":1550,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c1eaec485344b36b1b4fcd70d9f16cb","type":"text","conversion_output":true,"text":"Patients who do not enroll in the long-term safety and efficacy study for any reason but who","text_display":"\n\nPatients who do not enroll in the long-term safety and efficacy study for any reason but who","confidence":1,"confidence_rate":1},{"cnt":[[245,1474],[1635,1474],[1635,1525],[245,1525]],"region":{"top_left_x":244,"top_left_y":1473,"width":1391,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3a67f765dab4bc0a01c185e863dd447","type":"text","conversion_output":true,"text":"enter the long-term safety extension for the purpose of evaluating ADA will return","text_display":" enter the long-term safety extension for the purpose of evaluating ADA will return","confidence":1,"confidence_rate":1},{"cnt":[[245,1521],[1815,1521],[1815,1575],[245,1575]],"region":{"top_left_x":244,"top_left_y":1521,"width":1572,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d05599196c040b2a3ff737f9f050bd5","type":"text","conversion_output":true,"text":"approximately 7.5 months ( 225 days, the approximate equivalent of 5 half-lives) after the last","text_display":" approximately 7.5 months ( 225 days, the approximate equivalent of 5 half-lives) after the last","confidence":0.9970703125,"confidence_rate":0.9999730830463522},{"cnt":[[245,1573],[1755,1573],[1755,1622],[245,1622]],"region":{"top_left_x":244,"top_left_y":1572,"width":1512,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21cbd5981d724b24a3d43ac182ec7bf5","type":"text","conversion_output":true,"text":"dose of study drug. This is consistent with the 2009 FDA Guidance for Industry on Assay","text_display":" dose of study drug. This is consistent with the 2009 FDA Guidance for Industry on Assay","confidence":1,"confidence_rate":1},{"cnt":[[245,1620],[1824,1620],[1824,1674],[245,1674]],"region":{"top_left_x":244,"top_left_y":1619,"width":1581,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"897bccbea87d45fe911a66d579f7efa6","type":"text","conversion_output":true,"text":"Development for Immunogenicity Testing of Therapeutic Proteins; a complete washout of the","text_display":" Development for Immunogenicity Testing of Therapeutic Proteins; a complete washout of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1669],[1772,1669],[1772,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1669,"width":1529,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab818d0810db4b13b55dde2605872d22","type":"text","conversion_output":true,"text":"drug from the circulating blood is expected after approximately 7.5 months ( \\(\\geq 5\\) half-lives),","text_display":" drug from the circulating blood is expected after approximately 7.5 months ( \\(\\geq 5\\) half-lives),","confidence":1,"confidence_rate":1},{"cnt":[[245,1714],[995,1714],[995,1768],[245,1768]],"region":{"top_left_x":244,"top_left_y":1714,"width":751,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1058a5b41d04e40bc4b36d275d1a856","type":"text","conversion_output":true,"text":"allowing a more precise evaluation of ADA.","text_display":" allowing a more precise evaluation of ADA.","confidence":1,"confidence_rate":1},{"cnt":[[236,1805],[1377,1805],[1377,1871],[236,1871]],"region":{"top_left_x":236,"top_left_y":1804,"width":1142,"height":68},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb1deae93c3c463ea751a58b56fbdb05","type":"section_header","conversion_output":false,"children_ids":["0d90717aa9554abbadea4f1db6277be7"],"text":"","text_display":""},{"cnt":[[245,1809],[1371,1809],[1371,1867],[245,1867]],"region":{"top_left_x":244,"top_left_y":1808,"width":1127,"height":59},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d90717aa9554abbadea4f1db6277be7","type":"text","conversion_output":true,"parent_id":"bb1deae93c3c463ea751a58b56fbdb05","text":"3.12. Stopping Rules and Discontinuation Criteria","text_display":"\n\n\\subsection*{3.12. Stopping Rules and Discontinuation Criteria}","confidence":0.86083984375,"confidence_rate":0.99722890577901},{"cnt":[[245,1882],[1811,1882],[1811,1936],[245,1936]],"region":{"top_left_x":244,"top_left_y":1882,"width":1568,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"458834aefb7246cea639dd8df6f1e5fa","type":"text","conversion_output":true,"text":"There are no formal rules for early termination of this study. During the conduct of the study,","text_display":"\n\nThere are no formal rules for early termination of this study. During the conduct of the study,","confidence":1,"confidence_rate":1},{"cnt":[[245,1934],[1729,1934],[1729,1985],[245,1985]],"region":{"top_left_x":244,"top_left_y":1933,"width":1486,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fcfee0dd62c4208821cb8be4ae1f112","type":"text","conversion_output":true,"text":"serious adverse events will be reviewed (see Section 7.1.5) as they are reported from the","text_display":" serious adverse events will be reviewed (see Section 7.1.5) as they are reported from the","confidence":1,"confidence_rate":1},{"cnt":[[245,1981],[1867,1981],[1867,2035],[245,2035]],"region":{"top_left_x":244,"top_left_y":1980,"width":1623,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ae2e33a50264eba9fa1feea66edba6d","type":"text","conversion_output":true,"text":"investigational center to identify safety concerns. The study may be terminated by the sponsor at","text_display":" investigational center to identify safety concerns. The study may be terminated by the sponsor at","confidence":1,"confidence_rate":1},{"cnt":[[245,2030],[410,2030],[410,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2030,"width":167,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a3db6509f5e499093959f079b4fef6a","type":"text","conversion_output":true,"text":"any time.","text_display":" any time.","confidence":1,"confidence_rate":1},{"cnt":[[245,2099],[1772,2099],[1772,2151],[245,2151]],"region":{"top_left_x":244,"top_left_y":2099,"width":1529,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6705667fe254e09af1f0404cf969d0a","type":"text","conversion_output":true,"text":"A patient may discontinue participation in the study at any time for any reason (eg, lack of","text_display":"\nA patient may discontinue participation in the study at any time for any reason (eg, lack of","confidence":1,"confidence_rate":1},{"cnt":[[245,2148],[1876,2148],[1876,2202],[245,2202]],"region":{"top_left_x":244,"top_left_y":2148,"width":1632,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c21e624a521e4d459ad348af07e11c73","type":"text","conversion_output":true,"text":"efficacy, consent withdrawn, and adverse event). The investigator and/or sponsor can withdraw a","text_display":" efficacy, consent withdrawn, and adverse event). The investigator and/or sponsor can withdraw a","confidence":1,"confidence_rate":1},{"cnt":[[245,2196],[1846,2196],[1846,2249],[245,2249]],"region":{"top_left_x":244,"top_left_y":2195,"width":1602,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a67b54ad5af4c9fabdb21cf91cc789d","type":"text","conversion_output":true,"text":"patient from the study at any time for any reason (eg, protocol violation or deviation as defined","text_display":" patient from the study at any time for any reason (eg, protocol violation or deviation as defined","confidence":1,"confidence_rate":1},{"cnt":[[245,2245],[1858,2245],[1858,2297],[245,2297]],"region":{"top_left_x":244,"top_left_y":2245,"width":1615,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"648c5aa8a6e74b92a5d5a4004542ec10","type":"text","conversion_output":true,"text":"in Section 11.1.2, noncompliance, or adverse event). In addition, patients with abnormal hepatic","text_display":" in Section 11.1.2, noncompliance, or adverse event). In addition, patients with abnormal hepatic","confidence":1,"confidence_rate":1},{"cnt":[[245,2295],[1850,2295],[1850,2346],[245,2346]],"region":{"top_left_x":244,"top_left_y":2294,"width":1606,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"799c8209afd74921bba0a444813e829b","type":"text","conversion_output":true,"text":"laboratory values (eg, ALT, AST, ALP, gamma-glutamyl transpeptidase [GGT], total bilirubin,","text_display":" laboratory values (eg, ALT, AST, ALP, gamma-glutamyl transpeptidase [GGT], total bilirubin,","confidence":1,"confidence_rate":1},{"cnt":[[245,2342],[1807,2342],[1807,2396],[245,2396]],"region":{"top_left_x":244,"top_left_y":2341,"width":1563,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46f01be00d084844b1a44645136a3dde","type":"text","conversion_output":true,"text":"or international normalized ratio [INR]) may meet criteria for discontinuation from the study","text_display":" or international normalized ratio [INR]) may meet criteria for discontinuation from the study","confidence":1,"confidence_rate":1},{"cnt":[[245,2391],[855,2391],[855,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2391,"width":612,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8a967364e5241bb975118526a88c5c2","type":"text","conversion_output":true,"text":"drug as summarized in Appendix E.","text_display":" drug as summarized in Appendix E.","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2591],[1038,2591]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":53},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b321884e05b44e58a1c1219bd6e28594","type":"page_info","conversion_output":false,"text":"55","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-057","page":57,"lines":[{"cnt":[[1109,125],[1880,125],[1880,176],[1109,176]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdf47764e198496a9ab89dbc54985c9e","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74628315720f43788bc1cc69d641b6b2","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb09507ccb1243659dbbc2cada005ad3","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[236,249],[1452,249],[1452,316],[236,316]],"region":{"top_left_x":236,"top_left_y":249,"width":1217,"height":67},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f93fe01f84734d59a9930e92a208eba9","type":"section_header","conversion_output":false,"children_ids":["823bf65f4c1c48109ae8bd0f9fca7acd"],"text":"","text_display":""},{"cnt":[[243,254],[1446,254],[1446,312],[243,312]],"region":{"top_left_x":242,"top_left_y":253,"width":1204,"height":59},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"823bf65f4c1c48109ae8bd0f9fca7acd","type":"text","conversion_output":true,"parent_id":"f93fe01f84734d59a9930e92a208eba9","text":"3.13. Source Data Recorded on the Case Report Form","text_display":"\n\n\\subsection*{3.13. Source Data Recorded on the Case Report Form}","confidence":1,"confidence_rate":1},{"cnt":[[245,329],[1833,329],[1833,380],[245,380]],"region":{"top_left_x":244,"top_left_y":328,"width":1589,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15d20b9327ae44b597ced83ba293a726","type":"text","conversion_output":true,"text":"All patient data must have supportive original source documentation in the medical records, or","text_display":"\n\nAll patient data must have supportive original source documentation in the medical records, or","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":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c00748c4ce294707be7b75973ec0f82c","type":"text","conversion_output":true,"text":"equivalent, before they are transcribed onto the CRF. Data may not be recorded directly onto the","text_display":" equivalent, before they are transcribed onto the CRF. Data may not be recorded directly onto the","confidence":1,"confidence_rate":1},{"cnt":[[245,425],[1828,425],[1828,477],[245,477]],"region":{"top_left_x":244,"top_left_y":425,"width":1585,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"832c814d04ba40439d2197af33ea3620","type":"text","conversion_output":true,"text":"CRF and considered as source data unless the sponsor provides written instructions specifying","text_display":" CRF and considered as source data unless the sponsor provides written instructions specifying","confidence":1,"confidence_rate":1},{"cnt":[[245,475],[1298,475],[1298,524],[245,524]],"region":{"top_left_x":244,"top_left_y":474,"width":1054,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53d379ec7196467ea2965f402e882b79","type":"text","conversion_output":true,"text":"which data are permitted to be recorded directly onto the CRF.","text_display":" which data are permitted to be recorded directly onto the CRF.","confidence":1,"confidence_rate":1},{"cnt":[[245,546],[1760,546],[1760,595],[245,595]],"region":{"top_left_x":244,"top_left_y":545,"width":1516,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4551c173de74ab7880ca2c3c186dbbc","type":"text","conversion_output":true,"text":"Source data, including test results and/or assessments (eg, clinical laboratory, central ECG","text_display":"\n\nSource data, including test results and/or assessments (eg, clinical laboratory, central ECG","confidence":1,"confidence_rate":1},{"cnt":[[245,593],[1837,593],[1837,642],[245,642]],"region":{"top_left_x":244,"top_left_y":592,"width":1593,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfdf8d7f01fc4b6c88141213ba299318","type":"text","conversion_output":true,"text":"evaluation center, and electronic headache diary data) collected by other institutions outside of","text_display":" evaluation center, and electronic headache diary data) collected by other institutions outside of","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,640],[1811,640],[1811,690],[245,690]],"region":{"top_left_x":244,"top_left_y":640,"width":1568,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e20426ec07914ed2b660ae5331c5488c","type":"text","conversion_output":true,"text":"the study center, are sent to the investigational center where they are retained, but not entered","text_display":" the study center, are sent to the investigational center where they are retained, but not entered","confidence":1,"confidence_rate":1},{"cnt":[[245,690],[1837,690],[1837,741],[245,741]],"region":{"top_left_x":244,"top_left_y":689,"width":1593,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"091263050d1f402f85b16e5ccd802b20","type":"text","conversion_output":true,"text":"into the CRF unless otherwise noted in the protocol. These data may also be sent electronically","text_display":" into the CRF unless otherwise noted in the protocol. These data may also be sent electronically","confidence":1,"confidence_rate":1},{"cnt":[[245,739],[1811,739],[1811,788],[245,788]],"region":{"top_left_x":244,"top_left_y":739,"width":1568,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95c635f1d6c1486fa405f8b40d8f9d7f","type":"text","conversion_output":true,"text":"to the sponsor (or organization performing data management) for direct entry into the clinical","text_display":" to the sponsor (or organization performing data management) for direct entry into the clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,786],[1850,786],[1850,838],[245,838]],"region":{"top_left_x":244,"top_left_y":786,"width":1606,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16b6b627c4dc4cdda86ec599f59eb9c2","type":"text","conversion_output":true,"text":"database (see Section 13.1). All data from other institutions will be available to the investigator.","text_display":" database (see Section 13.1). All data from other institutions will be available to the investigator.","confidence":0.9765625,"confidence_rate":0.9997741538250182},{"cnt":[[245,855],[1046,855],[1046,907],[245,907]],"region":{"top_left_x":244,"top_left_y":855,"width":803,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"104c740482ec46a3ac5f9dda313420ec","type":"text","conversion_output":true,"text":"The CRFs are filed in the sponsor's central file.","text_display":"\nThe CRFs are filed in the sponsor's central file.","confidence":0.99951171875,"confidence_rate":0.9999909555872323},{"cnt":[[241,945],[814,945],[814,1008],[241,1008]],"region":{"top_left_x":240,"top_left_y":945,"width":575,"height":63},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1f2c24bf6094009af34f90354a4ae29","type":"section_header","conversion_output":false,"children_ids":["9b0dcd3f98784de390486d6da28ae78b"],"text":"","text_display":""},{"cnt":[[245,950],[810,950],[810,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":949,"width":566,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b0dcd3f98784de390486d6da28ae78b","type":"text","conversion_output":true,"parent_id":"c1f2c24bf6094009af34f90354a4ae29","text":"3.14. Study Procedures","text_display":"\n\n\\subsection*{3.14. Study Procedures}","confidence":0.9970703125,"confidence_rate":0.9998913397026693},{"cnt":[[245,1023],[1876,1023],[1876,1074],[245,1074]],"region":{"top_left_x":244,"top_left_y":1022,"width":1632,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bf90a32297e46408d2bd1cc9fc666a4","type":"text","conversion_output":true,"text":"Study procedures and assessments with their timing are summarized in Table 1. Detailed by-visit","text_display":"\n\nStudy procedures and assessments with their timing are summarized in Table 1. Detailed by-visit","confidence":1,"confidence_rate":1},{"cnt":[[245,1074],[1727,1074],[1727,1124],[245,1124]],"region":{"top_left_x":244,"top_left_y":1074,"width":1484,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e166e83f8924dc0904a92fa62aa3202","type":"text","conversion_output":true,"text":"information is provided in the sections following the table. Detailed descriptions of each","text_display":" information is provided in the sections following the table. Detailed descriptions of each","confidence":1,"confidence_rate":1},{"cnt":[[245,1121],[1820,1121],[1820,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1121,"width":1576,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a30c5904b4844160950eccf164a6cfef","type":"text","conversion_output":true,"text":"assessment are provided in Section 6 (efficacy assessments), Section 6.2 (safety assessments),","text_display":" assessment are provided in Section 6 (efficacy assessments), Section 6.2 (safety assessments),","confidence":1,"confidence_rate":1},{"cnt":[[245,1169],[1184,1169],[1184,1218],[245,1218]],"region":{"top_left_x":244,"top_left_y":1168,"width":940,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"770d88d38a5a40e49312de59df3c317e","type":"text","conversion_output":true,"text":"and Section 8 (pharmacokinetic and other assessments).","text_display":" and Section 8 (pharmacokinetic and other assessments).","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fda6ea6894fd48abaa3a0a307672ce78","type":"page_info","conversion_output":false,"text":"56","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-058","page":58,"lines":[{"cnt":[[1732,129],[2503,129],[2503,174],[1732,174]],"region":{"top_left_x":1731,"top_left_y":128,"width":772,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"202fca7952d1419c8ff09d134c106c3b","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2272e907d81f4e3792cb26c6b6195201","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2015,176],[2503,176],[2503,226],[2015,226]],"region":{"top_left_x":2015,"top_left_y":176,"width":488,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a34f4ae96ad241cfb187354caba47391","type":"page_info","conversion_output":false,"text":"Study 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":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a490b987b044f458a25ae3f0553f078","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":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc019a20b6fa467bab41316ed4172535","type":"table","conversion_output":true,"children_ids":["a9003a92aba74fdaa20426968ad60775","943ee5a38f6940c8968ef51e3d8dbc90","b9ee91f6ad6c490f849852dca0449e9e","5e27140b7d1749f88f0f89b32888b04a","00459e64c6e849e8aea95ca6ea1d2e6e","3f8fcab1153c4e228f31db35adffbde0","8c27905995964606be87b631df7bd78c","380e47a17b574546b131a02afce86e2a","5d9d0963341e474297f5b621155a7a0b","666706aa0f96471e86ea0ff46f905311","35b2f9565a8e48cc8c636873f66cd855","b5b26ff244f44dc4a791592259805746","f0c21ff711994caf941eea15af94928e","200ce3e4b51548ea901c6e50294dd3cc","02be666d2c344d15b2b28e09ed5624d0","75d39865967e4684a56ccb45887715db","de7fb06025dc48be8068b4f4af54ff8d","a6463640ad644f41a168a694a22517ad","65ffab5f229a4661a15a55900a24315c","1bc303d33990475ebc8412f876b35b24","e6405041332f43f5bf0e6db1d187531a","2fb3ef5c740c4782953e1c6fefb1780d","7ceffd3f37e84db8be2207b279e80ca6","44a7036a4be147c795edaca2474f1e78","dbc1905a00624bd894656c8b57d9b22e","f234f1b8157949e5b3fa6f2e3be10bee","3326995b55614316bfd5f716a5630dd7","a8b157af7978458eafbabf149330d608","7c2129f64ad64684929ba9ab16d8011b","927576559be3405ba184d9cf277e5c54","35f11d272f314e76b1a346a35f8148ca","4deaa7e945344e9388e32cf150af9548","02f376b7395e4ce7b1dcc877338fae38","ae6cbf0fa49b412c9c247c831725ecc8","fd7d7e3b86e04bc3aa367e52aeda6a5b","5191e8b1c279445c93856bce3c5822d6","9c9a582519684388883ff34dcc40ca3c","24cbcdbf628741b7b9a646dd43d491e2","4928b8124a8e435a97ae6d858e2a29dc","0cf003c400b742d690137451be39ce2c","a6ab9e0767674ad99ba619394714dbdd","43a9ab5a6d394978a75883bbbc22bd19","221cbb87049b4315860b4a5900185d2d","d51c347c665c4088a203560d5b2ff596","4a3ba5b14188414689c02fb66b1cae92","4663227a3a3f462996b9a652da7dac64","46951a21515c44a39e591f784b7bc0ce","832b0c23694c4ef6bdcdefc3a3aad397","143b4a683b70471d92860f5b39ab531c","eaf1dd74905f4a429c39536c32fafba8","9856194fd89c41e695da2c68a4893d73","f1c614c6af224d158ee785056b16d60e","dedb3cfac81d4a06ba579e23c161a25b","c2066563b89342c7976ebb67192dc980","fe0eef217ed9475aaeb0efa1409a3a4b","0520a3c6b8914a6798c013089c3187cc","f0ffdbe6d84b4770b159732ceb7da36d","d261353e142a4decad8b5c9e3486729d","abb79556957e4cb5ba0d155617ca7eb0","20e5e531ab8946b287ccf0ae5a898dfe","3a30e98b2f674cad9902838afdabdc54","68d03c6c95fa49518b2a9c1901ca5015","4e55de284d4445f588e3a74a4b53c215","06a2db106e164ea89b36c48cdafce90c","f38bf5de3d564dd286533a5ad78cedd5","9988b287075e497ca82075c40878d402","c52296e1ea65446a886b49602fdaf814","97683322de784c1ba7e4d7142bb8bda3","733026ee84aa4ef8a5c3cceace2c686f","374cdfdba33a4a8aae0d7b44218c4959","524725abac384dbaae8a326c16919235","979cbd28631b460d8cd6c0f40ba89e2d","95ec1c751a484afb87ce3cbc5e290f64","2f98fa6cdc154da49c45a3d00dd6d83f","c8a22f0ec3b341868ce50b23c2b97218","95b16d83bfe4436aa35290bbce45b7ee","1dbbd9927c32444a8fbd945a9d971b1a","02091cf0bc9942fbaf7c6616747d89f2","230527fd676e45a5abbe80d4313af56a","c016ce7ef63c422ebfc00bd426e8607b","8cc3f54797f9410b9e0ab4c7cc83192e","917c9b9763964d918bded2f3b04be1de","16b42ed7c2ff4cf9be64160134b5802f","3d720500b18746028b4c540d4d852014","82317da31d9d45aa9e3c53f439eb2581","4c4a32aa8e414b9697deade026c9bc0f","1f93aa2aa03e455eb27a3ce0cd8cad51","b40b338d94284662ac5a4a837d400580","de3056df82be496184ab420ee893806b","357e676804be417cb3cd337de2ba4fef","b74861cf8e274b49a9193d2a32a35ec6","b7096d8f484c4e86bedd42e1138b8a0d","ad70dc9524b04443bb1faf7c31a2d995","e20a09dc91644d30bf3dd013e474fc4b","3bd51d26dc8d4a92a9d3a6d7c971201b","7bfb3673955948a787e7b62042d8d91e","2d4297bd167842cdafa74b5f18cdcbd6","13e22ccf8810413b9985d3655dc3afce","d378c3a074d046ffacf7e5700ca58553","9e3ba26e6f3b460cac09a442e224fb6a"],"selected_labels":["0a490b987b044f458a25ae3f0553f078"],"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 & 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 & 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MSQOL=Migraine-Specific","confidence":0.9990234375,"confidence_rate":0.9999942527244696},{"cnt":[[245,1671],[2451,1671],[2451,1708],[245,1708]],"region":{"top_left_x":244,"top_left_y":1671,"width":2208,"height":38},"line":99,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb0e0d11a7564b01a9842b3dfcbd9ef4","type":"text","conversion_output":true,"text":"Quality of Life; PGIC \\(=\\) Patient Global Impression of Change; PHQ-2=2-item Patient Health Questionnaire; PHQ \\({ }^{-} 9=9\\)-item Patient Health Questionnaire; V=visit; WPAI=Work","text_display":" Quality of Life; PGIC \\(=\\) Patient Global Impression of Change; PHQ-2=2-item Patient Health Questionnaire; PHQ \\({ }^{-} 9=9\\)-item Patient Health Questionnaire; V=visit; WPAI=Work","confidence":0.447669237497077,"confidence_rate":0.9956650952201528},{"cnt":[[245,1704],[737,1704],[737,1740],[245,1740]],"region":{"top_left_x":244,"top_left_y":1703,"width":493,"height":38},"line":100,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f8bf4782ec034e3e9f8cf60db5749522","type":"text","conversion_output":true,"text":"Performance and Activity Impairment.","text_display":" Performance and Activity Impairment.","confidence":1,"confidence_rate":1},{"cnt":[[1349,1916],[1399,1916],[1399,1955],[1349,1955]],"region":{"top_left_x":1349,"top_left_y":1916,"width":50,"height":40},"line":101,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"688a5d93068f487e891aba01a1bd8376","type":"page_info","conversion_output":false,"text":"59","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-061","page":61,"lines":[{"cnt":[[1109,125],[1880,125],[1880,176],[1109,176]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05256f54cfb5429dbd44d3063c1d87a9","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1c1f654a30b4f1da76d55244c9d9e9a","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"741a44a2fa404a248b008bac834d208e","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[236,266],[1222,266],[1222,329],[236,329]],"region":{"top_left_x":236,"top_left_y":266,"width":987,"height":63},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"316384b155464ad9ae9aabeb4f8d65cd","type":"section_header","conversion_output":false,"children_ids":["754f2a09cf2a474dbc614612cb057b16"],"text":"","text_display":""},{"cnt":[[243,271],[1218,271],[1218,324],[243,324]],"region":{"top_left_x":242,"top_left_y":270,"width":977,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"754f2a09cf2a474dbc614612cb057b16","type":"text","conversion_output":true,"parent_id":"316384b155464ad9ae9aabeb4f8d65cd","text":"3.14.1. Procedures for Screening (Visit 1[Day -28])","text_display":"\n\n\\subsection*{3.14.1. Procedures for Screening (Visit 1[Day -28])}","confidence":0.9854283870429962,"confidence_rate":0.9997379125356939},{"cnt":[[245,339],[1725,339],[1725,393],[245,393]],"region":{"top_left_x":244,"top_left_y":339,"width":1482,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81328ceae6f344f8911799a0e06a5207","type":"text","conversion_output":true,"text":"A signed and dated informed consent form will be obtained before screening procedures","text_display":"\n\nA signed and dated informed consent form will be obtained before screening procedures","confidence":1,"confidence_rate":1},{"cnt":[[245,391],[1704,391],[1704,440],[245,440]],"region":{"top_left_x":244,"top_left_y":391,"width":1460,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9596fad89aa34ceaa00eddb64d2a7f5f","type":"text","conversion_output":true,"text":"commence (see Section 12.1). Evaluations obtained as part of routine medical care and","text_display":" commence (see Section 12.1). Evaluations obtained as part of routine medical care and","confidence":1,"confidence_rate":1},{"cnt":[[245,438],[1863,438],[1863,492],[245,492]],"region":{"top_left_x":244,"top_left_y":438,"width":1619,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1072a51f6ace46c2b6597da505a0e1e1","type":"text","conversion_output":true,"text":"performed during the screening period may be used in place of the protocol-specific evaluations.","text_display":" performed during the screening period may be used in place of the protocol-specific evaluations.","confidence":1,"confidence_rate":1},{"cnt":[[245,488],[1732,488],[1732,539],[245,539]],"region":{"top_left_x":244,"top_left_y":487,"width":1488,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3daf4bfb72204b64bfe5b2036827eea9","type":"text","conversion_output":true,"text":"In addition, disease-specific assessments performed within a specified time frame before","text_display":" In addition, disease-specific assessments performed within a specified time frame before","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1865,537],[1865,587],[245,587]],"region":{"top_left_x":244,"top_left_y":537,"width":1621,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3c848864edb4b3bb26d1ec2355797c2","type":"text","conversion_output":true,"text":"informed consent may be used for the study. Patients will acknowledge and agree to the possible","text_display":" informed consent may be used for the study. Patients will acknowledge and agree to the possible","confidence":1,"confidence_rate":1},{"cnt":[[245,584],[1332,584],[1332,634],[245,634]],"region":{"top_left_x":244,"top_left_y":584,"width":1089,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8682732248344fec8182f8f774020035","type":"text","conversion_output":true,"text":"use of this information for the study by giving informed consent.","text_display":" use of this information for the study by giving informed consent.","confidence":1,"confidence_rate":1},{"cnt":[[245,653],[1738,653],[1738,707],[245,707]],"region":{"top_left_x":244,"top_left_y":653,"width":1495,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5088be3351fe4347b3677af6e8981ce8","type":"text","conversion_output":true,"text":"After informed consent is obtained, patients who are screened will be assigned an 8 -digit","text_display":"\n\nAfter informed consent is obtained, patients who are screened will be assigned an 8 -digit","confidence":0.87890625,"confidence_rate":0.9986837543359314},{"cnt":[[245,705],[1652,705],[1652,754],[245,754]],"region":{"top_left_x":244,"top_left_y":704,"width":1409,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f1056b3136b40d2be1a0eb56d878f1c","type":"text","conversion_output":true,"text":"identification number such that all patients from each country are given consecutive","text_display":" identification number such that all patients from each country are given consecutive","confidence":1,"confidence_rate":1},{"cnt":[[245,752],[1880,752],[1880,801],[245,801]],"region":{"top_left_x":244,"top_left_y":751,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c47d04b9eae4adebbee4efdf928a40d","type":"text","conversion_output":true,"text":"identification numbers in successive order of inclusion. The first 2 digits of the screening number","text_display":" identification numbers in successive order of inclusion. The first 2 digits of the screening number","confidence":1,"confidence_rate":1},{"cnt":[[245,799],[1830,799],[1830,851],[245,851]],"region":{"top_left_x":244,"top_left_y":799,"width":1587,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91e7ca0f67ad40959b8794fd06c8b3a1","type":"text","conversion_output":true,"text":"will be the number assigned to the country where the investigational center is located, the next","text_display":" will be the number assigned to the country where the investigational center is located, the next","confidence":1,"confidence_rate":1},{"cnt":[[245,851],[1865,849],[1865,900],[245,902]],"region":{"top_left_x":244,"top_left_y":848,"width":1621,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d03ac3779bc4cabbc35902aba3d01a0","type":"text","conversion_output":true,"text":"3 digits will be the investigational center number, and the last 3 digits will be the patient number","text_display":" 3 digits will be the investigational center number, and the last 3 digits will be the patient number","confidence":1,"confidence_rate":1},{"cnt":[[245,894],[1717,894],[1717,947],[245,947]],"region":{"top_left_x":244,"top_left_y":893,"width":1473,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7bf7caeeed849f48a2dfa90d948bd37","type":"text","conversion_output":true,"text":"assigned at the investigator center (eg, the \\(3^{\\text {rd }}\\) patient screened in the US [country 01 ] at","text_display":" assigned at the investigator center (eg, the \\(3^{\\text {rd }}\\) patient screened in the US [country 01 ] at","confidence":0.4891378708216507,"confidence_rate":0.9938009384395167},{"cnt":[[245,945],[1863,945],[1863,999],[245,999]],"region":{"top_left_x":244,"top_left_y":945,"width":1619,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de0b6837fc8646cb910defb4d258511a","type":"text","conversion_output":true,"text":"center 101 would be assigned the number of 01101003 ). The screening number is the permanent","text_display":" center 101 would be assigned the number of 01101003 ). The screening number is the permanent","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,993],[1188,993],[1188,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":992,"width":945,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dbc374e81164338af970ec3a4243f26","type":"text","conversion_output":true,"text":"number assigned to the patient for the duration of study.","text_display":" number assigned to the patient for the duration of study.","confidence":1,"confidence_rate":1},{"cnt":[[245,1061],[1712,1061],[1712,1113],[245,1113]],"region":{"top_left_x":244,"top_left_y":1061,"width":1469,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"823775ccea8c4c60a11086fee343d056","type":"text","conversion_output":true,"text":"After confirmation of study eligibility, patients will be screen failed or randomized into","text_display":"\nAfter confirmation of study eligibility, patients will be screen failed or randomized into","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1833,1113],[1833,1162],[245,1162]],"region":{"top_left_x":244,"top_left_y":1112,"width":1589,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"708aa23dac854d4aaf576c70074c52a0","type":"text","conversion_output":true,"text":"Study TV48125-CNS-30049 (ie, patients with CM) or the current study (ie, patients with EM).","text_display":" Study TV48125-CNS-30049 (ie, patients with CM) or the current study (ie, patients with EM).","confidence":1,"confidence_rate":1},{"cnt":[[245,1160],[1738,1160],[1738,1212],[245,1212]],"region":{"top_left_x":244,"top_left_y":1160,"width":1495,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d36312bcbdc5471190658fee6d1d377c","type":"text","conversion_output":true,"text":"For randomized patients, an enrollment number will be assigned consisting of the 8-digit","text_display":" For randomized patients, an enrollment number will be assigned consisting of the 8-digit","confidence":0.974609375,"confidence_rate":0.9997234949089036},{"cnt":[[245,1210],[1858,1210],[1858,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1209,"width":1615,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9d37f7b704a4fa989fd1c5eaa79b599","type":"text","conversion_output":true,"text":"screening number and the last 2 digits of the assigned protocol (ie, 49 for Study TV48125-CNS-","text_display":" screening number and the last 2 digits of the assigned protocol (ie, 49 for Study TV48125-CNS","confidence":1,"confidence_rate":1},{"cnt":[[245,1259],[1749,1259],[1749,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1258,"width":1505,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6dbec71515c4930b7a1c4d4e4e70b1d","type":"text","conversion_output":true,"text":"30049 or 50 for the current study; in the example above, the enrollment number would be","text_display":"30049 or 50 for the current study; in the example above, the enrollment number would be","confidence":0.99560546875,"confidence_rate":0.9999531477403147},{"cnt":[[245,1306],[728,1306],[728,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1306,"width":485,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d74b19507124c188f0e08cf932006df","type":"text","conversion_output":true,"text":"01101003-50 for this study).","text_display":" 01101003-50 for this study).","confidence":1,"confidence_rate":1},{"cnt":[[245,1375],[1764,1375],[1764,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1375,"width":1520,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e5db02f939f49c19bfce63fdf72003c","type":"text","conversion_output":true,"text":"A patient who is screened and does not meet study entry criteria will not be considered for","text_display":"\nA patient who is screened and does not meet study entry criteria will not be considered for","confidence":1,"confidence_rate":1},{"cnt":[[245,1427],[522,1427],[522,1476],[245,1476]],"region":{"top_left_x":244,"top_left_y":1426,"width":279,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63f8646717954b4882c749100a328ab2","type":"text","conversion_output":true,"text":"screening again.","text_display":" screening again.","confidence":1,"confidence_rate":1},{"cnt":[[245,1495],[1850,1495],[1850,1545],[245,1545]],"region":{"top_left_x":244,"top_left_y":1495,"width":1606,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f438e1cff99439dbc9e43c17d1d3a0b","type":"text","conversion_output":true,"text":"The screening visit (visit 1) will take place approximately 28 days before the baseline visit. The","text_display":"\n\nThe screening visit (visit 1) will take place approximately 28 days before the baseline visit. 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Body mass index will","text_display":"\n- Perform a physical examination, including height and weight. 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Patients will","text_display":"\n\nPatients will complete electronic headache diary entries daily beginning on day -27 . Patients will","confidence":1,"confidence_rate":1},{"cnt":[[245,741],[1740,741],[1740,793],[245,793]],"region":{"top_left_x":244,"top_left_y":741,"width":1497,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4f78833f7d847c79b69282adafe3829","type":"text","conversion_output":true,"text":"enter headache information (ie, occurrence of headache, duration of headache, maximum","text_display":" enter headache information (ie, occurrence of headache, duration of headache, maximum","confidence":1,"confidence_rate":1},{"cnt":[[245,791],[1880,791],[1880,840],[245,840]],"region":{"top_left_x":244,"top_left_y":790,"width":1636,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f611bf8ba5a4503a0ecf00c01cbd275","type":"text","conversion_output":true,"text":"severity of headache, and acute migraine-specific medication use) about the previous day into the","text_display":" severity of headache, and acute migraine-specific medication use) about the previous day into the","confidence":1,"confidence_rate":1},{"cnt":[[245,838],[1519,838],[1519,889],[245,889]],"region":{"top_left_x":244,"top_left_y":837,"width":1275,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f29a3074aaa1477c90742d3f5426490f","type":"text","conversion_output":true,"text":"electronic headache diary device. Refer to Section 6.1 for additional details.","text_display":" electronic headache diary device. Refer to Section 6.1 for additional details.","confidence":1,"confidence_rate":1},{"cnt":[[241,924],[1068,924],[1068,986],[241,986]],"region":{"top_left_x":240,"top_left_y":923,"width":828,"height":64},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"896fdbec467047cea91ea4147dfa1268","type":"section_header","conversion_output":false,"children_ids":["35414329a5ca40d9bdd2932ed317095e"],"text":"","text_display":""},{"cnt":[[245,928],[1063,928],[1063,982],[245,982]],"region":{"top_left_x":244,"top_left_y":928,"width":820,"height":54},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35414329a5ca40d9bdd2932ed317095e","type":"text","conversion_output":true,"parent_id":"896fdbec467047cea91ea4147dfa1268","text":"3.14.2.2. Baseline (Visit 2 [Day 0 ( \\(\\pm 3\\) Days)])","text_display":"\n\n\\subsection*{3.14.2.2. 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Refer to Section 6.1 for additional details.","text_display":" device. Refer to Section 6.1 for additional details.","confidence":0.99951171875,"confidence_rate":0.999991860024828},{"cnt":[[241,1332],[1021,1332],[1021,1388],[241,1388]],"region":{"top_left_x":240,"top_left_y":1332,"width":781,"height":56},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"301a60391a9e41888b5c2a96f0e6739a","type":"section_header","conversion_output":false,"children_ids":["b0620e5bc0b9412d918973506a799f0e"],"text":"","text_display":""},{"cnt":[[245,1336],[1016,1336],[1016,1386],[245,1386]],"region":{"top_left_x":244,"top_left_y":1336,"width":773,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0620e5bc0b9412d918973506a799f0e","type":"text","conversion_output":true,"parent_id":"301a60391a9e41888b5c2a96f0e6739a","text":"3.14.3.1.1. Visit 2 (Day 0 [ \\(\\pm 3\\) Days]/Dose 1)","text_display":"\n\n\\subsection*{3.14.3.1.1. 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The following procedures/assessments will be performed after","text_display":" baseline procedures/assessments. The following procedures/assessments will be performed after","confidence":1,"confidence_rate":1},{"cnt":[[245,1504],[374,1504],[374,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1503,"width":130,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb69e19f3a0741cb890ed38decf01389","type":"text","conversion_output":true,"text":"dosing:","text_display":" dosing:","confidence":1,"confidence_rate":1},{"cnt":[[370,1573],[1772,1573],[1772,1624],[370,1624]],"region":{"top_left_x":369,"top_left_y":1572,"width":1404,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"100aa458bbb348459983513d0e5b4345","type":"text","conversion_output":true,"text":"- Perform local injection site assessment immediately and 1 hour after study drug","text_display":"\n- Perform local injection site assessment immediately and 1 hour after study drug","confidence":1,"confidence_rate":1},{"cnt":[[434,1624],[1820,1624],[1820,1674],[434,1674]],"region":{"top_left_x":433,"top_left_y":1624,"width":1387,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1a07537aaf6458ea80d479d23511366","type":"text","conversion_output":true,"text":"administration. Additional assessments may be performed based on the severity of","text_display":" administration. Additional assessments may be performed based on the severity of","confidence":1,"confidence_rate":1},{"cnt":[[434,1671],[1674,1671],[1674,1721],[434,1721]],"region":{"top_left_x":433,"top_left_y":1671,"width":1241,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d361d5a0adba4d7390f6151eba82044b","type":"text","conversion_output":true,"text":"any observed injection site reaction. See Section 7.9 for additional details.","text_display":" any observed injection site reaction. See Section 7.9 for additional details.","confidence":0.99853515625,"confidence_rate":0.9999827540583306},{"cnt":[[370,1745],[1772,1745],[1772,1794],[370,1794]],"region":{"top_left_x":369,"top_left_y":1744,"width":1404,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1edf2f3c1eba497fb5b2bb474fdc5272","type":"text","conversion_output":true,"text":"- Inquire about postdose adverse events before the patient leaves the study center.","text_display":"\n- Inquire about postdose adverse events before the patient leaves the study center.","confidence":1,"confidence_rate":1},{"cnt":[[241,1828],[1676,1828],[1676,1886],[241,1886]],"region":{"top_left_x":240,"top_left_y":1828,"width":1436,"height":59},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9335e9ae452e40a5bac150ea40c691e4","type":"section_header","conversion_output":false,"children_ids":["1d442162f9aa444a8d0dd28464f0506f"],"text":"","text_display":""},{"cnt":[[245,1830],[1669,1830],[1669,1884],[245,1884]],"region":{"top_left_x":244,"top_left_y":1830,"width":1426,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d442162f9aa444a8d0dd28464f0506f","type":"text","conversion_output":true,"parent_id":"9335e9ae452e40a5bac150ea40c691e4","text":"3.14.3.1.2. 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compliance.","confidence":0.9990234375,"confidence_rate":0.9999684830886739},{"cnt":[[370,2166],[1794,2166],[1794,2215],[370,2215]],"region":{"top_left_x":369,"top_left_y":2165,"width":1425,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a990368099f84fa8acfcd0d99a2e19f7","type":"text","conversion_output":true,"text":"- Perform vital signs measurements (includes systolic and diastolic blood pressure,","text_display":"\n- Perform vital signs measurements (includes systolic and diastolic blood pressure,","confidence":1,"confidence_rate":1},{"cnt":[[432,2213],[1210,2213],[1210,2262],[432,2262]],"region":{"top_left_x":431,"top_left_y":2212,"width":779,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10deac0208df47428e22edf1647d32b7","type":"text","conversion_output":true,"text":"pulse, body temperature, and respiratory rate).","text_display":" pulse, body temperature, and respiratory rate).","confidence":1,"confidence_rate":1},{"cnt":[[372,2288],[930,2288],[930,2335],[372,2335]],"region":{"top_left_x":371,"top_left_y":2288,"width":560,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfc0fbddf4c2435089289890fa7aebc6","type":"text","conversion_output":true,"text":"- Inquire about adverse events.","text_display":"\n- Inquire about adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[370,2359],[1227,2359],[1227,2408],[370,2408]],"region":{"top_left_x":369,"top_left_y":2358,"width":858,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2378486759ea453da0042a2141674dcb","type":"text","conversion_output":true,"text":"- Inquire about/review concomitant medications.","text_display":"\n- Inquire about/review concomitant medications.","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e4fe11228d848dfbc36ce5da4e0a87b","type":"page_info","conversion_output":false,"text":"62","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-064","page":64,"lines":[{"cnt":[[1109,125],[1880,125],[1880,176],[1109,176]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ac1524479614b8fbb9bee84e42e1ac6","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b071f4b56b147e8b7d712b86c7cc831","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0eb534633cc545ff84891199cb4834f9","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,254],[1794,254],[1794,305],[370,305]],"region":{"top_left_x":369,"top_left_y":253,"width":1425,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"529b2b61d25149fba7956dcbf57b0008","type":"text","conversion_output":true,"text":"- Perform clinical laboratory tests (serum chemistry, hematology, coagulation, and","text_display":"\n- Perform clinical laboratory tests (serum chemistry, hematology, coagulation, and","confidence":1,"confidence_rate":1},{"cnt":[[432,305],[625,305],[625,354],[432,354]],"region":{"top_left_x":431,"top_left_y":305,"width":195,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35a90bce5e574f49a10bc9718fda8ba4","type":"text","conversion_output":true,"text":"urinalysis).","text_display":" urinalysis).","confidence":1,"confidence_rate":1},{"cnt":[[370,374],[1549,374],[1549,428],[370,428]],"region":{"top_left_x":369,"top_left_y":373,"width":1181,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b58272cc9e14b249d878f28df4f2ab4","type":"text","conversion_output":true,"text":"- Perform urine \\(\\beta\\)-HCG test (women of childbearing potential only).","text_display":"\n- Perform urine \\(\\beta\\)-HCG test (women of childbearing potential only).","confidence":0.81298828125,"confidence_rate":0.9972432922664453},{"cnt":[[370,447],[1807,447],[1807,496],[370,496]],"region":{"top_left_x":369,"top_left_y":446,"width":1438,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6b46cd46c1349fa892b0f189aed4b9b","type":"text","conversion_output":true,"text":"- Obtain a \\(4- mL\\) blood sample for plasma TEV-48125 concentration determination.","text_display":"\n- Obtain a \\(4- mL\\) blood sample for plasma TEV-48125 concentration determination.","confidence":0.8121945412131026,"confidence_rate":0.9976654777316499},{"cnt":[[370,520],[1622,520],[1622,569],[370,569]],"region":{"top_left_x":369,"top_left_y":519,"width":1254,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d216330237fa435e95fa923e2dc45109","type":"text","conversion_output":true,"text":"- Obtain a \\(5- mL\\) blood sample for serum ADA assessment (visit 3 only).","text_display":"\n- Obtain a \\(5- mL\\) blood sample for serum ADA assessment (visit 3 only).","confidence":1,"confidence_rate":1},{"cnt":[[370,591],[1532,591],[1532,642],[370,642]],"region":{"top_left_x":369,"top_left_y":590,"width":1163,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2d85d3b46af4b7d851d8d53da467362","type":"text","conversion_output":true,"text":"- Obtain a \\(5- mL\\) urine sample for biomarker analysis (visit 4 only).","text_display":"\n- Obtain a \\(5- mL\\) urine sample for biomarker analysis (visit 4 only).","confidence":1,"confidence_rate":1},{"cnt":[[370,662],[1826,662],[1826,713],[370,713]],"region":{"top_left_x":369,"top_left_y":661,"width":1458,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"177f758442c44793841d3ee1de929438","type":"text","conversion_output":true,"text":"- Obtain an \\(18.5- mL\\) blood sample ( 6 mL each for serum and plasma and 6.5 mL for","text_display":"\n- Obtain an \\(18.5- mL\\) blood sample ( 6 mL each for serum and plasma and 6.5 mL for","confidence":0.9595115090487525,"confidence_rate":0.9995908662055261},{"cnt":[[432,709],[1594,709],[1594,763],[432,763]],"region":{"top_left_x":431,"top_left_y":708,"width":1164,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3933dde15b724ed0991901dfe5ea717e","type":"text","conversion_output":true,"text":"RNA) for serum, plasma, and RNA biomarker analysis (visit 4 only).","text_display":" RNA) for serum, plasma, and RNA biomarker analysis (visit 4 only).","confidence":1,"confidence_rate":1},{"cnt":[[370,782],[1253,782],[1253,834],[370,834]],"region":{"top_left_x":369,"top_left_y":782,"width":884,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0036c191fc7142b1b3474ac249519452","type":"text","conversion_output":true,"text":"- Complete the eC-SSRS Since Last Visit version.","text_display":"\n- Complete the eC-SSRS Since Last Visit version.","confidence":1,"confidence_rate":1},{"cnt":[[370,855],[1420,855],[1420,904],[370,904]],"region":{"top_left_x":369,"top_left_y":855,"width":1052,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f0aaf20d64349d9915127327119de8d","type":"text","conversion_output":true,"text":"- Administer the MSQOL questionnaire and the PGIC scale.","text_display":"\n- Administer the MSQOL questionnaire and the PGIC scale.","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1820,924],[1820,973],[245,973]],"region":{"top_left_x":244,"top_left_y":923,"width":1576,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e7d2e763afc4c8abc4d077fba4fedea","type":"text","conversion_output":true,"text":"In addition, a single \\(6- mL\\) blood sample for pharmacogenomics (DNA) may be obtained from","text_display":"\n\nIn addition, a single \\(6- mL\\) blood sample for pharmacogenomics (DNA) may be obtained from","confidence":0.9682769775390625,"confidence_rate":0.9996711041102306},{"cnt":[[245,971],[1768,971],[1768,1023],[245,1023]],"region":{"top_left_x":244,"top_left_y":971,"width":1525,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"adf83864181c4e4c9d3b04520856dd4b","type":"text","conversion_output":true,"text":"patients who consent to pharmacogenomics analysis at visit 3 or visit 4 if the sample is not","text_display":" patients who consent to pharmacogenomics analysis at visit 3 or visit 4 if the sample is not","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,1023],[561,1023],[561,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1022,"width":317,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8ea81dd2c5940e28165c832c1316901","type":"text","conversion_output":true,"text":"obtained at visit 2 .","text_display":" obtained at visit 2 .","confidence":0.9951171875,"confidence_rate":0.9998312289890597},{"cnt":[[245,1091],[1708,1091],[1708,1141],[245,1141]],"region":{"top_left_x":244,"top_left_y":1091,"width":1465,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c43ca16b7cd24e2ca3f22aeaa5a25392","type":"text","conversion_output":true,"text":"Patients will receive a sc TEV-48125 at 225 mg or sc placebo after completing predose","text_display":"\n\nPatients will receive a sc TEV-48125 at 225 mg or sc placebo after completing predose","confidence":0.6923828125,"confidence_rate":0.9961378323854576},{"cnt":[[245,1139],[1841,1139],[1841,1188],[245,1188]],"region":{"top_left_x":244,"top_left_y":1138,"width":1598,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ab2f64ff02c48a786265e75890ff954","type":"text","conversion_output":true,"text":"procedures/assessments. The following procedures/assessments will be performed after dosing:","text_display":" procedures/assessments. The following procedures/assessments will be performed after dosing:","confidence":1,"confidence_rate":1},{"cnt":[[370,1212],[1772,1212],[1772,1261],[370,1261]],"region":{"top_left_x":369,"top_left_y":1211,"width":1404,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0e451885a784ca8a2cb2585516a98e3","type":"text","conversion_output":true,"text":"- Perform local injection site assessment immediately and 1 hour after study drug","text_display":"\n- Perform local injection site assessment immediately and 1 hour after study drug","confidence":1,"confidence_rate":1},{"cnt":[[432,1259],[1820,1259],[1820,1308],[432,1308]],"region":{"top_left_x":431,"top_left_y":1258,"width":1389,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8beeedbcc6f743849684be97d4021796","type":"text","conversion_output":true,"text":"administration. Additional assessments may be performed based on the severity of","text_display":" administration. Additional assessments may be performed based on the severity of","confidence":1,"confidence_rate":1},{"cnt":[[432,1308],[1674,1308],[1674,1360],[432,1360]],"region":{"top_left_x":431,"top_left_y":1308,"width":1243,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e04c866204164b75a1a50f67fe5545bf","type":"text","conversion_output":true,"text":"any observed injection site reaction. See Section 7.9 for additional details.","text_display":" any observed injection site reaction. See Section 7.9 for additional details.","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[370,1379],[1772,1379],[1772,1429],[370,1429]],"region":{"top_left_x":369,"top_left_y":1379,"width":1404,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1e164fc0a90474da20049c98d27f49b","type":"text","conversion_output":true,"text":"- Inquire about postdose adverse events before the patient leaves the study center.","text_display":"\n- Inquire about postdose adverse events before the patient leaves the study center.","confidence":1,"confidence_rate":1},{"cnt":[[241,1465],[1360,1465],[1360,1523],[241,1523]],"region":{"top_left_x":240,"top_left_y":1465,"width":1120,"height":59},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca3efa450d3846d6b830f14b885a87d2","type":"section_header","conversion_output":false,"children_ids":["c8cf48f692c34de18eff5aa68cfa0eaf"],"text":"","text_display":""},{"cnt":[[245,1470],[1356,1470],[1356,1519],[245,1519]],"region":{"top_left_x":244,"top_left_y":1469,"width":1112,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8cf48f692c34de18eff5aa68cfa0eaf","type":"text","conversion_output":true,"parent_id":"ca3efa450d3846d6b830f14b885a87d2","text":"3.14.3.1.3. End-of-Treatment Visit (Visit 5 [Day 84 ( \\(\\pm 3\\) Days)])","text_display":"\n\n\\subsection*{3.14.3.1.3. End-of-Treatment Visit (Visit 5 [Day 84 ( \\(\\pm 3\\) Days)])}","confidence":0.7727695103682557,"confidence_rate":0.9969359603242217},{"cnt":[[245,1538],[1635,1538],[1635,1588],[245,1588]],"region":{"top_left_x":244,"top_left_y":1538,"width":1391,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a478b8c1b084e77a77999ad55f2a24c","type":"text","conversion_output":true,"text":"The following procedures/assessments will be performed at the EOT visit (visit 5):","text_display":"\n\nThe following procedures/assessments will be performed at the EOT visit (visit 5):","confidence":1,"confidence_rate":1},{"cnt":[[370,1611],[1781,1611],[1781,1661],[370,1661]],"region":{"top_left_x":369,"top_left_y":1611,"width":1413,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b00c448f0be49d182addac8877f9d41","type":"text","conversion_output":true,"text":"- Review headache diary. (Note: Patients will return the electronic headache diary","text_display":"\n- Review headache diary. (Note: Patients will return the electronic headache diary","confidence":1,"confidence_rate":1},{"cnt":[[434,1659],[849,1659],[849,1708],[434,1708]],"region":{"top_left_x":433,"top_left_y":1658,"width":416,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cea1c45a8ef477187dc1f9b1e417ab8","type":"text","conversion_output":true,"text":"device at the EOT visit.)","text_display":" device at the EOT visit.)","confidence":1,"confidence_rate":1},{"cnt":[[372,1732],[879,1732],[879,1781],[372,1781]],"region":{"top_left_x":371,"top_left_y":1731,"width":508,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf3f334e5b284d56a90adeebd8d1837e","type":"text","conversion_output":true,"text":"- Review study compliance.","text_display":"\n- Review study 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(Note: Patients","text_display":" questionnaire, PGIC scale, WPAI questionnaire, and PHQ-2/PHQ-9. (Note: Patients","confidence":1,"confidence_rate":1},{"cnt":[[434,688],[1833,688],[1833,737],[434,737]],"region":{"top_left_x":433,"top_left_y":687,"width":1400,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f70fc7503f2f4476ac7094c1f7900b1b","type":"text","conversion_output":true,"text":"will respond first to the PHQ-2. They will respond to questions 3 through 9 [unique","text_display":" will respond first to the PHQ-2. They will respond to questions 3 through 9 [unique","confidence":1,"confidence_rate":1},{"cnt":[[434,735],[1362,735],[1362,786],[434,786]],"region":{"top_left_x":433,"top_left_y":734,"width":930,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e613092fb1884f0e8554a95b5543cacb","type":"text","conversion_output":true,"text":"questions] of the PHQ-9 only if the PHQ-2 is positive.)","text_display":" questions] of the PHQ-9 only if the PHQ-2 is positive.)","confidence":1,"confidence_rate":1},{"cnt":[[245,804],[1820,804],[1820,855],[245,855]],"region":{"top_left_x":244,"top_left_y":803,"width":1576,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b81f415d04a484789ceeed5d0a2c2e0","type":"text","conversion_output":true,"text":"In addition, a single \\(6- mL\\) blood sample for pharmacogenomics (DNA) may be obtained from","text_display":"\nIn addition, a single \\(6- mL\\) blood sample for pharmacogenomics (DNA) may be obtained from","confidence":0.865234375,"confidence_rate":0.998524000003956},{"cnt":[[245,855],[1815,855],[1815,904],[245,904]],"region":{"top_left_x":244,"top_left_y":855,"width":1572,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7d1622ae0784850a17575edac40ac21","type":"text","conversion_output":true,"text":"patients who consent to pharmacogenomics analysis if the sample is not obtained at an earlier","text_display":" patients who consent to pharmacogenomics analysis if the sample is not obtained at an earlier","confidence":0.99755859375,"confidence_rate":0.9999750575422747},{"cnt":[[245,902],[335,902],[335,947],[245,947]],"region":{"top_left_x":244,"top_left_y":902,"width":92,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7daa116889cf42d19ddecf7899150dcb","type":"text","conversion_output":true,"text":"visit.","text_display":" visit.","confidence":1,"confidence_rate":1},{"cnt":[[241,993],[1171,993],[1171,1046],[241,1046]],"region":{"top_left_x":240,"top_left_y":992,"width":931,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b15e82d6fe674672a533c5e740d0896b","type":"section_header","conversion_output":false,"children_ids":["aa282d1dcc7c448da0ec05fd127b12d7"],"text":"","text_display":""},{"cnt":[[245,993],[1167,993],[1167,1042],[245,1042]],"region":{"top_left_x":244,"top_left_y":992,"width":923,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa282d1dcc7c448da0ec05fd127b12d7","type":"text","conversion_output":true,"parent_id":"b15e82d6fe674672a533c5e740d0896b","text":"3.14.4. Procedures After Study Drug Treatment","text_display":"\n\n\\subsection*{3.14.4. Procedures After Study Drug Treatment}","confidence":0.99951171875,"confidence_rate":0.9999902320377446},{"cnt":[[245,1061],[1850,1061],[1850,1111],[245,1111]],"region":{"top_left_x":244,"top_left_y":1061,"width":1606,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5841d763838d4c64b6a4c9d33795705a","type":"text","conversion_output":true,"text":"Patients who participate in the study in compliance with the protocol for the entire double-blind","text_display":"\n\nPatients who participate in the study in compliance with the protocol for the entire double-blind","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1738,1113],[1738,1160],[245,1160]],"region":{"top_left_x":244,"top_left_y":1112,"width":1495,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d08e22635e534e8e8498845e8364f2ca","type":"text","conversion_output":true,"text":"treatment period (ie, through visit 5) will be considered to have completed the study. See","text_display":" treatment period (ie, through visit 5) will be considered to have completed the study. See","confidence":0.682283878326416,"confidence_rate":0.9959837765387285},{"cnt":[[245,1160],[1824,1160],[1824,1210],[245,1210]],"region":{"top_left_x":244,"top_left_y":1160,"width":1581,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8f5f6cd330342a8a33f40971d5a8792","type":"text","conversion_output":true,"text":"Section 12.4 for the definition of the end of the study. Patients who complete the double-blind","text_display":" Section 12.4 for the definition of the end of the study. Patients who complete the double-blind","confidence":1,"confidence_rate":1},{"cnt":[[245,1207],[1772,1207],[1772,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1207,"width":1529,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d749e41e366c46e1af15c306950ef8f1","type":"text","conversion_output":true,"text":"treatment period may enter the 12-month double-blind, long-term safety and efficacy study","text_display":" treatment period may enter the 12-month double-blind, long-term safety and efficacy study","confidence":0.515625,"confidence_rate":0.9929782206027422},{"cnt":[[245,1257],[1850,1257],[1850,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1256,"width":1606,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"322e9a47586b4d3fa415097664f5f023","type":"text","conversion_output":true,"text":"(Study TV48125-CNS-30051). For these patients, final evaluations for the current study will be","text_display":" (Study TV48125-CNS-30051). For these patients, final evaluations for the current study will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[853,1306],[853,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1306,"width":609,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"336ba036ce30451fa19b3a0657acbf85","type":"text","conversion_output":true,"text":"performed at the EOT visit (visit 5).","text_display":" performed at the EOT visit (visit 5).","confidence":0.9990234375,"confidence_rate":0.9999767374218201},{"cnt":[[245,1375],[1785,1375],[1785,1424],[245,1424]],"region":{"top_left_x":244,"top_left_y":1375,"width":1542,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2248ee3059474893a0771b52e55771b8","type":"text","conversion_output":true,"text":"Patients who withdraw from the study should have final evaluations (EOT/early withdrawal","text_display":"\n\nPatients who withdraw from the study should have final evaluations (EOT/early withdrawal","confidence":1,"confidence_rate":1},{"cnt":[[245,1422],[1790,1422],[1790,1472],[245,1472]],"region":{"top_left_x":244,"top_left_y":1422,"width":1546,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5498a92275c04bd89249f30020761816","type":"text","conversion_output":true,"text":"visit) performed on the last day they receive the study drug or as soon as possible thereafter.","text_display":" visit) performed on the last day they receive the study drug or as soon as possible thereafter.","confidence":1,"confidence_rate":1},{"cnt":[[245,1472],[1835,1472],[1835,1521],[245,1521]],"region":{"top_left_x":244,"top_left_y":1471,"width":1591,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92cd1682e7894f55acff0c19bf28ea89","type":"text","conversion_output":true,"text":"Procedures for patients who withdraw prematurely from the study are described in Section 4.4.","text_display":" Procedures for patients who withdraw prematurely from the study are described in Section 4.4.","confidence":1,"confidence_rate":1},{"cnt":[[245,1521],[1729,1521],[1729,1571],[245,1571]],"region":{"top_left_x":244,"top_left_y":1521,"width":1486,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec7d21be2fe6485faf702366b18553ee","type":"text","conversion_output":true,"text":"All protocol-specified evaluations should be performed at the early withdrawal visit (see","text_display":" All protocol-specified evaluations should be performed at the early withdrawal visit (see","confidence":1,"confidence_rate":1},{"cnt":[[245,1568],[402,1568],[402,1618],[245,1618]],"region":{"top_left_x":244,"top_left_y":1568,"width":158,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3da0a4f48bed4ea5a533746ee984b21f","type":"text","conversion_output":true,"text":"Table 1).","text_display":" Table 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drug in this study.","text_display":" administration of the final dose of study drug in this study.","confidence":1,"confidence_rate":1},{"cnt":[[241,1869],[784,1869],[784,1921],[241,1921]],"region":{"top_left_x":240,"top_left_y":1869,"width":545,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54e27e55e444452ca508e13ebb81d68a","type":"section_header","conversion_output":false,"children_ids":["e3637f21f29b49e6b65b0a9bf35e9702"],"text":"","text_display":""},{"cnt":[[245,1876],[780,1876],[780,1919],[245,1919]],"region":{"top_left_x":244,"top_left_y":1875,"width":536,"height":44},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3637f21f29b49e6b65b0a9bf35e9702","type":"text","conversion_output":true,"parent_id":"54e27e55e444452ca508e13ebb81d68a","text":"3.14.5. Unscheduled Visits","text_display":"\n\n\\subsection*{3.14.5. Unscheduled Visits}","confidence":0.9560546875,"confidence_rate":0.9985513676027058},{"cnt":[[245,1944],[1841,1944],[1841,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1944,"width":1598,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0922a24daf7492da5584793ea26deb6","type":"text","conversion_output":true,"text":"An unscheduled visit may be performed at any time during the study, at the patient's request or","text_display":"\n\nAn unscheduled visit may be performed at any time during the study, at the patient's request or","confidence":1,"confidence_rate":1},{"cnt":[[245,1992],[1824,1992],[1824,2041],[245,2041]],"region":{"top_left_x":244,"top_left_y":1991,"width":1581,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bef70bb065ab465dbe5375de6991e769","type":"text","conversion_output":true,"text":"as deemed necessary by the investigator. The date and reason for the unscheduled visit will be","text_display":" as deemed necessary by the investigator. The date and reason for the unscheduled visit will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2041],[1732,2041],[1732,2090],[245,2090]],"region":{"top_left_x":244,"top_left_y":2041,"width":1488,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"555d34fbde5440079b95d9542f3c5771","type":"text","conversion_output":true,"text":"recorded on the CRF as well as any other data obtained (eg, adverse events, concomitant","text_display":" recorded on the CRF as well as any other data obtained (eg, adverse events, concomitant","confidence":1,"confidence_rate":1},{"cnt":[[245,2088],[1347,2088],[1347,2138],[245,2138]],"region":{"top_left_x":244,"top_left_y":2088,"width":1104,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7807275de4a041339da875b07201b683","type":"text","conversion_output":true,"text":"medications and treatments, and results from procedures or tests).","text_display":" medications and treatments, and results from procedures or tests).","confidence":1,"confidence_rate":1},{"cnt":[[245,2159],[1437,2159],[1437,2209],[245,2209]],"region":{"top_left_x":244,"top_left_y":2159,"width":1194,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42f8fcc7c06044aebce78f2c2d9c77de","type":"text","conversion_output":true,"text":"Procedures performed during unscheduled visits include the following:","text_display":"\n\nProcedures performed during unscheduled visits include the following:","confidence":1,"confidence_rate":1},{"cnt":[[372,2230],[838,2230],[838,2279],[372,2279]],"region":{"top_left_x":371,"top_left_y":2230,"width":467,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93c164844e5142b38439ab08a59e3e8b","type":"text","conversion_output":true,"text":"- Review headache diary.","text_display":"\n- Review headache 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Not using preventive medications (presented in Appendix B) (ie, at least 5 half-lives","text_display":"\ne. 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Justification for Key Inclusion and Exclusion Criteria","text_display":"\n\n\\subsection*{4.3. Justification for Key Inclusion and Exclusion Criteria}","confidence":0.98779296875,"confidence_rate":0.9998081098352787},{"cnt":[[245,971],[1811,971],[1811,1021],[245,1021]],"region":{"top_left_x":244,"top_left_y":971,"width":1568,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13b82fde1b1542e095f007d597c99c53","type":"text","conversion_output":true,"text":"The inclusion and exclusion criteria select for patients who meet ICHD-3 revision criteria for","text_display":"\n\nThe inclusion and exclusion criteria select for patients who meet ICHD-3 revision criteria for","confidence":1,"confidence_rate":1},{"cnt":[[245,1018],[1772,1018],[1772,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1018,"width":1529,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebb4294b52fd4c3bbf092f29195d9edd","type":"text","conversion_output":true,"text":"EM (Classification Committee of the IHS, 2013). Because headache consortium guidelines","text_display":" EM (Classification Committee of the IHS, 2013). Because headache consortium guidelines","confidence":1,"confidence_rate":1},{"cnt":[[245,1068],[1818,1068],[1818,1119],[245,1119]],"region":{"top_left_x":244,"top_left_y":1067,"width":1574,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b33f8d0403841739979b4a81ef35df4","type":"text","conversion_output":true,"text":"recommend preventive therapies for patients with EM occurring on 4 or more days per month","text_display":" recommend preventive therapies for patients with EM occurring on 4 or more days per month","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[1858,1117],[1858,1167],[245,1167]],"region":{"top_left_x":244,"top_left_y":1117,"width":1615,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e33e623aec0458d8ed0338b61b4c177","type":"text","conversion_output":true,"text":"due to the frequency of headaches and the high degree of disability, Inclusion Criterion e allows","text_display":" due to the frequency of headaches and the high degree of disability, Inclusion Criterion e allows","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1164],[1332,1164],[1332,1214],[245,1214]],"region":{"top_left_x":244,"top_left_y":1164,"width":1089,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9efef24a75704545bbe070be32e95473","type":"text","conversion_output":true,"text":"for the use of 1 concomitant preventive medication for migraine.","text_display":" for the use of 1 concomitant preventive medication for migraine.","confidence":1,"confidence_rate":1},{"cnt":[[236,1250],[1218,1250],[1218,1315],[236,1315]],"region":{"top_left_x":236,"top_left_y":1250,"width":983,"height":65},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecb973a4da6440a881e233c5dfe63ba4","type":"section_header","conversion_output":false,"children_ids":["b9e08698947e4f2686fbd7a71c041701"],"text":"","text_display":""},{"cnt":[[245,1257],[1210,1257],[1210,1308],[245,1308]],"region":{"top_left_x":244,"top_left_y":1256,"width":966,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9e08698947e4f2686fbd7a71c041701","type":"text","conversion_output":true,"parent_id":"ecb973a4da6440a881e233c5dfe63ba4","text":"4.4. 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A complete final evaluation at the time of the patient's withdrawal","text_display":" to the time of withdrawal. 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If a patient withdraws consent, every attempt will be made to determine the reason. If","text_display":" the CRF. If a patient withdraws consent, every attempt will be made to determine the reason. 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The specific event or test result must be recorded on the source documentation and","text_display":" made). 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Generic or trade name, indication, and dosage will be recorded. In addition,","text_display":" on the CRF. Generic or trade name, indication, and dosage will be recorded. In addition,","confidence":1,"confidence_rate":1},{"cnt":[[245,1671],[1646,1671],[1646,1721],[245,1721]],"region":{"top_left_x":244,"top_left_y":1671,"width":1402,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78b2a3c95ba04829896b57fc5c7a9bc2","type":"text","conversion_output":true,"text":"migraine preventive medication that a patient took within 2 years before study drug","text_display":" migraine preventive medication that a patient took within 2 years before study drug","confidence":1,"confidence_rate":1},{"cnt":[[245,1721],[1863,1721],[1863,1772],[245,1772]],"region":{"top_left_x":244,"top_left_y":1720,"width":1619,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79e8370ad2ea4aeb9c0e48d2cc3890d8","type":"text","conversion_output":true,"text":"administration will be recorded on the CRF. The sponsor will encode all therapy and medication","text_display":" administration will be recorded on the CRF. The sponsor will encode all therapy and medication","confidence":1,"confidence_rate":1},{"cnt":[[245,1770],[1263,1770],[1263,1820],[245,1820]],"region":{"top_left_x":244,"top_left_y":1770,"width":1020,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15afef7ba2894a1d902e5f05ab32bbe8","type":"text","conversion_output":true,"text":"according to the World Health Organization drug dictionary.","text_display":" according to the World Health Organization drug dictionary.","confidence":1,"confidence_rate":1},{"cnt":[[236,1852],[1680,1852],[1680,1916],[236,1916]],"region":{"top_left_x":236,"top_left_y":1851,"width":1445,"height":66},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c11763561ec543f3a98a25e9c2e9d5fc","type":"section_header","conversion_output":false,"children_ids":["302411c151d64c73959366f6f513d694"],"text":"","text_display":""},{"cnt":[[245,1858],[1674,1858],[1674,1910],[245,1910]],"region":{"top_left_x":244,"top_left_y":1858,"width":1430,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"302411c151d64c73959366f6f513d694","type":"text","conversion_output":true,"parent_id":"c11763561ec543f3a98a25e9c2e9d5fc","text":"5.3.1. Prior Medications and Therapeutic Failures of Migraine Preventives:","text_display":"\n\n\\subsection*{5.3.1. Prior Medications and Therapeutic Failures of Migraine Preventives:}","confidence":0.56982421875,"confidence_rate":0.9929059488285025},{"cnt":[[245,1929],[1794,1929],[1794,1979],[245,1979]],"region":{"top_left_x":244,"top_left_y":1929,"width":1550,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"623d52fecb6c4004b314b480cc7b518c","type":"text","conversion_output":true,"text":"Details regarding excluded prior medications, including migraine preventive treatments, and","text_display":"\n\nDetails regarding excluded prior medications, including migraine preventive treatments, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1977],[1848,1977],[1848,2026],[245,2026]],"region":{"top_left_x":244,"top_left_y":1976,"width":1604,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c6392588961408e910ecd630c52a04f","type":"text","conversion_output":true,"text":"therapeutic failures of migraine preventives are described in the exclusion criteria (Section 4.2).","text_display":" therapeutic failures of migraine preventives are described in the exclusion criteria (Section 4.2).","confidence":1,"confidence_rate":1},{"cnt":[[236,2058],[1175,2058],[1175,2125],[236,2125]],"region":{"top_left_x":236,"top_left_y":2058,"width":940,"height":67},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ce9e33e1bd946068ff008f2b2d4bbe9","type":"section_header","conversion_output":false,"children_ids":["1a3342d19aa840adb68eb3a29c5c4d2e"],"text":"","text_display":""},{"cnt":[[245,2067],[1171,2067],[1171,2116],[245,2116]],"region":{"top_left_x":244,"top_left_y":2066,"width":927,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a3342d19aa840adb68eb3a29c5c4d2e","type":"text","conversion_output":true,"parent_id":"2ce9e33e1bd946068ff008f2b2d4bbe9","text":"5.3.2 Concomitant Therapies and Medications","text_display":"\n\n\\subsection*{5.3.2 Concomitant Therapies and Medications}","confidence":0.9590041637420654,"confidence_rate":0.9991282996859423},{"cnt":[[245,2136],[1811,2136],[1811,2185],[245,2185]],"region":{"top_left_x":244,"top_left_y":2135,"width":1568,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e048ec294204063a41a9ae2ba7d2117","type":"text","conversion_output":true,"text":"Up to \\(30 \\%\\) of patients will be allowed to remain on stable doses of no more than 1 preventive","text_display":"\n\nUp to \\(30 \\%\\) of patients will be allowed to remain on stable doses of no more than 1 preventive","confidence":0.9980475902557373,"confidence_rate":0.999981026217086},{"cnt":[[245,2185],[1850,2185],[1850,2237],[245,2237]],"region":{"top_left_x":244,"top_left_y":2184,"width":1606,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cb5118bf7b24c7b9ad225260bf26a5a","type":"text","conversion_output":true,"text":"migraine medication for the duration of the study provided the medication has at least moderate","text_display":" migraine medication for the duration of the study provided the medication has at least moderate","confidence":1,"confidence_rate":1},{"cnt":[[245,2234],[1682,2234],[1682,2284],[245,2284]],"region":{"top_left_x":244,"top_left_y":2234,"width":1439,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8e49f7aac4143879393fbabf4f9207d","type":"text","conversion_output":true,"text":"evidence of efficacy as defined by guidelines (Silberstein et al 2012) and presented in","text_display":" evidence of efficacy as defined by guidelines (Silberstein et al 2012) and presented in","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[245,2282],[1863,2282],[1863,2331],[245,2331]],"region":{"top_left_x":244,"top_left_y":2281,"width":1619,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"127d31bc8f1e4809832ab59baa160c71","type":"text","conversion_output":true,"text":"Appendix A. Patients on preventive medication must be on a stable dose for at least 2 months of","text_display":" Appendix A. Patients on preventive medication must be on a stable dose for at least 2 months of","confidence":1,"confidence_rate":1},{"cnt":[[245,2329],[1704,2327],[1704,2380],[245,2383]],"region":{"top_left_x":244,"top_left_y":2326,"width":1460,"height":57},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18416e8479c44edcb2487f3c7c3ae43b","type":"text","conversion_output":true,"text":"consecutive use prior to study entry. Alternatively, patients must have discontinued the","text_display":" consecutive use prior to study entry. Alternatively, patients must have discontinued the","confidence":1,"confidence_rate":1},{"cnt":[[245,2380],[1824,2380],[1824,2430],[245,2430]],"region":{"top_left_x":244,"top_left_y":2380,"width":1581,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f0eed4ab8d243da985f11f040af22f5","type":"text","conversion_output":true,"text":"preventive medication at least 5 half-lives prior to screening. Preventive migraine medications","text_display":" preventive medication at least 5 half-lives prior to screening. Preventive migraine medications","confidence":1,"confidence_rate":1},{"cnt":[[245,2428],[1865,2428],[1865,2477],[245,2477]],"region":{"top_left_x":244,"top_left_y":2427,"width":1621,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a850cd0d00c04ecb8cfbd6ac53006f42","type":"text","conversion_output":true,"text":"disallowed for at least \\(70 \\%\\) of patients for the duration of the study are presented in Appendix B.","text_display":" disallowed for at least \\(70 \\%\\) of patients for the duration of the study are presented in Appendix B.","confidence":0.51953125,"confidence_rate":0.9938414166718694},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b0c19cc5e6d46ba91c5e01ca9e576ea","type":"page_info","conversion_output":false,"text":"72","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-074","page":74,"lines":[{"cnt":[[1109,125],[1880,125],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b65b31c41a94e3c9a2ba1a9886703d9","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"304fdbef67ab464b8b5df5d4647d32db","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dbc2582a9424dc7832a99e75ea2cdd6","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1760,254],[1760,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1516,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc9d53f7aa2a453f891eee346666a6fa","type":"text","conversion_output":true,"text":"Patients will be allowed to use acute medication to treat acute migraine attacks, as needed.","text_display":"\n\nPatients will be allowed to use acute medication to treat acute migraine attacks, as needed.","confidence":1,"confidence_rate":1},{"cnt":[[245,322],[1807,322],[1807,372],[245,372]],"region":{"top_left_x":244,"top_left_y":322,"width":1563,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f31318c8d9c84b53b04bcb2f8051514f","type":"text","conversion_output":true,"text":"All concomitant medications taken during the study, including over-the-counter medications,","text_display":"\nAll concomitant medications taken during the study, including over-the-counter medications,","confidence":1,"confidence_rate":1},{"cnt":[[245,370],[1858,370],[1858,419],[245,419]],"region":{"top_left_x":244,"top_left_y":369,"width":1615,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"837d83a0f0ed4dc3b3e04ec3062b3ede","type":"text","conversion_output":true,"text":"vitamins, or herbal or nutritional supplements, must be recorded with indication, daily dose, and","text_display":" vitamins, or herbal or nutritional supplements, must be recorded with indication, daily dose, and","confidence":1,"confidence_rate":1},{"cnt":[[245,421],[1721,421],[1721,468],[245,468]],"region":{"top_left_x":244,"top_left_y":421,"width":1477,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9dccd375e7fe46e280cd6b21ac24ba34","type":"text","conversion_output":true,"text":"start and stop dates of administration. All patients will be questioned about concomitant","text_display":" start and stop dates of administration. All patients will be questioned about concomitant","confidence":1,"confidence_rate":1},{"cnt":[[245,468],[724,468],[724,513],[245,513]],"region":{"top_left_x":244,"top_left_y":468,"width":481,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3c0159b000c4b16b1b37e781be9c3db","type":"text","conversion_output":true,"text":"medication use at each visit.","text_display":" medication use at each visit.","confidence":1,"confidence_rate":1},{"cnt":[[241,554],[1429,554],[1429,621],[241,621]],"region":{"top_left_x":240,"top_left_y":554,"width":1189,"height":67},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ef6d9b5a6b445fd8734a2c79b3afe14","type":"section_header","conversion_output":false,"children_ids":["118f7ca9bbd44f0981ede6eb5c31c985"],"text":"","text_display":""},{"cnt":[[245,559],[1424,559],[1424,617],[245,617]],"region":{"top_left_x":244,"top_left_y":558,"width":1181,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"118f7ca9bbd44f0981ede6eb5c31c985","type":"text","conversion_output":true,"parent_id":"6ef6d9b5a6b445fd8734a2c79b3afe14","text":"5.4. Procedures for Monitoring Patient Compliance","text_display":"\n\n\\subsection*{5.4. Procedures for Monitoring Patient Compliance}","confidence":0.98486328125,"confidence_rate":0.9997175871414805},{"cnt":[[245,632],[1858,632],[1858,685],[245,685]],"region":{"top_left_x":244,"top_left_y":631,"width":1615,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c65c975f9ae041e0812aa49a611167fa","type":"text","conversion_output":true,"text":"The investigator will be responsible for monitoring patient compliance. If the investigator or the","text_display":"\n\nThe investigator will be responsible for monitoring patient compliance. If the investigator or the","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1861,683],[1861,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1617,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7dfb94a1458949a487824d8e7148e6bc","type":"text","conversion_output":true,"text":"sponsor determines that the patient is not in compliance with the study protocol, the investigator","text_display":" sponsor determines that the patient is not in compliance with the study protocol, the investigator","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1871,730],[1871,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1628,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e5ac82b1fbf40a9a57e721a6175b894","type":"text","conversion_output":true,"text":"and the sponsor should determine whether the patient should be withdrawn. The IEC/IRB should","text_display":" and the sponsor should determine whether the patient should be withdrawn. The IEC/IRB should","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[445,782],[445,827],[245,827]],"region":{"top_left_x":244,"top_left_y":782,"width":201,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"958fb3ab92af41e3b394ec5d27345b4e","type":"text","conversion_output":true,"text":"be notified.","text_display":" be notified.","confidence":1,"confidence_rate":1},{"cnt":[[241,868],[866,868],[866,926],[241,926]],"region":{"top_left_x":240,"top_left_y":867,"width":626,"height":59},"line":15,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"a5d6f58f11094b24a730a80a4944696f","type":"section_header","conversion_output":false,"children_ids":["06401ad724434bb1a85894da6a52f98f"],"text":"","text_display":""},{"cnt":[[245,872],[862,872],[862,922],[245,922]],"region":{"top_left_x":244,"top_left_y":872,"width":618,"height":50},"line":16,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"06401ad724434bb1a85894da6a52f98f","type":"text","conversion_output":true,"parent_id":"a5d6f58f11094b24a730a80a4944696f","text":"5.5. Total Blood Volume","text_display":"\n\n\\subsection*{5.5. Total Blood Volume}","confidence":0.87744140625,"confidence_rate":0.9953414171810777},{"cnt":[[245,947],[1717,947],[1717,999],[245,999]],"region":{"top_left_x":244,"top_left_y":947,"width":1473,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a777d9655fb4c8d8a20aef0282464c9","type":"text","conversion_output":true,"text":"The total volume of blood to be collected for each patient in this study is approximately","text_display":"\n\nThe total volume of blood to be collected for each patient in this study is approximately","confidence":1,"confidence_rate":1},{"cnt":[[247,997],[801,997],[801,1044],[247,1044]],"region":{"top_left_x":247,"top_left_y":996,"width":555,"height":49},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"088e4c6361524761b9b344a9a23fbb12","type":"text","conversion_output":true,"text":"140.5 mL , as detailed in Table 2.","text_display":" 140.5 mL , as detailed in Table 2.","confidence":0.99609375,"confidence_rate":0.9998996486426847},{"cnt":[[243,1061],[780,1061],[780,1115],[243,1115]],"region":{"top_left_x":242,"top_left_y":1061,"width":538,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"971a4b0dd53940a5be242cd5f395a9c9","type":"figure_label","conversion_output":false,"text":"Table 2: Blood Volumes","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[226,1128],[1901,1128],[1901,1790],[226,1790]],"region":{"top_left_x":225,"top_left_y":1127,"width":1677,"height":663},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"495adb4ee56043e38831976c18665b6f","type":"table","conversion_output":true,"children_ids":["513d5ac8cbf74fe195d609f77e6b6a6a","faf01fac8fd24a208a8d3b4e8d08ec42","6d6aa4ea140b4695819f9a6b351ea2a2","912874f247644dfb96d29393aa7d73ae","e38312cd3ecc42e1bea885f93580d51f","1404690392e2440dadb480289cabc7a3","1c64fcfd3edc42c8a7beab2aab796064","3e6092876128449684519b080e8016e2","360d347a812a457b8cc593f15ea9e4b9","af516af21140493f9805bc2c01ced47d","7146cea24f3f40b5a57d9c0a5323c787","94085ddd7e734b39ac097c5515d001a5","847a5487d48144d88465363fabd37f28","11ac951a7e9444d29cba7c34d031c564","e8bc99bd80264336baa13c9359c65d6f","2d4443fc403d478bad2ba3f716a2a976","097f2013fc9148d7808edb53e99cd80b","4e6ae47988d6426ebb24c2619eb9b091","df21b186a20e4efa86d3a54b1bc83284","96d18539c1de4e93852d6cbb8df1ea83","de7eceebb7664d2c8ca8f42b045f014b","7b3c6d4d509442b8974aae6ead7192de","3e73bd7e735845a0979b03df3a66611e","72f686d6f49f4015b8286af029bbfb84","5f8ff519ade94e77a1a1cfb65876e6e3","19e2c8e084fe46169743a58140f984c4","3e880af9110e47b68b1b985e0c52720c","12f472c0e67142cb9c0656108ad6d4a5","d07a830362fc4cf39fcc30e4ebe5ffcc","18f0e0a2a5844f47ba364a3d70dba5e5","0c4a2765c15849e8bcda2d82db3e9a63","8e4d330a4ad34b0db94e839dd2482877","c78d357c58684aaab85474f3b9e87933","d61beaff7bb14f858f23981efce3a9d3","1a6b7bead8eb4a76a13fe0913212d70a","bae7ecab15f24206a8b7d3ad0121944b","4eef010b503e4ab5a5d979e2eb7d95ed","0ecd821ae72645a4a1a3e886fd108fb2","ea60c6d768e64445a5b8f20bc8dc5816","090c5061b4b54574bfcd3eccd10da429","1e8240d2484e4c919375844df0649b7d","ba0b5a5fb40246f3ac9504de9745145b","88ab88236c1c477fa353b2c0d76b34f6","2ddd862a0b7f47e9a9e27d052be57bbb","c571b57636c344b4b2e5520301d68346","dcd6969f153640ff8734130205abcfa3","068210c690cc4987a7babf31a01be5c1","9a33a9822c3d4c07a939b8228f9c381b","c53f666d5cb3424e8809a721bf750677"],"selected_labels":["971a4b0dd53940a5be242cd5f395a9c9"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline 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Overall headache duration will be recorded numerically, in hours, as well as","text_display":" electronic diary. Overall headache duration will be recorded numerically, in hours, as well as","confidence":1,"confidence_rate":1},{"cnt":[[245,1448],[1268,1448],[1268,1497],[245,1497]],"region":{"top_left_x":244,"top_left_y":1448,"width":1024,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6be11e98107f4abc962cfe70a2bcd7f4","type":"text","conversion_output":true,"text":"number of hours with headache of at least moderate severity.","text_display":" number of hours with headache of at least moderate severity.","confidence":1,"confidence_rate":1},{"cnt":[[245,1517],[1747,1517],[1747,1566],[245,1566]],"region":{"top_left_x":244,"top_left_y":1516,"width":1503,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6676542639004294ae98529236e594f3","type":"text","conversion_output":true,"text":"If headache is reported, then headache severity will be subjectively rated by the patient as","text_display":"\n\nIf headache is reported, then headache severity will be subjectively rated by the patient as","confidence":1,"confidence_rate":1},{"cnt":[[245,1566],[389,1566],[389,1609],[245,1609]],"region":{"top_left_x":244,"top_left_y":1566,"width":145,"height":44},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"512acc8015a9457a94c551f65f68ee6a","type":"text","conversion_output":true,"text":"follows:","text_display":" follows:","confidence":1,"confidence_rate":1},{"cnt":[[372,1637],[681,1637],[681,1680],[372,1680]],"region":{"top_left_x":371,"top_left_y":1637,"width":311,"height":44},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1b8ddaa615f4059b89e83e60e4e0c5b","type":"text","conversion_output":true,"text":"- mild headache","text_display":"\n- mild headache","confidence":1,"confidence_rate":1},{"cnt":[[372,1710],[763,1710],[763,1751],[372,1751]],"region":{"top_left_x":371,"top_left_y":1710,"width":392,"height":41},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2c5b3e743294bbdb4f775a1292e9e97","type":"text","conversion_output":true,"text":"- moderate headache","text_display":"\n- moderate headache","confidence":1,"confidence_rate":1},{"cnt":[[370,1783],[713,1783],[713,1824],[370,1824]],"region":{"top_left_x":369,"top_left_y":1783,"width":345,"height":42},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fb09296d379428cb9d4f086724ae264","type":"text","conversion_output":true,"text":"- severe headache","text_display":"\n- severe headache","confidence":1,"confidence_rate":1},{"cnt":[[245,1852],[1835,1852],[1835,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1851,"width":1591,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2771bcd52e9949248e2e792af07f3032","type":"text","conversion_output":true,"text":"Patients will also record whether photophobia, phonophobia, nausea, and vomiting are present,","text_display":"\n\nPatients will also record whether photophobia, phonophobia, nausea, and vomiting are present,","confidence":1,"confidence_rate":1},{"cnt":[[245,1899],[1824,1899],[1824,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1899,"width":1581,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1b19c7a9f814d60a652aea585b3b75f","type":"text","conversion_output":true,"text":"and they will record any migraine medications (name of drug, number of tablets/capsules, and","text_display":" and they will record any migraine medications (name of drug, number of tablets/capsules, and","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,1946],[1261,1946],[1261,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1946,"width":1018,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd9aa2c9d6b84b67af684c97118ddf8e","type":"text","conversion_output":true,"text":"the dose in milligrams per tablet/capsule) taken on each day.","text_display":" the dose in milligrams per tablet/capsule) taken on each day.","confidence":1,"confidence_rate":1},{"cnt":[[243,2037],[1102,2037],[1102,2099],[243,2099]],"region":{"top_left_x":242,"top_left_y":2036,"width":861,"height":64},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfc05ff50de445d891e38394a67fa915","type":"section_header","conversion_output":false,"children_ids":["0a294b86d249494788bfe665cf8f76b0"],"text":"","text_display":""},{"cnt":[[245,2041],[1098,2041],[1098,2095],[245,2095]],"region":{"top_left_x":244,"top_left_y":2041,"width":854,"height":54},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a294b86d249494788bfe665cf8f76b0","type":"text","conversion_output":true,"parent_id":"dfc05ff50de445d891e38394a67fa915","text":"6.2 Migraine Disability Assessment","text_display":"\n\n\\subsection*{6.2 Migraine Disability Assessment}","confidence":0.9765625,"confidence_rate":0.9993920687979898},{"cnt":[[245,2114],[1867,2114],[1867,2163],[245,2163]],"region":{"top_left_x":244,"top_left_y":2114,"width":1623,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"290d9d8f9fad475e928329c9e52f3b7f","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":0.99609375,"confidence_rate":0.9999604664448944},{"cnt":[[245,2166],[1764,2166],[1764,2211],[245,2211]],"region":{"top_left_x":244,"top_left_y":2165,"width":1520,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1eca75cbb5d47729b1aa9ca1515c7a1","type":"text","conversion_output":true,"text":"based on lost days of activity in 3 domains (work, household work, and nonwork) over the","text_display":" based on lost days of activity in 3 domains (work, household work, and nonwork) over the","confidence":1,"confidence_rate":1},{"cnt":[[245,2213],[1876,2213],[1876,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2212,"width":1632,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e403ee76f5c422683ea6455179f6cbd","type":"text","conversion_output":true,"text":"previous 3 months. The total of the scores of the first 5 questions is used for grading of disability,","text_display":" previous 3 months. The total of the scores of the first 5 questions is used for grading of disability,","confidence":1,"confidence_rate":1},{"cnt":[[245,2260],[1794,2260],[1794,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1550,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4914e79c094d4ad2a9171b27d532d1fe","type":"text","conversion_output":true,"text":"with scores of 0 to 5,6 to 10,11 to 20 , and \\(\\geq 21\\) interpreted as disability grades 1 (little or no","text_display":" with scores of 0 to 5,6 to 10,11 to 20 , and \\(\\geq 21\\) interpreted as disability grades 1 (little or no","confidence":0.48538329990845286,"confidence_rate":0.9939946347999364},{"cnt":[[245,2307],[1837,2307],[1837,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2307,"width":1593,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ac25a823d82473eae38304374740f16","type":"text","conversion_output":true,"text":"disability), 2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively. It","text_display":" disability), 2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively. It","confidence":1,"confidence_rate":1},{"cnt":[[245,2359],[1876,2359],[1876,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2358,"width":1632,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f11961d52fd946a6988f7572fa8956c4","type":"text","conversion_output":true,"text":"has been shown to be reliable and valid for migraine, with substantially higher scores in migraine","text_display":" has been shown to be reliable and valid for migraine, with substantially higher scores in migraine","confidence":1,"confidence_rate":1},{"cnt":[[245,2406],[1467,2406],[1467,2456],[245,2456]],"region":{"top_left_x":244,"top_left_y":2406,"width":1224,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ba1bb6ed36845ec932974f5af10f5ac","type":"text","conversion_output":true,"text":"cases than non-migraine cases (Stewart et al 1999a, Stewart et al 1999b).","text_display":" cases than non-migraine cases (Stewart et al 1999a, Stewart et al 1999b).","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35b58b8487e64ef4a43025c932f8a232","type":"page_info","conversion_output":false,"text":"74","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-076","page":76,"lines":[{"cnt":[[1109,125],[1880,125],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":51},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a62c230ae6594ba1b02f9149a5b45c10","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4319e88c66c3498ca82c5e1d09bcf34c","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7cc051bee434ebc9b6322f60f45e7bc","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[1850,251],[1850,303],[245,303]],"region":{"top_left_x":244,"top_left_y":251,"width":1606,"height":52},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d188b08d5624284964b267ecc1fdeb2","type":"text","conversion_output":true,"text":"Patients will complete the MIDAS questionnaire at baseline (visit 2) and the EOT visit (visit 5).","text_display":"\n\nPatients will complete the MIDAS questionnaire at baseline (visit 2) and the EOT visit (visit 5).","confidence":0.85986328125,"confidence_rate":0.9985208804902359},{"cnt":[[236,337],[1738,337],[1738,462],[236,462]],"region":{"top_left_x":236,"top_left_y":337,"width":1503,"height":125},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e146246a2384cd6897e4a643cf4f76a","type":"section_header","conversion_output":false,"children_ids":["6f3caaacfa824c7da8f8068c52939ff3","ecee7257d3f64ee681574f79cdb961eb"],"text":"","text_display":""},{"cnt":[[245,344],[1732,344],[1732,402],[245,402]],"region":{"top_left_x":244,"top_left_y":343,"width":1488,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f3caaacfa824c7da8f8068c52939ff3","type":"text","conversion_output":true,"parent_id":"9e146246a2384cd6897e4a643cf4f76a","text":"6.3. Two-Item Patient Health Questionnaire/9-Item Patient Health","text_display":"\n\n\\subsection*{6.3. Two-Item Patient Health Questionnaire/9-Item Patient Health","confidence":0.93115234375,"confidence_rate":0.9989667315730303},{"cnt":[[434,404],[737,404],[737,458],[434,458]],"region":{"top_left_x":433,"top_left_y":403,"width":304,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecee7257d3f64ee681574f79cdb961eb","type":"text","conversion_output":true,"parent_id":"9e146246a2384cd6897e4a643cf4f76a","text":"Questionnaire","text_display":" Questionnaire}","confidence":1,"confidence_rate":1},{"cnt":[[245,475],[1863,475],[1863,526],[245,526]],"region":{"top_left_x":244,"top_left_y":474,"width":1619,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c78d589d27494cf6853732deb8998056","type":"text","conversion_output":true,"text":"The PHQ is a 9-item questionnaire with each item corresponding to 1 criterion of the Diagnostic","text_display":"\n\nThe PHQ is a 9-item questionnaire with each item corresponding to 1 criterion of the Diagnostic","confidence":0.9907412528991699,"confidence_rate":0.9999096946047924},{"cnt":[[245,518],[1830,518],[1830,574],[245,574]],"region":{"top_left_x":244,"top_left_y":517,"width":1587,"height":57},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16c36a3bf4d54cffb53d6452c687ff01","type":"text","conversion_output":true,"text":"and Statistical Manual for Mental Disorders \\(4{ }^{\\text {th }}\\) edition diagnostic criteria for major depressive","text_display":" and Statistical Manual for Mental Disorders \\(4{ }^{\\text {th }}\\) edition diagnostic criteria for major depressive","confidence":0.9716796875,"confidence_rate":0.9997523662831808},{"cnt":[[245,571],[1824,571],[1824,621],[245,621]],"region":{"top_left_x":244,"top_left_y":571,"width":1581,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae8431aa1f1d4d629699d03ecd08d94c","type":"text","conversion_output":true,"text":"disorder. Each of the items is scored on a scale of 0 (\"not at all\"), 1 (\"several days\"), 2 (\"more","text_display":" disorder. Each of the items is scored on a scale of 0 (\"not at all\"), 1 (\"several days\"), 2 (\"more","confidence":0.998046875,"confidence_rate":0.9999825444841725},{"cnt":[[245,621],[1850,621],[1850,672],[245,672]],"region":{"top_left_x":244,"top_left_y":620,"width":1606,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51ac3d6206f1400baa15ff2b71374b35","type":"text","conversion_output":true,"text":"than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during the","text_display":" than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during the","confidence":1,"confidence_rate":1},{"cnt":[[245,670],[1837,670],[1837,720],[245,720]],"region":{"top_left_x":244,"top_left_y":670,"width":1593,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aea0486446a44ea0b3129b1ca17cdd07","type":"text","conversion_output":true,"text":"past 2 weeks (Spitzer et al 1999). The PHQ-2 was developed from the PHQ-9 to rapidly screen","text_display":" 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":[[245,718],[1841,718],[1841,767],[245,767]],"region":{"top_left_x":244,"top_left_y":717,"width":1598,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"091159f2cfbe432c9c81dee8199f49a0","type":"text","conversion_output":true,"text":"for depression and consists of the first 2 questions from the PHQ-9. The PHQ-2 and the PHQ-9","text_display":" for depression and consists of the first 2 questions from the PHQ-9. The PHQ-2 and the PHQ-9","confidence":1,"confidence_rate":1},{"cnt":[[245,767],[1760,767],[1760,819],[245,819]],"region":{"top_left_x":244,"top_left_y":766,"width":1516,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6c528c2df5d48218c4dfa0270879490","type":"text","conversion_output":true,"text":"are validated measures for detecting and monitoring depression, anxiety, and somatization","text_display":" are validated measures for detecting and monitoring depression, anxiety, and somatization","confidence":1,"confidence_rate":1},{"cnt":[[245,816],[608,816],[608,866],[245,866]],"region":{"top_left_x":244,"top_left_y":816,"width":365,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"007e804a9e614cff81652f753bd5c0f8","type":"text","conversion_output":true,"text":"(Kroenke et al 2010).","text_display":" (Kroenke et al 2010).","confidence":1,"confidence_rate":1},{"cnt":[[245,885],[1867,885],[1867,935],[245,935]],"region":{"top_left_x":244,"top_left_y":885,"width":1623,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d10678bf98e74a75a5b6a901c92a6d7c","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":0.99658203125,"confidence_rate":0.9999670791635416},{"cnt":[[245,932],[1876,932],[1876,986],[245,986]],"region":{"top_left_x":244,"top_left_y":932,"width":1632,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"363e15b98b8743cab81c42ec35c47e18","type":"text","conversion_output":true,"text":"positive (ie, a score of \\(\\geq 3\\) ), patients will complete questions 3 through 9 (unique questions) of the","text_display":" positive (ie, a score of \\(\\geq 3\\) ), patients will complete questions 3 through 9 (unique questions) of the","confidence":1,"confidence_rate":1},{"cnt":[[245,984],[380,984],[380,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":983,"width":137,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"170d32c979164e33ab34a6309c2f55f8","type":"text","conversion_output":true,"text":"PHQ-9.","text_display":" PHQ-9.","confidence":1,"confidence_rate":1},{"cnt":[[241,1070],[1442,1070],[1442,1137],[241,1137]],"region":{"top_left_x":240,"top_left_y":1069,"width":1202,"height":68},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cd93c3f37df48c3bcef9652b0864c74","type":"section_header","conversion_output":false,"children_ids":["6d77ce752db8499298cdb47c9387f295"],"text":"","text_display":""},{"cnt":[[245,1074],[1437,1074],[1437,1132],[245,1132]],"region":{"top_left_x":244,"top_left_y":1074,"width":1194,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d77ce752db8499298cdb47c9387f295","type":"text","conversion_output":true,"parent_id":"6cd93c3f37df48c3bcef9652b0864c74","text":"6.4 Migraine-Specific Quality of Life Questionnaire","text_display":"\n\n\\subsection*{6.4 Migraine-Specific Quality of Life Questionnaire}","confidence":0.9111328125,"confidence_rate":0.9983394765409029},{"cnt":[[245,1147],[1803,1147],[1803,1201],[245,1201]],"region":{"top_left_x":244,"top_left_y":1147,"width":1559,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9581d67bde6a4da6bc9dd6f38ceb384e","type":"text","conversion_output":true,"text":"The MSQOL, version 2.1 is a 14-item questionnaire that assesses the impact of migraine and","text_display":"\n\nThe MSQOL, version 2.1 is a 14-item questionnaire that assesses the impact of migraine and","confidence":0.98681640625,"confidence_rate":0.9998645880592717},{"cnt":[[245,1199],[1800,1199],[1800,1248],[245,1248]],"region":{"top_left_x":244,"top_left_y":1198,"width":1557,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4a3eff103ff42d2977a7d542fd1057c","type":"text","conversion_output":true,"text":"migraine treatment on a patient's quality of life during the previous 4 weeks, which has been","text_display":" migraine treatment on a patient's quality of life during the previous 4 weeks, which has been","confidence":1,"confidence_rate":1},{"cnt":[[245,1246],[1818,1246],[1818,1298],[245,1298]],"region":{"top_left_x":244,"top_left_y":1246,"width":1574,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63f0b4bfeb0e424eb7929c2757d98b2e","type":"text","conversion_output":true,"text":"shown to be a reliable and valid tool for use in CM and EM (Bagley et al 2012). The MSQOL","text_display":" shown to be a reliable and valid tool for use in CM and EM (Bagley et al 2012). The MSQOL","confidence":1,"confidence_rate":1},{"cnt":[[245,1293],[1783,1293],[1783,1345],[245,1345]],"region":{"top_left_x":244,"top_left_y":1293,"width":1540,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15dacb05e92a4116a59eed367b6f03fc","type":"text","conversion_output":true,"text":"measures the degree to which performance of normal activities is limited by migraine (Role","text_display":" measures the degree to which performance of normal activities is limited by migraine (Role","confidence":1,"confidence_rate":1},{"cnt":[[245,1343],[1820,1343],[1820,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1342,"width":1576,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a51295fd631f486fa6d3f2acf6f1440a","type":"text","conversion_output":true,"text":"Function-Restrictive domain comprising 7 items), the degree to which performance of normal","text_display":" Function-Restrictive domain comprising 7 items), the degree to which performance of normal","confidence":1,"confidence_rate":1},{"cnt":[[245,1392],[1841,1392],[1841,1446],[245,1446]],"region":{"top_left_x":244,"top_left_y":1392,"width":1598,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41b51b18158741b08a9c89ec5417b998","type":"text","conversion_output":true,"text":"activities is prevented by migraine (Role Function-Preventive domain comprising 4 items), and","text_display":" activities is prevented by migraine (Role Function-Preventive domain comprising 4 items), and","confidence":1,"confidence_rate":1},{"cnt":[[245,1439],[1880,1439],[1880,1491],[245,1491]],"region":{"top_left_x":244,"top_left_y":1439,"width":1636,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d48ac5abdd04a129ea962657065acf1","type":"text","conversion_output":true,"text":"the emotional effects of migraine (Emotional Function domain comprising 3 items). Scores range","text_display":" the emotional effects of migraine (Emotional Function domain comprising 3 items). Scores range","confidence":1,"confidence_rate":1},{"cnt":[[245,1489],[1577,1489],[1577,1540],[245,1540]],"region":{"top_left_x":244,"top_left_y":1488,"width":1333,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6c5d5e465f44f50943f50025c55ec4f","type":"text","conversion_output":true,"text":"from 0 to 100 , with higher scores indicating better health-related quality of life.","text_display":" from 0 to 100 , with higher scores indicating better health-related quality of life.","confidence":0.6686186790466309,"confidence_rate":0.9957716870380882},{"cnt":[[245,1558],[1732,1558],[1732,1609],[245,1609]],"region":{"top_left_x":244,"top_left_y":1557,"width":1488,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"989c7c88e7cc41f091652fb51e40a4b6","type":"text","conversion_output":true,"text":"Patients will complete the MSQOL at baseline (visit 2), visits 3 and 4, and the EOT visit","text_display":"\nPatients will complete the MSQOL at baseline (visit 2), visits 3 and 4, and the EOT visit","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,1607],[393,1607],[393,1656],[245,1656]],"region":{"top_left_x":244,"top_left_y":1607,"width":150,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b67a7b6882044896acb1ca73cf8867ce","type":"text","conversion_output":true,"text":"(visit 5).","text_display":" (visit 5).","confidence":1,"confidence_rate":1},{"cnt":[[241,1693],[1210,1693],[1210,1760],[241,1760]],"region":{"top_left_x":240,"top_left_y":1692,"width":970,"height":68},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23212e92d4c3498eb5cee9161c66aef9","type":"section_header","conversion_output":false,"children_ids":["72bfc9e9a1c84bfc8f00f3e5e956a74f"],"text":"","text_display":""},{"cnt":[[245,1697],[1205,1697],[1205,1755],[245,1755]],"region":{"top_left_x":244,"top_left_y":1697,"width":962,"height":59},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72bfc9e9a1c84bfc8f00f3e5e956a74f","type":"text","conversion_output":true,"parent_id":"23212e92d4c3498eb5cee9161c66aef9","text":"6.5. 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The","confidence":1,"confidence_rate":1},{"cnt":[[245,1822],[1815,1822],[1815,1876],[245,1876]],"region":{"top_left_x":244,"top_left_y":1821,"width":1572,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a6c2f66bd7f4b1eb1e49c4a0bcef5df","type":"text","conversion_output":true,"text":"EQ-5D-5L consists of 2 parts. In Part 1, patients rate their health state in 5 domains: mobility,","text_display":" EQ-5D-5L consists of 2 parts. In Part 1, patients rate their health state in 5 domains: mobility,","confidence":1,"confidence_rate":1},{"cnt":[[245,1869],[1729,1869],[1729,1923],[245,1923]],"region":{"top_left_x":244,"top_left_y":1869,"width":1486,"height":54},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5a3a768461149ca97df59e48ce03f45","type":"text","conversion_output":true,"text":"self-care, usual activities, pain/discomfort, and mood, using a scale of 1 to 5 where \\(1=\\) no","text_display":" self-care, usual activities, pain/discomfort, and mood, using a scale of 1 to 5 where \\(1=\\) no","confidence":1,"confidence_rate":1},{"cnt":[[245,1921],[1727,1921],[1727,1972],[245,1972]],"region":{"top_left_x":244,"top_left_y":1920,"width":1484,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acf57b89b32140a6805e83d7785a4315","type":"text","conversion_output":true,"text":"problems, \\(2=\\) slight problems, \\(3=\\) moderate problems, \\(4=\\) severe problems, and \\(5=\\) extreme","text_display":" problems, \\(2=\\) slight problems, \\(3=\\) moderate problems, \\(4=\\) severe problems, and \\(5=\\) extreme","confidence":0.948580926284194,"confidence_rate":0.9994876247753695},{"cnt":[[245,1968],[1863,1968],[1863,2022],[245,2022]],"region":{"top_left_x":244,"top_left_y":1967,"width":1619,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ae53e99b3c44f328ac597468d51c799","type":"text","conversion_output":true,"text":"problems. In Part 2, patients rate their health state on a 100 mm visual analog scale; a rating of 0","text_display":" problems. In Part 2, patients rate their health state on a 100 mm visual analog scale; a rating of 0","confidence":1,"confidence_rate":1},{"cnt":[[245,2020],[1833,2020],[1833,2069],[245,2069]],"region":{"top_left_x":244,"top_left_y":2019,"width":1589,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b2ca2e44f3b4619ac519254b78148a0","type":"text","conversion_output":true,"text":"represents the worst imaginable health state, and a rating of 100 represents the best imaginable","text_display":" represents the worst imaginable health state, and a rating of 100 represents the best imaginable","confidence":1,"confidence_rate":1},{"cnt":[[245,2067],[453,2067],[453,2112],[245,2112]],"region":{"top_left_x":244,"top_left_y":2066,"width":210,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"155d90a1db9a4301a581d428600fd133","type":"text","conversion_output":true,"text":"health state.","text_display":" health state.","confidence":1,"confidence_rate":1},{"cnt":[[245,2136],[1661,2136],[1661,2187],[245,2187]],"region":{"top_left_x":244,"top_left_y":2135,"width":1417,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afb7b072d89948299f6dc03125ef0d10","type":"text","conversion_output":true,"text":"Patients will complete the EQ-5D-5L at baseline (visit 2) and the EOT visit (visit 5).","text_display":"\n\nPatients will complete the EQ-5D-5L at baseline (visit 2) and the EOT visit (visit 5).","confidence":0.9279057313688099,"confidence_rate":0.9991780837393263},{"cnt":[[241,2221],[1338,2221],[1338,2288],[241,2288]],"region":{"top_left_x":240,"top_left_y":2221,"width":1099,"height":68},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97da013e16fd4bc8adb5d269b3ea8d75","type":"section_header","conversion_output":false,"children_ids":["aff6f37740b14595bc27810c917987c3"],"text":"","text_display":""},{"cnt":[[245,2226],[1332,2226],[1332,2284],[245,2284]],"region":{"top_left_x":244,"top_left_y":2225,"width":1089,"height":59},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aff6f37740b14595bc27810c917987c3","type":"text","conversion_output":true,"parent_id":"97da013e16fd4bc8adb5d269b3ea8d75","text":"6.6. Patient Global Impression of Change Scale","text_display":"\n\n\\subsection*{6.6. Patient Global Impression of Change Scale}","confidence":0.6142578125,"confidence_rate":0.9904898135585158},{"cnt":[[245,2299],[1807,2299],[1807,2353],[245,2353]],"region":{"top_left_x":244,"top_left_y":2298,"width":1563,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"917a2c0207ac4728a893779536edd0a2","type":"text","conversion_output":true,"text":"The PGIC scale is a validated generic tool for assessment of overall change in the severity of","text_display":"\n\nThe PGIC scale is a validated generic tool for assessment of overall change in the severity of","confidence":1,"confidence_rate":1},{"cnt":[[245,2350],[1800,2350],[1800,2402],[245,2402]],"region":{"top_left_x":244,"top_left_y":2350,"width":1557,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f377afeb12346529bc7ac336b674f4a","type":"text","conversion_output":true,"text":"illness following treatment. Patients will rate how they describe the change (if any) that their","text_display":" illness following treatment. Patients will rate how they describe the change (if any) that their","confidence":1,"confidence_rate":1},{"cnt":[[245,2400],[1867,2400],[1867,2451],[245,2451]],"region":{"top_left_x":244,"top_left_y":2399,"width":1623,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c319fbb2b0048d1986393c962a6dc43","type":"text","conversion_output":true,"text":"migraine/headaches have had in their general quality of life and health status since beginning the","text_display":" migraine/headaches have had in their general quality of life and health status since beginning the","confidence":1,"confidence_rate":1},{"cnt":[[245,2449],[1760,2449],[1760,2499],[245,2499]],"region":{"top_left_x":244,"top_left_y":2449,"width":1516,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e10a2e4074234b9dbae688dd92abcdb7","type":"text","conversion_output":true,"text":"treatment in this study on a 7-point scale where 1=no change (or condition has got worse);","text_display":" treatment in this study on a 7-point scale where 1=no change (or condition has got worse);","confidence":0.8319389058598745,"confidence_rate":0.9980650715364102},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1a8a639a4294f6ba41630d533a5ccf5","type":"page_info","conversion_output":false,"text":"75","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-077","page":77,"lines":[{"cnt":[[1109,125],[1880,125],[1880,176],[1109,176]],"region":{"top_left_x":1108,"top_left_y":124,"width":772,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc6229d1604f48ab8113a0d182448d38","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,174],[995,174],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":751,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c587b23fb925468ea4d57476886fda27","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c5641aa4c08483495c5e8f5d9901e43","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1710,254],[1710,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1467,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8dd4f48a0d74fdbb76b3b2ad93b8be1","type":"text","conversion_output":true,"text":"\\(2=\\) almost the same, hardly any change at all; \\(3=\\) a little better, but no noticeable change;","text_display":"\n\\(2=\\) almost the same, hardly any change at all; \\(3=\\) a little better, but no noticeable change;","confidence":0.7769067342756888,"confidence_rate":0.9974274476689327},{"cnt":[[245,301],[1858,301],[1858,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1615,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb6806c41a5a49949b7a61fa868d915b","type":"text","conversion_output":true,"text":"\\(4=\\) somewhat better, but the change has not made any real difference; \\(5=\\) moderately better, and a","text_display":"\n\\(4=\\) somewhat better, but the change has not made any real difference; \\(5=\\) moderately better, and a","confidence":0.9762488594278693,"confidence_rate":0.9997666510539011},{"cnt":[[245,350],[1775,350],[1775,400],[245,400]],"region":{"top_left_x":244,"top_left_y":350,"width":1531,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28f0436750d84bbfb34f1dcb794e08c4","type":"text","conversion_output":true,"text":"slight but noticeable change; \\(6=\\) better, and a definite improvement that has made a real and","text_display":" slight but noticeable change; \\(6=\\) better, and a definite improvement that has made a real and","confidence":0.98637122779337,"confidence_rate":0.9998627844503033},{"cnt":[[245,400],[1861,400],[1861,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1617,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"add4669637a24746bfaa1404b544858e","type":"text","conversion_output":true,"text":"worthwhile difference; and \\(7=\\) a great deal better, and a considerable improvement that has made","text_display":" worthwhile difference; and \\(7=\\) a great deal better, and a considerable improvement that has made","confidence":0.9118379399826608,"confidence_rate":0.9991043527676998},{"cnt":[[245,447],[544,447],[544,492],[245,492]],"region":{"top_left_x":244,"top_left_y":446,"width":300,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66258d0e517e478ba046e8fd34348fbf","type":"text","conversion_output":true,"text":"all the difference.","text_display":" all the difference.","confidence":1,"confidence_rate":1},{"cnt":[[245,518],[1824,518],[1824,569],[245,569]],"region":{"top_left_x":244,"top_left_y":517,"width":1581,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb1370e8c2fc4c9986b04ddb833f66ac","type":"text","conversion_output":true,"text":"Patients will complete the PGIC scale before study drug administration at visits 3 and 4 and at","text_display":"\n\nPatients will complete the PGIC scale before study drug administration at visits 3 and 4 and at","confidence":1,"confidence_rate":1},{"cnt":[[245,563],[629,563],[629,612],[245,612]],"region":{"top_left_x":244,"top_left_y":562,"width":386,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72d925f0baa04eb8810c66fbe4ed3bfc","type":"text","conversion_output":true,"text":"the EOT visit (visit 5).","text_display":" the EOT visit (visit 5).","confidence":1,"confidence_rate":1},{"cnt":[[243,653],[1678,653],[1678,718],[243,718]],"region":{"top_left_x":242,"top_left_y":653,"width":1436,"height":65},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41d91c114cfc46b3b4ae1b75c8214c73","type":"section_header","conversion_output":false,"children_ids":["2f6db81996c5481a8f0b97f2c8dd9f2d"],"text":"","text_display":""},{"cnt":[[245,657],[1671,657],[1671,713],[245,713]],"region":{"top_left_x":244,"top_left_y":657,"width":1428,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f6db81996c5481a8f0b97f2c8dd9f2d","type":"text","conversion_output":true,"parent_id":"41d91c114cfc46b3b4ae1b75c8214c73","text":"6.7. Work Productivity and Activity Impairment Questionnaire","text_display":"\n\n\\subsection*{6.7. 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The specific health problems version of the WPAI","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[1790,829],[1790,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":1546,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0555bd705dcc422dab90c7ca29742b1b","type":"text","conversion_output":true,"text":"questionnaire allows investigators to attribute productivity and activity impairment issues to","text_display":" questionnaire allows investigators to attribute productivity and activity impairment issues to","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1661,877],[1661,926],[245,926]],"region":{"top_left_x":244,"top_left_y":876,"width":1417,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82b1465319df4d89bce063d51d44c850","type":"text","conversion_output":true,"text":"specific health conditions. 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Refer to Appendix E for guidance regarding monitoring","text_display":" as a serious adverse event. Refer to Appendix E for guidance regarding monitoring","confidence":0.99462890625,"confidence_rate":0.9999373790545804},{"cnt":[[430,348],[1137,348],[1137,402],[430,402]],"region":{"top_left_x":429,"top_left_y":348,"width":708,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f5f2819bcf54cd2a5bf1d372327777c","type":"text","conversion_output":true,"parent_id":"3cabd18d7f9344259f14f314848e5196","text":"patients with elevated liver function tests.","text_display":" patients with elevated liver function tests.","confidence":1,"confidence_rate":1},{"cnt":[[243,417],[1766,417],[1766,471],[243,471]],"region":{"top_left_x":242,"top_left_y":416,"width":1525,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"733eea900e744a229fbcab69a530eb76","type":"text","conversion_output":true,"text":"Migraine exacerbations, including acute headache, requiring headache medications will be","text_display":"\n\nMigraine exacerbations, including acute headache, requiring headache medications will be","confidence":1,"confidence_rate":1},{"cnt":[[243,466],[1880,466],[1880,518],[243,518]],"region":{"top_left_x":242,"top_left_y":466,"width":1638,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f531d2d2bf97453dac6ae240c98bffbb","type":"text","conversion_output":true,"text":"collected as part of the efficacy assessment in this study. Migraine exacerbations (including acute","text_display":" collected as part of the efficacy assessment in this study. Migraine exacerbations (including acute","confidence":1,"confidence_rate":1},{"cnt":[[243,516],[1790,516],[1790,569],[243,569]],"region":{"top_left_x":242,"top_left_y":515,"width":1548,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c922382cefb24f3d979097d1f323df2b","type":"text","conversion_output":true,"text":"headache) should be recorded as an adverse event only if the presentation and/or outcome is","text_display":" headache) should be recorded as an adverse event only if the presentation and/or outcome is","confidence":1,"confidence_rate":1},{"cnt":[[243,563],[1729,563],[1729,614],[243,614]],"region":{"top_left_x":242,"top_left_y":562,"width":1488,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e99258c28f5343b59037527ca45437ee","type":"text","conversion_output":true,"text":"more severe than would typically be expected from the normal course of the disease in a","text_display":" more severe than would typically be expected from the normal course of the disease in a","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[241,612],[1837,612],[1837,666],[241,666]],"region":{"top_left_x":240,"top_left_y":612,"width":1597,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b1cd1a648654ef19ecd3b3eea9eb472","type":"text","conversion_output":true,"text":"particular patient or if they are severe enough to require hospitalization of the patient, in which","text_display":" particular patient or if they are severe enough to require hospitalization of the patient, in which","confidence":1,"confidence_rate":1},{"cnt":[[243,662],[1063,662],[1063,711],[243,711]],"region":{"top_left_x":242,"top_left_y":661,"width":822,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bea278afa7f467b93622a404783a683","type":"text","conversion_output":true,"text":"case they are recorded as serious adverse events.","text_display":" case they are recorded as serious adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[236,743],[1188,743],[1188,810],[236,810]],"region":{"top_left_x":236,"top_left_y":743,"width":953,"height":67},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27ede5ddccbc4dd8929b9caf62063eba","type":"section_header","conversion_output":false,"children_ids":["96da61218f3c40e0a86a8412904e88b1"],"text":"","text_display":""},{"cnt":[[243,750],[1184,750],[1184,804],[243,804]],"region":{"top_left_x":242,"top_left_y":749,"width":942,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96da61218f3c40e0a86a8412904e88b1","type":"text","conversion_output":true,"parent_id":"27ede5ddccbc4dd8929b9caf62063eba","text":"7.1.2. 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Adverse events will be collected","text_display":" visit for patients who withdraw from the study for any reason. 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A precise diagnosis will be recorded whenever possible.","text_display":" medical condition or disease state. A precise diagnosis will be recorded whenever possible.","confidence":1,"confidence_rate":1},{"cnt":[[245,1689],[1745,1689],[1745,1740],[245,1740]],"region":{"top_left_x":244,"top_left_y":1688,"width":1501,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04a47db4af98416fbd12d24928b471b9","type":"text","conversion_output":true,"text":"When such a diagnosis is made, all related signs, symptoms, and any test findings will be","text_display":" When such a diagnosis is made, all related signs, symptoms, and any test findings will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1738],[1833,1738],[1833,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1738,"width":1589,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b47e26f41cc4ba6ae2a037261b8b8d2","type":"text","conversion_output":true,"text":"recorded collectively as a single diagnosis on the CRF and, if it is a serious adverse 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regarding study drug, treatment administered, and outcome for each adverse event must be","confidence":1,"confidence_rate":1},{"cnt":[[245,2168],[1403,2168],[1403,2215],[245,2215]],"region":{"top_left_x":244,"top_left_y":2167,"width":1159,"height":49},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"103ad59918844df599899401d8b9995d","type":"text","conversion_output":true,"text":"recorded on the source documentation and transcribed onto the CRF.","text_display":" recorded on the source documentation and transcribed onto the CRF.","confidence":1,"confidence_rate":1},{"cnt":[[245,2237],[1850,2237],[1850,2288],[245,2288]],"region":{"top_left_x":244,"top_left_y":2236,"width":1606,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ca1a26385434cdbb2b137312bce6e62","type":"text","conversion_output":true,"text":"The relationship of each adverse event to study drug and study procedures, and the severity 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Severity of an Adverse Event","text_display":"\n\n\\subsection*{7.1.3. Severity of an Adverse Event}","confidence":0.998046875,"confidence_rate":0.9999511253235108},{"cnt":[[245,322],[1835,322],[1835,372],[245,372]],"region":{"top_left_x":244,"top_left_y":322,"width":1591,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2a5876a2fe94206b7e342825cfee1cc","type":"text","conversion_output":true,"text":"The severity of each adverse event must be recorded as 1 of the choices on the following scale:","text_display":"\n\nThe severity of each adverse event must be recorded as 1 of the choices on the following scale:","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[245,391],[999,391],[999,432],[245,432]],"region":{"top_left_x":244,"top_left_y":391,"width":756,"height":41},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5eb28a8f7484d098a3c6a85a23d3255","type":"text","conversion_output":true,"text":"Mild: No limitation of usual activities","text_display":"\nMild: No limitation of usual activities","confidence":1,"confidence_rate":1},{"cnt":[[245,460],[1042,460],[1042,501],[245,501]],"region":{"top_left_x":244,"top_left_y":459,"width":798,"height":42},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cdebc4bf8e544e6b8d9ca78e9e4592b","type":"text","conversion_output":true,"text":"Moderate: Some limitation of usual activities","text_display":"\nModerate: Some limitation of usual activities","confidence":1,"confidence_rate":1},{"cnt":[[245,529],[1076,529],[1076,578],[245,578]],"region":{"top_left_x":244,"top_left_y":528,"width":833,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"566c73faa0b44f2fb50d8c7539cd9ee4","type":"text","conversion_output":true,"text":"Severe: Inability to carry out usual activities","text_display":"\nSevere: Inability to carry out usual activities","confidence":1,"confidence_rate":1},{"cnt":[[241,614],[1371,614],[1371,672],[241,672]],"region":{"top_left_x":240,"top_left_y":614,"width":1131,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9629ce96d434ace9517fc53e0eae6c3","type":"section_header","conversion_output":false,"children_ids":["1a325d8b282e41298d85eb8c3e690a60"],"text":"","text_display":""},{"cnt":[[245,621],[1364,621],[1364,668],[245,668]],"region":{"top_left_x":244,"top_left_y":620,"width":1121,"height":49},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a325d8b282e41298d85eb8c3e690a60","type":"text","conversion_output":true,"parent_id":"e9629ce96d434ace9517fc53e0eae6c3","text":"7.1.4. Relationship of an Adverse Event to the Study Drug","text_display":"\n\n\\subsection*{7.1.4. 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There are important exceptions when an adverse event does not disappear upon discontinuation of the study drug, yet a drug relationship clearly exists. \\\\\n- It follows a known pattern of response to the study drug.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Term & Definition & Clarification \\\\\n\\hline No reasonable possibility (not related) & This category applies to adverse events that, after careful consideration, are clearly due to extraneous causes (disease, environment, etc) or to adverse events that, after careful medical consideration at the time they are evaluated, are judged to be unrelated to the study drug. & \\begin{tabular}{l}\nThe relationship of an adverse event may be considered \"no reasonable possibility\" if it is clearly due to extraneous causes or if at least 2 of the following apply: \\\\\n- It does not follow a reasonable temporal sequence from the administration of the study drug. \\\\\n- It could readily have been produced by the patient's clinical state, environmental, or toxic factors or other modes of therapy administered to the patient. \\\\\n- It does not follow a known pattern of response to the study drug. \\\\\n- It does not reappear or worsen when the study drug is re-administered.\n\\end{tabular} \\\\\n\\hline Reasonable possibility (related) & This category applies to adverse events for which, after careful medical consideration at the time they are evaluated, a connection with the study drug administration cannot be ruled out with certainty. & \\begin{tabular}{l}\nThe relationship of an adverse event may be considered \"reasonable possibility\" if at least 2 of the following apply: \\\\\n- It follows a reasonable temporal sequence from administration of the study drug. \\\\\n- It cannot be reasonably explained by the known characteristics of the patient's clinical state, environmental, or toxic factors or other modes of therapy administered to the patient. \\\\\n- It disappears or decreases on cessation or reduction in dose. There are important exceptions when an adverse event does not disappear upon discontinuation of the study drug, yet a drug relationship clearly exists. \\\\\n- It follows a known pattern of response to the study drug.\n\\end{tabular} 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Severe hypersensitivity reactions will be","text_display":" anaphylaxis and severe hypersensitivity reactions. Severe hypersensitivity reactions will be","confidence":1,"confidence_rate":1},{"cnt":[[245,350],[1811,350],[1811,397],[245,397]],"region":{"top_left_x":244,"top_left_y":350,"width":1568,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d1ff621e193482684272417f3efa26b","type":"text","conversion_output":true,"text":"monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint National","text_display":" monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint National","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,400],[1777,400],[1777,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1533,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bb41da2ebd441738042cc934db51476","type":"text","conversion_output":true,"text":"Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network Second","text_display":" Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network Second","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1747,447],[1747,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1503,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6feb5d09625845ac96a18cec68f1366d","type":"text","conversion_output":true,"text":"Symposium on Anaphylaxis (Sampson et al, 2006 [also see Appendix F]). 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Other assessments will be performed at the discretion of the investigator.","text_display":" measured. 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If a patient is withdrawn because of an","text_display":" drug at any time, at the discretion of the investigator. 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The process for","confidence":1,"confidence_rate":1},{"cnt":[[245,524],[1629,524],[1629,574],[245,574]],"region":{"top_left_x":244,"top_left_y":524,"width":1385,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98f0fb9827014b148a5b513add947f16","type":"text","conversion_output":true,"text":"reporting a pregnancy is the same as that for reporting a serious adverse event (see","text_display":" reporting a pregnancy is the same as that for reporting a serious adverse event (see","confidence":1,"confidence_rate":1},{"cnt":[[245,571],[526,571],[526,621],[245,621]],"region":{"top_left_x":244,"top_left_y":571,"width":283,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d025d271bea4190a4eef345d5dddccb","type":"text","conversion_output":true,"text":"Section 7.1.5.3).","text_display":" Section 7.1.5.3).","confidence":1,"confidence_rate":1},{"cnt":[[245,642],[1785,640],[1785,692],[245,694]],"region":{"top_left_x":244,"top_left_y":640,"width":1542,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f80f3b42de842d8bd5e450ff8337569","type":"text","conversion_output":true,"text":"Any female patient becoming pregnant during the study will discontinue the study drug. 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The Investigator's interpretation will be recorded in the CRF regardless of","confidence":1,"confidence_rate":1},{"cnt":[[245,614],[1727,614],[1727,664],[245,664]],"region":{"top_left_x":244,"top_left_y":614,"width":1484,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c807cdef46b4e70a410dda51d564a98","type":"text","conversion_output":true,"text":"the central reading interpretation. Any abnormal findings assessed by the Investigator as","text_display":" the central reading interpretation. Any abnormal findings assessed by the Investigator as","confidence":1,"confidence_rate":1},{"cnt":[[245,662],[1878,662],[1878,711],[245,711]],"region":{"top_left_x":244,"top_left_y":661,"width":1634,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b72cc369d4d944bd865320f061edb289","type":"text","conversion_output":true,"text":"clinically significant should be recorded in the relevant CRF modules (eg, adverse event, medical","text_display":" clinically significant should be recorded in the relevant CRF modules (eg, adverse event, medical","confidence":1,"confidence_rate":1},{"cnt":[[244,758],[245,708],[394,711],[393,761]],"region":{"top_left_x":244,"top_left_y":708,"width":150,"height":53},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83fa0a394be740b6bea9e257d19651e1","type":"text","conversion_output":true,"text":"history).","text_display":" history).","confidence":1,"confidence_rate":1},{"cnt":[[245,782],[1833,782],[1833,831],[245,831]],"region":{"top_left_x":244,"top_left_y":782,"width":1589,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"081ed12270204e72b4c360f0bbc72594","type":"text","conversion_output":true,"text":"Objective alerts are predefined as described in the central ECG reading manual. In these cases,","text_display":"\n\nObjective alerts are predefined as described in the central ECG reading manual. In these cases,","confidence":1,"confidence_rate":1},{"cnt":[[245,829],[1160,829],[1160,879],[245,879]],"region":{"top_left_x":244,"top_left_y":829,"width":917,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1572b7c89b142129bf60713e2b9ab40","type":"text","conversion_output":true,"text":"the site and the sponsor will be informed immediately.","text_display":" the site and the sponsor will be informed immediately.","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1467,898],[1467,947],[245,947]],"region":{"top_left_x":244,"top_left_y":898,"width":1224,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6f0d489de7f44419a738e387746eb73","type":"text","conversion_output":true,"text":"Any unscheduled ECGs must also be submitted for central ECG reading.","text_display":"\n\nAny unscheduled ECGs must also be submitted for central ECG reading.","confidence":1,"confidence_rate":1},{"cnt":[[245,967],[1850,967],[1850,1016],[245,1016]],"region":{"top_left_x":244,"top_left_y":966,"width":1606,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4af18b3938942f0aea9a1801aeeb108","type":"text","conversion_output":true,"text":"Any ECG finding that is judged by the investigator as a potentially clinically significant change","text_display":"\nAny ECG finding that is judged by the investigator as a potentially clinically significant change","confidence":1,"confidence_rate":1},{"cnt":[[245,1016],[1876,1016],[1876,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1016,"width":1632,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c994053a2b6446a6b1474afe39b9312b","type":"text","conversion_output":true,"text":"(worsening) compared with a baseline value will be considered an adverse event, recorded on the","text_display":" (worsening) compared with a baseline value will be considered an adverse event, recorded on the","confidence":1,"confidence_rate":1},{"cnt":[[245,1066],[1644,1066],[1644,1113],[245,1113]],"region":{"top_left_x":244,"top_left_y":1065,"width":1400,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"644629ef05a74ea298ba32fbe9a2cc97","type":"text","conversion_output":true,"text":"source documentation and transcribed onto the CRF, and monitored as described in","text_display":" source documentation and transcribed onto the CRF, and monitored as described in","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[483,1113],[483,1158],[245,1158]],"region":{"top_left_x":244,"top_left_y":1112,"width":240,"height":47},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3644c97380149e1bba5279f0ff22bc4","type":"text","conversion_output":true,"text":"Section 7.1.2.","text_display":" Section 7.1.2.","confidence":1,"confidence_rate":1},{"cnt":[[241,1199],[920,1199],[920,1265],[241,1265]],"region":{"top_left_x":240,"top_left_y":1198,"width":680,"height":68},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00eff7677dda4e14aa6e3efb4dac5a09","type":"section_header","conversion_output":false,"children_ids":["0d2e03caa4044e829637ed6c6b94fa73"],"text":"","text_display":""},{"cnt":[[245,1207],[913,1207],[913,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1207,"width":670,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d2e03caa4044e829637ed6c6b94fa73","type":"text","conversion_output":true,"parent_id":"00eff7677dda4e14aa6e3efb4dac5a09","text":"7.6. Physical Examinations","text_display":"\n\n\\subsection*{7.6. Physical Examinations}","confidence":0.99609375,"confidence_rate":0.9998737531529931},{"cnt":[[245,1280],[1828,1280],[1828,1330],[245,1330]],"region":{"top_left_x":244,"top_left_y":1280,"width":1585,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4624fdb9ac2841b6b25af9b4e823502c","type":"text","conversion_output":true,"text":"Physical examinations, including height (to be obtained at the screening visit only) and weight","text_display":"\n\nPhysical examinations, including height (to be obtained at the screening visit only) and weight","confidence":1,"confidence_rate":1},{"cnt":[[245,1330],[1182,1330],[1182,1379],[245,1379]],"region":{"top_left_x":244,"top_left_y":1329,"width":938,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e6f62abb71b4b4694660654f83756f7","type":"text","conversion_output":true,"text":"will be performed at the time points detailed in Table 1.","text_display":" will be performed at the time points detailed in Table 1.","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[245,1399],[1858,1399],[1858,1448],[245,1448]],"region":{"top_left_x":244,"top_left_y":1398,"width":1615,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9906ac0c9b7f4a64b617966b8ad334eb","type":"text","conversion_output":true,"text":"A complete physical examination will include the following organ systems: general appearance;","text_display":"\n\nA complete physical examination will include the following organ systems: general appearance;","confidence":1,"confidence_rate":1},{"cnt":[[245,1448],[1869,1448],[1869,1497],[245,1497]],"region":{"top_left_x":244,"top_left_y":1448,"width":1626,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a9e0d457a894afca0c65554b9a9e945","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":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1495],[1871,1495],[1871,1545],[245,1545]],"region":{"top_left_x":244,"top_left_y":1495,"width":1628,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"942bf3698d864d2bb41e87cdfa719a08","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":[[245,1543],[1785,1543],[1785,1594],[245,1594]],"region":{"top_left_x":244,"top_left_y":1542,"width":1542,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee13312868a7435f8b222b9abf35a7b8","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":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,1594],[1850,1594],[1850,1639],[245,1639]],"region":{"top_left_x":244,"top_left_y":1594,"width":1606,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8af582efd74499b8b9f64fe562aeb31","type":"text","conversion_output":true,"text":"considered an adverse event, recorded on the CRF, and monitored as described in Section 7.1.2.","text_display":" considered an adverse event, recorded on the CRF, and monitored as described in Section 7.1.2.","confidence":1,"confidence_rate":1},{"cnt":[[241,1680],[1502,1680],[1502,1747],[241,1747]],"region":{"top_left_x":240,"top_left_y":1680,"width":1262,"height":67},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc3de3da165d4fcc9d73e593c2e6c6af","type":"section_header","conversion_output":false,"children_ids":["c7faa37ed76c48c5941f123fc4194ecf"],"text":"","text_display":""},{"cnt":[[245,1684],[1495,1684],[1495,1742],[245,1742]],"region":{"top_left_x":244,"top_left_y":1684,"width":1252,"height":59},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7faa37ed76c48c5941f123fc4194ecf","type":"text","conversion_output":true,"parent_id":"bc3de3da165d4fcc9d73e593c2e6c6af","text":"7.7. Electronic Columbia-Suicide Severity Rating Scale","text_display":"\n\n\\subsection*{7.7. 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The eC-SSRS Baseline/Screening version will be completed by the","text_display":" behavior (Posner et al 2011). The eC-SSRS Baseline/Screening version will be completed by the","confidence":0.9975595474243164,"confidence_rate":0.9999750672972136},{"cnt":[[245,1858],[1828,1858],[1828,1908],[245,1908]],"region":{"top_left_x":244,"top_left_y":1858,"width":1585,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d8f5f06e0b5438e953ab044739d9baf","type":"text","conversion_output":true,"text":"patient at visit 2, and the eC-SSRS Since Last Visit version will be completed by the patient at","text_display":" patient at visit 2, and the eC-SSRS Since Last Visit version will be completed by the patient at","confidence":1,"confidence_rate":1},{"cnt":[[245,1908],[1841,1908],[1841,1955],[245,1955]],"region":{"top_left_x":244,"top_left_y":1907,"width":1598,"height":49},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e687969ff45447c991a97cbfae46528f","type":"text","conversion_output":true,"text":"all other time points, as described in Table 1. Any positive findings on the eC-SSRS Since Last","text_display":" all other time points, as described in Table 1. Any positive findings on the eC-SSRS Since Last","confidence":0.99853515625,"confidence_rate":0.9999853409306202},{"cnt":[[245,1955],[1566,1955],[1566,2004],[245,2004]],"region":{"top_left_x":244,"top_left_y":1955,"width":1323,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bc62a984df64c75a10021132e2cb872","type":"text","conversion_output":true,"text":"Visit version requires evaluation by a physician or doctoral-level psychologist.","text_display":" Visit version requires evaluation by a physician or doctoral-level psychologist.","confidence":1,"confidence_rate":1},{"cnt":[[241,2041],[1214,2041],[1214,2108],[241,2108]],"region":{"top_left_x":240,"top_left_y":2041,"width":974,"height":67},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"779dc68b441c4b52807fcdcdfcd2f41f","type":"section_header","conversion_output":false,"children_ids":["71c88fa904fc4a5ebeb4c817b4fe9eaf"],"text":"","text_display":""},{"cnt":[[245,2047],[1210,2047],[1210,2103],[245,2103]],"region":{"top_left_x":244,"top_left_y":2047,"width":966,"height":57},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71c88fa904fc4a5ebeb4c817b4fe9eaf","type":"text","conversion_output":true,"parent_id":"779dc68b441c4b52807fcdcdfcd2f41f","text":"7.8. 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Details of","confidence":1,"confidence_rate":1},{"cnt":[[245,2170],[1055,2170],[1055,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2169,"width":811,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f534972300f4549aefbb51a342f9c88","type":"text","conversion_output":true,"text":"prohibited medications are found in Section 5.3.","text_display":" prohibited medications are found in Section 5.3.","confidence":1,"confidence_rate":1},{"cnt":[[241,2256],[788,2256],[788,2322],[241,2322]],"region":{"top_left_x":240,"top_left_y":2255,"width":549,"height":68},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87106ff1275d45dfb6af3def15bcf76c","type":"section_header","conversion_output":false,"children_ids":["def7c69f4713468da55f476334da4a2d"],"text":"","text_display":""},{"cnt":[[245,2260],[782,2260],[782,2318],[245,2318]],"region":{"top_left_x":244,"top_left_y":2260,"width":539,"height":59},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"def7c69f4713468da55f476334da4a2d","type":"text","conversion_output":true,"parent_id":"87106ff1275d45dfb6af3def15bcf76c","text":"7.9. 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Only the samples from TEV-48125-treated patients will be analyzed for ADA.","text_display":" withdrawal visit. Only the samples from TEV-48125-treated patients will be analyzed for ADA.","confidence":1,"confidence_rate":1},{"cnt":[[245,2436],[1751,2436],[1751,2486],[245,2486]],"region":{"top_left_x":244,"top_left_y":2436,"width":1507,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"027317970cf94d2780b8dcdd4450f4a7","type":"text","conversion_output":true,"text":"Blood samples for ADA assessment will also be collected upon observation of any severe","text_display":" Blood samples for ADA assessment will also be collected upon observation of any severe","confidence":1,"confidence_rate":1},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81387088df604985bb90436fc93eccde","type":"page_info","conversion_output":false,"text":"88","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-090","page":90,"lines":[{"cnt":[[1109,127],[1880,127],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":126,"width":772,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92f1705dc0ad46bea4c84271d8bfb1c7","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e69d7538a8145f7af32a0f3063147db","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0499dcc394644cccbc89f2f144ce53eb","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[243,254],[1695,254],[1695,303],[243,303]],"region":{"top_left_x":242,"top_left_y":253,"width":1454,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a5fcfdb88b9415cb03ee84531e1f4d4","type":"text","conversion_output":true,"text":"hypersensitivity reaction (eg, anaphylaxis). See Appendix F for the clinical criteria for","text_display":"\nhypersensitivity reaction (eg, anaphylaxis). See Appendix F for the clinical criteria for","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1772,301],[1772,352],[245,352]],"region":{"top_left_x":244,"top_left_y":300,"width":1529,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4bffa32028d4cbdba3c551705929732","type":"text","conversion_output":true,"text":"diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis","text_display":" diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis","confidence":1,"confidence_rate":1},{"cnt":[[245,350],[1846,350],[1846,402],[245,402]],"region":{"top_left_x":244,"top_left_y":350,"width":1602,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"243ed5af70644d56a0e1d2f9c5cec571","type":"text","conversion_output":true,"text":"occurrence as soon as possible in case an anti-TEV-48125 immunoglobulin E assay is required.","text_display":" occurrence as soon as possible in case an anti-TEV-48125 immunoglobulin E assay is required.","confidence":0.9775497913360596,"confidence_rate":0.9997659443953735},{"cnt":[[241,438],[993,438],[993,503],[241,503]],"region":{"top_left_x":240,"top_left_y":438,"width":753,"height":65},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"683c5ce333a34bf3a16bd1a063ddded7","type":"section_header","conversion_output":false,"children_ids":["bfd0b19e6cce4691bf0a7d9954904d8a"],"text":"","text_display":""},{"cnt":[[245,443],[986,443],[986,501],[245,501]],"region":{"top_left_x":244,"top_left_y":442,"width":743,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfd0b19e6cce4691bf0a7d9954904d8a","type":"text","conversion_output":true,"parent_id":"683c5ce333a34bf3a16bd1a063ddded7","text":"7.10. 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Injection Site Assessments}","confidence":0.9990234375,"confidence_rate":0.9999735938716796},{"cnt":[[245,567],[245,516],[1869,518],[1869,569]],"region":{"top_left_x":244,"top_left_y":515,"width":1626,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe7d703b24d248039962178249f03414","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":[[245,567],[1785,567],[1785,617],[245,617]],"region":{"top_left_x":244,"top_left_y":567,"width":1542,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"117f87f7f13d4bc89a00343c5c8bfa59","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":[[245,614],[1676,614],[1676,664],[245,664]],"region":{"top_left_x":244,"top_left_y":614,"width":1432,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a4fbe7178414f75ac3895e3d734d294","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":[[370,683],[1837,683],[1837,737],[370,737]],"region":{"top_left_x":369,"top_left_y":683,"width":1468,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ff2768bfaf049849b9cd94a21a31ac8","type":"text","conversion_output":true,"text":"- Injection-site erythema, injection-site induration, and injection-site ecchymosis will","text_display":"\n- Injection-site erythema, injection-site induration, and injection-site ecchymosis will","confidence":1,"confidence_rate":1},{"cnt":[[432,735],[1755,735],[1755,784],[432,784]],"region":{"top_left_x":431,"top_left_y":734,"width":1325,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09d3bc79c91b4412aa0b3d796a7fd86f","type":"text","conversion_output":true,"text":"be graded according to measurements: absent, 5 mm to \\(\\leq 50 mm\\) (mild), \\(>50\\) to","text_display":" be graded according to measurements: absent, 5 mm to \\(\\leq 50 mm\\) (mild), \\(>50\\) to","confidence":0.9921875,"confidence_rate":0.9999147517049182},{"cnt":[[430,782],[1858,782],[1858,831],[430,831]],"region":{"top_left_x":429,"top_left_y":782,"width":1430,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26cc9fb6c82e4abaab8b2ecb20faa1f1","type":"text","conversion_output":true,"text":"\\(\\leq 100 mm\\) (moderate), and \\(>100 mm\\) (severe). Induration must be assessed by careful","text_display":" \\(\\leq 100 mm\\) (moderate), and \\(>100 mm\\) (severe). Induration must be assessed by careful","confidence":0.9975595474243164,"confidence_rate":0.9999731494227478},{"cnt":[[432,831],[1641,831],[1641,883],[432,883]],"region":{"top_left_x":431,"top_left_y":831,"width":1211,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c02ad6f58594590abe571035c700d78","type":"text","conversion_output":true,"text":"superficial palpation avoiding pressuring or squeezing the injection site.","text_display":" superficial palpation avoiding pressuring or squeezing the injection site.","confidence":1,"confidence_rate":1},{"cnt":[[370,902],[1487,902],[1487,956],[370,956]],"region":{"top_left_x":369,"top_left_y":902,"width":1118,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8be4d82457df4c16986bc99108dd596b","type":"text","conversion_output":true,"text":"- Injection-site pain will be measured as summarized in Table 3.","text_display":"\n- Injection-site pain will be measured as summarized in Table 3.","confidence":1,"confidence_rate":1},{"cnt":[[243,971],[1433,971],[1433,1027],[243,1027]],"region":{"top_left_x":242,"top_left_y":971,"width":1192,"height":56},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0cf1ea674b74730b88038108fd623de","type":"figure_label","conversion_output":false,"text":"Table 3: Severity of Pain Scale for Injection Site 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Grade & Assessments \\\\\n\\hline 0 & No pain \\\\\n\\hline 1 & Mild \\\\\n\\hline 2 & Moderate \\\\\n\\hline 3 & Severe \\\\\n\\hline 4 & Worst possible \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 3: Severity of Pain Scale for Injection Site Assessments}\n\\begin{tabular}{|l|l|}\n\\hline Grade & Assessments \\\\\n\\hline 0 & No pain \\\\\n\\hline 1 & Mild \\\\\n\\hline 2 & Moderate \\\\\n\\hline 3 & Severe \\\\\n\\hline 4 & Worst possible 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and","confidence":1,"confidence_rate":1},{"cnt":[[245,1616],[1429,1616],[1429,1665],[245,1665]],"region":{"top_left_x":244,"top_left_y":1615,"width":1185,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6612e4e9b3d41049e1e86306dfeea9f","type":"text","conversion_output":true,"text":"hourly thereafter until the reaction/pain is of moderate or less severity.","text_display":" hourly thereafter until the reaction/pain is of moderate or less severity.","confidence":1,"confidence_rate":1},{"cnt":[[245,1684],[1747,1684],[1747,1738],[245,1738]],"region":{"top_left_x":244,"top_left_y":1684,"width":1503,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f8430d279f24b929178346d73a5da75","type":"text","conversion_output":true,"text":"Appropriate treatment may be provided if necessary, in which case it must be recorded as","text_display":"\n\nAppropriate treatment may be provided if necessary, in which 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Safety data will additionally be","text_display":" as interim/preliminary safety databases become available. Safety data will additionally be","confidence":1,"confidence_rate":1},{"cnt":[[245,2172],[1538,2172],[1538,2224],[245,2224]],"region":{"top_left_x":244,"top_left_y":2172,"width":1295,"height":52},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81a489f7bab949d0b09dde83696f440e","type":"text","conversion_output":true,"text":"evaluated periodically and ad hoc (if necessary) in the Product Safety Group.","text_display":" evaluated periodically and ad hoc (if necessary) in the Product Safety Group.","confidence":1,"confidence_rate":1},{"cnt":[[245,2243],[1751,2243],[1751,2292],[245,2292]],"region":{"top_left_x":244,"top_left_y":2242,"width":1507,"height":51},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9806c878d0384082b9f9ffa5b178696b","type":"text","conversion_output":true,"text":"Methods and timing of assessing safety data are discussed in Section 3.14. 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Procedures for","confidence":1,"confidence_rate":1},{"cnt":[[245,2290],[1790,2290],[1790,2340],[245,2340]],"region":{"top_left_x":244,"top_left_y":2290,"width":1546,"height":50},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a2bdad319804ba2b1f9e8a887a016da","type":"text","conversion_output":true,"text":"recording safety data are discussed in Section 13.1 and methods of analyses are discussed in","text_display":" recording safety data are discussed in Section 13.1 and methods of analyses are discussed in","confidence":1,"confidence_rate":1},{"cnt":[[245,2337],[483,2337],[483,2383],[245,2383]],"region":{"top_left_x":244,"top_left_y":2337,"width":240,"height":46},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccb160f44b634b52ae81cfd6b830392a","type":"text","conversion_output":true,"text":"Section 9.7.2.","text_display":" Section 9.7.2.","confidence":0.9765625,"confidence_rate":0.9987525404822938},{"cnt":[[1038,2539],[1089,2539],[1089,2578],[1038,2578]],"region":{"top_left_x":1037,"top_left_y":2539,"width":53,"height":40},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6db7a58196d4d2cba8effd6b417a877","type":"page_info","conversion_output":false,"text":"89","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-091","page":91,"lines":[{"cnt":[[1109,127],[1880,127],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":126,"width":772,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68d7fafc7a8d4679949e1183045a4468","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d039597c2fd8479e8b7a20b9292f6ce0","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"533d345e08b842c391aff18d896c62f4","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[236,309],[1766,309],[1766,425],[236,425]],"region":{"top_left_x":236,"top_left_y":309,"width":1531,"height":117},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78308303478448338eb78f2d046a6d77","type":"section_header","conversion_output":false,"children_ids":["c100ce9db734409897e9fae5b3175dd1","22554238d65342308237b56e8b91935d"],"text":"","text_display":""},{"cnt":[[243,314],[1762,314],[1762,367],[243,367]],"region":{"top_left_x":242,"top_left_y":313,"width":1520,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c100ce9db734409897e9fae5b3175dd1","type":"text","conversion_output":true,"parent_id":"78308303478448338eb78f2d046a6d77","text":"8. 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Thus, the TEV-48125 pharmacokinetic samples","text_display":"\n\nSampling for pharmacokinetics will be sparse. Thus, the TEV-48125 pharmacokinetic samples","confidence":1,"confidence_rate":1},{"cnt":[[245,593],[1863,593],[1863,642],[245,642]],"region":{"top_left_x":244,"top_left_y":592,"width":1619,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19b58441048649bba1e4c2af4ce4b522","type":"text","conversion_output":true,"text":"will be analyzed using a population pharmacokinetic approach and will be reported separately to","text_display":" will be analyzed using a population pharmacokinetic approach and will be reported separately to","confidence":1,"confidence_rate":1},{"cnt":[[245,645],[655,645],[655,694],[245,694]],"region":{"top_left_x":244,"top_left_y":644,"width":412,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79dbbc7c61cd4682ab1bd8f0fc9254e1","type":"text","conversion_output":true,"text":"the clinical study report.","text_display":" the clinical study report.","confidence":1,"confidence_rate":1},{"cnt":[[245,711],[1818,711],[1818,763],[245,763]],"region":{"top_left_x":244,"top_left_y":711,"width":1574,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b08f0d954264500b3dda92246d9bbef","type":"text","conversion_output":true,"text":"Samples from patients who receive active study drug will be analyzed for TEV-48125 using a","text_display":"\nSamples from patients who receive active study drug will be analyzed for TEV-48125 using a","confidence":0.9892578125,"confidence_rate":0.999886319079526},{"cnt":[[245,761],[1644,761],[1644,810],[245,810]],"region":{"top_left_x":244,"top_left_y":760,"width":1400,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c91f8ba88caa4efda8d814c46aa43bdb","type":"text","conversion_output":true,"text":"validated method. Samples from patients who receive placebo will not be analyzed.","text_display":" validated method. Samples from patients who receive placebo will not be analyzed.","confidence":1,"confidence_rate":1},{"cnt":[[236,844],[1055,844],[1055,907],[236,907]],"region":{"top_left_x":236,"top_left_y":844,"width":819,"height":63},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49f8c69d535b4a138801481f024f6de9","type":"section_header","conversion_output":false,"children_ids":["c4377c16d37c4123b5c9d10842f61d90"],"text":"","text_display":""},{"cnt":[[245,851],[1051,851],[1051,900],[245,900]],"region":{"top_left_x":244,"top_left_y":850,"width":807,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4377c16d37c4123b5c9d10842f61d90","type":"text","conversion_output":true,"parent_id":"49f8c69d535b4a138801481f024f6de9","text":"8.1.1. Specimen Sampling and Handling","text_display":"\n\n\\subsection*{8.1.1. 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Blood samples","text_display":" inverted slowly 6 to 8 times to mix the contents, and placed on water/ice ( \\(\\sim 4^{\\circ} C\\) ). Blood samples","confidence":0.5355420112609863,"confidence_rate":0.9948523366835048},{"cnt":[[245,1250],[1742,1250],[1742,1302],[245,1302]],"region":{"top_left_x":244,"top_left_y":1250,"width":1499,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e1b177a100c42ba844c79658cf2fb67","type":"text","conversion_output":true,"text":"will be centrifuged \\(\\left(1500 g, \\sim 10\\right.\\) minutes, \\(2^{\\circ} C\\) to \\(\\left.6^{\\circ} C \\right)\\) between 5 minutes and 1 hour after","text_display":" will be centrifuged \\(\\left(1500 g, \\sim 10\\right.\\) minutes, \\(2^{\\circ} C\\) to \\(\\left.6^{\\circ} C \\right)\\) between 5 minutes and 1 hour after","confidence":0.5978107452392578,"confidence_rate":0.9960197171781482},{"cnt":[[245,1302],[1699,1302],[1699,1351],[245,1351]],"region":{"top_left_x":244,"top_left_y":1301,"width":1456,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df06cf74cef34096a1facdfaa05c5f4c","type":"text","conversion_output":true,"text":"sampling. If a refrigerated centrifuge is not available, samples should be chilled before","text_display":" sampling. If a refrigerated centrifuge is not available, samples should be chilled before","confidence":1,"confidence_rate":1},{"cnt":[[245,1349],[1835,1349],[1835,1399],[245,1399]],"region":{"top_left_x":244,"top_left_y":1349,"width":1591,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a39c54faa09c414f9c01edcca7c9384c","type":"text","conversion_output":true,"text":"centrifugation. Other measures should be taken as appropriate to prevent samples from heating","text_display":" centrifugation. Other measures should be taken as appropriate to prevent samples from heating","confidence":1,"confidence_rate":1},{"cnt":[[245,1399],[1850,1399],[1850,1450],[245,1450]],"region":{"top_left_x":244,"top_left_y":1398,"width":1606,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bdeb53ff065499aa41d21f824a53d74","type":"text","conversion_output":true,"text":"significantly during centrifugation. Separated plasma will be transferred in approximately equal","text_display":" significantly during centrifugation. Separated plasma will be transferred in approximately equal","confidence":1,"confidence_rate":1},{"cnt":[[245,1448],[1349,1448],[1349,1497],[245,1497]],"region":{"top_left_x":244,"top_left_y":1448,"width":1106,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4d13d2f8f0c46319bb16e564dff61f2","type":"text","conversion_output":true,"text":"portions into 2 labeled, \\(2- mL\\) polypropylene tubes (sets A and B ).","text_display":" portions into 2 labeled, \\(2- mL\\) polypropylene tubes (sets A and B ).","confidence":0.99365234375,"confidence_rate":0.9999307862183984},{"cnt":[[245,1517],[1794,1517],[1794,1566],[245,1566]],"region":{"top_left_x":244,"top_left_y":1516,"width":1550,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9594aec39d34abcb537c4255ff5b1df","type":"text","conversion_output":true,"text":"Labels for samples should include study number, patient number, period, nominal collection","text_display":"\n\nLabels for samples should include study number, patient number, period, nominal collection","confidence":1,"confidence_rate":1},{"cnt":[[245,1564],[1854,1564],[1854,1618],[245,1618]],"region":{"top_left_x":244,"top_left_y":1564,"width":1611,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5946956567a4fcd95ab11306ae4339e","type":"text","conversion_output":true,"text":"time, set (A or B), and indication that they are pharmacokinetic samples. Samples will be stored","text_display":" time, set (A or B), and indication that they are pharmacokinetic samples. 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Exploratory analysis will be conducted on","text_display":" and neovascularization of tumors. Exploratory analysis will be conducted on","confidence":1,"confidence_rate":1},{"cnt":[[245,468],[1691,468],[1691,518],[245,518]],"region":{"top_left_x":244,"top_left_y":468,"width":1447,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"711c3d41ea1d4ae4986dfb2fcf6dc59e","type":"text","conversion_output":true,"text":"endothelial/angiogenic markers to determine if TEV-48125 alters angiogenic markers.","text_display":" endothelial/angiogenic markers to determine if TEV-48125 alters angiogenic markers.","confidence":1,"confidence_rate":1},{"cnt":[[245,537],[1815,537],[1815,587],[245,587]],"region":{"top_left_x":244,"top_left_y":537,"width":1572,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37a1ededc7844e89ab7ffce07686f5e5","type":"text","conversion_output":true,"text":"Calcitonin gene-related peptide is known to act directly on macrophage and dendritic cells by","text_display":"\n\nCalcitonin gene-related peptide is known to act directly on macrophage and dendritic cells by","confidence":0.9306640625,"confidence_rate":0.999267035056816},{"cnt":[[245,636],[245,584],[1871,587],[1871,638]],"region":{"top_left_x":244,"top_left_y":584,"width":1628,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9288353bccb24911b832b60f223df3e1","type":"text","conversion_output":true,"text":"inhibiting them from producing inflammatory cytokines and presenting antigens to T cells. It has","text_display":" inhibiting them from producing inflammatory cytokines and presenting antigens to T cells. It has","confidence":0.98486328125,"confidence_rate":0.999857463914325},{"cnt":[[245,636],[1871,636],[1871,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1628,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4036fb79d706492d94251066a8ca7124","type":"text","conversion_output":true,"text":"been hypothesized that CGRP may act as a regulator of the innate immune response. Exploratory","text_display":" been hypothesized that CGRP may act as a regulator of the innate immune response. 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Multiplex","text_display":" potentially include markers of bone remodeling, inflammation, and angiogenesis. Multiplex","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1777,898],[1777,947],[245,947]],"region":{"top_left_x":244,"top_left_y":898,"width":1533,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96a3fb7515bb4261a2b6466fe2745a71","type":"text","conversion_output":true,"text":"immunoassay panels will be applied to measure changes in urine, serum, plasma, and RNA","text_display":" immunoassay panels will be applied to measure changes in urine, serum, plasma, and RNA","confidence":1,"confidence_rate":1},{"cnt":[[245,945],[449,945],[449,990],[245,990]],"region":{"top_left_x":244,"top_left_y":945,"width":206,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab48eb9beb5242c8ab05da8e26dbd7c7","type":"text","conversion_output":true,"text":"biomarkers.","text_display":" biomarkers.","confidence":1,"confidence_rate":1},{"cnt":[[245,1016],[1846,1016],[1846,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1016,"width":1602,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f828b1c304049fa9acbc65d9fe491c0","type":"text","conversion_output":true,"text":"The planned biomarker analysis will be detailed in a separate document, which may be updated","text_display":"\n\nThe planned biomarker analysis will be detailed in a separate document, which may be updated","confidence":0.99853515625,"confidence_rate":0.9999848875607663},{"cnt":[[245,1066],[1661,1066],[1661,1115],[245,1115]],"region":{"top_left_x":244,"top_left_y":1065,"width":1417,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a742eceffcac490abc804457004586f7","type":"text","conversion_output":true,"text":"at a later stage before the analysis to allow updating with new scientific information.","text_display":" at a later stage before the analysis to allow updating with new scientific information.","confidence":0.99853515625,"confidence_rate":0.9999840662390905},{"cnt":[[236,1152],[993,1152],[993,1210],[236,1210]],"region":{"top_left_x":236,"top_left_y":1151,"width":757,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0e6dff647034f318070628a5c3e07f4","type":"section_header","conversion_output":false,"children_ids":["a4ae3dbbec954c238859d4d28cb89027"],"text":"","text_display":""},{"cnt":[[245,1156],[988,1156],[988,1205],[245,1205]],"region":{"top_left_x":244,"top_left_y":1155,"width":745,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4ae3dbbec954c238859d4d28cb89027","type":"text","conversion_output":true,"parent_id":"a0e6dff647034f318070628a5c3e07f4","text":"8.3.1. 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Genetic analysis could also include sequencing of the whole","text_display":" with new scientific information. Genetic analysis could also include sequencing of the whole","confidence":1,"confidence_rate":1},{"cnt":[[245,1856],[990,1856],[990,1906],[245,1906]],"region":{"top_left_x":244,"top_left_y":1856,"width":747,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ce1a6ded612490d83a2f880923a276c","type":"text","conversion_output":true,"text":"genome and/or RNA transcripts, if required.","text_display":" genome and/or RNA transcripts, if required.","confidence":1,"confidence_rate":1},{"cnt":[[245,1925],[1880,1925],[1880,1974],[245,1974]],"region":{"top_left_x":244,"top_left_y":1925,"width":1636,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"934d43f0f2c840d982aa45d5f29906e2","type":"text","conversion_output":true,"text":"Pharmacogenomic assessment will be performed based on study results. Samples will be used for","text_display":"\n\nPharmacogenomic assessment will be performed based on study results. Samples will be used for","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[245,1972],[1749,1972],[1749,2024],[245,2024]],"region":{"top_left_x":244,"top_left_y":1972,"width":1505,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e136cbee6d940b3886a0030c7350a24","type":"text","conversion_output":true,"text":"investigations related to headache, indications where CGRP pathways are implicated, and","text_display":" investigations related to headache, indications where CGRP pathways are implicated, and","confidence":1,"confidence_rate":1},{"cnt":[[245,2024],[1687,2024],[1687,2073],[245,2073]],"region":{"top_left_x":244,"top_left_y":2023,"width":1443,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f31932df780c47408907772e9a72cea5","type":"text","conversion_output":true,"text":"indications that may be associated with the risk of headache or those that are common","text_display":" indications that may be associated with the risk of headache or those that are common","confidence":1,"confidence_rate":1},{"cnt":[[245,2071],[1841,2071],[1841,2121],[245,2121]],"region":{"top_left_x":244,"top_left_y":2071,"width":1598,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6059e6b10d04718a79aca2596c407cc","type":"text","conversion_output":true,"text":"comorbidities associated with headache and/or response to study drug or related investigational","text_display":" comorbidities associated with headache and/or response to study drug or related investigational","confidence":1,"confidence_rate":1},{"cnt":[[245,2121],[354,2121],[354,2168],[245,2168]],"region":{"top_left_x":244,"top_left_y":2120,"width":111,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8452ebaabfc8417b839710951c44881a","type":"text","conversion_output":true,"text":"drugs.","text_display":" drugs.","confidence":1,"confidence_rate":1},{"cnt":[[241,2204],[1053,2204],[1053,2264],[241,2264]],"region":{"top_left_x":240,"top_left_y":2204,"width":813,"height":61},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56c53ad6f39b442eab4536de2cbb2c82","type":"section_header","conversion_output":false,"children_ids":["29f290b675ec426ba3c58fa3691438d0"],"text":"","text_display":""},{"cnt":[[245,2209],[1048,2209],[1048,2260],[245,2260]],"region":{"top_left_x":244,"top_left_y":2208,"width":805,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29f290b675ec426ba3c58fa3691438d0","type":"text","conversion_output":true,"parent_id":"56c53ad6f39b442eab4536de2cbb2c82","text":"8.3.2 Specimen Sampling and Handling","text_display":"\n\n\\subsection*{8.3.2 Specimen Sampling and Handling}","confidence":0.98876953125,"confidence_rate":0.9997245743605401},{"cnt":[[245,2277],[1751,2277],[1751,2329],[245,2329]],"region":{"top_left_x":244,"top_left_y":2277,"width":1507,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c65ca0d5fa544156bea14d4d55001f81","type":"text","conversion_output":true,"text":"Blood samples (a total of \\(18.5 mL ; 6 mL\\) each for plasma and serum and 6.5 mL for RNA","text_display":"\n\nBlood samples (a total of \\(18.5 mL ; 6 mL\\) each for plasma and serum and 6.5 mL for RNA","confidence":0.9834063053131104,"confidence_rate":0.9998326848759697},{"cnt":[[245,2327],[1850,2327],[1850,2378],[245,2378]],"region":{"top_left_x":244,"top_left_y":2326,"width":1606,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9d5ccc9115b4f5aaab61f030f324894","type":"text","conversion_output":true,"text":"[PAXgene]) will be collected via venipuncture or indwelling catheter at the time points detailed","text_display":" [PAXgene]) will be collected via venipuncture or indwelling catheter at the time points detailed","confidence":0.998046875,"confidence_rate":0.9999806434067887},{"cnt":[[245,2376],[1841,2376],[1841,2426],[245,2426]],"region":{"top_left_x":244,"top_left_y":2376,"width":1598,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56bf4a0aa18c4403ab7c65d7304d8365","type":"text","conversion_output":true,"text":"in Table 1 for serum, plasma, and RNA biomarker measures. 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Details for processing and handling of each type of biomarker sample will be outlined in","text_display":"\n\nDNA. 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Following DNA","text_display":"\n\nAll blood and urine tubes will be labeled with the patient coded number. 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Sample labels should","text_display":" central laboratory on dry ice, per instructions in the laboratory manual. 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Shipments should be made as specified in laboratory","text_display":" indication that they are biomarker samples. Shipments should be made as specified in laboratory","confidence":1,"confidence_rate":1},{"cnt":[[245,941],[1811,941],[1811,990],[245,990]],"region":{"top_left_x":244,"top_left_y":941,"width":1568,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5570141a58ef496bbe4ce799bdf697cc","type":"text","conversion_output":true,"text":"manual. An electronic file containing sample demographics will be e-mailed to the respective","text_display":" manual. 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Data will be kept confidential and stored separately.","text_display":" number. Data will be kept confidential and stored separately.","confidence":1,"confidence_rate":1},{"cnt":[[245,1225],[1826,1225],[1826,1274],[245,1274]],"region":{"top_left_x":244,"top_left_y":1224,"width":1583,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b65e12f997c46e69d3be8892ca1f272","type":"text","conversion_output":true,"text":"The biomarker sample analyses will be performed if and when required. Since new techniques","text_display":"\n\nThe biomarker sample analyses will be performed if and when required. Since new techniques","confidence":1,"confidence_rate":1},{"cnt":[[245,1274],[1807,1274],[1807,1321],[245,1321]],"region":{"top_left_x":244,"top_left_y":1274,"width":1563,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c67b744d895a4bd7880888b567931556","type":"text","conversion_output":true,"text":"continue to be developed, the method and laboratory that will be recommended for the future","text_display":" continue to be developed, the method and laboratory that will be recommended for the future","confidence":1,"confidence_rate":1},{"cnt":[[245,1323],[943,1323],[943,1371],[245,1371]],"region":{"top_left_x":244,"top_left_y":1323,"width":700,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20929b5967d84395a3b09a376e41bd6a","type":"text","conversion_output":true,"text":"biomarker analysis cannot be anticipated.","text_display":" biomarker analysis cannot be anticipated.","confidence":1,"confidence_rate":1},{"cnt":[[241,1409],[1884,1409],[1884,1532],[241,1532]],"region":{"top_left_x":240,"top_left_y":1409,"width":1645,"height":123},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b09726f95784fac841a00661cd1675d","type":"section_header","conversion_output":false,"children_ids":["3f491c58088a4a92a05937a60c3db722","e92870f902684c57a8d0358bc915c556"],"text":"","text_display":""},{"cnt":[[245,1414],[1880,1414],[1880,1472],[245,1472]],"region":{"top_left_x":244,"top_left_y":1413,"width":1636,"height":59},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f491c58088a4a92a05937a60c3db722","type":"text","conversion_output":true,"parent_id":"6b09726f95784fac841a00661cd1675d","text":"8.4 Methods and Timing of Assessing, Recording, and Analyzing Clinical","text_display":"\n\n\\subsection*{8.4 Methods and Timing of Assessing, Recording, and Analyzing 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Study Population","text_display":"\n\n\\subsection*{9.4. Study Population}","confidence":0.94384765625,"confidence_rate":0.9977797565888935},{"cnt":[[245,331],[1803,331],[1803,380],[245,380]],"region":{"top_left_x":244,"top_left_y":330,"width":1559,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba0f12f761874f19b99f8db64e8e6b5e","type":"text","conversion_output":true,"text":"The ITT analysis set (see Section 9.2) will be used for all study population summaries unless","text_display":"\n\nThe ITT analysis set (see Section 9.2) will be used for all study population summaries unless","confidence":1,"confidence_rate":1},{"cnt":[[245,378],[1678,378],[1678,428],[245,428]],"region":{"top_left_x":244,"top_left_y":378,"width":1434,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76b15372c89047bf97bd7d2772a6f97e","type":"text","conversion_output":true,"text":"otherwise noted. Summaries will be presented by treatment group and for all patients.","text_display":" otherwise noted. Summaries will be presented by treatment group and for all patients.","confidence":1,"confidence_rate":1},{"cnt":[[241,464],[782,464],[782,522],[241,522]],"region":{"top_left_x":240,"top_left_y":464,"width":543,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d20ffb9991042ada9d3bd0f28a600c7","type":"section_header","conversion_output":false,"children_ids":["b8335fd5f39843c3bc0584ce66ac7e56"],"text":"","text_display":""},{"cnt":[[245,468],[778,468],[778,518],[245,518]],"region":{"top_left_x":244,"top_left_y":468,"width":534,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8335fd5f39843c3bc0584ce66ac7e56","type":"text","conversion_output":true,"parent_id":"0d20ffb9991042ada9d3bd0f28a600c7","text":"9.4.1. Patient Disposition","text_display":"\n\n\\subsection*{9.4.1. Patient Disposition}","confidence":0.9658527374267578,"confidence_rate":0.9988798567931995},{"cnt":[[245,537],[1830,537],[1830,587],[245,587]],"region":{"top_left_x":244,"top_left_y":537,"width":1587,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ad2d972b4144778b716b552aa231df9","type":"text","conversion_output":true,"text":"Data from patients screened, patients screened but not randomized and reason not randomized,","text_display":"\n\nData from patients screened, patients screened but not randomized and reason not randomized,","confidence":1,"confidence_rate":1},{"cnt":[[245,587],[1850,587],[1850,638],[245,638]],"region":{"top_left_x":244,"top_left_y":586,"width":1606,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95de988727b8485e86e405ac6b2e4130","type":"text","conversion_output":true,"text":"patients who are randomized (ie, in the ITT set), patients randomized but not treated, patients in","text_display":" patients who are randomized (ie, in the ITT set), patients randomized but not treated, patients in","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[1828,636],[1828,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":1585,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15b5177e8e134e379adfe0127f9b22f7","type":"text","conversion_output":true,"text":"the safety and other analysis sets, patients who complete the study, and patients who withdraw","text_display":" the safety and other analysis sets, patients who complete the study, and patients who withdraw","confidence":1,"confidence_rate":1},{"cnt":[[245,683],[1865,683],[1865,733],[245,733]],"region":{"top_left_x":244,"top_left_y":683,"width":1621,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34c9a4aea942493c9cf35d81f53a4c97","type":"text","conversion_output":true,"text":"from the study will be summarized using descriptive statistics. Data from patients who withdraw","text_display":" from the study will be summarized using descriptive statistics. Data from patients who withdraw","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1798,730],[1798,782],[245,782]],"region":{"top_left_x":244,"top_left_y":730,"width":1555,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09a533491fae478a9c04e5a8a3633295","type":"text","conversion_output":true,"text":"from the study will also be summarized by reason for withdrawal using descriptive statistics.","text_display":" from the study will also be summarized by reason for withdrawal using descriptive statistics.","confidence":1,"confidence_rate":1},{"cnt":[[241,816],[1205,816],[1205,874],[241,874]],"region":{"top_left_x":240,"top_left_y":816,"width":966,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57d2fbb111ef416b8853784d084336fb","type":"section_header","conversion_output":false,"children_ids":["ff487766c32340cfad775ca7acd048df"],"text":"","text_display":""},{"cnt":[[245,821],[1199,821],[1199,870],[245,870]],"region":{"top_left_x":244,"top_left_y":820,"width":955,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff487766c32340cfad775ca7acd048df","type":"text","conversion_output":true,"parent_id":"57d2fbb111ef416b8853784d084336fb","text":"9.4.2. Demographic and Baseline Characteristics","text_display":"\n\n\\subsection*{9.4.2. 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For categorical variables, patient counts and percentages will be","text_display":" maximum) will be provided. For categorical variables, patient counts and percentages will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1083],[1394,1083],[1394,1137],[245,1137]],"region":{"top_left_x":244,"top_left_y":1082,"width":1151,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd227d88d2374492a6ef01112939083f","type":"text","conversion_output":true,"text":"provided. Categories for missing data will be presented if necessary.","text_display":" provided. Categories for missing data will be presented if necessary.","confidence":1,"confidence_rate":1},{"cnt":[[245,1154],[1815,1154],[1815,1205],[245,1205]],"region":{"top_left_x":244,"top_left_y":1153,"width":1572,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18bbc6580dc94714838238ced788b4ed","type":"text","conversion_output":true,"text":"Treatment groups will be compared for all continuous variables, using an analysis of variance","text_display":"\nTreatment groups will be compared for all continuous variables, using an analysis of variance","confidence":1,"confidence_rate":1},{"cnt":[[245,1203],[1734,1203],[1734,1253],[245,1253]],"region":{"top_left_x":244,"top_left_y":1203,"width":1490,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4513f9917d3145859812847744f7cb2d","type":"text","conversion_output":true,"text":"with treatment group as a factor. The categorical variables of patient sex and race will be","text_display":" with treatment group as a factor. The categorical variables of patient sex and race will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1250],[1811,1250],[1811,1300],[245,1300]],"region":{"top_left_x":244,"top_left_y":1250,"width":1568,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"124e9aec86624ab7abe234811121488d","type":"text","conversion_output":true,"text":"summarized using descriptive statistics for each variable category. Missing categories will be","text_display":" summarized using descriptive statistics for each variable category. Missing categories will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1300],[1833,1300],[1833,1351],[245,1351]],"region":{"top_left_x":244,"top_left_y":1299,"width":1589,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4deca028ff1149b7a277d1a725f49c5e","type":"text","conversion_output":true,"text":"presented if necessary. Treatment groups will be compared for all categorical variables using a","text_display":" presented if necessary. Treatment groups will be compared for all categorical variables using a","confidence":1,"confidence_rate":1},{"cnt":[[245,1349],[1416,1349],[1416,1399],[245,1399]],"region":{"top_left_x":244,"top_left_y":1349,"width":1172,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9531caf8b46a44529e3e06601ceb0bd5","type":"text","conversion_output":true,"text":"Pearson's chi-square (or Fisher's exact test if cell sizes are too small).","text_display":" Pearson's chi-square (or Fisher's exact test if cell sizes are too small).","confidence":0.9985356330871582,"confidence_rate":0.9999814502967829},{"cnt":[[241,1437],[804,1437],[804,1502],[241,1502]],"region":{"top_left_x":240,"top_left_y":1437,"width":564,"height":65},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b76a735b7ab843628899bb8c5ae392fb","type":"section_header","conversion_output":false,"children_ids":["a52f66d7b9dc41caafd89cb4e1abbcd0"],"text":"","text_display":""},{"cnt":[[245,1444],[797,1444],[797,1497],[245,1497]],"region":{"top_left_x":244,"top_left_y":1443,"width":554,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a52f66d7b9dc41caafd89cb4e1abbcd0","type":"text","conversion_output":true,"parent_id":"b76a735b7ab843628899bb8c5ae392fb","text":"9.5. 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The sequence of comparisons will be described in detail in the statistical analysis","text_display":" rate at 0.05 . The sequence of comparisons will be described in detail in the statistical analysis","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,2161],[337,2161],[337,2215],[245,2215]],"region":{"top_left_x":244,"top_left_y":2161,"width":94,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca87731ec9cd499eb30ed65b6bbae6ac","type":"text","conversion_output":true,"text":"plan.","text_display":" plan.","confidence":1,"confidence_rate":1},{"cnt":[[236,2245],[1433,2245],[1433,2322],[236,2322]],"region":{"top_left_x":236,"top_left_y":2245,"width":1198,"height":78},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c2662b8728140638c38900bd67ff4ed","type":"section_header","conversion_output":false,"children_ids":["c7560f804c564987b0c9cadb1b206cf8"],"text":"","text_display":""},{"cnt":[[245,2254],[1424,2254],[1424,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2253,"width":1181,"height":61},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7560f804c564987b0c9cadb1b206cf8","type":"text","conversion_output":true,"parent_id":"7c2662b8728140638c38900bd67ff4ed","text":"9.7. Safety and Tolerability Endpoints and Analysis","text_display":"\n\n\\subsection*{9.7. Safety and Tolerability Endpoints and Analysis}","confidence":0.998046875,"confidence_rate":0.99996508927304},{"cnt":[[245,2329],[1519,2329],[1519,2383],[245,2383]],"region":{"top_left_x":244,"top_left_y":2328,"width":1275,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11740463aff1484d8ab8e3bcdae0f93a","type":"text","conversion_output":true,"text":"Safety and tolerability analyses will be performed on the safety analysis set.","text_display":"\n\nSafety and tolerability analyses will be performed on the safety analysis set.","confidence":1,"confidence_rate":1},{"cnt":[[1036,2539],[1089,2539],[1089,2591],[1036,2591]],"region":{"top_left_x":1035,"top_left_y":2539,"width":55,"height":53},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23a141d6483f4c97b83ad98df5273bef","type":"page_info","conversion_output":false,"text":"98","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"60edbef1-ac01-453e-9bd7-2603ff2aa50a-100","page":100,"lines":[{"cnt":[[1109,127],[1880,127],[1880,174],[1109,174]],"region":{"top_left_x":1108,"top_left_y":126,"width":772,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d70fe3d8085046a9a341dd6493645839","type":"page_info","conversion_output":false,"text":"Placebo-Controlled Study-Episodic Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4a82ac6ef0e4273b6f67660a25e4596","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e32166cd46234c26b74cd46940a6aeb7","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,249],[1051,249],[1051,307],[241,307]],"region":{"top_left_x":240,"top_left_y":249,"width":811,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4785cfa79eae476685f7ce3ea9f00479","type":"section_header","conversion_output":false,"children_ids":["40dc816e8b1740cda44022093a7e1b96"],"text":"","text_display":""},{"cnt":[[245,254],[1044,254],[1044,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":801,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40dc816e8b1740cda44022093a7e1b96","type":"text","conversion_output":true,"parent_id":"4785cfa79eae476685f7ce3ea9f00479","text":"9.7.1. Safety and Tolerability Endpoints","text_display":"\n\n\\subsection*{9.7.1. Safety and Tolerability Endpoints}","confidence":0.962890625,"confidence_rate":0.9991600096341083},{"cnt":[[245,322],[1347,322],[1347,372],[245,372]],"region":{"top_left_x":244,"top_left_y":322,"width":1104,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27d7cf93cf9c49f08fcf61587347e634","type":"text","conversion_output":true,"text":"The safety and tolerability endpoints for this study are as follows:","text_display":"\n\nThe safety and tolerability endpoints for this study are as follows:","confidence":1,"confidence_rate":1},{"cnt":[[370,395],[1278,395],[1278,445],[370,445]],"region":{"top_left_x":369,"top_left_y":395,"width":910,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dde779c73ba4dc28b71b961aa69baf5","type":"text","conversion_output":true,"text":"- occurrence of adverse events throughout the study","text_display":"\n- occurrence of adverse events throughout the study","confidence":1,"confidence_rate":1},{"cnt":[[370,466],[1124,466],[1124,513],[370,513]],"region":{"top_left_x":369,"top_left_y":466,"width":755,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9913b601100947dfa1e6fb1ba315689a","type":"text","conversion_output":true,"text":"- abnormal standard 12-lead ECG findings","text_display":"\n- abnormal standard 12-lead ECG findings","confidence":0.99951171875,"confidence_rate":0.9999891467144949},{"cnt":[[370,537],[1880,537],[1880,587],[370,587]],"region":{"top_left_x":369,"top_left_y":537,"width":1511,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fb08d4d55c7473d9f70e3a15c61c1a8","type":"text","conversion_output":true,"text":"- changes from baseline in vital signs (systolic and diastolic blood pressure, pulse, body","text_display":"\n- changes from baseline in vital signs (systolic and diastolic blood pressure, pulse, body","confidence":1,"confidence_rate":1},{"cnt":[[434,587],[1248,587],[1248,634],[434,634]],"region":{"top_left_x":433,"top_left_y":586,"width":816,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"639fe92e98f94fd7aac8530ab46c3188","type":"text","conversion_output":true,"text":"temperature, and respiratory rate) measurements","text_display":" temperature, and respiratory rate) measurements","confidence":1,"confidence_rate":1},{"cnt":[[370,657],[1699,657],[1699,707],[370,707]],"region":{"top_left_x":369,"top_left_y":657,"width":1331,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4718010588754477ae353aea5e5113ab","type":"text","conversion_output":true,"text":"- changes from baseline in clinical laboratory (serum chemistry, hematology,","text_display":"\n- changes from baseline in clinical laboratory (serum chemistry, hematology,","confidence":1,"confidence_rate":1},{"cnt":[[434,707],[1089,707],[1089,754],[434,754]],"region":{"top_left_x":433,"top_left_y":706,"width":657,"height":49},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e77a5bb5162740e59f5962d6516d3c6f","type":"text","conversion_output":true,"text":"coagulation, and urinalysis) test results","text_display":" coagulation, and urinalysis) test results","confidence":1,"confidence_rate":1},{"cnt":[[370,778],[1111,778],[1111,827],[370,827]],"region":{"top_left_x":369,"top_left_y":777,"width":742,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b94021cad7bb4c9b833f1a6e2eb01553","type":"text","conversion_output":true,"text":"- abnormal physical examination findings","text_display":"\n- abnormal physical examination findings","confidence":1,"confidence_rate":1},{"cnt":[[370,849],[1687,849],[1687,898],[370,898]],"region":{"top_left_x":369,"top_left_y":848,"width":1318,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edfa34dbf484483d9e32f7904456ef2c","type":"text","conversion_output":true,"text":"- abnormal local injection site tolerability findings (ie, erythema, induration,","text_display":"\n- abnormal local injection site tolerability findings (ie, erythema, induration,","confidence":1,"confidence_rate":1},{"cnt":[[434,898],[1265,898],[1265,947],[434,947]],"region":{"top_left_x":433,"top_left_y":898,"width":833,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd8c3c66669f4bc78b7e04e328c32fa4","type":"text","conversion_output":true,"text":"ecchymosis) and occurrence of injection site pain","text_display":" ecchymosis) and occurrence of injection site pain","confidence":1,"confidence_rate":1},{"cnt":[[370,971],[1442,971],[1442,1018],[370,1018]],"region":{"top_left_x":369,"top_left_y":971,"width":1073,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f80ce666550042678750b1263fd6ff3f","type":"text","conversion_output":true,"text":"- suicidal ideation and behavior as suggested by the eC-SSRS","text_display":"\n- suicidal ideation and behavior as suggested by the eC-SSRS","confidence":1,"confidence_rate":1},{"cnt":[[245,1040],[1463,1040],[1463,1087],[245,1087]],"region":{"top_left_x":244,"top_left_y":1039,"width":1220,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c30ca845f25e4decbad06c385cc95535","type":"text","conversion_output":true,"text":"Safety and tolerability measures and time points are provided in Table 1.","text_display":"\n\nSafety and tolerability measures and time points are provided in Table 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Each","text_display":"\n\nAll adverse events will be coded using the Medical Dictionary for Regulatory Activities. Each","confidence":0.998046875,"confidence_rate":0.9999800508639274},{"cnt":[[245,1248],[1828,1248],[1828,1296],[245,1296]],"region":{"top_left_x":244,"top_left_y":1248,"width":1585,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc434e7a5d53440497b0c20aa592c5fc","type":"text","conversion_output":true,"text":"patient will be counted only once in each preferred term or system organ class category for the","text_display":" patient will be counted only once in each preferred term or system organ class category for the","confidence":1,"confidence_rate":1},{"cnt":[[245,1298],[1846,1298],[1846,1343],[245,1343]],"region":{"top_left_x":244,"top_left_y":1297,"width":1602,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e283d4d1fbba44bbb8daff14784e6d16","type":"text","conversion_output":true,"text":"analyses of safety. Summaries will be presented for all adverse events (overall and by severity),","text_display":" analyses of safety. Summaries will be presented for all adverse events (overall and by severity),","confidence":1,"confidence_rate":1},{"cnt":[[245,1345],[1798,1345],[1798,1392],[245,1392]],"region":{"top_left_x":244,"top_left_y":1344,"width":1555,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76903e60a55b4b979cbe0be0b23dd182","type":"text","conversion_output":true,"text":"adverse events determined by the investigator to be related to study treatment (ie, reasonable","text_display":" adverse events determined by the investigator to be related to study treatment (ie, reasonable","confidence":1,"confidence_rate":1},{"cnt":[[245,1392],[1818,1392],[1818,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1392,"width":1574,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce2fcc4df8fe4033bad46280d4264f60","type":"text","conversion_output":true,"text":"possibility; see Section 7.1.4) (defined as related or with missing relationship) (overall and by","text_display":" possibility; see Section 7.1.4) (defined as related or with missing relationship) (overall and by","confidence":1,"confidence_rate":1},{"cnt":[[245,1439],[1854,1439],[1854,1489],[245,1489]],"region":{"top_left_x":244,"top_left_y":1439,"width":1611,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15021fbb38cc48a7b434b54b0ad746f8","type":"text","conversion_output":true,"text":"severity), serious adverse events, and adverse events causing withdrawal from the study. 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All","text_display":"\n\nChanges in laboratory and vital signs measurement data will be summarized descriptively. All","confidence":1,"confidence_rate":1},{"cnt":[[245,1727],[1876,1727],[1876,1775],[245,1775]],"region":{"top_left_x":244,"top_left_y":1727,"width":1632,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c8692357d3243aa9d9024474edcd4a0","type":"text","conversion_output":true,"text":"values will be compared with prespecified boundaries to identify potentially clinically significant","text_display":" values will be compared with prespecified boundaries to identify potentially clinically significant","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,1775],[1068,1775],[1068,1824],[245,1824]],"region":{"top_left_x":244,"top_left_y":1774,"width":824,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8841061d5dac4a2d9c1124ac1f2220ca","type":"text","conversion_output":true,"text":"changes or values, and such values will be listed.","text_display":" changes or values, and such values will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[245,1843],[1830,1843],[1830,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1843,"width":1587,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9beacad472bd4b98800160e1addb8635","type":"text","conversion_output":true,"text":"The use of concomitant medications will be summarized by therapeutic class using descriptive","text_display":"\n\nThe use of concomitant medications will be summarized by therapeutic class using descriptive","confidence":0.9985356330871582,"confidence_rate":0.9999848924837492},{"cnt":[[245,1893],[1869,1893],[1869,1940],[245,1940]],"region":{"top_left_x":244,"top_left_y":1892,"width":1626,"height":49},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6162b508dbb146f4bc13b822eda182e7","type":"text","conversion_output":true,"text":"statistics. Concomitant medications will include all medications taken while the patient is treated","text_display":" statistics. Concomitant medications will include all medications taken while the patient is treated","confidence":1,"confidence_rate":1},{"cnt":[[245,1942],[524,1942],[524,1989],[245,1989]],"region":{"top_left_x":244,"top_left_y":1942,"width":281,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0db2bc3841342babde84dc0684b5001","type":"text","conversion_output":true,"text":"with study drug.","text_display":" with study drug.","confidence":1,"confidence_rate":1},{"cnt":[[245,2011],[1800,2011],[1800,2058],[245,2058]],"region":{"top_left_x":244,"top_left_y":2010,"width":1557,"height":49},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53323b943b5f468ab53013ac02def740","type":"text","conversion_output":true,"text":"Safety data will be summarized descriptively overall and by treatment group. For continuous","text_display":"\n\nSafety data will be summarized descriptively overall and by treatment group. 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The principal investigator at each investigational center, the coordinating","text_display":" administration. 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Protocol violations may include nonadherence on the part of the","text_display":" considered a protocol violation. 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The investigator and","text_display":" accompany the study monitor on visits to the investigational center. 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Examples of a product complaint include, but are not","text_display":" clinical research study sponsored by Teva. Examples of a product complaint include, but are not","confidence":1,"confidence_rate":1},{"cnt":[[245,1912],[672,1912],[672,1962],[245,1962]],"region":{"top_left_x":244,"top_left_y":1912,"width":429,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ae463b00a52447792a41d83b3cbd572","type":"text","conversion_output":true,"text":"limited to, the following:","text_display":" limited to, the following:","confidence":1,"confidence_rate":1},{"cnt":[[370,1985],[853,1985],[853,2035],[370,2035]],"region":{"top_left_x":369,"top_left_y":1985,"width":484,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4a770b964a149b7a477af1bc6b91889","type":"text","conversion_output":true,"text":"- suspected contamination","text_display":"\n- suspected 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inside)","confidence":1,"confidence_rate":1},{"cnt":[[370,2320],[1414,2320],[1414,2370],[370,2370]],"region":{"top_left_x":369,"top_left_y":2320,"width":1045,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab6cb930f7e545fcbc39f3bf3a97b51f","type":"text","conversion_output":true,"text":"- incorrect packaging or incorrect or missing labeling/labels","text_display":"\n- incorrect packaging or incorrect or missing labeling/labels","confidence":1,"confidence_rate":1},{"cnt":[[370,2393],[1287,2393],[1287,2443],[370,2443]],"region":{"top_left_x":369,"top_left_y":2393,"width":918,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f78ca3a0a05f4f3f9dd9667b5089d7b3","type":"text","conversion_output":true,"text":"- unexpected or unanticipated taste or odor (or both)","text_display":"\n- unexpected or unanticipated taste or odor (or 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for reporting a possible clinical product complaint","confidence":1,"confidence_rate":1},{"cnt":[[245,374],[1588,374],[1588,423],[245,423]],"region":{"top_left_x":244,"top_left_y":373,"width":1344,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8fe1a3f42d343ad933a563e85809b51","type":"text","conversion_output":true,"text":"by completing the Product Complaint Form provided by Teva and emailing it to","text_display":" by completing the Product Complaint Form provided by Teva and emailing it 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For complaints","text_display":" item) be sent back to the sponsor for investigative testing whenever possible. 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\\multicolumn{3}{|l|}{CLINICAL STUDY PROTOCOL SYNOPSIS} \\\\\n\\hline \\multicolumn{3}{|l|}{Study Drug Dose, Mode of Administration, and Administration Rate} \\\\\n\\hline Prefilled syringes (active or placebo) will be contained in uniquely numbered kits and stored (refrigerated at \\(2^{\\circ} C\\) to \\(8^{\\circ} C\\) ) on site. Active syringes will contain \\(150 mg / mL\\) of TEV-48125, and placebo syringes will contain the same vehicle and excipients as those for active injections. Each kit will contain 1 prefilled syringe. All study drugs will be administered by a qualified clinic staff member separate from the staff member(s) responsible for cellecting safety and efficacy information from the patients. & Prefilled syringes (active or placebo) will be contained in uniquely numbered kits and stored (refrigerated at \\(2^{\\circ} C\\) to \\(8^{\\circ} C\\) ) on site. Active syringes will contain \\(150 mg / mL\\) of TEV-48125, and placebo syringes will contain the same vehicle and excipients as those for active injections. Each kit will contain 1 prefilled syringe. & The requirement for administration of study drugs by a qualified clinic staff member separate from the staff member(s) responsible for collecting safety and efficacy information from the patients was removed. \\\\\n\\hline \\multicolumn{3}{|l|}{1 BACKGROUND INFORMATION} \\\\\n\\hline \\multicolumn{3}{|l|}{1.1 Introduction (Other sections affected by this change: Section 16)} \\\\\n\\hline \\begin{tabular}{l}\nHowever, approximately \\(3 \\%\\) 6\\% of individuals with EM evolve, in any given year, to a significantly more disabling condition called chronic migraine (CM) (Bigal et al 2008, Lipton et al 2007, Scher et al 2003). Individuals with CM present with headaches of any severity on 15 or more days per month and have full-blown migraine on at least 8 days per month (Classification Committee of the IHS, 2013). A sizable proportion of individuals with CM experiences daily headaches and, therefore, faces considerable disability (Bigal and Lipton 2008). [...] \\\\\nCalcitonin gene-related peptide (CGRP) is a wellstudied neuropeptide found at the centers of the migraine processes, both centrally and peripherally (Eftekhari and Edvinsson 2010,-Olesen 2014).\n\\end{tabular} & \\begin{tabular}{l}\nHowever, approximately 3\\% of individuals with EM evolve, in any given year, to a significantly more disabling condition called chronic migraine (CM) (Bigal et al 2008, Lipton et al 2007, Scher et al 2003). Individuals with CM present with headaches of any severity on 15 or more days per month and have full-blown migraine on at least 8 days per month (Classification Committee of the IHS, 2013). 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A sizable proportion of individuals with CM experiences daily headaches and, therefore, faces considerable disability (Bigal and Lipton 2008). \\\\\n[...] \\\\\nCalcitonin gene-related peptide (CGRP) is a wellstudied neuropeptide found at the centers of the migraine processes, both centrally and peripherally (Eftekhari and Edvinsson 2010).\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.923828125,"confidence_rate":0.9994553136462053},{"cnt":[[1109,1040],[1921,1040],[1921,1085],[1109,1085]],"region":{"top_left_x":1108,"top_left_y":1039,"width":813,"height":47},"line":69,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dffcb2137cd8489b832eec9c32c05554","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"However, approximately 3\\% of individuals with EM","text_display":"However, approximately 3\\% of individuals with EM","confidence":1,"confidence_rate":1},{"cnt":[[1109,1087],[1864,1087],[1864,1128],[1109,1128]],"region":{"top_left_x":1108,"top_left_y":1087,"width":757,"height":42},"line":70,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"703142b1e79d4e30bb539b4da16a3cac","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"evolve, in any given year, to a significantly more","text_display":" evolve, in any given year, to a significantly more","confidence":1,"confidence_rate":1},{"cnt":[[1109,1131],[1873,1131],[1873,1172],[1109,1172]],"region":{"top_left_x":1108,"top_left_y":1130,"width":765,"height":42},"line":71,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b7b7c9a9a364d008ee1b8a980903d77","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"disabling condition called chronic migraine (CM)","text_display":" disabling condition called chronic migraine (CM)","confidence":1,"confidence_rate":1},{"cnt":[[1109,1174],[1834,1174],[1834,1219],[1109,1219]],"region":{"top_left_x":1108,"top_left_y":1173,"width":726,"height":47},"line":72,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"309158c0522f4191a2a3e525deca6e94","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"(Bigal et al 2008, Lipton et al 2007, Scher et al","text_display":" (Bigal et al 2008, Lipton et al 2007, Scher et al","confidence":1,"confidence_rate":1},{"cnt":[[1109,1217],[1908,1217],[1908,1263],[1109,1263]],"region":{"top_left_x":1108,"top_left_y":1217,"width":800,"height":46},"line":73,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1d45aa2385842bc807f74d6f67b37ac","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"2003). Individuals with CM present with headaches","text_display":" 2003). Individuals with CM present with headaches","confidence":1,"confidence_rate":1},{"cnt":[[1109,1260],[1877,1260],[1877,1306],[1109,1306]],"region":{"top_left_x":1108,"top_left_y":1260,"width":770,"height":46},"line":74,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22b518400f09499fa1a9d259d171b8ae","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"of any severity on 15 or more days per month and","text_display":" of any severity on 15 or more days per month and","confidence":1,"confidence_rate":1},{"cnt":[[1109,1306],[1838,1306],[1838,1349],[1109,1349]],"region":{"top_left_x":1108,"top_left_y":1305,"width":731,"height":45},"line":75,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c8f57711aa6463397e2aa8362ba9f3a","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"have full-blown migraine on at least 8 days per","text_display":" have full-blown migraine on at least 8 days per","confidence":1,"confidence_rate":1},{"cnt":[[1109,1347],[1908,1347],[1908,1393],[1109,1393]],"region":{"top_left_x":1108,"top_left_y":1347,"width":800,"height":46},"line":76,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cda86c70d08841988a868a76852898ce","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"month (Classification Committee of the IHS, 2013).","text_display":" month (Classification Committee of the IHS, 2013).","confidence":1,"confidence_rate":1},{"cnt":[[1109,1395],[1797,1395],[1797,1436],[1109,1436]],"region":{"top_left_x":1108,"top_left_y":1394,"width":690,"height":42},"line":77,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f0d8c969caa4dc49064981585503014","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"A sizable proportion of individuals with CM","text_display":" A sizable proportion of individuals with CM","confidence":1,"confidence_rate":1},{"cnt":[[1109,1438],[1869,1438],[1869,1479],[1109,1479]],"region":{"top_left_x":1108,"top_left_y":1438,"width":761,"height":42},"line":78,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45cf16bdff3248c6aa93117c0fd3a13a","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"experiences daily headaches and, therefore, faces","text_display":" experiences daily headaches and, therefore, faces","confidence":1,"confidence_rate":1},{"cnt":[[1109,1481],[1847,1481],[1847,1525],[1109,1525]],"region":{"top_left_x":1108,"top_left_y":1481,"width":739,"height":44},"line":79,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fb83ef9529247feb67040694b54ce97","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"considerable disability (Bigal and Lipton 2008).","text_display":" considerable disability (Bigal and Lipton 2008).","confidence":1,"confidence_rate":1},{"cnt":[[1109,1535],[1182,1535],[1182,1579],[1109,1579]],"region":{"top_left_x":1108,"top_left_y":1535,"width":75,"height":44},"line":80,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa2c8b1d565d4875abeeb26dd28d841f","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"[...]","text_display":"\n[...]","confidence":0.923828125,"confidence_rate":0.9921083799782091},{"cnt":[[1109,1590],[1877,1590],[1877,1635],[1109,1635]],"region":{"top_left_x":1108,"top_left_y":1589,"width":770,"height":47},"line":81,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdf8b0fd9c4941bd8fb8d719a54e3447","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"Calcitonin gene-related peptide (CGRP) is a well-","text_display":"\nCalcitonin gene-related peptide (CGRP) is a well","confidence":0.9580078125,"confidence_rate":0.9992058831438545},{"cnt":[[1109,1633],[1843,1633],[1843,1678],[1109,1678]],"region":{"top_left_x":1108,"top_left_y":1632,"width":735,"height":47},"line":82,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a149559ffcf445a2ac8f9f0b2ee16fa8","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"studied neuropeptide found at the centers of the","text_display":"studied neuropeptide found at the centers of the","confidence":1,"confidence_rate":1},{"cnt":[[1109,1676],[1897,1676],[1897,1722],[1109,1722]],"region":{"top_left_x":1108,"top_left_y":1676,"width":789,"height":46},"line":83,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e17c2ac591d40d1a9f4f79691286c5e","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"migraine processes, both centrally and peripherally","text_display":" migraine processes, both centrally and peripherally","confidence":1,"confidence_rate":1},{"cnt":[[1109,1722],[1613,1722],[1613,1765],[1109,1765]],"region":{"top_left_x":1108,"top_left_y":1721,"width":506,"height":45},"line":84,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21e9aa3c3007445f890b7741b26f0c81","type":"text","conversion_output":false,"parent_id":"97b6984ae7cc4f9f906dc6399c2d0fb2","text":"(Eftekhari and Edvinsson 2010).","text_display":" (Eftekhari and Edvinsson 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select literature cited was made here and throughout the document.\n\\end{tabular}","cell_row":5,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1966,1040],[2479,1040],[2479,1085],[1966,1085]],"region":{"top_left_x":1966,"top_left_y":1039,"width":514,"height":47},"line":86,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"181b80ebe0524b42880f7da40cf6752e","type":"text","conversion_output":false,"parent_id":"3ba483a5d5b34a4a814076fd59c568bf","text":"Update/correction of information","text_display":"Update/correction of information","confidence":1,"confidence_rate":1},{"cnt":[[1964,1087],[2388,1087],[2388,1124],[1964,1124]],"region":{"top_left_x":1963,"top_left_y":1087,"width":426,"height":38},"line":87,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c35cc83894748b58a0f944cfe8c3184","type":"text","conversion_output":false,"parent_id":"3ba483a5d5b34a4a814076fd59c568bf","text":"and associated 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Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[247,176],[995,176],[995,226],[247,226]],"region":{"top_left_x":247,"top_left_y":176,"width":748,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18babd45eaa34c5aa4dfda06b681afa6","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1985,176],[2473,176],[2473,226],[1985,226]],"region":{"top_left_x":1985,"top_left_y":176,"width":488,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6375f4981084387961f4a005df9203d","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[226,245],[2524,245],[2524,1843],[226,1843]],"region":{"top_left_x":225,"top_left_y":244,"width":2300,"height":1600},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b57f3eff406442d8b280c9b9f7434e5d","type":"table","conversion_output":true,"children_ids":["041318d41fcb4e11961cfeaeb32ea518","b7b0b36313b84479b818b017a9bed642","372b1b299625428d8cd1fb28e259c610","02876ad55d31410db236f96e25f87ad8","d2ab1037dcfa4a048b3ed2bcf1ec92ef","e516f83e8d754202992852605a5da241","9ef7e5564420420d96a4d74157d53d21","d6beba86784949889fac487b13acba84","c3753cce798d4c8990304c4119e602ac","5269d8d0c9c248dcb67a253ef8f74160","bfebb63ea0864b7e931bf052e6ea8e6f","c4470f2e09c14b8b9a1fce96a85706dd","0371d6acc4cf47069a1f00a2472c7769"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline these classes of drugs that are used with varying response rates to prevent migraine, only 5 marketed drugs are approved by the Food and Drug Administration (FDA) in the United States (US) for the preventive treatment of migraine; 4 of them are approved for the prophylaxis of migraine: propranolol, timolol maleate, divalproex sodium, and topiramate. The clinical trials (Brandes et al 2004, Klapper 1997, Mathew et al 1995, Nadelmann et al 1986, Silberstein et al 2004) that supported registration of these drugs for this indication were conducted before the establishment of CM as a single entity and generally included patients with headaches on less than 15 days per month. 4 (propranolol [Indera] \\({ }^{®}\\), Akrimax Pharmaceuticals], timolol [Blocadren \\({ }^{\\circledR}\\), Merck \\& Co, Inc.], divalproex sodium [Depakote \\({ }^{\\circledR}\\), AbbVie, Inc.], and topiramate [Topamax \\({ }^{\\circledR}\\), Jannsen]) are approved by the United States Food and Drug Administration (FDA) for the prevention or prophylaxis of EM and only 1 (onabotulinumtoxinA [Botox \\({ }^{\\text {® }}\\), Allergan, Inc.]) is approved for the prevention of CM Only 1 medication, onabotulinumtoxinA, is approved for prophylaxis of CM (Lipton and Silberstein 2015). Notably, despite evidence suggesting that inhibition of CGRP is effective as a preventive migraine treatment, no available treatment directly targets CGRP. & these classes of drugs that are used with varying response rates to prevent migraine, only 5 marketed drugs are approved by the Food and Drug Administration (FDA) in the United States (US) for the preventive treatment of migraine; 4 of them are approved for the prophylaxis of migraine: propranolol, timolol maleate, divalproex sodium, and topiramate. The clinical studies (Brandes et al 2004, Klapper 1997, Mathew et al 1995, Nadelmann et al 1986, Silberstein et al 2004) that supported registration of these drugs for this indication were conducted before the establishment of CM as a single entity and generally included patients with headaches on less than 15 days per month. Only 1 medication, onabotulinumtoxinA, is approved for prophylaxis of CM (Lipton and Silberstein 2015). & regarding approved drugs for preventive treatment of migraine and associated literature. \\\\\n\\hline \\multicolumn{3}{|l|}{1.3.1 Nonclinical Studies} \\\\\n\\hline In vivo pharmacology studies of TEV-48125 in animal models indicate that TEV-48125 prevented an increase in blood flow in rat paw skin and the middle meningeal artery after electrical stimulation and produced a dose-dependent inhibition of the capsaicin-induced skin flare & In vivo pharmacology studies of TEV-48125 in animal models indicate that TEV-48125 prevented an increase in blood flow in rat paw skin and the middle meningeal artery after electrical stimulation and produced a dose-dependent inhibition of the capsaicin-induced skin flare response in cynomolgus & Text was updated with the latest relevant information available from the nonclinical studies. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline these classes of drugs that are used with varying response rates to prevent migraine, only 5 marketed drugs are approved by the Food and Drug Administration (FDA) in the United States (US) for the preventive treatment of migraine; 4 of them are approved for the prophylaxis of migraine: propranolol, timolol maleate, divalproex sodium, and topiramate. The clinical trials (Brandes et al 2004, Klapper 1997, Mathew et al 1995, Nadelmann et al 1986, Silberstein et al 2004) that supported registration of these drugs for this indication were conducted before the establishment of CM as a single entity and generally included patients with headaches on less than 15 days per month. 4 (propranolol [Indera] \\({ }^{®}\\), Akrimax Pharmaceuticals], timolol [Blocadren \\({ }^{\\circledR}\\), Merck \\& Co, Inc.], divalproex sodium [Depakote \\({ }^{\\circledR}\\), AbbVie, Inc.], and topiramate [Topamax \\({ }^{\\circledR}\\), Jannsen]) are approved by the United States Food and Drug Administration (FDA) for the prevention or prophylaxis of EM and only 1 (onabotulinumtoxinA [Botox \\({ }^{\\text {® }}\\), Allergan, Inc.]) is approved for the prevention of CM Only 1 medication, onabotulinumtoxinA, is approved for prophylaxis of CM (Lipton and Silberstein 2015). Notably, despite evidence suggesting that inhibition of CGRP is effective as a preventive migraine treatment, no available treatment directly targets CGRP. & these classes of drugs that are used with varying response rates to prevent migraine, only 5 marketed drugs are approved by the Food and Drug Administration (FDA) in the United States (US) for the preventive treatment of migraine; 4 of them are approved for the prophylaxis of migraine: propranolol, timolol maleate, divalproex sodium, and topiramate. The clinical studies (Brandes et al 2004, Klapper 1997, Mathew et al 1995, Nadelmann et al 1986, Silberstein et al 2004) that supported registration of these drugs for this indication were conducted before the establishment of CM as a single entity and generally included patients with headaches on less than 15 days per month. 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The clinical trials (Brandes et al 2004, Klapper 1997, Mathew et al 1995, Nadelmann et al 1986, Silberstein et al 2004) that supported registration of these drugs for this indication were conducted before the establishment of CM as a single entity and generally included patients with headaches on less than 15 days per month. 4 (propranolol [Indera] \\({ }^{®}\\), Akrimax Pharmaceuticals], timolol [Blocadren \\({ }^{\\circledR}\\), Merck \\& Co, Inc.], divalproex sodium [Depakote \\({ }^{\\circledR}\\), AbbVie, Inc.], and topiramate [Topamax \\({ }^{\\circledR}\\), Jannsen]) are approved by the United States Food and Drug Administration (FDA) for the prevention or prophylaxis of EM and only 1 (onabotulinumtoxinA [Botox \\({ }^{\\text {® }}\\), Allergan, Inc.]) is approved for the prevention of CM Only 1 medication, onabotulinumtoxinA, is approved for prophylaxis of CM (Lipton and Silberstein 2015). 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The clinical trials (Brandes et al 2004, Klapper 1997, Mathew et al 1995, Nadelmann et al 1986, Silberstein et al 2004) that supported registration of these drugs for this indication were conducted before the establishment of CM as a single entity and generally included patients with headaches on less than 15 days per month. 4 (propranolol [Indera] \\({ }^{®}\\), Akrimax Pharmaceuticals], timolol [Blocadren \\({ }^{\\circledR}\\), Merck \\& Co, Inc.], divalproex sodium [Depakote \\({ }^{\\circledR}\\), AbbVie, Inc.], and topiramate [Topamax \\({ }^{\\circledR}\\), Jannsen]) are approved by the United States Food and Drug Administration (FDA) for the prevention or prophylaxis of EM and only 1 (onabotulinumtoxinA [Botox \\({ }^{\\text {® }}\\), Allergan, Inc.]) is approved for the prevention of CM Only 1 medication, onabotulinumtoxinA, is approved for prophylaxis of CM (Lipton and Silberstein 2015). 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\\multicolumn{3}{|l|}{3.14 Study Procedures, Table 1 (Related to the change in Section 7.1.6 described below; Other sections affected by this change: Sections 3.14.2.2, 3.14.3.1.2, and 3.14.3.1.3)} \\\\\n\\hline \\begin{tabular}{l}\nBlood samples for serum ADA concentrationassessment \\({ }^{\\text {k }}\\) \\\\\nk Blood samples for serum ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis).\n\\end{tabular} & \\begin{tabular}{l}\nBlood samples for serum ADA assessment \\({ }^{ k }\\) \\\\\nk Blood samples for serum ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis).\n\\end{tabular} & \\begin{tabular}{l}\nThese additional blood sample collections are related to the designation of anaphylaxis and severe hypersensitivity reactions as adverse events of special interest in this amendment. \\\\\n\"Concentration\" and \"assay\" were changed to \"assessment\" throughout the document for consistency of verbiage.\" Please check if this should also be added here.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{3.14 Study Procedures, Table 1} \\\\\n\\hline \\begin{tabular}{l}\nBlood sample for pharmacogenomic analysis \\({ }^{1}\\) \\\\\n\\({ }^{1}\\) A single blood sample for pharmacogenomic analysis will be collected at visit 2 or any visit thereafter from patients who consent to this procedure. A separate informed consent form for pharmacogenomic sampling must be signed by the patient.\n\\end{tabular} & \\begin{tabular}{l}\nBlood sample for pharmacogenomic analysis \\({ }^{1}\\) \\\\\n\\({ }^{1}\\) A single blood sample for pharmacogenomic analysis will be collected at visit 2 or any visit thereafter from patients who consent to this procedure. A separate informed consent form for pharmacogenomic sampling must be signed by the patient.\n\\end{tabular} & Details of this sampling were moved to a footnote and revised to emphasize that a separate ICF is required. \\\\\n\\hline \\multicolumn{3}{|l|}{3.14 Study Procedures, Table 1 (Other sections affected by this change: Section 7.5)} \\\\\n\\hline \\({ }^{ c }\\) Electrocardiograms will be performed in triplicate, with approximately 1 minute between recordings. & \\({ }^{ c }\\) Electrocardiograms will be performed in triplicate. & Specification for approximately 1 minute interval between recordings was removed, as it was deemed unnecessary. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|l|}{3.14 Study Procedures, Table 1 (Related to the change in Section 7.1.6 described below; Other sections affected by this change: Sections 3.14.2.2, 3.14.3.1.2, and 3.14.3.1.3)} \\\\\n\\hline \\begin{tabular}{l}\nBlood samples for serum ADA concentrationassessment \\({ }^{\\text {k }}\\) \\\\\nk Blood samples for serum ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis).\n\\end{tabular} & \\begin{tabular}{l}\nBlood samples for serum ADA assessment \\({ }^{ k }\\) \\\\\nk Blood samples for serum ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis).\n\\end{tabular} & \\begin{tabular}{l}\nThese additional blood sample collections are related to the designation of anaphylaxis and severe hypersensitivity reactions as adverse events of special interest in this amendment. \\\\\n\"Concentration\" and \"assay\" were changed to \"assessment\" throughout the document for consistency of verbiage.\" Please check if this should also be added here.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{3.14 Study Procedures, Table 1} \\\\\n\\hline \\begin{tabular}{l}\nBlood sample for pharmacogenomic analysis \\({ }^{1}\\) \\\\\n\\({ }^{1}\\) A single blood sample for pharmacogenomic analysis will be collected at visit 2 or any visit thereafter from patients who consent to this procedure. A separate informed consent form for pharmacogenomic sampling must be signed by the patient.\n\\end{tabular} & \\begin{tabular}{l}\nBlood sample for pharmacogenomic analysis \\({ }^{1}\\) \\\\\n\\({ }^{1}\\) A single blood sample for pharmacogenomic analysis will be collected at visit 2 or any visit thereafter from patients who consent to this procedure. A separate informed consent form for pharmacogenomic sampling must be signed by the patient.\n\\end{tabular} & Details of this sampling were moved to a footnote and revised to emphasize that a separate ICF is required. \\\\\n\\hline \\multicolumn{3}{|l|}{3.14 Study Procedures, Table 1 (Other sections affected by this change: Section 7.5)} \\\\\n\\hline \\({ }^{ c }\\) Electrocardiograms will be performed in triplicate, with approximately 1 minute between recordings. & \\({ }^{ c }\\) Electrocardiograms will be performed in triplicate. & Specification for approximately 1 minute interval between recordings was removed, as it was deemed unnecessary. 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\"assessment\"","confidence":1,"confidence_rate":1},{"cnt":[[1962,793],[2412,793],[2412,838],[1962,838]],"region":{"top_left_x":1961,"top_left_y":792,"width":452,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b0e0fef06d94f5cbc1051cca7f66d6e","type":"text","conversion_output":false,"parent_id":"3f9e929ed77c49edb3535fdbceedb51f","text":"throughout the document for","text_display":" throughout the document for","confidence":1,"confidence_rate":1},{"cnt":[[1962,836],[2466,836],[2466,881],[1962,881]],"region":{"top_left_x":1961,"top_left_y":836,"width":506,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88639867d22644a3b0f4e8ff9c12fea1","type":"text","conversion_output":false,"parent_id":"3f9e929ed77c49edb3535fdbceedb51f","text":"consistency of verbiage.\" Please","text_display":" consistency of verbiage.\" 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A separate informed consent form for pharmacogenomic sampling must be signed by the patient.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nBlood sample for pharmacogenomic analysis \\({ }^{1}\\) \\\\\n\\({ }^{1}\\) A single blood sample for pharmacogenomic analysis will be collected at visit 2 or any visit thereafter from patients who consent to this procedure. A separate informed consent form for pharmacogenomic sampling must be signed by the patient.\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.81396484375,"confidence_rate":0.9994556029907418},{"cnt":[[244,1053],[955,1053],[955,1107],[244,1107]],"region":{"top_left_x":244,"top_left_y":1052,"width":711,"height":55},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51859ef8d48645f0906380c74a8cdd8b","type":"text","conversion_output":false,"parent_id":"f6e27237595c47c69e630cc32a54ea38","text":"Blood sample for pharmacogenomic analysis \\({ }^{1}\\)","text_display":"Blood sample for pharmacogenomic analysis \\({ }^{1}\\)","confidence":1,"confidence_rate":1},{"cnt":[[244,1161],[1041,1161],[1041,1215],[244,1215]],"region":{"top_left_x":244,"top_left_y":1160,"width":798,"height":55},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04ee2921a2a141b494eac85126e2283a","type":"text","conversion_output":false,"parent_id":"f6e27237595c47c69e630cc32a54ea38","text":"\\({ }^{1}\\) A single blood sample for pharmacogenomic","text_display":"\n\\({ }^{1}\\) A single blood sample for pharmacogenomic","confidence":0.81396484375,"confidence_rate":0.996195439021476},{"cnt":[[247,1213],[994,1213],[994,1258],[247,1258]],"region":{"top_left_x":246,"top_left_y":1212,"width":748,"height":47},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd25334325174e8da369914d9e6314af","type":"text","conversion_output":false,"parent_id":"f6e27237595c47c69e630cc32a54ea38","text":"analysis will be collected at visit 2 or any visit","text_display":" analysis will be collected at visit 2 or any visit","confidence":1,"confidence_rate":1},{"cnt":[[247,1256],[968,1256],[968,1302],[247,1302]],"region":{"top_left_x":246,"top_left_y":1256,"width":722,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60b6ffaf1ee5406e83294bd9d1ef49f4","type":"text","conversion_output":false,"parent_id":"f6e27237595c47c69e630cc32a54ea38","text":"thereafter from patients who consent to this","text_display":" thereafter from patients who consent to this","confidence":1,"confidence_rate":1},{"cnt":[[247,1299],[1059,1299],[1059,1345],[247,1345]],"region":{"top_left_x":246,"top_left_y":1299,"width":813,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98832cd16bd045268c1dcdd1f4814e39","type":"text","conversion_output":false,"parent_id":"f6e27237595c47c69e630cc32a54ea38","text":"procedure. 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recordings.","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.8522558584809303,"confidence_rate":0.9981299616766195},{"cnt":[[247,1520],[937,1520],[937,1566],[247,1566]],"region":{"top_left_x":246,"top_left_y":1520,"width":692,"height":46},"line":68,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02b6ecc603d64283ade03d01d06b9f89","type":"text","conversion_output":false,"parent_id":"05d0d444acd44fffb27ad584bcc6be71","text":"\\({ }^{ c }\\) Electrocardiograms will be performed in","text_display":"\\({ }^{ c }\\) Electrocardiograms will be performed 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unnecessary.","cell_row":5,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1964,1520],[2458,1520],[2458,1566],[1964,1566]],"region":{"top_left_x":1963,"top_left_y":1520,"width":495,"height":46},"line":75,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"074cd117851a4bb194c25366175eab8e","type":"text","conversion_output":false,"parent_id":"367b276a09a0426096b9400df657356d","text":"Specification for approximately","text_display":"Specification for approximately","confidence":1,"confidence_rate":1},{"cnt":[[1966,1566],[2371,1566],[2371,1607],[1966,1607]],"region":{"top_left_x":1966,"top_left_y":1565,"width":405,"height":42},"line":76,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24934914ee924e93aeff4797196b0fda","type":"text","conversion_output":false,"parent_id":"367b276a09a0426096b9400df657356d","text":"1 minute interval between","text_display":" 1 minute interval 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\\multicolumn{3}{|l|}{3.14.1 Procedures for Screening (Visit 1 [Day -28])} \\\\\n\\hline The first 2 digits of the screening number will be the number assigned to the country where the investigational center is located, the next 3 digits will be the investigational center number, and the last 3 digits will be the patient number assigned at the investigator center (eg, the \\(3{ }^{\\text {rd }}\\) patient screened in Italythe US [country 01] at center 101 would be assigned the number of 01101003). & The first 2 digits of the screening number will be the number assigned to the country where the investigational center is located, the next 3 digits will be the investigational center number, and the last 3 digits will be the patient number assigned at the investigator center (eg, the \\(3{ }^{\\text {rd }}\\) patient screened in the US [country 01] at center 101 would be assigned the number of 01101003). & Country 01 is the US. \\\\\n\\hline \\multicolumn{3}{|l|}{4 SELECTION AND WITHDRAWAL OF PATIENTS} \\\\\n\\hline \\multicolumn{3}{|l|}{4.1 Patient Inclusion Criteria (Other sections affected by this change: Synopsis)} \\\\\n\\hline \\begin{tabular}{l}\nd. [...] \\\\\n- on \\(\\geq 4\\) days, fulfilling any of the following: \\\\\n- ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura (Appendix CD) \\\\\n- ICHD-3 criteria B and C for 1.2 Migraine with aura (Appendix ED) \\\\\n- Probable migraine (a migraine subtype where only 1 migraine criterion is missing) \\\\\n- […] \\\\\ne. Not using preventive medications (presented in Appendix B) (ie, at least \\(5\\) half-lives have passed since last use) or using no more than 1 preventive medication (presented in Appendix Amedications) for migraine or other medical conditions (eg, topiramate) for migraine or other medical conditions (eg, propranolol used for hypertension) if the dose and regimen have been stable for at least 2 months prior to\n\\end{tabular} & \\begin{tabular}{l}\nd. [...] \\\\\n- on \\(\\geq 4\\) days, fulfilling any of the following: \\\\\n- ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura (Appendix D) \\\\\n- ICHD-3 criteria B and C for 1.2 Migraine with aura (Appendix D) \\\\\n- Probable migraine (a migraine subtype where only 1 migraine criterion is missing) \\\\\n- […] \\\\\ne. Not using preventive medications (presented in Appendix B) (ie, at least 5 half-lives have passed since last use) or using no more than 1 preventive medication (presented in Appendix A) for migraine or other medical conditions (eg, propranolol used for hypertension) if the dose and regimen have been stable for at least 2 months prior to beginning the 28 day run-in period. \\\\\nf. Body mass index of 17.5 to \\(37.5 kg / m ^{2}\\) and a total body weight between 45 and 120 kg , inclusive\n\\end{tabular} & \\begin{tabular}{l}\nA criterion of a probable migraine was added to further define the patient population. \\\\\nAllowed/disallowed preventive medication was clarified. \\\\\nUpper boundary of the total body weight was expanded up to 120 kg . This limit was used in Phase 2 studies; no associated safety signals were detected. \\\\\nContraception criteria were updated and clarified to comply with the current Teva standards. \\\\\nLanguage regarding the timing of the serum \\(\\beta\\)-HCG pregnancy testing was clarified.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|l|}{3.14.1 Procedures for Screening (Visit 1 [Day -28])} \\\\\n\\hline The first 2 digits of the screening number will be the number assigned to the country where the investigational center is located, the next 3 digits will be the investigational center number, and the last 3 digits will be the patient number assigned at the investigator center (eg, the \\(3{ }^{\\text {rd }}\\) patient screened in Italythe US [country 01] at center 101 would be assigned the number of 01101003). & The first 2 digits of the screening number will be the number assigned to the country where the investigational center is located, the next 3 digits will be the investigational center number, and the last 3 digits will be the patient number assigned at the investigator center (eg, the \\(3{ }^{\\text {rd }}\\) patient screened in the US [country 01] at center 101 would be assigned the number of 01101003). & Country 01 is the US. \\\\\n\\hline \\multicolumn{3}{|l|}{4 SELECTION AND WITHDRAWAL OF PATIENTS} \\\\\n\\hline \\multicolumn{3}{|l|}{4.1 Patient Inclusion Criteria (Other sections affected by this change: Synopsis)} \\\\\n\\hline \\begin{tabular}{l}\nd. [...] \\\\\n- on \\(\\geq 4\\) days, fulfilling any of the following: \\\\\n- ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura (Appendix CD) \\\\\n- ICHD-3 criteria B and C for 1.2 Migraine with aura (Appendix ED) \\\\\n- Probable migraine (a migraine subtype where only 1 migraine criterion is missing) \\\\\n- […] \\\\\ne. Not using preventive medications (presented in Appendix B) (ie, at least \\(5\\) half-lives have passed since last use) or using no more than 1 preventive medication (presented in Appendix Amedications) for migraine or other medical conditions (eg, topiramate) for migraine or other medical conditions (eg, propranolol used for hypertension) if the dose and regimen have been stable for at least 2 months prior to\n\\end{tabular} & \\begin{tabular}{l}\nd. 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Body mass index of 17.5 to \\(37.5 kg / m ^{2}\\) and a total body weight between 45 and 120 kg , inclusive\n\\end{tabular} & \\begin{tabular}{l}\nA criterion of a probable migraine was added to further define the patient population. \\\\\nAllowed/disallowed preventive medication was clarified. \\\\\nUpper boundary of the total body weight was expanded up to 120 kg . 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\\begin{tabular}{l}\nUp to 30\\% of patients will be allowed to remain on stable doses of no more than 1 preventive migraine medication for the duration of the study provided the medication has at least moderate evidence of efficacy as defined by guidelines (Silberstein et al 2012) and presented in Appendix A. Patients on preventive medication must be on a stable dose for at least 2 months of consecutive use prior to study entry. \\\\\nAlternatively, patients must have discontinued the preventive medication at least 5 half-lives prior to screening. Preventive migraine medications disallowed for at least 70\\% of patients for the duration of the study are presented in Appendix B. \\\\\nPatients will be allowed to use acute medications to treat acute migraine attacks, as needed, with the exception of medications containing opioids and barbiturates, which cannot be used more than 4 times per month prior to study entry. \\\\\nUse of concomitant therapies for indications other than migraine prevention is allowed throughout the course of the study, provided they are not effective for migraine or they meet the criteria for permitted concomitant preventive medication. \\\\\nAll concomitant medications taken during the study...\n\\end{tabular} & \\begin{tabular}{l}\nUp to 30\\% of patients will be allowed to remain on stable doses of no more than 1 preventive migraine medication for the duration of the study provided the medication has at least moderate evidence of efficacy as defined by guidelines (Silberstein et al 2012) and presented in Appendix A. Patients on preventive medication must be on a stable dose for at least 2 months of consecutive use prior to study entry. Alternatively, patients must have discontinued the preventive medication at least 5 half-lives prior to screening. Preventive migraine medications disallowed for at least \\(70 \\%\\) of patients for the duration of the study are presented in Appendix B. \\\\\nPatients will be allowed to use acute medications to treat acute migraines attacks, as needed. \\\\\nAll concomitant medications taken during the study...\n\\end{tabular} & \\begin{tabular}{l}\nThe title of this section was updated. \\\\\nIt was specified that up to \\(30 \\%\\) of patients could remain on stable doses of 1 preventive migraine medication. \\\\\nAn alternative option was provided for patients to discontinue preventive medication at least 5 half-lives prior to screening. \\\\\nProvision regarding the use of medications containing opioids and barbiturates was removed, as it was redundant with exclusion criterion b. \\\\\nProvision regarding the use of other concomitant medications was removed to further align with current approach. \\\\\nA clarification was made. In this study, acute medications can be used to treat acute migraine attacks.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{5.5 Total Blood Volume, Table 2} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|l|}{5.3.2 Concomitant Therapy: Therapies and Medications (Other sections affected by this change: Synopsis, Sections 3.1 and 4.1, and Appendix A)} \\\\\n\\hline \\begin{tabular}{l}\nUp to 30\\% of patients will be allowed to remain on stable doses of no more than 1 preventive migraine medication for the duration of the study provided the medication has at least moderate evidence of efficacy as defined by guidelines (Silberstein et al 2012) and presented in Appendix A. Patients on preventive medication must be on a stable dose for at least 2 months of consecutive use prior to study entry. \\\\\nAlternatively, patients must have discontinued the preventive medication at least 5 half-lives prior to screening. 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Patients on preventive medication must be on a stable dose for at least 2 months of consecutive use prior to study entry. Alternatively, patients must have discontinued the preventive medication at least 5 half-lives prior to screening. 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In this study, acute medications can be used to treat acute migraine attacks.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{5.5 Total Blood Volume, Table 2} 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Patients on preventive medication must be on a stable dose for at least 2 months of consecutive use prior to study entry. \\\\\nAlternatively, patients must have discontinued the preventive medication at least 5 half-lives prior to screening. Preventive migraine medications disallowed for at least 70\\% of patients for the duration of the study are presented in Appendix B. \\\\\nPatients will be allowed to use acute medications to treat acute migraine attacks, as needed, with the exception of medications containing opioids and barbiturates, which cannot be used more than 4 times per month prior to study entry. \\\\\nUse of concomitant therapies for indications other than migraine prevention is allowed throughout the course of the study, provided they are not effective for migraine or they meet the criteria for permitted concomitant preventive medication. \\\\\nAll concomitant medications taken during the study...\n\\end{tabular}","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.57763671875,"confidence_rate":0.9990342230027026},{"cnt":[[247,378],[1050,378],[1050,419],[247,419]],"region":{"top_left_x":246,"top_left_y":378,"width":805,"height":42},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"342bbb9492b245188328010024becdac","type":"text","conversion_output":false,"parent_id":"83d3654287ee403cb5e773e523d6cb71","text":"Up to 30\\% of patients will be allowed to remain on","text_display":"Up to 30\\% of patients will be allowed to remain on","confidence":1,"confidence_rate":1},{"cnt":[[247,422],[1035,422],[1035,463],[247,463]],"region":{"top_left_x":246,"top_left_y":421,"width":789,"height":42},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"710e5deebea14e169d13c46b7ceaf17c","type":"text","conversion_output":false,"parent_id":"83d3654287ee403cb5e773e523d6cb71","text":"stable doses of no more than 1 preventive migraine","text_display":" stable doses of no more than 1 preventive migraine","confidence":1,"confidence_rate":1},{"cnt":[[247,465],[1063,465],[1063,510],[247,510]],"region":{"top_left_x":246,"top_left_y":464,"width":818,"height":47},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d47864bdcc1f4d97a4ff6a8cf6b4871f","type":"text","conversion_output":false,"parent_id":"83d3654287ee403cb5e773e523d6cb71","text":"medication for the duration of the study provided the","text_display":" medication for the duration of the study provided the","confidence":1,"confidence_rate":1},{"cnt":[[247,508],[1072,508],[1072,554],[247,554]],"region":{"top_left_x":246,"top_left_y":508,"width":826,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10d452ebf6a0417a82d094f725dbb36b","type":"text","conversion_output":false,"parent_id":"83d3654287ee403cb5e773e523d6cb71","text":"medication has at least moderate evidence of efficacy","text_display":" medication has at least moderate evidence of efficacy","confidence":1,"confidence_rate":1},{"cnt":[[247,551],[1050,551],[1050,597],[247,597]],"region":{"top_left_x":246,"top_left_y":551,"width":805,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba804ac4089343b89165c595c783a4c1","type":"text","conversion_output":false,"parent_id":"83d3654287ee403cb5e773e523d6cb71","text":"as defined by guidelines (Silberstein et al 2012) and","text_display":" as defined by guidelines (Silberstein et al 2012) and","confidence":0.9990234375,"confidence_rate":0.9999831546307154},{"cnt":[[247,599],[998,599],[998,640],[247,640]],"region":{"top_left_x":246,"top_left_y":599,"width":753,"height":42},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66443cc599794649ab8945a018a7956f","type":"text","conversion_output":false,"parent_id":"83d3654287ee403cb5e773e523d6cb71","text":"presented in Appendix A. 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Patients on preventive medication must be on a stable dose for at least 2 months of consecutive use prior to study entry. Alternatively, patients must have discontinued the preventive medication at least 5 half-lives prior to screening. 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In this","text_display":"\nA clarification was made. In this","confidence":1,"confidence_rate":1},{"cnt":[[1966,1623],[2455,1623],[2455,1667],[1966,1667]],"region":{"top_left_x":1966,"top_left_y":1623,"width":490,"height":44},"line":82,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9a09edbf46546b3bde99caeb5835a86","type":"text","conversion_output":false,"parent_id":"c5cd61b6d7064ba98b6ca168a51e4b49","text":"study, acute medications can be","text_display":" study, acute medications can be","confidence":1,"confidence_rate":1},{"cnt":[[1964,1669],[2393,1669],[2393,1710],[1964,1710]],"region":{"top_left_x":1963,"top_left_y":1668,"width":430,"height":43},"line":83,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87643dbd1dae4158b14c1a907406a1d8","type":"text","conversion_output":false,"parent_id":"c5cd61b6d7064ba98b6ca168a51e4b49","text":"used to treat acute migraine","text_display":" used to treat acute 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Migraine","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[995,176],[995,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":751,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57699a79cf9449439abc3c0d0e6cb304","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol with Amendment 01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1985,176],[2473,176],[2473,226],[1985,226]],"region":{"top_left_x":1985,"top_left_y":176,"width":488,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38b9f7c7158f4d7cad73cf1fe8c37eaf","type":"page_info","conversion_output":false,"text":"Study TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[226,245],[2524,245],[2524,1858],[226,1858]],"region":{"top_left_x":225,"top_left_y":244,"width":2300,"height":1615},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21817154811e4c429183bb8ab7991293","type":"table","conversion_output":true,"children_ids":["4ba16a5a200f44719d8a823db623debb","f9acdab3da344f3f989f17662793dbbd","179d0a3e45ff40bdba2fca75f05d73db","f3eac35a3b8447d09193fad81d37b3f5","dcb28c96a26947e297ed58d589cc2843","665cf29c21fb4587a2278604cb3d6740","3ccec4079a264968a7591f5f41d541ba","c1c3738c462a45408c4bb1921ccdc8b2","1d0598955dac47f6925642ec1fd0278f","2265f3ad59324000812bc0029964fe5c","e8b674dac61a449aaa9a6a55b550480d","be0cba9ce3994a1aa464b4f0c8311610","90ac7f942c914f41966ce8adb6ef86fa","b4b7d0ef9f9346e097acc55fe09cadd5","90470df55d9e4fd7b5bdb395950b0610","f900cc511a5c47aab0ed566a65106f5e","9d108350c16d4cf387beb85d6b1fdbc1","86f8af5ef3314c859593329df8a7789d","9092fab3c79a4d1aaf858f2802984119","56bc01d2767343a3ada50f89bfdfe32e","5f2f7c46554b4bafb2cf5f82733d2769"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline \\begin{tabular}{l}\n\\({ }^{ c }\\) For each \\(1 8 . 5 - m L\\) sample, individual volumes will be \\(6 ~ m L\\) each for serum and plasma and 6.5 mL for RNA. \\\\\nd For patients who consent to pharmacogenomic testing.\n\\end{tabular} & \\begin{tabular}{l}\n\\({ }^{ c }\\) For each \\(18.5- mL\\) sample, individual volumes will be 6 mL each for serum and plasma and 6.5 mL for RNA. \\\\\nd For patients who consent to pharmacogenomic testing.\n\\end{tabular} & A footnote was added for consistency with the blood volumes described throughout the protocol. \\\\\n\\hline \\multicolumn{3}{|l|}{6 ASSESSMENT OF EFFICACY} \\\\\n\\hline \\multicolumn{3}{|l|}{6.3 Two-Item Patient Health Questionnaire/9-Item Patient Health Questionnaire (Other sections affected by this change: Synopsis and Sections 3.6, 3.14 [Table 1], 3.14.2.2, and 3.14.3.1.3)} \\\\\n\\hline \\begin{tabular}{l}\nEach of the items is scored on a scale of 0 (\"not at all\") to, 1 (\"several days\"), 2 (\"more than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during the past 2 weeks (Spitzer et al 1999). The PHQ-2 was developed from the PHQ-9 to rapidly screen for depression and consists of the first 2 questions from the PHQ-9. [...] \\\\\nIf the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients will complete questions 3 through 9 (unique questions) of the PHQ-9.\n\\end{tabular} & Each of the items is scored on a scale of 0 (\"not at all\"), 1 (\"several days\"), 2 (\"more than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during the past 2 weeks (Spitzer et al 1999). The PHQ-2 was developed from the PHQ-9 to rapidly screen for depression and consists of the first 2 questions from the PHQ-9. [...] If the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients will complete questions 3 through 9 ([unique questions) of the PHQ-9. & \\begin{tabular}{l}\nTime period for symptom frequency in the PHQ was specified. \\\\\nUpdate/correction was made indicating that patients will only complete the unique portions of the PHQ-9 after a positive PHQ-2 score.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{6.6 Patient Global Impression of Change Scale} \\\\\n\\hline The PGIC scale is a validated generic tool for assessment of overall change in the severity of illness following treatment. Patients will rate how they feel now compared with how they felt before receiving study drug on a 7 point scale where 3 is \"very much worse,\" 0 is \"no change,\" and 3 is \"very much improved\".Patients will rate how they describe the change (if any) that their migraine/headaches have had in their general quality of life and health status since beginning the treatment in this study on a 7-point scale where \\(1 =\\) no change (or condition has got worse); 2=almost the same, hardly any change at all; \\(3 =\\) a little better, but no & The PGIC scale is a validated generic tool for assessment of overall change in the severity of illness following treatment. Patients will rate how they describe the change (if any) that their migraine/headaches have had in their general quality of life and health status since beginning the treatment in this study on a 7-point scale where \\(1=\\) no change (or condition has got worse); 2=almost the same, hardly any change at all; \\(3=\\) a little better, but no noticeable change; \\(4=\\) somewhat better, but the change has not made any real difference; 5=moderately better, and a slight but noticeable change; \\(6=\\) better, and a definite improvement that & Correction was made regarding PGIC scale numbering and descriptors. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\begin{tabular}{l}\n\\({ }^{ c }\\) For each \\(1 8 . 5 - m L\\) sample, individual volumes will be \\(6 ~ m L\\) each for serum and plasma and 6.5 mL for RNA. \\\\\nd For patients who consent to pharmacogenomic testing.\n\\end{tabular} & \\begin{tabular}{l}\n\\({ }^{ c }\\) For each \\(18.5- mL\\) sample, individual volumes will be 6 mL each for serum and plasma and 6.5 mL for RNA. \\\\\nd For patients who consent to pharmacogenomic testing.\n\\end{tabular} & A footnote was added for consistency with the blood volumes described throughout the protocol. \\\\\n\\hline \\multicolumn{3}{|l|}{6 ASSESSMENT OF EFFICACY} \\\\\n\\hline \\multicolumn{3}{|l|}{6.3 Two-Item Patient Health Questionnaire/9-Item Patient Health Questionnaire (Other sections affected by this change: Synopsis and Sections 3.6, 3.14 [Table 1], 3.14.2.2, and 3.14.3.1.3)} \\\\\n\\hline \\begin{tabular}{l}\nEach of the items is scored on a scale of 0 (\"not at all\") to, 1 (\"several days\"), 2 (\"more than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during the past 2 weeks (Spitzer et al 1999). The PHQ-2 was developed from the PHQ-9 to rapidly screen for depression and consists of the first 2 questions from the PHQ-9. [...] \\\\\nIf the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients will complete questions 3 through 9 (unique questions) of the PHQ-9.\n\\end{tabular} & Each of the items is scored on a scale of 0 (\"not at all\"), 1 (\"several days\"), 2 (\"more than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during the past 2 weeks (Spitzer et al 1999). The PHQ-2 was developed from the PHQ-9 to rapidly screen for depression and consists of the first 2 questions from the PHQ-9. [...] If the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients will complete questions 3 through 9 ([unique questions) of the PHQ-9. & \\begin{tabular}{l}\nTime period for symptom frequency in the PHQ was specified. \\\\\nUpdate/correction was made indicating that patients will only complete the unique portions of the PHQ-9 after a positive PHQ-2 score.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{6.6 Patient Global Impression of Change Scale} \\\\\n\\hline The PGIC scale is a validated generic tool for assessment of overall change in the severity of illness following treatment. Patients will rate how they feel now compared with how they felt before receiving study drug on a 7 point scale where 3 is \"very much worse,\" 0 is \"no change,\" and 3 is \"very much improved\".Patients will rate how they describe the change (if any) that their migraine/headaches have had in their general quality of life and health status since beginning the treatment in this study on a 7-point scale where \\(1 =\\) no change (or condition has got worse); 2=almost the same, hardly any change at all; \\(3 =\\) a little better, but no & The PGIC scale is a validated generic tool for assessment of overall change in the severity of illness following treatment. Patients will rate how they describe the change (if any) that their migraine/headaches have had in their general quality of life and health status since beginning the treatment in this study on a 7-point scale where \\(1=\\) no change (or condition has got worse); 2=almost the same, hardly any change at all; \\(3=\\) a little better, but no noticeable change; \\(4=\\) somewhat better, but the change has not made any real difference; 5=moderately better, and a slight but noticeable change; \\(6=\\) better, and a definite improvement that & Correction was made regarding PGIC scale numbering and descriptors. 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[...] \\\\\nIf the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients will complete questions 3 through 9 (unique questions) of the PHQ-9.\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.51806640625,"confidence_rate":0.99368782107323},{"cnt":[[244,697],[1024,697],[1024,742],[244,742]],"region":{"top_left_x":244,"top_left_y":696,"width":781,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d7185b4c00148e890d6e1527e41c27d","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"Each of the items is scored on a scale of 0 (\"not at","text_display":"Each of the items is scored on a scale of 0 (\"not at","confidence":0.9990234375,"confidence_rate":0.999983716138453},{"cnt":[[244,740],[1054,740],[1054,788],[244,788]],"region":{"top_left_x":244,"top_left_y":739,"width":811,"height":49},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1ab3f30bb194c3ebc5ed21dfbecfdff","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"all\") to, 1 (\"several days\"), 2 (\"more than half the","text_display":" all\") to, 1 (\"several days\"), 2 (\"more than half the","confidence":0.7875480651855469,"confidence_rate":0.9962162103713019},{"cnt":[[247,785],[996,785],[996,831],[247,831]],"region":{"top_left_x":246,"top_left_y":785,"width":750,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cf22c5143af43f78cf8a6eb6ebc7d7a","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"days\"), and 3 (\"nearly every day\") based on the","text_display":" days\"), and 3 (\"nearly every day\") based on the","confidence":1,"confidence_rate":1},{"cnt":[[247,829],[1011,829],[1011,874],[247,874]],"region":{"top_left_x":246,"top_left_y":828,"width":766,"height":47},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e710105e70d43c18b265c25fd58379a","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"frequency of symptoms during the past 2 weeks","text_display":" frequency of symptoms during the past 2 weeks","confidence":0.99609375,"confidence_rate":0.9999261555696316},{"cnt":[[247,872],[1065,872],[1065,922],[247,922]],"region":{"top_left_x":246,"top_left_y":871,"width":820,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a490c19a05a4077bd742f16fe8be99c","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"(Spitzer et al 1999). The PHQ-2 was developed from","text_display":" (Spitzer et al 1999). The PHQ-2 was developed from","confidence":1,"confidence_rate":1},{"cnt":[[244,915],[983,915],[983,963],[244,963]],"region":{"top_left_x":244,"top_left_y":915,"width":739,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90a9476012174cbaa6f7cfd4323a36cd","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"the PHQ-9 to rapidly screen for depression and","text_display":" the PHQ-9 to rapidly screen for depression and","confidence":1,"confidence_rate":1},{"cnt":[[247,961],[1033,961],[1033,1008],[247,1008]],"region":{"top_left_x":246,"top_left_y":960,"width":787,"height":49},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"512cb60b1b9c4bdeb8341744a748b12f","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"consists of the first 2 questions from the PHQ-9.","text_display":" consists of the first 2 questions from the PHQ-9.","confidence":1,"confidence_rate":1},{"cnt":[[247,1006],[318,1006],[318,1052],[247,1052]],"region":{"top_left_x":246,"top_left_y":1006,"width":73,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e43314b3838e4a87ad263e2be5dda801","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"[...]","text_display":" [...]","confidence":0.51806640625,"confidence_rate":0.936350707900604},{"cnt":[[247,1058],[1041,1058],[1041,1106],[247,1106]],"region":{"top_left_x":246,"top_left_y":1058,"width":796,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a1cb655ec0a427e9898e99b54a7e0fc","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"If the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients","text_display":"\nIf the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[247,1102],[963,1102],[963,1151],[247,1151]],"region":{"top_left_x":246,"top_left_y":1101,"width":718,"height":51},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f751f0e1ed5d4b2ea564b7bfb9ea639c","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"will complete questions 3 through 9 (unique","text_display":" will complete questions 3 through 9 (unique","confidence":1,"confidence_rate":1},{"cnt":[[247,1147],[643,1147],[643,1192],[247,1192]],"region":{"top_left_x":246,"top_left_y":1147,"width":397,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fad08d3ce514bab80720f96c0660721","type":"text","conversion_output":false,"parent_id":"90470df55d9e4fd7b5bdb395950b0610","text":"questions) of the PHQ-9.","text_display":" questions) of the PHQ-9.","confidence":1,"confidence_rate":1},{"cnt":[[1100,690],[1934,690],[1934,1156],[1100,1156]],"region":{"top_left_x":1099,"top_left_y":690,"width":835,"height":466},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f900cc511a5c47aab0ed566a65106f5e","type":"complex_cell","conversion_output":false,"parent_id":"21817154811e4c429183bb8ab7991293","children_ids":["ef7763dd5db34893b3c5800851896c08","cb00481dd76c4a78a3651d31f1b49d85","fd736619d68442d4adc9dc238e6ca29b","3cd5750ce12f46bf98be2dbc07f361dc","e17ffecd1ddb4a449c296a9f2fd9773f","d00e48a6abed446abd31769d16767d87","2f43a4bf1fc141e8a09ccd63ddab211b","6374932d3f944628aa5f22c47855e397","74191e7c64ad46ca88ee65c546890dfc","0c5b107ca51747c49b94f689493671cf"],"text":"Each of the items is scored on a scale of 0 (\"not at all\"), 1 (\"several days\"), 2 (\"more than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during the past 2 weeks (Spitzer et al 1999). The PHQ-2 was developed from the PHQ-9 to rapidly screen for depression and consists of the first 2 questions from the PHQ-9. [...] If the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients will complete questions 3 through 9 ([unique questions) of the PHQ-9.","text_display":"Each of the items is scored on a scale of 0 (\"not at all\"), 1 (\"several days\"), 2 (\"more than half the days\"), and 3 (\"nearly every day\") based on the frequency of symptoms during the past 2 weeks (Spitzer et al 1999). The PHQ-2 was developed from the PHQ-9 to rapidly screen for depression and consists of the first 2 questions from the PHQ-9. [...] If the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients will complete questions 3 through 9 ([unique questions) of the PHQ-9.","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99853515625,"confidence_rate":0.9999967815701558},{"cnt":[[1104,697],[1884,697],[1884,740],[1104,740]],"region":{"top_left_x":1104,"top_left_y":696,"width":780,"height":44},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef7763dd5db34893b3c5800851896c08","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"Each of the items is scored on a scale of 0 (\"not at","text_display":"Each of the items is scored on a scale of 0 (\"not at","confidence":0.99853515625,"confidence_rate":0.999975568337083},{"cnt":[[1109,740],[1838,740],[1838,788],[1109,788]],"region":{"top_left_x":1108,"top_left_y":739,"width":731,"height":49},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb00481dd76c4a78a3651d31f1b49d85","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"all\"), 1 (\"several days\"), 2 (\"more than half the","text_display":" all\"), 1 (\"several days\"), 2 (\"more than half the","confidence":1,"confidence_rate":1},{"cnt":[[1109,785],[1843,785],[1843,831],[1109,831]],"region":{"top_left_x":1108,"top_left_y":785,"width":735,"height":46},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd736619d68442d4adc9dc238e6ca29b","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"days\"), and 3 (\"nearly every day\") based on the","text_display":" days\"), and 3 (\"nearly every day\") based on the","confidence":1,"confidence_rate":1},{"cnt":[[1109,829],[1847,829],[1847,874],[1109,874]],"region":{"top_left_x":1108,"top_left_y":828,"width":739,"height":47},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cd5750ce12f46bf98be2dbc07f361dc","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"frequency of symptoms during the past 2 weeks","text_display":" frequency of symptoms during the past 2 weeks","confidence":1,"confidence_rate":1},{"cnt":[[1109,872],[1927,872],[1927,917],[1109,917]],"region":{"top_left_x":1108,"top_left_y":871,"width":820,"height":47},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e17ffecd1ddb4a449c296a9f2fd9773f","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"(Spitzer et al 1999). The PHQ-2 was developed from","text_display":" (Spitzer et al 1999). The PHQ-2 was developed from","confidence":1,"confidence_rate":1},{"cnt":[[1109,915],[1838,915],[1838,963],[1109,963]],"region":{"top_left_x":1108,"top_left_y":915,"width":731,"height":48},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d00e48a6abed446abd31769d16767d87","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"the PHQ-9 to rapidly screen for depression and","text_display":" the PHQ-9 to rapidly screen for depression and","confidence":1,"confidence_rate":1},{"cnt":[[1109,959],[1929,959],[1929,1008],[1109,1008]],"region":{"top_left_x":1108,"top_left_y":958,"width":822,"height":51},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f43a4bf1fc141e8a09ccd63ddab211b","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"consists of the first 2 questions from the PHQ-9. [...]","text_display":" consists of the first 2 questions from the PHQ-9. [...]","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[1109,1015],[1899,1015],[1899,1060],[1109,1060]],"region":{"top_left_x":1108,"top_left_y":1014,"width":791,"height":47},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6374932d3f944628aa5f22c47855e397","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"If the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients","text_display":" If the PHQ-2 is positive (ie, a score of \\(\\geq 3\\) ), patients","confidence":1,"confidence_rate":1},{"cnt":[[1109,1058],[1806,1058],[1806,1104],[1109,1104]],"region":{"top_left_x":1108,"top_left_y":1058,"width":698,"height":46},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74191e7c64ad46ca88ee65c546890dfc","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"will complete questions 3 through 9 ([unique","text_display":" will complete questions 3 through 9 ([unique","confidence":1,"confidence_rate":1},{"cnt":[[1109,1102],[1496,1102],[1496,1151],[1109,1151]],"region":{"top_left_x":1108,"top_left_y":1101,"width":389,"height":51},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c5b107ca51747c49b94f689493671cf","type":"text","conversion_output":false,"parent_id":"f900cc511a5c47aab0ed566a65106f5e","text":"questions) of the PHQ-9.","text_display":" questions) of the PHQ-9.","confidence":1,"confidence_rate":1},{"cnt":[[1957,690],[2492,690],[2492,1119],[1957,1119]],"region":{"top_left_x":1957,"top_left_y":690,"width":536,"height":429},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d108350c16d4cf387beb85d6b1fdbc1","type":"complex_cell","conversion_output":false,"parent_id":"21817154811e4c429183bb8ab7991293","children_ids":["758df6d0ddfe4056aa276662dbcef409","e967f754cec14495a8c2a6e379b42c8d","ff64d80299c4408db33e1443ad087415","748947a3bf7040ca89ffdc4989b5162a","fdfb8ee8de0f4594a380a535147ee203","5218114966154166b7bc81776da5c1d2","d5b12ba8dbdf4e06af4fd21d0732edf2","9196081cf32742ce94344543ca5d2767"],"text":"\\begin{tabular}{l}\nTime period for symptom frequency in the PHQ was specified. \\\\\nUpdate/correction was made indicating that patients will only complete the unique portions of the PHQ-9 after a positive PHQ-2 score.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nTime period for symptom frequency in the PHQ was specified. \\\\\nUpdate/correction was made indicating that patients will only complete the unique portions of the PHQ-9 after a positive PHQ-2 score.\n\\end{tabular}","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1962,697],[2367,697],[2367,742],[1962,742]],"region":{"top_left_x":1961,"top_left_y":696,"width":406,"height":47},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"758df6d0ddfe4056aa276662dbcef409","type":"text","conversion_output":false,"parent_id":"9d108350c16d4cf387beb85d6b1fdbc1","text":"Time period for symptom","text_display":"Time period for symptom","confidence":1,"confidence_rate":1},{"cnt":[[1962,742],[2375,742],[2375,788],[1962,788]],"region":{"top_left_x":1961,"top_left_y":742,"width":415,"height":46},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e967f754cec14495a8c2a6e379b42c8d","type":"text","conversion_output":false,"parent_id":"9d108350c16d4cf387beb85d6b1fdbc1","text":"frequency in the PHQ was","text_display":" frequency in the PHQ was","confidence":1,"confidence_rate":1},{"cnt":[[1962,785],[2120,785],[2120,835],[1962,835]],"region":{"top_left_x":1961,"top_left_y":785,"width":159,"height":51},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff64d80299c4408db33e1443ad087415","type":"text","conversion_output":false,"parent_id":"9d108350c16d4cf387beb85d6b1fdbc1","text":"specified.","text_display":" 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PHQ-2","confidence":1,"confidence_rate":1},{"cnt":[[1962,1076],[2064,1076],[2064,1112],[1962,1112]],"region":{"top_left_x":1961,"top_left_y":1075,"width":103,"height":38},"line":68,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9196081cf32742ce94344543ca5d2767","type":"text","conversion_output":false,"parent_id":"9d108350c16d4cf387beb85d6b1fdbc1","text":"score.","text_display":" score.","confidence":1,"confidence_rate":1},{"cnt":[[236,1208],[2505,1208],[2505,1268],[236,1268]],"region":{"top_left_x":235,"top_left_y":1207,"width":2271,"height":62},"line":69,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86f8af5ef3314c859593329df8a7789d","type":"table_spanning_cell","conversion_output":false,"parent_id":"21817154811e4c429183bb8ab7991293","children_ids":["ad0a285ba0554972a8d9ef238ec50715"],"text":"","text_display":"6.6 Patient Global Impression of Change 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Patients will rate how they feel now compared with how they felt before receiving study drug on a 7 point scale where 3 is \"very much worse,\" 0 is \"no change,\" and 3 is \"very much improved\".Patients will rate how they describe the change (if any) that their migraine/headaches have had in their general quality of life and health status since beginning the treatment in this study on a 7-point scale where \\(1 =\\) no change (or condition has got worse); 2=almost the same, hardly any change at all; \\(3 =\\) a little better, but no","text_display":"The PGIC scale is a validated generic tool for assessment of overall change in the severity of illness following treatment. 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Patients will rate how","text_display":" illness following treatment. Patients will rate how","confidence":1,"confidence_rate":1},{"cnt":[[1109,1413],[1765,1413],[1765,1459],[1109,1459]],"region":{"top_left_x":1108,"top_left_y":1413,"width":657,"height":46},"line":89,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"904480c22c6a4515955d2242d6636ee1","type":"text","conversion_output":false,"parent_id":"56bc01d2767343a3ada50f89bfdfe32e","text":"they describe the change (if any) that their","text_display":" they describe the change (if any) that their","confidence":1,"confidence_rate":1},{"cnt":[[1109,1457],[1925,1457],[1925,1504],[1109,1504]],"region":{"top_left_x":1108,"top_left_y":1456,"width":817,"height":49},"line":90,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73fd57c1a77a47ce9931e1f4598609a5","type":"text","conversion_output":false,"parent_id":"56bc01d2767343a3ada50f89bfdfe32e","text":"migraine/headaches have had in their general quality","text_display":" migraine/headaches have had in their general quality","confidence":1,"confidence_rate":1},{"cnt":[[1109,1502],[1934,1502],[1934,1548],[1109,1548]],"region":{"top_left_x":1108,"top_left_y":1502,"width":826,"height":46},"line":91,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"540cde070f354120a238e69f25ba3a85","type":"text","conversion_output":false,"parent_id":"56bc01d2767343a3ada50f89bfdfe32e","text":"of life and health status since beginning the treatment","text_display":" of life and health status since beginning the treatment","confidence":1,"confidence_rate":1},{"cnt":[[1109,1545],[1890,1545],[1890,1591],[1109,1591]],"region":{"top_left_x":1108,"top_left_y":1545,"width":783,"height":46},"line":92,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7adc404ed684900ad29e76d121a6d0b","type":"text","conversion_output":false,"parent_id":"56bc01d2767343a3ada50f89bfdfe32e","text":"in this study on a 7-point scale where \\(1=\\) no change","text_display":" in this study on a 7-point scale where \\(1=\\) no change","confidence":0.8855208270251751,"confidence_rate":0.9979414555798745},{"cnt":[[1109,1591],[1864,1591],[1864,1636],[1109,1636]],"region":{"top_left_x":1108,"top_left_y":1590,"width":757,"height":47},"line":93,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e939e80bf2f42d4bdef72e9dea0aa41","type":"text","conversion_output":false,"parent_id":"56bc01d2767343a3ada50f89bfdfe32e","text":"(or condition has got worse); 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\\(4=\\) somewhat better, but the","text_display":" noticeable change; \\(4=\\) somewhat better, but the","confidence":0.99609375,"confidence_rate":0.9999275230095259},{"cnt":[[1109,1721],[1743,1721],[1743,1766],[1109,1766]],"region":{"top_left_x":1108,"top_left_y":1720,"width":636,"height":47},"line":96,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a56ed01dfd45402f96aaf6b6157c7899","type":"text","conversion_output":false,"parent_id":"56bc01d2767343a3ada50f89bfdfe32e","text":"change has not made any real difference;","text_display":" change has not made any real difference;","confidence":1,"confidence_rate":1},{"cnt":[[1109,1764],[1847,1764],[1847,1812],[1109,1812]],"region":{"top_left_x":1108,"top_left_y":1764,"width":739,"height":48},"line":97,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"914cc64e4cec4ee598331498f35b88aa","type":"text","conversion_output":false,"parent_id":"56bc01d2767343a3ada50f89bfdfe32e","text":"5=moderately better, and a slight but noticeable","text_display":" 5=moderately better, and a slight but noticeable","confidence":0.99560546875,"confidence_rate":0.9999169050453139},{"cnt":[[1109,1810],[1882,1810],[1882,1853],[1109,1853]],"region":{"top_left_x":1108,"top_left_y":1809,"width":774,"height":44},"line":98,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4741892585764695b515bca09bf3dbf0","type":"text","conversion_output":false,"parent_id":"56bc01d2767343a3ada50f89bfdfe32e","text":"change; 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Severe hypersensitivity reactions will be monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network Second Symposium on Anaphylaxis (Sampson et al, 2006 [also see Appendix F]). In the event of suspected anaphylaxis, vital signs, including oxygen saturation and respiration rate, will be measured. Other assessments will be performed at the discretion of the investigator. The process for reporting a protocol-defined adverse event is the same as that for reporting a\n\\end{tabular} & \\begin{tabular}{l}\n7.1.6 Protocol-Defined Adverse Events of Special Interest \\\\\nThe following are considered protocol-defined adverse events to be sent to the sponsor's Global Patient Safety and Pharmacovigilance Department for evaluation: ophthalmic adverse events of at least moderate severity, events of possible drug-induced liver injury (AST or ALT \\(\\geq 3 \\times\\) the ULN, total bilirubin \\(\\geq 2 \\times\\) the ULN or INR > 1.5), Hy's Law events, or events of suspected anaphylaxis and severe hypersensitivity reactions. Severe hypersensitivity reactions will be monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network Second Symposium on Anaphylaxis (Sampson et al, 2006 [also see Appendix F]). In the event of suspected anaphylaxis, vital signs, including oxygen saturation and respiration rate, will be measured. Other assessments will be performed at the discretion of the investigator. \\\\\nThe process for reporting a protocol-defined adverse event is the same as that for reporting a serious\n\\end{tabular} & \\begin{tabular}{l}\nThe title of this section was updated, adding the word \"Special\". \\\\\nAdverse events of special interest were updated to include anaphylaxis and severe hypersensitivity reactions. \\\\\nRelatedly, Appendix F (clinical criteria for diagnosing anaphylaxis) was added.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline noticeable change; \\(4 =\\) somewhat better, but the change has not made any real difference; 5=moderately better, and a slight but noticeable change; \\(6=\\) better, and a definite improvement that has made a real and worthwhile difference; and 7=a great deal better, and a considerable improvement that has made all the difference. & has made a real and worthwhile difference; and 7=a great deal better, and a considerable improvement that has made all the difference. & \\\\\n\\hline \\multicolumn{3}{|l|}{7 ASSESSMENT OF SAFETY} \\\\\n\\hline \\multicolumn{3}{|l|}{7.1.6 Protocol Defined Adverse Events of Special Interest (Other sections affected by this change: Appendices [Appendix F added], Section 3.14 [Table 1], and Section 16)} \\\\\n\\hline \\begin{tabular}{l}\n7.1.6 Protocol-Defined Adverse Events of Special Interest \\\\\nThe following are considered protocol-defined adverse events to be sent to the sponsor's Global Patient Safety and Pharmacovigilance Department for evaluation: ophthalmic related adverse events of at least moderate severity, events of possible druginduced liver injury (AST or ALT \\(\\geq 3 \\times\\) the ULN, total bilirubin \\(\\geq 2 \\times\\) the ULN or INR \\(>1.5\\) ), or Hy 's Law events, or events of suspected anaphylaxis and severe hypersensitivity reactions. 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The process for reporting a protocol-defined adverse event is the same as that for reporting a\n\\end{tabular} & \\begin{tabular}{l}\n7.1.6 Protocol-Defined Adverse Events of Special Interest \\\\\nThe following are considered protocol-defined adverse events to be sent to the sponsor's Global Patient Safety and Pharmacovigilance Department for evaluation: ophthalmic adverse events of at least moderate severity, events of possible drug-induced liver injury (AST or ALT \\(\\geq 3 \\times\\) the ULN, total bilirubin \\(\\geq 2 \\times\\) the ULN or INR > 1.5), Hy's Law events, or events of suspected anaphylaxis and severe hypersensitivity reactions. Severe hypersensitivity reactions will be monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network Second Symposium on Anaphylaxis (Sampson et al, 2006 [also see Appendix F]). In the event of suspected anaphylaxis, vital signs, including oxygen saturation and respiration rate, will be measured. 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Other assessments will be","text_display":" will be measured. 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Other assessments will be performed at the discretion of the investigator. \\\\\nThe process for reporting a protocol-defined adverse event is the same as that for reporting a serious\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n7.1.6 Protocol-Defined Adverse Events of Special Interest \\\\\nThe following are considered protocol-defined adverse events to be sent to the sponsor's Global Patient Safety and Pharmacovigilance Department for evaluation: ophthalmic adverse events of at least moderate severity, events of possible drug-induced liver injury (AST or ALT \\(\\geq 3 \\times\\) the ULN, total bilirubin \\(\\geq 2 \\times\\) the ULN or INR > 1.5), Hy's Law events, or events of suspected anaphylaxis and severe hypersensitivity reactions. 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serious adverse event (see Section 7.1.5.3). & adverse event (see Section 7.1.5.3). & \\\\\n\\hline \\multicolumn{3}{|l|}{7.3.1 Serum Chemistry (Other sections affected by this change: Sections 7.1.1, 7.1.6, 7.3.4. and Appendix E)} \\\\\n\\hline \\begin{tabular}{l}\nThe following serum chemistry tests will be performed: \\\\\n- […] \\\\\n- total bilirubin \\\\\n- direct bilirubin \\\\\n- indirect bilirubin (calculated) \\\\\n- lactate dehydrogenase \\\\\n- […]\n\\end{tabular} & \\begin{tabular}{l}\nThe following serum chemistry tests will be performed: \\\\\n- […] \\\\\n- total bilirubin \\\\\n- direct bilirubin \\\\\n- indirect bilirubin (calculated) \\\\\n- lactate dehydrogenase \\\\\n- […]\n\\end{tabular} & \\begin{tabular}{l}\nTotal and direct bilirubin tests will be conducted at all visits that have chemistry laboratory assessments. Previously, direct bilirubin collection was triggered only under certain conditions. \\\\\nRelatedly, editorial changes were made throughout the protocol to clarify when total or direct (or both) bilirubin was being referred to.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{7.3.2 Hematology} \\\\\n\\hline \\begin{tabular}{l}\nThe following hematology tests will be performed: \\\\\n- […] \\\\\n- white blood cell (WBC) count and differential count (absolute values and percentages) \\\\\n- neutrophils \\\\\n- lymphocytes \\\\\n- eosinophils \\\\\n- monocytes \\\\\n- basophils \\\\\n- atypical lymphocytes\n\\end{tabular} & \\begin{tabular}{l}\nThe following hematology tests will be performed: \\\\\n- […] \\\\\n- white blood cell (WBC) count and differential count (absolute values and percentages) \\\\\n- neutrophils \\\\\n- lymphocytes \\\\\n- eosinophils \\\\\n- monocytes \\\\\n- basophils\n\\end{tabular} & A hematology test that was determined not to be needed was removed. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline serious adverse event (see Section 7.1.5.3). & adverse event (see Section 7.1.5.3). & \\\\\n\\hline \\multicolumn{3}{|l|}{7.3.1 Serum Chemistry (Other sections affected by this change: Sections 7.1.1, 7.1.6, 7.3.4. and Appendix E)} \\\\\n\\hline \\begin{tabular}{l}\nThe following serum chemistry tests will be performed: \\\\\n- […] \\\\\n- total bilirubin \\\\\n- direct bilirubin \\\\\n- indirect bilirubin (calculated) \\\\\n- lactate dehydrogenase \\\\\n- […]\n\\end{tabular} & \\begin{tabular}{l}\nThe following serum chemistry tests will be performed: \\\\\n- […] \\\\\n- total bilirubin \\\\\n- direct bilirubin \\\\\n- indirect bilirubin (calculated) \\\\\n- lactate dehydrogenase \\\\\n- […]\n\\end{tabular} & \\begin{tabular}{l}\nTotal and direct bilirubin tests will be conducted at all visits that have chemistry laboratory assessments. 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[…]\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe following serum chemistry tests will be performed: \\\\\n- […] \\\\\n- total bilirubin \\\\\n- direct bilirubin \\\\\n- indirect bilirubin (calculated) \\\\\n- lactate dehydrogenase \\\\\n- […]\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.8511466979980469,"confidence_rate":0.9978097832566157},{"cnt":[[247,389],[929,389],[929,437],[247,437]],"region":{"top_left_x":246,"top_left_y":389,"width":683,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6b072c460fa4aeb943850b98d23ec56","type":"text","conversion_output":false,"parent_id":"0270e06596e34bcba89095450f4f768c","text":"The following serum chemistry tests will be","text_display":"The following serum chemistry tests will 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\\multicolumn{3}{|l|}{7.4 Vital Signs} \\\\\n\\hline In addition, potentially clinically significant values may be predefined by the sponsor for selected vital signs (see Section 9.7.2) and, if so, will be documented in the statistical analysis plan or other relevant documents (eg, medical monitoring plan). & In addition, potentially clinically significant values may be predefined by the sponsor for selected vital signs (see Section 9.7.2) and, if so, will be documented in the statistical analysis plan or other relevant documents (eg, medical monitoring plan). & This language was added to align with Teva's standard practices. \\\\\n\\hline \\multicolumn{3}{|l|}{7.9 Immunogenicity} \\\\\n\\hline \\begin{tabular}{l}\n7.9. Injection Site Assessments Immunogenicity \\\\\nBlood samples for serum ADA assessment will be collected at visits 2, 3, and the EOT/early withdrawal visit. Only the samples from TEV-48125-treated patients will be analyzed for ADA. Blood samples for ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis). See Appendix \\(F\\) for the clinical criteria for diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis occurrence as soon as possible in case an anti-TEV-48125 immunoglobulin \\(E\\) assay is required. \\\\\n7.10. Injection Site Assessments\n\\end{tabular} & \\begin{tabular}{l}\n7.9. Immunogenicity \\\\\nBlood samples for serum ADA assessment will be collected at visits 2, 3, and the EOT/early withdrawal visit. Only the samples from TEV-48125-treated patients will be analyzed for ADA. Blood samples for ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis). See Appendix F for the clinical criteria for diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis occurrence as soon as possible in case an anti-TEV48125 immunoglobulin E assay is required. \\\\\n7.10. Injection Site Assessments\n\\end{tabular} & A dedicated immunogenicity subsection was added for clarity and completeness; it includes anaphylaxis-related text according to the change to Section 7.1.6 (above). \\\\\n\\hline \\multicolumn{3}{|l|}{8 ASSESSMENT OF PHARMACOKINETICS/ BIOMARKERS/ IMMUNOGENICITY} \\\\\n\\hline \\multicolumn{3}{|l|}{8.1.1 Specimen Sampling and Handling (Other sections affected by this change: Section 8.2.1)} \\\\\n\\hline Blood samples will be centrifuged \\((1500 g, \\sim 10\\) minutes, \\(\\theta 2 ^{\\circ} C\\) to \\(5 6 ^{\\circ} C\\) ) between 5 minutes and 1 hour after sampling...Separated plasma will be transferred in approximately equal portions into 2 өрадие,-labeled, 2-mL polypropylene tubes (sets A and B). & Blood samples will be centrifuged ( \\(1500 g, \\sim 10\\) minutes, \\(2^{\\circ} C\\) to \\(6^{\\circ} C\\) ) between 5 minutes and 1 hour after sampling...Separated plasma will be transferred in approximately equal portions into 2 labeled, \\(2- mL\\) polypropylene tubes (sets A and B ). & Procedures for plasma and serum collection were updated. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|l|}{7.4 Vital Signs} \\\\\n\\hline In addition, potentially clinically significant values may be predefined by the sponsor for selected vital signs (see Section 9.7.2) and, if so, will be documented in the statistical analysis plan or other relevant documents (eg, medical monitoring plan). & In addition, potentially clinically significant values may be predefined by the sponsor for selected vital signs (see Section 9.7.2) and, if so, will be documented in the statistical analysis plan or other relevant documents (eg, medical monitoring plan). & This language was added to align with Teva's standard practices. \\\\\n\\hline \\multicolumn{3}{|l|}{7.9 Immunogenicity} \\\\\n\\hline \\begin{tabular}{l}\n7.9. Injection Site Assessments Immunogenicity \\\\\nBlood samples for serum ADA assessment will be collected at visits 2, 3, and the EOT/early withdrawal visit. Only the samples from TEV-48125-treated patients will be analyzed for ADA. Blood samples for ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis). See Appendix \\(F\\) for the clinical criteria for diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis occurrence as soon as possible in case an anti-TEV-48125 immunoglobulin \\(E\\) assay is required. \\\\\n7.10. Injection Site Assessments\n\\end{tabular} & \\begin{tabular}{l}\n7.9. Immunogenicity \\\\\nBlood samples for serum ADA assessment will be collected at visits 2, 3, and the EOT/early withdrawal visit. Only the samples from TEV-48125-treated patients will be analyzed for ADA. Blood samples for ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis). See Appendix F for the clinical criteria for diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis occurrence as soon as possible in case an anti-TEV48125 immunoglobulin E assay is required. \\\\\n7.10. Injection Site Assessments\n\\end{tabular} & A dedicated immunogenicity subsection was added for clarity and completeness; it includes anaphylaxis-related text according to the change to Section 7.1.6 (above). \\\\\n\\hline \\multicolumn{3}{|l|}{8 ASSESSMENT OF PHARMACOKINETICS/ BIOMARKERS/ IMMUNOGENICITY} \\\\\n\\hline \\multicolumn{3}{|l|}{8.1.1 Specimen Sampling and Handling (Other sections affected by this change: Section 8.2.1)} \\\\\n\\hline Blood samples will be centrifuged \\((1500 g, \\sim 10\\) minutes, \\(\\theta 2 ^{\\circ} C\\) to \\(5 6 ^{\\circ} C\\) ) between 5 minutes and 1 hour after sampling...Separated plasma will be transferred in approximately equal portions into 2 өрадие,-labeled, 2-mL polypropylene tubes (sets A and B). & Blood samples will be centrifuged ( \\(1500 g, \\sim 10\\) minutes, \\(2^{\\circ} C\\) to \\(6^{\\circ} C\\) ) between 5 minutes and 1 hour after sampling...Separated plasma will be transferred in approximately equal portions into 2 labeled, \\(2- mL\\) polypropylene tubes (sets A and B ). & Procedures for plasma and serum collection were updated. 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Immunogenicity","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":3,"confidence":1,"confidence_rate":1},{"cnt":[[238,681],[1072,681],[1072,1329],[238,1329]],"region":{"top_left_x":237,"top_left_y":681,"width":835,"height":648},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a868a47466b4d438cb411b23024fed3","type":"complex_cell","conversion_output":false,"parent_id":"7947cbcae5cd460a918e1bd037bb6f99","children_ids":["88ad65bc7d0b45c787ce50eb2108aef4","e35f4caa66024f7eb28337db4d9ab463","15c37e1689df4ecb9d56a6733f1a2751","2f243b8b0fa94739baa069b617a22d2b","6139505c7bd944e6842350b9db35eb58","642ddde3e02346208178c70a495477f5","843ace28cfbb41f1804db431c19403ea","a86516300e6044cd844311083c6d637d","e15d7218b8284eaa957f1b18e611793b","5f5189597fc14fffa278fe494ffd7f05","e8e86dbee1f240ccb1449ab600497e5d","0b99a63a00bc4fcd939df27d02fd761f","cabd7276a40f41d78fea0c43e943981a","f40a6fe491d24e608b592ef2da4f58d9"],"text":"\\begin{tabular}{l}\n7.9. Injection Site Assessments Immunogenicity \\\\\nBlood samples for serum ADA assessment will be collected at visits 2, 3, and the EOT/early withdrawal visit. Only the samples from TEV-48125-treated patients will be analyzed for ADA. Blood samples for ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis). See Appendix \\(F\\) for the clinical criteria for diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis occurrence as soon as possible in case an anti-TEV-48125 immunoglobulin \\(E\\) assay is required. \\\\\n7.10. Injection Site Assessments\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n7.9. Injection Site Assessments Immunogenicity \\\\\nBlood samples for serum ADA assessment will be collected at visits 2, 3, and the EOT/early withdrawal visit. Only the samples from TEV-48125-treated patients will be analyzed for ADA. Blood samples for ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis). See Appendix \\(F\\) for the clinical criteria for diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis occurrence as soon as possible in case an anti-TEV-48125 immunoglobulin \\(E\\) assay is required. \\\\\n7.10. Injection Site Assessments\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.7218308448791504,"confidence_rate":0.999405936860123},{"cnt":[[247,686],[1028,686],[1028,731],[247,731]],"region":{"top_left_x":246,"top_left_y":685,"width":783,"height":47},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88ad65bc7d0b45c787ce50eb2108aef4","type":"text","conversion_output":false,"parent_id":"7a868a47466b4d438cb411b23024fed3","text":"7.9. Injection Site Assessments Immunogenicity","text_display":"7.9. 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Only the samples from TEV-","text_display":" withdrawal visit. Only the samples from TEV-","confidence":1,"confidence_rate":1},{"cnt":[[247,876],[1048,876],[1048,917],[247,917]],"region":{"top_left_x":246,"top_left_y":876,"width":802,"height":42},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6139505c7bd944e6842350b9db35eb58","type":"text","conversion_output":false,"parent_id":"7a868a47466b4d438cb411b23024fed3","text":"48125-treated patients will be analyzed for ADA.","text_display":"48125-treated patients will be analyzed for ADA.","confidence":1,"confidence_rate":1},{"cnt":[[247,920],[1018,920],[1018,963],[247,963]],"region":{"top_left_x":246,"top_left_y":919,"width":772,"height":44},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"642ddde3e02346208178c70a495477f5","type":"text","conversion_output":false,"parent_id":"7a868a47466b4d438cb411b23024fed3","text":"Blood samples for ADA assessment will also be","text_display":" Blood samples for ADA assessment will also be","confidence":1,"confidence_rate":1},{"cnt":[[247,963],[911,963],[911,1008],[247,1008]],"region":{"top_left_x":246,"top_left_y":962,"width":666,"height":47},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"843ace28cfbb41f1804db431c19403ea","type":"text","conversion_output":false,"parent_id":"7a868a47466b4d438cb411b23024fed3","text":"collected upon observation of any severe","text_display":" collected upon observation of any severe","confidence":1,"confidence_rate":1},{"cnt":[[247,1006],[1015,1006],[1015,1052],[247,1052]],"region":{"top_left_x":246,"top_left_y":1006,"width":770,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a86516300e6044cd844311083c6d637d","type":"text","conversion_output":false,"parent_id":"7a868a47466b4d438cb411b23024fed3","text":"hypersensitivity reaction (eg, anaphylaxis). See","text_display":" hypersensitivity reaction (eg, anaphylaxis). See","confidence":1,"confidence_rate":1},{"cnt":[[247,1052],[1067,1052],[1067,1095],[247,1095]],"region":{"top_left_x":246,"top_left_y":1051,"width":822,"height":45},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e15d7218b8284eaa957f1b18e611793b","type":"text","conversion_output":false,"parent_id":"7a868a47466b4d438cb411b23024fed3","text":"Appendix \\(F\\) for the clinical criteria for diagnosing","text_display":" Appendix \\(F\\) for the clinical criteria for diagnosing","confidence":0.7218308448791504,"confidence_rate":0.994756305217931},{"cnt":[[247,1095],[1018,1095],[1018,1138],[247,1138]],"region":{"top_left_x":246,"top_left_y":1095,"width":772,"height":44},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f5189597fc14fffa278fe494ffd7f05","type":"text","conversion_output":false,"parent_id":"7a868a47466b4d438cb411b23024fed3","text":"anaphylaxis. Bioanalytical personnel should be","text_display":" anaphylaxis. 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Immunogenicity \\\\\nBlood samples for serum ADA assessment will be collected at visits 2, 3, and the EOT/early withdrawal visit. Only the samples from TEV-48125-treated patients will be analyzed for ADA. Blood samples for ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis). See Appendix F for the clinical criteria for diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis occurrence as soon as possible in case an anti-TEV48125 immunoglobulin E assay is required. \\\\\n7.10. Injection Site Assessments\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n7.9. Immunogenicity \\\\\nBlood samples for serum ADA assessment will be collected at visits 2, 3, and the EOT/early withdrawal visit. Only the samples from TEV-48125-treated patients will be analyzed for ADA. Blood samples for ADA assessment will also be collected upon observation of any severe hypersensitivity reaction (eg, anaphylaxis). See Appendix F for the clinical criteria for diagnosing anaphylaxis. Bioanalytical personnel should be made aware of any anaphylaxis occurrence as soon as possible in case an anti-TEV48125 immunoglobulin E assay is required. \\\\\n7.10. Injection Site Assessments\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9805490362923592,"confidence_rate":0.9999743906498555},{"cnt":[[1109,690],[1451,690],[1451,731],[1109,731]],"region":{"top_left_x":1108,"top_left_y":690,"width":343,"height":42},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1b4f3281cae4db3887e767ca037e229","type":"text","conversion_output":false,"parent_id":"ef7b96599ae04729b92fef90bcdc6092","text":"7.9. Immunogenicity","text_display":"7.9. 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Blood samples","confidence":1,"confidence_rate":1},{"cnt":[[1109,920],[1851,920],[1851,961],[1109,961]],"region":{"top_left_x":1108,"top_left_y":919,"width":744,"height":42},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cb1203af3d0401f9b43ea46175a85f9","type":"text","conversion_output":false,"parent_id":"ef7b96599ae04729b92fef90bcdc6092","text":"for ADA assessment will also be collected upon","text_display":" for ADA assessment will also be collected upon","confidence":1,"confidence_rate":1},{"cnt":[[1109,963],[1895,963],[1895,1008],[1109,1008]],"region":{"top_left_x":1108,"top_left_y":962,"width":787,"height":47},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ca7abe052ed46beb60c03b206226bb4","type":"text","conversion_output":false,"parent_id":"ef7b96599ae04729b92fef90bcdc6092","text":"observation of any severe hypersensitivity reaction","text_display":" observation of any severe hypersensitivity reaction","confidence":1,"confidence_rate":1},{"cnt":[[1109,1006],[1873,1006],[1873,1052],[1109,1052]],"region":{"top_left_x":1108,"top_left_y":1006,"width":765,"height":46},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39b428ffefb24f59b3fb730b510ff665","type":"text","conversion_output":false,"parent_id":"ef7b96599ae04729b92fef90bcdc6092","text":"(eg, anaphylaxis). See Appendix F for the clinical","text_display":" (eg, anaphylaxis). See Appendix F for the clinical","confidence":1,"confidence_rate":1},{"cnt":[[1109,1050],[1869,1050],[1869,1095],[1109,1095]],"region":{"top_left_x":1108,"top_left_y":1049,"width":761,"height":47},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"372bee04568c40b48af3ec4a7bd3b441","type":"text","conversion_output":false,"parent_id":"ef7b96599ae04729b92fef90bcdc6092","text":"criteria for diagnosing anaphylaxis. Bioanalytical","text_display":" criteria for diagnosing anaphylaxis. Bioanalytical","confidence":1,"confidence_rate":1},{"cnt":[[1109,1093],[1912,1093],[1912,1138],[1109,1138]],"region":{"top_left_x":1108,"top_left_y":1092,"width":804,"height":47},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce248c3a980040f4a43a893fa72ed0be","type":"text","conversion_output":false,"parent_id":"ef7b96599ae04729b92fef90bcdc6092","text":"personnel should be made aware of any anaphylaxis","text_display":" personnel should be made aware of any anaphylaxis","confidence":1,"confidence_rate":1},{"cnt":[[1109,1136],[1908,1136],[1908,1182],[1109,1182]],"region":{"top_left_x":1108,"top_left_y":1136,"width":800,"height":46},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d575bd1c2a346fcbb22082eba9f0e07","type":"text","conversion_output":false,"parent_id":"ef7b96599ae04729b92fef90bcdc6092","text":"occurrence as soon as possible in case an anti-TEV-","text_display":" occurrence as soon as possible in case an anti-TEV","confidence":1,"confidence_rate":1},{"cnt":[[1109,1179],[1778,1179],[1778,1225],[1109,1225]],"region":{"top_left_x":1108,"top_left_y":1179,"width":670,"height":46},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a971ea6964b47459057f02db152ec57","type":"text","conversion_output":false,"parent_id":"ef7b96599ae04729b92fef90bcdc6092","text":"48125 immunoglobulin E assay is required.","text_display":"48125 immunoglobulin E assay is required.","confidence":1,"confidence_rate":1},{"cnt":[[1109,1236],[1630,1236],[1630,1281],[1109,1281]],"region":{"top_left_x":1108,"top_left_y":1235,"width":523,"height":47},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61c155cf3e964e6281079f7cc4660acd","type":"text","conversion_output":false,"parent_id":"ef7b96599ae04729b92fef90bcdc6092","text":"7.10. 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\\multicolumn{3}{|l|}{8.2.2 Shipment and Analysis of Samples} \\\\\n\\hline Serum samples for all patients will be shipped frozen on dry ice from the investigational center to the central laboratory & Serum samples for all patients will be shipped frozen on dry ice from the investigational center to the central laboratory & Shipping requirements for serum were clarified and aligned with those for plasma (Section 8.1.2). \\\\\n\\hline \\multicolumn{3}{|c|}{8.3 Assessment of Exploratory Biofluid Biomarkers (Other sections affected by this change: Synopsis and Sections 3.14 [Table 1], 3.14.2.2, 3.14.3.1.2, 3.14.3.1.3, 5.5 [Table 2], 8.3.2, and 9.9)} \\\\\n\\hline \\begin{tabular}{l}\nIn the current study, exploratory analysis may be conducted on blood (serum, plasma, and RNA) and urine biomarkers for extracellular matrix turnover, bone formation, and bone resorption. \\\\\n[...] \\\\\nValidated mMultiplex immunoassay panels will be applied to measure changes in urine, serum, and plasma markers, and RNA biomarkers.\n\\end{tabular} & \\begin{tabular}{l}\nIn the current study, exploratory analysis may be conducted on blood (serum, plasma, and RNA) and urine biomarkers for extracellular matrix turnover, bone formation, and bone resorption. \\\\\n[...] \\\\\nMultiplex immunoassay panels will be applied to measure changes in urine, serum, plasma, and RNA biomarkers.\n\\end{tabular} & \\begin{tabular}{l}\nClarification was made for internal consistency throughout the protocol specifying that serum, plasma, and RNA would be collected from blood. The blood volume required for each separate biomarker assessment is now reiterated in Table 2. \\\\\nStatement regarding the assays being validated was removed to allow for operational flexibility.\n\\end{tabular} \\\\\n\\hline \\multicolumn{3}{|l|}{9 STATISTICS} \\\\\n\\hline \\multicolumn{3}{|l|}{9.2.4 Additional Analysis Sets} \\\\\n\\hline The per-protocol population will consist of all patients who have completed the study without any violations of the inclusion/exclusion criteria or any violations or omissions of the drug administration. & The per-protocol population will consist of all patients who have completed the study without any violations of the inclusion/exclusion criteria or any violations or omissions of the drug administration. & An error was corrected. \\\\\n\\hline \\multicolumn{3}{|l|}{9.4.1 Patient Disposition} \\\\\n\\hline Data from patients screened; patients screened but not randomized and reason not randomized; patients who are randomized (ie, in the ITT set); patients randomized but not treated; patients in the ITT, safety; and other analysis sets; patients who complete the study; and patients who withdraw from the study will be summarized using descriptive statistics. & Data from patients screened, patients screened but not randomized and reason not randomized, patients who are randomized (ie, in the ITT set), patients randomized but not treated, patients in the safety and other analysis sets; patients who complete the study; and patients who withdraw from the study will be summarized using descriptive statistics. & Editorial changes were made. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|l|}{8.2.2 Shipment and Analysis of Samples} \\\\\n\\hline Serum samples for all patients will be shipped frozen on dry ice from the investigational center to the central laboratory & Serum samples for all patients will be shipped frozen on dry ice from the investigational center to the central laboratory & Shipping requirements for serum were clarified and aligned with those for plasma (Section 8.1.2). \\\\\n\\hline \\multicolumn{3}{|c|}{8.3 Assessment of Exploratory Biofluid Biomarkers (Other sections affected by this change: Synopsis and Sections 3.14 [Table 1], 3.14.2.2, 3.14.3.1.2, 3.14.3.1.3, 5.5 [Table 2], 8.3.2, and 9.9)} \\\\\n\\hline \\begin{tabular}{l}\nIn the current study, exploratory analysis may be conducted on blood (serum, plasma, and RNA) and urine biomarkers for extracellular matrix turnover, bone formation, and bone resorption. \\\\\n[...] \\\\\nValidated mMultiplex immunoassay panels will be applied to measure changes in urine, serum, and plasma markers, and RNA biomarkers.\n\\end{tabular} & \\begin{tabular}{l}\nIn the current study, exploratory analysis may be conducted on blood (serum, plasma, and RNA) and urine biomarkers for extracellular matrix turnover, bone formation, and bone resorption. \\\\\n[...] \\\\\nMultiplex immunoassay panels will be applied to measure changes in urine, serum, plasma, and RNA biomarkers.\n\\end{tabular} & \\begin{tabular}{l}\nClarification was made for internal consistency throughout the protocol specifying that serum, plasma, and RNA would be collected from blood. 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If the resulting 2 sided p value from the first eomparison is \\(\\leq 0.05\\), then the next comparison of interest will be interpreted inferentially at the alpha level of 0.05 . This process will continue either until all comparisons of interest are interpreted inferentially or until the point at which the resulting \\(Z\\) sided \\(p\\) value for a comparison of interest is \\(>0.05\\). 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Each investigator The principal investigator at each investigational center, the coordinating investigator (if applicable), and the sponsor will sign the protocol amendment. & No changes from the final approved (signed) protocol will be initiated without the prior written approval or favorable opinion of a written amendment by the IEC/IRB and national and local competent authorities, as applicable, except when necessary to address immediate safety concerns to the patients, or when the change involves only nonsubstantial logistics or administration. The principal investigator at each investigational center, the coordinating investigator (if applicable), and the sponsor will sign the protocol amendment. & Updates were made to align with the latest Teva practices. \\\\\n\\hline \\multicolumn{3}{|l|}{11.1.2 Protocol Violations} \\\\\n\\hline \\begin{tabular}{l}\nA protocol deviation is any change, divergence, or departure from the study design or procedures defined in the protocol. \\\\\nImportant protocol deviations, referred to as protocol violations, are a subset of protocol deviations that may significantly impact the completeness, accuracy, and/or reliability of the study data or that may\n\\end{tabular} & Any deviation from the protocol that affects, to a significant degree, (a) the safety, physical, or mental integrity of the subjects of the study and/or (b) the scientific value of the study will be considered a protocol violation. 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At the point where \\(p >0.05\\), no further comparisons will be interpreted inferentially. & & \\\\\n\\hline \\multicolumn{3}{|l|}{9.11 Immunogenicity Analysis (Other sections affected by this change: Synopsis)} \\\\\n\\hline This impact analysis will be reported separately. & This impact analysis will be reported separately. & Clarification was added. \\\\\n\\hline \\multicolumn{3}{|l|}{11 QUALITY CONTROL AND QUALITY ASSURANCE} \\\\\n\\hline \\multicolumn{3}{|l|}{11.1.1 Protocol Amendments} \\\\\n\\hline No changes from the final approved (signed) protocol will be initiated without the prior written approval or favorable opinion of a written amendment by the IEC/IRB and national and local competent authorities, (as applicable), except when necessary to address immediate safety concerns to the patients, or when the change involves only nonsubstantial logistics or administration. Each investigator The principal investigator at each investigational center, the coordinating investigator (if applicable), and the sponsor will sign the protocol amendment. & No changes from the final approved (signed) protocol will be initiated without the prior written approval or favorable opinion of a written amendment by the IEC/IRB and national and local competent authorities, as applicable, except when necessary to address immediate safety concerns to the patients, or when the change involves only nonsubstantial logistics or administration. The principal investigator at each investigational center, the coordinating investigator (if applicable), and the sponsor will sign the protocol amendment. & Updates were made to align with the latest Teva practices. \\\\\n\\hline \\multicolumn{3}{|l|}{11.1.2 Protocol Violations} \\\\\n\\hline \\begin{tabular}{l}\nA protocol deviation is any change, divergence, or departure from the study design or procedures defined in the protocol. \\\\\nImportant protocol deviations, referred to as protocol violations, are a subset of protocol deviations that may significantly impact the completeness, accuracy, and/or reliability of the study data or that may\n\\end{tabular} & Any deviation from the protocol that affects, to a significant degree, (a) the safety, physical, or mental integrity of the subjects of the study and/or (b) the scientific value of the study will be considered a protocol violation. 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If such patient has already completed the study or has withdrawn early, no action will be taken; but the violation will be recorded. If such patient is still participating in the study, a determination will be made by the sponsor and the investigator as to whether it is in the best interest of the patient to continue in the study. & & \\\\\n\\hline \\multicolumn{3}{|l|}{APPENDIX A PREVENTIVE MEDICATIONS ALLOWED FOR THE DURATION OF THE STUDY} \\\\\n\\hline \\begin{tabular}{l}\nPreventive migraine medications allowed for up to 30\\% of patients for the duration of the study specifically include the following (only if they were previously prescribed for migraine or for another indication if used at an approved dose for migraine prophylaxis): \\\\\n- beta-blockers: atenolol, propranolol, metoprolol, nadolol, and timolol \\\\\n- calcium channel blocker/benzocycloheptene: verapamilflunarizine and pizotifen \\\\\n- tricyclic-antidepressants: amitriptyline, venlafaxine, nortriptyline, and duloxetine \\\\\n- serotonin norepinephrine reuptake inhibitor: venlafaxine \\\\\n- triptans: frovatriptan, naratriptan, and zolmitriptan if they were used as preventive medications for the treatment of menstrual migraine. (Note: They cannot be used daily for the preventive treatment of migraine.) \\\\\n- anti-epileptic medications: topiramate, valproate, and divalproate\n\\end{tabular} & \\begin{tabular}{l}\nPreventive migraine medications allowed for up to \\(30 \\%\\) of patients for the duration of the study specifically include the following (if they were previously prescribed for migraine or for another indication): \\\\\n- beta-blockers: atenolol, propranolol, metoprolol, nadolol, and timolol \\\\\n- calcium channel blocker/benzocycloheptene: flunarizine and pizotifen \\\\\n- antidepressants: amitriptyline, venlafaxine, nortriptyline, and duloxetine \\\\\n- anti-epileptic medications: topiramate, valproate, and divalproate\n\\end{tabular} & Appendix A was updated to reflect the most recent list of preventive medications allowed for the duration of the study. \\\\\n\\hline \\multicolumn{3}{|l|}{APPENDIX B. DISALLOWED MEDICATIONS FOR THE DURATION OF THE STUDY} \\\\\n\\hline Preventive migraine medications/treatments & Preventive migraine medications disallowed for at & A new Appendix B was added to \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline inform the sponsor of the protocol violation. If such patient has already completed the study or has withdrawn early, no action will be taken; but the violation will be recorded. 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study.","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1966,695],[2404,692],[2404,740],[1966,742]],"region":{"top_left_x":1965,"top_left_y":692,"width":439,"height":51},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ba702c7ac6a74bd1bf0b48fdf5f05c87","type":"text","conversion_output":false,"parent_id":"e3ec8d776b274f1f894ebf3c21650346","text":"Appendix A was updated to","text_display":"Appendix A was updated to","confidence":1,"confidence_rate":1},{"cnt":[[1966,742],[2421,742],[2421,783],[1966,783]],"region":{"top_left_x":1966,"top_left_y":742,"width":455,"height":42},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"754e196a40594f3b9845a48d62babdeb","type":"text","conversion_output":false,"parent_id":"e3ec8d776b274f1f894ebf3c21650346","text":"reflect the most recent list of","text_display":" reflect the most recent list 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DISALLOWED MEDICATIONS FOR THE DURATION OF THE STUDY","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":3},{"cnt":[[242,1721],[1745,1721],[1745,1764],[242,1764]],"region":{"top_left_x":242,"top_left_y":1720,"width":1504,"height":45},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c566b09784364f3cb83592d340bac5c6","type":"simple_cell","conversion_output":false,"parent_id":"eea50e10edfd48f8a67fbe1c76ad51c7","text":"APPENDIX B. DISALLOWED MEDICATIONS FOR THE DURATION OF THE STUDY","text_display":"APPENDIX B. 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TV48125-CNS-30050","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[226,247],[2524,247],[2524,1865],[226,1865]],"region":{"top_left_x":225,"top_left_y":247,"width":2300,"height":1618},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a71333ea2194e7eb211d8342a7f52b8","type":"table","conversion_output":true,"children_ids":["d3976ec043d94df3be22056f544a3268","36293e3a81f74a47a7a991225a8d5f53","90af8e8caae148f2b166f98613edd222","4bf01dfd66a7448e9e8ff6f2004f203b","db339c54700f46bbb7a813fe380d4dea","0863515961644341993b97dc6c17ce12","2830e1f4a29441679154cce962ad3eb1","ffe7544f7f2a4298be7862282298a5a1","94d8d2123a854a549606911fbb4f65af","6d6b78050c4841af977e784bd99f049f","0ca59e08e579434c842b10c4900c9fa9","b135a5584995498b8e3eee851d5f3e18","816328937af6470580a5167323fb5928"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline \\begin{tabular}{l}\ndisallowed for at least \\(70 \\%\\) of patients for the duration of the study specifically include the following: \\\\\n- beta-blockers: atenolol, propranolol, metoprolol, nadolol, and timolol \\\\\n- calcium channel blocker/benzocycloheptene: flunarizine and pizotifen \\\\\n- antidepressants: amitriptyline, venlafaxine, nortriptyline, and duloxetine \\\\\n- anti-epileptic medications: topiramate, valproate, carbamazepine, and divalproate \\\\\n- angiotensin receptor blocker: candesartan and lisinopril \\\\\n- onabotulinimtoxinA: botox \\\\\n- triptans/ergots: used as preventive therapy for migraine \\\\\n- NSAIDs: used as preventive therapy for migraine or on a daily basis for other indications \\\\\n- devices for migraine prophylaxis \\\\\n- nerve blocks in the head and neck \\\\\nAny of the listed medications are allowed if given as topical or eye drops. \\\\\nOther medications in the same classes but not included in this list are allowed.\n\\end{tabular} & \\begin{tabular}{l}\nleast 70\\% of patients for the duration of the study specifically include the following: \\\\\n- beta-blockers: atenolol, propranolol, metoprolol, nadolol, and timolol \\\\\n- calcium channel blocker/benzocycloheptene: flunarizine and pizotifen \\\\\n- antidepressants: amitriptyline, venlafaxine, nortriptyline, and duloxetine \\\\\n- anti-epileptic medications: topiramate, valproate, carbamazepine, and divalproate \\\\\n- angiotensin receptor blocker: candesartan and lisinopril \\\\\n- onabotulinimtoxinA: botox \\\\\n- triptans/ergots: used as preventive therapies for migraine \\\\\n- NSAIDs: used as preventive therapy for migraine or on a daily basis for other indications \\\\\n- devices for migraine prophylaxis \\\\\n- nerve blocks in the head and neck \\\\\nAny of the listed medications are allowed if given as topical or eye drops. \\\\\nOther medications in the same classes but not included in this list are allowed.\n\\end{tabular} & show the most recent list of preventive medications disallowed for the duration of the study. The numbering of all subsequent appendices shifted. \\\\\n\\hline \\multicolumn{3}{|l|}{APPENDIX F. CLINICAL CRITERIA FOR DIAGNOSING ANAPHYLAXIS} \\\\\n\\hline \\begin{tabular}{l}\nAnaphylaxis is highly likely when any one of the following 3 criteria are fulfilled: \\\\\na. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal\n\\end{tabular} & \\begin{tabular}{l}\nAnaphylaxis is highly likely when any one of the following 3 criteria are fulfilled: \\\\\na. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal\n\\end{tabular} & Appendix F was added to provide the criteria for diagnosis of anaphylaxis. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\begin{tabular}{l}\ndisallowed for at least \\(70 \\%\\) of patients for the duration of the study specifically include the following: \\\\\n- beta-blockers: atenolol, propranolol, metoprolol, nadolol, and timolol \\\\\n- calcium channel blocker/benzocycloheptene: flunarizine and pizotifen \\\\\n- antidepressants: amitriptyline, venlafaxine, nortriptyline, and duloxetine \\\\\n- anti-epileptic medications: topiramate, valproate, carbamazepine, and divalproate \\\\\n- angiotensin receptor blocker: candesartan and lisinopril \\\\\n- onabotulinimtoxinA: botox \\\\\n- triptans/ergots: used as preventive therapy for migraine \\\\\n- NSAIDs: used as preventive therapy for migraine or on a daily basis for other indications \\\\\n- devices for migraine prophylaxis \\\\\n- nerve blocks in the head and neck \\\\\nAny of the listed medications are allowed if given as topical or eye drops. \\\\\nOther medications in the same classes but not included in this list are allowed.\n\\end{tabular} & \\begin{tabular}{l}\nleast 70\\% of patients for the duration of the study specifically include the following: \\\\\n- beta-blockers: atenolol, propranolol, metoprolol, nadolol, and timolol \\\\\n- calcium channel blocker/benzocycloheptene: flunarizine and pizotifen \\\\\n- antidepressants: amitriptyline, venlafaxine, nortriptyline, and duloxetine \\\\\n- anti-epileptic medications: topiramate, valproate, carbamazepine, and divalproate \\\\\n- angiotensin receptor blocker: candesartan and lisinopril \\\\\n- onabotulinimtoxinA: botox \\\\\n- triptans/ergots: used as preventive therapies for migraine \\\\\n- NSAIDs: used as preventive therapy for migraine or on a daily basis for other indications \\\\\n- devices for migraine prophylaxis \\\\\n- nerve blocks in the head and neck \\\\\nAny of the listed medications are allowed if given as topical or eye drops. \\\\\nOther medications in the same classes but not included in this list are allowed.\n\\end{tabular} & show the most recent list of preventive medications disallowed for the duration of the study. The numbering of all subsequent appendices shifted. \\\\\n\\hline \\multicolumn{3}{|l|}{APPENDIX F. CLINICAL CRITERIA FOR DIAGNOSING ANAPHYLAXIS} \\\\\n\\hline \\begin{tabular}{l}\nAnaphylaxis is highly likely when any one of the following 3 criteria are fulfilled: \\\\\na. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal\n\\end{tabular} & \\begin{tabular}{l}\nAnaphylaxis is highly likely when any one of the following 3 criteria are fulfilled: \\\\\na. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal\n\\end{tabular} & Appendix F was added to provide the criteria for diagnosis of anaphylaxis. 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The numbering of all subsequent appendices shifted.","text_display":"show the most recent list of preventive medications disallowed for the duration of the study. The numbering of all subsequent appendices shifted.","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1966,256],[2403,256],[2403,297],[1966,297]],"region":{"top_left_x":1966,"top_left_y":255,"width":438,"height":42},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5713506b54d64c9fac4a10050ecc3115","type":"text","conversion_output":false,"parent_id":"94d8d2123a854a549606911fbb4f65af","text":"show the most recent list of","text_display":"show the most recent list of","confidence":1,"confidence_rate":1},{"cnt":[[1966,299],[2332,299],[2332,344],[1966,344]],"region":{"top_left_x":1966,"top_left_y":298,"width":367,"height":47},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e50255879c7f429593c75408aa068e32","type":"text","conversion_output":false,"parent_id":"94d8d2123a854a549606911fbb4f65af","text":"preventive medications","text_display":" preventive medications","confidence":1,"confidence_rate":1},{"cnt":[[1966,342],[2488,342],[2488,383],[1966,383]],"region":{"top_left_x":1966,"top_left_y":342,"width":522,"height":42},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad719a0491804105b93a52e6f573e295","type":"text","conversion_output":false,"parent_id":"94d8d2123a854a549606911fbb4f65af","text":"disallowed for the duration of the","text_display":" disallowed for the duration of the","confidence":1,"confidence_rate":1},{"cnt":[[1966,386],[2403,386],[2403,431],[1966,431]],"region":{"top_left_x":1966,"top_left_y":385,"width":438,"height":47},"line":68,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4193e9bf87a4ea79d6d6a60611bbaef","type":"text","conversion_output":false,"parent_id":"94d8d2123a854a549606911fbb4f65af","text":"study. 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CLINICAL CRITERIA FOR DIAGNOSING ANAPHYLAXIS","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":3},{"cnt":[[244,1607],[1537,1607],[1537,1648],[244,1648]],"region":{"top_left_x":244,"top_left_y":1606,"width":1294,"height":43},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3ae65f6b2954daaa00e425feeb9186c","type":"simple_cell","conversion_output":false,"parent_id":"6d6b78050c4841af977e784bd99f049f","text":"APPENDIX F. CLINICAL CRITERIA FOR DIAGNOSING ANAPHYLAXIS","text_display":"APPENDIX F. 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not to be sent in a confirmatory test]).","text_display":" count, separate tube], and INR [separate tube; not to be sent in a confirmatory test]).","confidence":0.9794921875,"confidence_rate":0.999774796909442},{"cnt":[[432,1813],[1609,1813],[1609,1863],[432,1863]],"region":{"top_left_x":431,"top_left_y":1813,"width":1179,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d508fd08fa904d03a6fcbee4dc5837f7","type":"text","conversion_output":true,"text":"The investigator should also question the patient regarding symptoms.","text_display":" The investigator should also question the patient regarding symptoms.","confidence":1,"confidence_rate":1},{"cnt":[[245,1882],[1622,1882],[1622,1931],[245,1931]],"region":{"top_left_x":244,"top_left_y":1882,"width":1379,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18e843c13d8b451d85fc686b97d0cc1e","type":"text","conversion_output":true,"text":"The abnormality will be regarded as confirmed in each of the following scenarios:","text_display":"\n\nThe abnormality will be regarded as confirmed in each of the following scenarios:","confidence":1,"confidence_rate":1},{"cnt":[[370,1955],[1867,1955],[1867,2004],[370,2004]],"region":{"top_left_x":369,"top_left_y":1955,"width":1498,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ad53ef18e794a67a40542fe3aabb8f3","type":"text","conversion_output":true,"text":"- the baseline value was within the normal range and ALT or AST is still \\(\\geq 3 \\times\\) the ULN","text_display":"\n- the baseline value was within the normal range and ALT or AST is still \\(\\geq 3 \\times\\) the ULN","confidence":1,"confidence_rate":1},{"cnt":[[370,2028],[1803,2028],[1803,2073],[370,2073]],"region":{"top_left_x":369,"top_left_y":2028,"width":1434,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23bb4bda05e24ae993806609a82d81b6","type":"text","conversion_output":true,"text":"- the baseline value was above the ULN and ALT or AST is \\(\\geq 2 \\times\\) the baseline value","text_display":"\n- the baseline value was above the ULN and ALT or AST is \\(\\geq 2 \\times\\) the baseline value","confidence":1,"confidence_rate":1},{"cnt":[[241,2247],[1884,2247],[1884,2512],[241,2512]],"region":{"top_left_x":240,"top_left_y":2247,"width":1645,"height":265},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc50b01333084974925cb891b0f1289f","type":"footnote","conversion_output":false,"children_ids":["e67fd76ed67f45a980a4e43438775ca1","fd274c7e1c054d6a8e99c3ef360a9f46","d7f82de9e77540bbaa0d6516c605fed9","75d8edd5639a40bd923cd9d46379805e","e6fd236a1c6146bab91447584e2a39f8","ac87d45af21342a19fd08379c151697f"],"text":"","text_display":""},{"cnt":[[247,2256],[1876,2256],[1876,2305],[247,2305]],"region":{"top_left_x":247,"top_left_y":2255,"width":1629,"height":51},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e67fd76ed67f45a980a4e43438775ca1","type":"text","conversion_output":true,"parent_id":"bc50b01333084974925cb891b0f1289f","text":"\\({ }^{1}\\) Thorough medical history with a focus on liver disease: personal or family history of liver disease; 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