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Approximately one-third of migraineurs have","text_display":" occurring between the ages of 25 to 55 years. 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In the United States, work loss due to","text_display":" for bed rest during an attack (Lipton et al, 2007). In the United States, work loss due to","confidence":0.9697265625,"confidence_rate":0.9996764613861798},{"cnt":[[309,683],[1858,683],[1858,733],[309,733]],"region":{"top_left_x":309,"top_left_y":683,"width":1550,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c35956fad6d841248e441019c5e2f17d","type":"text","conversion_output":true,"text":"migraine is estimated to cost \\(\\sim \\$ 13\\) billion annually (Hu et al, 1999). Prevalence is similar in","text_display":" migraine is estimated to cost \\(\\sim \\$ 13\\) billion annually (Hu et al, 1999). 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It is currently ranked by the World Health Organization as 19th","text_display":" (Stovner and Andree, 2010). 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Episodic migraine is a syndrome diagnosis","confidence":1,"confidence_rate":1},{"cnt":[[309,1547],[1858,1547],[1858,1596],[309,1596]],"region":{"top_left_x":309,"top_left_y":1546,"width":1550,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f5040c034ea4b8c8eb4746d9a54c2ea","type":"text","conversion_output":true,"text":"applied to patients with migraine (with or without aura) who have 1 to 14 headache days per","text_display":" applied to patients with migraine (with or without aura) who have 1 to 14 headache days per","confidence":1,"confidence_rate":1},{"cnt":[[309,1607],[1798,1607],[1798,1656],[309,1656]],"region":{"top_left_x":309,"top_left_y":1607,"width":1490,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1aebbe2b4b904a058dd09a13df77fff6","type":"text","conversion_output":true,"text":"month. 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CGRP levels in the cranial venous outflow (ie, external jugular vein) are","text_display":" of migraine. CGRP levels in the cranial venous outflow (ie, external jugular vein) are","confidence":1,"confidence_rate":1},{"cnt":[[309,2110],[1742,2110],[1742,2159],[309,2159]],"region":{"top_left_x":309,"top_left_y":2109,"width":1434,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57dcaf88a5aa4cb485d4603e4716c006","type":"text","conversion_output":true,"text":"increased during a migraine attack (Goadsby and Edvinsson, 1993) and exogenously","text_display":" increased during a migraine attack (Goadsby and Edvinsson, 1993) and exogenously","confidence":1,"confidence_rate":1},{"cnt":[[309,2170],[1833,2170],[1833,2219],[309,2219]],"region":{"top_left_x":309,"top_left_y":2169,"width":1524,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a23777b82dfc4942bfff6928a142de54","type":"text","conversion_output":true,"text":"administered CGRP has been shown to trigger migraine-like headache in migraineurs. The","text_display":" administered CGRP has been shown to trigger migraine-like headache in migraineurs. 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using an intravenous (IV) formulation of olcegepant (Olesen et al, 2004),","confidence":1,"confidence_rate":1},{"cnt":[[309,696],[1785,696],[1785,741],[309,741]],"region":{"top_left_x":309,"top_left_y":696,"width":1477,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9add39e74861461d8917f8246b2df73c","type":"text","conversion_output":true,"text":"and replicated by Merck \\& Co., Inc with an oral formulation of telcagepant, a highly","text_display":" and replicated by Merck \\& Co., Inc with an oral formulation of telcagepant, a highly","confidence":1,"confidence_rate":1},{"cnt":[[309,756],[1790,756],[1790,801],[309,801]],"region":{"top_left_x":309,"top_left_y":756,"width":1481,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8acb35d4c8a4c1481cfe1900c0f5ffd","type":"text","conversion_output":true,"text":"selective CGRP receptor antagonist (CGRP RA). 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Overall, all the ubrogepant","text_display":" doses of ubrogepant to placebo in the acute treatment of migraine. 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For the primary efficacy endpoint of pain freedom","text_display":" did not differ significantly from placebo. 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A practice session with a hypothetical scenario should be","text_display":" experience a qualifying migraine. A practice session with a hypothetical scenario should be","confidence":1,"confidence_rate":1},{"cnt":[[309,1332],[1876,1332],[1876,1377],[309,1377]],"region":{"top_left_x":309,"top_left_y":1332,"width":1567,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a905ee95085d446b9be5048741955dd9","type":"text","conversion_output":true,"text":"administered to ensure the patients' comprehension of the questions and the information to be","text_display":" administered to ensure the patients' comprehension of the questions and the information to be","confidence":1,"confidence_rate":1},{"cnt":[[309,1388],[1781,1388],[1781,1437],[309,1437]],"region":{"top_left_x":309,"top_left_y":1387,"width":1473,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb6b6ddc1e24493b905aaa5304a3a9b6","type":"text","conversion_output":true,"text":"entered. In addition, criteria for a qualifying migraine to be treated as well as prohibited","text_display":" entered. In addition, criteria for a qualifying migraine to be treated as well as prohibited","confidence":1,"confidence_rate":1},{"cnt":[[309,1448],[1820,1448],[1820,1497],[309,1497]],"region":{"top_left_x":309,"top_left_y":1448,"width":1511,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be6d881da8da4907bdc529a4700701d5","type":"text","conversion_output":true,"text":"medications should be reviewed with the patients. Patients will be instructed to bring their","text_display":" medications should be reviewed with the patients. Patients will be instructed to bring their","confidence":1,"confidence_rate":1},{"cnt":[[309,1508],[1433,1508],[1433,1558],[309,1558]],"region":{"top_left_x":309,"top_left_y":1508,"width":1125,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"767a558ac27a4e9088ab9b7b6f268d41","type":"text","conversion_output":true,"text":"eDiary at the next clinic visit and return their IP (used and unused).","text_display":" eDiary at the next clinic visit and return their IP (used and unused).","confidence":1,"confidence_rate":1},{"cnt":[[305,1770],[965,1770],[965,1828],[305,1828]],"region":{"top_left_x":305,"top_left_y":1770,"width":660,"height":59},"line":13,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"b333ad5cf31a4694a9d0dcde689f5299","type":"section_header","conversion_output":false,"children_ids":["c2437ce807d042e79715202d6ddd019d"],"text":"","text_display":""},{"cnt":[[309,1775],[960,1775],[960,1824],[309,1824]],"region":{"top_left_x":309,"top_left_y":1774,"width":652,"height":51},"line":14,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"c2437ce807d042e79715202d6ddd019d","type":"text","conversion_output":true,"parent_id":"b333ad5cf31a4694a9d0dcde689f5299","text":"8.6 Unscheduled Visits","text_display":"\n\n\\subsection*{8.6 Unscheduled Visits}","confidence":0.998046875,"confidence_rate":0.9999275939238241},{"cnt":[[309,1865],[1766,1865],[1766,1912],[309,1912]],"region":{"top_left_x":309,"top_left_y":1864,"width":1458,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90dcc8e8bace4dc9b9b97806bf32ce8e","type":"text","conversion_output":true,"text":"Additional examinations and laboratory assessments may be performed as necessary to","text_display":"\n\nAdditional examinations and laboratory assessments may be performed as necessary to","confidence":1,"confidence_rate":1},{"cnt":[[309,1921],[1824,1921],[1824,1972],[309,1972]],"region":{"top_left_x":309,"top_left_y":1920,"width":1516,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d34c5a348dc1464fb828705532640105","type":"text","conversion_output":true,"text":"ensure the safety and well-being of the patients during the study period. Unscheduled visit","text_display":" ensure the safety and well-being of the patients during the study period. Unscheduled visit","confidence":1,"confidence_rate":1},{"cnt":[[309,1983],[1798,1983],[1798,2030],[309,2030]],"region":{"top_left_x":309,"top_left_y":1983,"width":1490,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b30c77cc99e54a8aa4312477f78b0356","type":"text","conversion_output":true,"text":"eCRFs should be completed for each unscheduled visit. For all parameters not measured,","text_display":" eCRFs should be completed for each unscheduled visit. For all parameters not measured,","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[309,2041],[649,2041],[649,2086],[309,2086]],"region":{"top_left_x":309,"top_left_y":2041,"width":340,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f297b0ba1014a38a4c22b95f4b0a1ec","type":"text","conversion_output":true,"text":"indicate \"not done\".","text_display":" indicate \"not done\".","confidence":1,"confidence_rate":1},{"cnt":[[305,2144],[1111,2144],[1111,2206],[305,2206]],"region":{"top_left_x":305,"top_left_y":2144,"width":806,"height":63},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd016b3d78184a2e8db94208955d130e","type":"section_header","conversion_output":false,"children_ids":["3a8391b799474972bd2c8aca1dbef394"],"text":"","text_display":""},{"cnt":[[309,2148],[1106,2148],[1106,2202],[309,2202]],"region":{"top_left_x":309,"top_left_y":2148,"width":798,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a8391b799474972bd2c8aca1dbef394","type":"text","conversion_output":true,"parent_id":"cd016b3d78184a2e8db94208955d130e","text":"8.7 Compliance with Protocol","text_display":"\n\n\\subsection*{8.7 Compliance with Protocol}","confidence":0.99853515625,"confidence_rate":0.9999555792386768},{"cnt":[[309,2234],[1798,2234],[1798,2284],[309,2284]],"region":{"top_left_x":309,"top_left_y":2234,"width":1490,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9943d769aace41fa9cb61b04c3cfc1d3","type":"text","conversion_output":true,"text":"All assessments will be conducted at the appropriate visits as outlined in Table 1, and the","text_display":"\n\nAll assessments will be conducted at the appropriate visits as outlined in Table 1, and the","confidence":1,"confidence_rate":1},{"cnt":[[309,2295],[1824,2295],[1824,2344],[309,2344]],"region":{"top_left_x":309,"top_left_y":2294,"width":1516,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e886798313114ae6958c9ac03a1f05a2","type":"text","conversion_output":true,"text":"timing of the visits should occur as close as possible to the specified day. At each visit, the","text_display":" timing of the visits should occur as close as possible to the specified day. At each visit, the","confidence":1,"confidence_rate":1},{"cnt":[[309,2355],[1803,2355],[1803,2404],[309,2404]],"region":{"top_left_x":309,"top_left_y":2354,"width":1494,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4fea9970d1d4006a826b68150c8b877","type":"text","conversion_output":true,"text":"patient will be asked if the patient changed the dose/regimen of any existing concomitant","text_display":" patient will be asked if the patient changed the dose/regimen of any existing concomitant","confidence":1,"confidence_rate":1},{"cnt":[[1038,2527],[1089,2527],[1089,2561],[1038,2561]],"region":{"top_left_x":1037,"top_left_y":2526,"width":53,"height":35},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b21b3fdc47364855963eef4e8e82ee5c","type":"page_info","conversion_output":false,"text":"58","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[509,2625],[700,2625],[700,2662],[509,2662]],"region":{"top_left_x":509,"top_left_y":2625,"width":192,"height":37},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ada36da8e26c4da892d6aecdd3dcb4fc","type":"page_info","conversion_output":false,"text":"UBR-MD-02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1038,2625],[1089,2625],[1089,2664],[1038,2664]],"region":{"top_left_x":1037,"top_left_y":2625,"width":53,"height":40},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a14b56f75ba04fb987cf8cf4c7b61824","type":"page_info","conversion_output":false,"text":"58","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"b79a4e99-2c62-433f-94cd-d3b521e11517-060","page":60,"lines":[{"cnt":[[309,146],[621,146],[621,187],[309,187]],"region":{"top_left_x":309,"top_left_y":146,"width":312,"height":41},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cdd59c83a3f146aba7584d4995f1127d","type":"page_info","conversion_output":false,"text":"Allergan Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1336,150],[1854,150],[1854,183],[1336,183]],"region":{"top_left_x":1336,"top_left_y":150,"width":519,"height":33},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3a9d17c82c74907b7a5e6d84daff48e","type":"page_info","conversion_output":false,"text":"Protocol UBR-MD-02 Amendment 3","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,254],[1811,254],[1811,299],[309,299]],"region":{"top_left_x":309,"top_left_y":253,"width":1503,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9783b40c7be54276a6b92d07be0b6535","type":"text","conversion_output":true,"text":"medications or initiated the use of any new concomitant medications since the last visit to","text_display":"\nmedications or initiated the use of any new concomitant medications since the last visit to","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[930,314],[930,359],[309,359]],"region":{"top_left_x":309,"top_left_y":313,"width":622,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4cefeb14eaf494ba6dabd47714b85df","type":"text","conversion_output":true,"text":"ensure compliance with the protocol.","text_display":" ensure compliance with the protocol.","confidence":1,"confidence_rate":1},{"cnt":[[309,415],[1781,415],[1781,460],[309,460]],"region":{"top_left_x":309,"top_left_y":414,"width":1473,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ff456bc5ad74abba65a73e3982b5d59","type":"text","conversion_output":true,"text":"Patients will record the requested information regarding their migraine attack and the IP","text_display":"\n\nPatients will record the requested information regarding their migraine attack and the IP","confidence":1,"confidence_rate":1},{"cnt":[[309,475],[1781,475],[1781,522],[309,522]],"region":{"top_left_x":309,"top_left_y":474,"width":1473,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80b708b1ee064482bc1010e9a395f6b4","type":"text","conversion_output":true,"text":"taken in the eDiary. IP compliance will be closely monitored by counting the number of","text_display":" taken in the eDiary. IP compliance will be closely monitored by counting the number of","confidence":1,"confidence_rate":1},{"cnt":[[309,535],[1665,535],[1665,580],[309,580]],"region":{"top_left_x":309,"top_left_y":534,"width":1357,"height":47},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc80f60a82c848f5a622c801ecfcc34b","type":"text","conversion_output":true,"text":"tablets dispensed and returned. Every effort will be made to collect all unused IP.","text_display":" tablets dispensed and returned. Every effort will be made to collect all unused IP.","confidence":1,"confidence_rate":1},{"cnt":[[305,636],[1257,636],[1257,694],[305,694]],"region":{"top_left_x":305,"top_left_y":635,"width":952,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24c0385138c24470bff140cdb5fcdddf","type":"section_header","conversion_output":false,"children_ids":["e6f9277dfe074604b8ea705b837363b1"],"text":"","text_display":""},{"cnt":[[309,640],[1253,640],[1253,692],[309,692]],"region":{"top_left_x":309,"top_left_y":640,"width":944,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6f9277dfe074604b8ea705b837363b1","type":"text","conversion_output":true,"parent_id":"24c0385138c24470bff140cdb5fcdddf","text":"8.8 Early Discontinuation of Patients","text_display":"\n\n\\subsection*{8.8 Early Discontinuation of Patients}","confidence":0.945091724395752,"confidence_rate":0.9986563013500164},{"cnt":[[309,726],[1876,726],[1876,771],[309,771]],"region":{"top_left_x":309,"top_left_y":726,"width":1567,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1502006564b4063a4844bdcc1b3995d","type":"text","conversion_output":true,"text":"A premature discontinuation will occur when a patient who signed the informed consent form","text_display":"\n\nA premature discontinuation will occur when a patient who signed the informed consent form","confidence":0.98876953125,"confidence_rate":0.9998811227862585},{"cnt":[[309,786],[1869,786],[1869,831],[309,831]],"region":{"top_left_x":309,"top_left_y":786,"width":1561,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d67ab1d03b3746e8b9f118567e7365d0","type":"text","conversion_output":true,"text":"(ICF) and has been randomized ceases participation in the study, regardless of circumstances,","text_display":" (ICF) and has been randomized ceases participation in the study, regardless of circumstances,","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[309,846],[1841,846],[1841,892],[309,892]],"region":{"top_left_x":309,"top_left_y":846,"width":1533,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1ca72aedb714607a849da02d896410d","type":"text","conversion_output":true,"text":"before completion of the study. Patients can be prematurely discontinued from the study for","text_display":" before completion of the study. Patients can be prematurely discontinued from the study for","confidence":1,"confidence_rate":1},{"cnt":[[309,907],[799,907],[799,952],[309,952]],"region":{"top_left_x":309,"top_left_y":906,"width":491,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ce9638db8b54112820fa985c31d2509","type":"text","conversion_output":true,"text":"one of the following reasons:","text_display":" one of the following reasons:","confidence":1,"confidence_rate":1},{"cnt":[[361,1010],[483,1010],[483,1046],[361,1046]],"region":{"top_left_x":360,"top_left_y":1009,"width":124,"height":38},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5afb8286721e4c0991a4d4e88e5f4067","type":"text","conversion_output":true,"text":"- AE","text_display":"\n- AE","confidence":1,"confidence_rate":1},{"cnt":[[361,1096],[728,1096],[728,1132],[361,1132]],"region":{"top_left_x":360,"top_left_y":1095,"width":369,"height":38},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a405f76568d4eef88afa2b677d4198f","type":"text","conversion_output":true,"text":"- Protocol violation","text_display":"\n- Protocol violation","confidence":1,"confidence_rate":1},{"cnt":[[361,1177],[823,1177],[823,1222],[361,1222]],"region":{"top_left_x":360,"top_left_y":1177,"width":463,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa6ff4f89f6b459cb321ccd0d848e22a","type":"text","conversion_output":true,"text":"- Noncompliance with IP","text_display":"\n- Noncompliance with IP","confidence":1,"confidence_rate":1},{"cnt":[[361,1263],[1429,1263],[1429,1308],[361,1308]],"region":{"top_left_x":360,"top_left_y":1263,"width":1069,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81e60489f2e7480cbaf4d6621b099041","type":"text","conversion_output":true,"text":"- Withdrawal of consent (a clear reason must be documented)","text_display":"\n- Withdrawal of consent (a clear reason must be documented)","confidence":1,"confidence_rate":1},{"cnt":[[361,1345],[1596,1345],[1596,1390],[361,1390]],"region":{"top_left_x":360,"top_left_y":1344,"width":1237,"height":47},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8007d35de75649cfb30db42c2e4ae826","type":"text","conversion_output":true,"text":"- Lost to follow-up. (Every effort must be made to contact the patient; a","text_display":"\n- Lost to follow-up. 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Notification of early patient","text_display":"\n\nPatients may voluntarily withdraw from the study at any time. 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An AE can therefore be any unfavorable and unintended sign","confidence":1,"confidence_rate":1},{"cnt":[[307,2423],[1850,2423],[1850,2473],[307,2473]],"region":{"top_left_x":307,"top_left_y":2423,"width":1543,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5eb2d5c8829d4c519dcbfbb451227daf","type":"text","conversion_output":true,"text":"(including an abnormal laboratory finding), symptom, or disease temporally associated with","text_display":" (including an abnormal laboratory finding), symptom, or disease temporally associated with","confidence":1,"confidence_rate":1},{"cnt":[[1038,2527],[1089,2527],[1089,2561],[1038,2561]],"region":{"top_left_x":1037,"top_left_y":2526,"width":53,"height":35},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b83f49910a254e1fafc3c03420105096","type":"page_info","conversion_output":false,"text":"60","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[507,2625],[700,2625],[700,2662],[507,2662]],"region":{"top_left_x":507,"top_left_y":2625,"width":194,"height":37},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"372ee5867b0c4ef49a88ba831023cd5c","type":"page_info","conversion_output":false,"text":"UBR-MD-02","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1038,2625],[1089,2625],[1089,2662],[1038,2662]],"region":{"top_left_x":1037,"top_left_y":2625,"width":53,"height":37},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e55487cb56044867b280b07887b9c50a","type":"page_info","conversion_output":false,"text":"60","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"b79a4e99-2c62-433f-94cd-d3b521e11517-062","page":62,"lines":[{"cnt":[[309,146],[621,146],[621,187],[309,187]],"region":{"top_left_x":309,"top_left_y":146,"width":312,"height":41},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc3280d4518544ed9e3e1d51c5590c44","type":"page_info","conversion_output":false,"text":"Allergan Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1336,148],[1858,148],[1858,183],[1336,183]],"region":{"top_left_x":1336,"top_left_y":148,"width":523,"height":35},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"428445bbd75a4f1ca3b7391abd943509","type":"page_info","conversion_output":false,"text":"Protocol UBR-MD-02 Amendment 3","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,254],[1768,254],[1768,299],[309,299]],"region":{"top_left_x":309,"top_left_y":253,"width":1460,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5799efcba7184717816a00f142661c8d","type":"text","conversion_output":true,"text":"the use of a medicinal (investigational) product, whether or not related to the medicinal","text_display":"\nthe use of a medicinal (investigational) product, whether or not related to the medicinal","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[1772,314],[1772,359],[309,359]],"region":{"top_left_x":309,"top_left_y":313,"width":1464,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3084ff02d9b44c7a3217f372dea4983","type":"text","conversion_output":true,"text":"(investigational) product. In addition, during the screening period, AEs will be assessed","text_display":" (investigational) product. In addition, during the screening period, AEs will be assessed","confidence":1,"confidence_rate":1},{"cnt":[[309,374],[1326,374],[1326,419],[309,419]],"region":{"top_left_x":309,"top_left_y":373,"width":1017,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"590da7cc3adc44fcacc69840454d6db5","type":"text","conversion_output":true,"text":"regardless of the administration of a pharmaceutical product.","text_display":" regardless of the administration of a pharmaceutical product.","confidence":1,"confidence_rate":1},{"cnt":[[309,520],[309,473],[1738,475],[1738,522]],"region":{"top_left_x":309,"top_left_y":472,"width":1430,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32691b85970346b0a99afdda3ceabfa2","type":"text","conversion_output":true,"text":"Note: AEs must be collected once informed consent has been obtained, regardless of","text_display":"\n\nNote: AEs must be collected once informed consent has been obtained, regardless of","confidence":1,"confidence_rate":1},{"cnt":[[309,535],[1319,535],[1319,580],[309,580]],"region":{"top_left_x":309,"top_left_y":534,"width":1011,"height":47},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cb107c492f54a56a817f279de5483e0","type":"text","conversion_output":true,"text":"whether or not the patient has been administered study drug.","text_display":" whether or not the patient has been administered study drug.","confidence":1,"confidence_rate":1},{"cnt":[[309,636],[1846,636],[1846,681],[309,681]],"region":{"top_left_x":309,"top_left_y":635,"width":1537,"height":47},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1787fca41b644097ab1f57afaddadc99","type":"text","conversion_output":true,"text":"Progression of treatment indication including new or worsening of anticipated clinical signs","text_display":"\n\nProgression of treatment indication including new or worsening of anticipated clinical signs","confidence":1,"confidence_rate":1},{"cnt":[[309,696],[1876,696],[1876,741],[309,741]],"region":{"top_left_x":309,"top_left_y":696,"width":1567,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f583588def3e478d807320fc9814c528","type":"text","conversion_output":true,"text":"or symptoms, which are collected as clinical efficacy variables and assessed as unequivocally","text_display":" or symptoms, which are collected as clinical efficacy variables and assessed as unequivocally","confidence":1,"confidence_rate":1},{"cnt":[[309,756],[1833,756],[1833,801],[309,801]],"region":{"top_left_x":309,"top_left_y":756,"width":1524,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28de29ef4c6b4c6bb0c4b33a4f96943b","type":"text","conversion_output":true,"text":"associated with the disease progression and/or lack of efficacy, should NOT be reported as","text_display":" associated with the disease progression and/or lack of efficacy, should NOT be reported as","confidence":0.71240234375,"confidence_rate":0.996436758857887},{"cnt":[[309,816],[1794,816],[1794,862],[309,862]],"region":{"top_left_x":309,"top_left_y":816,"width":1485,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88ee8d9c160542b58e22f1b8f6cef224","type":"text","conversion_output":true,"text":"AEs unless the disease progression is greater than anticipated in the natural course of the","text_display":" AEs unless the disease progression is greater than anticipated in the natural course of the","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[309,877],[445,877],[445,913],[309,913]],"region":{"top_left_x":309,"top_left_y":876,"width":136,"height":38},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d39272a0dba4bf6afe508a4e3b4c87b","type":"text","conversion_output":true,"text":"disease.","text_display":" disease.","confidence":1,"confidence_rate":1},{"cnt":[[309,978],[1876,978],[1876,1025],[309,1025]],"region":{"top_left_x":309,"top_left_y":977,"width":1567,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d453cd886b54f579c22ebdac15b0b28","type":"text","conversion_output":true,"text":"Adverse events will be assessed, documented, and recorded in the eCRF throughout the study","text_display":"\n\nAdverse events will be assessed, documented, and recorded in the eCRF throughout the study","confidence":1,"confidence_rate":1},{"cnt":[[309,1038],[1818,1038],[1818,1085],[309,1085]],"region":{"top_left_x":309,"top_left_y":1037,"width":1509,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8ce909c13f8412e9f07d29068a32b27","type":"text","conversion_output":true,"text":"(ie, after informed consent has been obtained). At each visit, the investigator will begin by","text_display":" (ie, after informed consent has been obtained). At each visit, the investigator will begin by","confidence":1,"confidence_rate":1},{"cnt":[[309,1096],[1858,1096],[1858,1145],[309,1145]],"region":{"top_left_x":309,"top_left_y":1095,"width":1550,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96be1a9328784316a9297e68a6260664","type":"text","conversion_output":true,"text":"querying for AEs by asking each patient a general, non-directed question such as \"How have","text_display":" querying for AEs by asking each patient a general, non-directed question such as \"How have","confidence":1,"confidence_rate":1},{"cnt":[[309,1156],[1790,1156],[1790,1205],[309,1205]],"region":{"top_left_x":309,"top_left_y":1155,"width":1481,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fdcf9fd17884cb582f2b838aad13baf","type":"text","conversion_output":true,"text":"you been feeling since the last visit?\" Directed questioning and examination will then be","text_display":" you been feeling since the last visit?\" Directed questioning and examination will then be","confidence":1,"confidence_rate":1},{"cnt":[[309,1216],[1712,1216],[1712,1261],[309,1261]],"region":{"top_left_x":309,"top_left_y":1216,"width":1404,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4367d4427afe4179b932e27c7f5b17fa","type":"text","conversion_output":true,"text":"done as appropriate. All reported AEs will be documented on the appropriate eCRF.","text_display":" done as appropriate. All reported AEs will be documented on the appropriate eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[305,1319],[1033,1319],[1033,1369],[305,1369]],"region":{"top_left_x":305,"top_left_y":1319,"width":729,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81ce48ee986749dc85fa972f49a999cb","type":"section_header","conversion_output":false,"children_ids":["49dd455900e74128a9e194b1bd28ac05"],"text":"","text_display":""},{"cnt":[[309,1323],[1029,1323],[1029,1364],[309,1364]],"region":{"top_left_x":309,"top_left_y":1323,"width":721,"height":42},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49dd455900e74128a9e194b1bd28ac05","type":"text","conversion_output":true,"parent_id":"81ce48ee986749dc85fa972f49a999cb","text":"9.1.2 Serious Adverse Event","text_display":"\n\n\\subsection*{9.1.2 Serious Adverse Event}","confidence":1,"confidence_rate":1},{"cnt":[[309,1409],[1871,1409],[1871,1454],[309,1454]],"region":{"top_left_x":309,"top_left_y":1409,"width":1563,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6cf1a91cc28497bb405417128b453d8","type":"text","conversion_output":true,"text":"An SAEis any AE occurring at any dose that results in any of the following outcomes: death,","text_display":"\n\nAn SAEis any AE occurring at any dose that results in any of the following outcomes: death,","confidence":1,"confidence_rate":1},{"cnt":[[309,1470],[1721,1470],[1721,1515],[309,1515]],"region":{"top_left_x":309,"top_left_y":1469,"width":1412,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec7b27f3190342788bccec659d24233c","type":"text","conversion_output":true,"text":"a life-threatening adverse event, inpatient hospitalization or prolongation of existing","text_display":" a life-threatening adverse event, inpatient hospitalization or prolongation of existing","confidence":1,"confidence_rate":1},{"cnt":[[309,1530],[1858,1530],[1858,1575],[309,1575]],"region":{"top_left_x":309,"top_left_y":1529,"width":1550,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdaa565af74a49fe865c789e1abad7d1","type":"text","conversion_output":true,"text":"hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth","text_display":" hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth","confidence":1,"confidence_rate":1},{"cnt":[[309,1590],[1837,1590],[1837,1635],[309,1635]],"region":{"top_left_x":309,"top_left_y":1589,"width":1528,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"189d8bbba14b42d4ba1c79daa7cef9c1","type":"text","conversion_output":true,"text":"defect. Important medical events that may not result in death, be life-threatening, or require","text_display":" defect. Important medical events that may not result in death, be life-threatening, or require","confidence":1,"confidence_rate":1},{"cnt":[[309,1650],[1841,1650],[1841,1695],[309,1695]],"region":{"top_left_x":309,"top_left_y":1650,"width":1533,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a49f2f2868bd4a748329242ccc9eaf61","type":"text","conversion_output":true,"text":"hospitalization may be considered an SAEwhen, based upon appropriate medical judgment,","text_display":" hospitalization may be considered an SAEwhen, based upon appropriate medical judgment,","confidence":1,"confidence_rate":1},{"cnt":[[309,1710],[1841,1710],[1841,1755],[309,1755]],"region":{"top_left_x":309,"top_left_y":1710,"width":1533,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84fce865f7ca4967a6979bf2f37b3406","type":"text","conversion_output":true,"text":"they may jeopardize the patient and may require medical or surgical intervention to prevent","text_display":" they may jeopardize the patient and may require medical or surgical intervention to prevent","confidence":1,"confidence_rate":1},{"cnt":[[309,1770],[1807,1770],[1807,1815],[309,1815]],"region":{"top_left_x":309,"top_left_y":1770,"width":1498,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13cdef7725924e93a5323eddb710b07e","type":"text","conversion_output":true,"text":"one of the outcomes listed in this definition. (See Section 9.3 for procedures for reporting","text_display":" one of the outcomes listed in this definition. (See Section 9.3 for procedures for reporting","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[309,1830],[432,1830],[432,1876],[309,1876]],"region":{"top_left_x":309,"top_left_y":1830,"width":123,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14fae951559940ff9f300e05099bc704","type":"text","conversion_output":true,"text":"SAEs.)","text_display":" SAEs.)","confidence":1,"confidence_rate":1},{"cnt":[[309,1929],[1785,1929],[1785,1979],[309,1979]],"region":{"top_left_x":309,"top_left_y":1929,"width":1477,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fe4b27207f64b5384c45f6af993bb1b","type":"text","conversion_output":true,"text":"Allergan considers all cancer AEs as SAEs. In addition, Allergan considers any abortion","text_display":"\n\nAllergan considers all cancer AEs as SAEs. 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If it has not been documented at the time of the patient's entry into the study, then it","text_display":" study. 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The severity","text_display":"\n\nA clinical determination will be made of the intensity of an adverse event. The severity","confidence":1,"confidence_rate":1},{"cnt":[[309,404],[1869,404],[1869,449],[309,449]],"region":{"top_left_x":309,"top_left_y":403,"width":1561,"height":47},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9561a31db3943978f5a17c41ad16da7","type":"text","conversion_output":true,"text":"assessment for a clinical AE must be completed using the following definitions as guidelines:","text_display":" assessment for a clinical AE must be completed using the following definitions as guidelines:","confidence":1,"confidence_rate":1},{"cnt":[[324,524],[1646,524],[1646,754],[324,754]],"region":{"top_left_x":324,"top_left_y":524,"width":1322,"height":231},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"412c4ad522e842938a852ca792af9fb7","type":"table","conversion_output":true,"text":"\\begin{tabular}{ll} \nMild & Awareness of sign or symptom, but easily tolerated \\\\\nModerate & Discomfort enough to cause interference with usual activity \\\\\nSevere & Incapacitating with inability to work or do usual activity\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{ll} \nMild & Awareness of sign or symptom, but easily tolerated \\\\\nModerate & Discomfort enough to cause interference with usual activity \\\\\nSevere & Incapacitating with inability to work or do usual activity\n\\end{tabular}","confidence":0.9956088066101074,"confidence_rate":0.9999815091499605},{"cnt":[[305,795],[1549,795],[1549,853],[305,853]],"region":{"top_left_x":305,"top_left_y":794,"width":1245,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf1f2e93123e4fcba1433352386b8422","type":"section_header","conversion_output":false,"children_ids":["d6471364189f4994ba77d81e5807e49a"],"text":"","text_display":""},{"cnt":[[309,799],[1547,799],[1547,851],[309,851]],"region":{"top_left_x":309,"top_left_y":799,"width":1238,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6471364189f4994ba77d81e5807e49a","type":"text","conversion_output":true,"parent_id":"cf1f2e93123e4fcba1433352386b8422","text":"9.1.4 Relationship to Study Drug or Study Procedure","text_display":"\n\n\\subsection*{9.1.4 Relationship to Study Drug or Study Procedure}","confidence":1,"confidence_rate":1},{"cnt":[[309,885],[1841,885],[1841,930],[309,930]],"region":{"top_left_x":309,"top_left_y":885,"width":1533,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90671ea8695549be860fd08ffe5ecab4","type":"text","conversion_output":true,"text":"A determination will be made of the relationship (if any) between an AE and the study drug","text_display":"\n\nA determination will be made of the relationship (if any) between an AE and the study drug","confidence":1,"confidence_rate":1},{"cnt":[[309,945],[1846,945],[1846,990],[309,990]],"region":{"top_left_x":309,"top_left_y":945,"width":1537,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79d27e73839245e8b742effb4ba3c531","type":"text","conversion_output":true,"text":"or study procedure, as applicable. A causal relationship is present if a determination is made","text_display":" or study procedure, as applicable. 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but the reverse and","text_display":" visual, then sensory, then aphasic; but the reverse and","confidence":1,"confidence_rate":1},{"cnt":[[1091,1018],[1699,1018],[1699,1051],[1091,1051]],"region":{"top_left_x":1091,"top_left_y":1018,"width":609,"height":33},"line":78,"column":2,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"adcdbe4b2fdb48baa405a81983ab77e2","type":"text","conversion_output":true,"parent_id":"7250a610e4ff4e06811848f32959aa41","text":"other orders have been noted. The accepted duration","text_display":" other orders have been noted. 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The clinical picture","text_display":" time and record them prospectively. The clinical picture","confidence":1,"confidence_rate":1},{"cnt":[[1091,1199],[1699,1199],[1699,1233],[1091,1233]],"region":{"top_left_x":1091,"top_left_y":1198,"width":609,"height":36},"line":84,"column":2,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c17f68c6b8f048f1958adbe3e31c962b","type":"text","conversion_output":true,"parent_id":"7250a610e4ff4e06811848f32959aa41","text":"then becomes clearer. Common mistakes are incorrect","text_display":" then becomes clearer. Common mistakes are incorrect","confidence":0.99951171875,"confidence_rate":0.9999912786005654},{"cnt":[[1091,1233],[1699,1233],[1699,1265],[1091,1265]],"region":{"top_left_x":1091,"top_left_y":1233,"width":609,"height":33},"line":85,"column":2,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"0b13a4c3150a4713af682f4a061c41c7","type":"text","conversion_output":true,"parent_id":"7250a610e4ff4e06811848f32959aa41","text":"reports of lateralization, of sudden rather than gradual","text_display":" reports of lateralization, of sudden rather than gradual","confidence":1,"confidence_rate":1},{"cnt":[[1091,1263],[1699,1263],[1699,1296],[1091,1296]],"region":{"top_left_x":1091,"top_left_y":1263,"width":609,"height":33},"line":86,"column":2,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6c2e49833b1444adb205a4603a1d9a75","type":"text","conversion_output":true,"parent_id":"7250a610e4ff4e06811848f32959aa41","text":"onset and of monocular rather than homonymous","text_display":" onset and of monocular rather than homonymous","confidence":1,"confidence_rate":1},{"cnt":[[1091,1293],[1699,1293],[1699,1326],[1091,1326]],"region":{"top_left_x":1091,"top_left_y":1293,"width":609,"height":33},"line":87,"column":2,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e3425301cf844809a5924d1d54be06fc","type":"text","conversion_output":true,"parent_id":"7250a610e4ff4e06811848f32959aa41","text":"visual disturbances, as well as of duration of aura and","text_display":" visual disturbances, as well as of duration of aura and","confidence":1,"confidence_rate":1},{"cnt":[[1089,1323],[1699,1323],[1699,1356],[1089,1356]],"region":{"top_left_x":1089,"top_left_y":1323,"width":611,"height":33},"line":88,"column":2,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e00b67db1b0847e3b83d9c15382233c9","type":"text","conversion_output":true,"parent_id":"7250a610e4ff4e06811848f32959aa41","text":"mistaking sensory loss for weakness. 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\\\\\n\\hline Antibiotics & Rifabutin (Mycobutin \\({ }^{\\text {R }}\\) ) Rifampicin/ Rifampin (Rifadin \\({ }^{®}\\), Rifater \\({ }^{®}\\), Rimactane \\({ }^{\\text {® }}\\) ) & Erythromycin ( Benzamycin \\({ }^{\\text {® }}\\), EryTab \\({ }^{\\text {® }}\\) ) Clarithromycin (Biaxin \\({ }^{\\text {® }}\\) ) Telithromycin (Ketek \\({ }^{\\circledR}\\) ) \\\\\n\\hline Antifungal & & Fluconazole (Diflucan \\({ }^{\\text {® }}\\), Trican \\({ }^{\\text {® }}\\) ) Itraconazole (Sporanox \\({ }^{\\circledR}\\) ) Ketoconazole (Nizoral \\({ }^{\\text {® }}\\) ) \\\\\n\\hline Anti-HIV & Efavirenz (Stocrin \\({ }^{(R)}\\), Sustiva \\({ }^{(R)}\\) ) Nevirapine (Viramune \\({ }^{\\circledR}\\) ) & \\begin{tabular}{l}\nIndinavir (Crixivan \\({ }^{\\text {® }}\\) ) \\\\\nNelfinavir (Viracept \\({ }^{\\text {® }}\\) ) \\\\\nRitonavir (Norvir \\({ }^{\\text {R }}\\) ) \\\\\nSaquinavir (Fortovase \\({ }^{\\text {® }}\\), Invirase \\({ }^{\\text {® }}\\) )\n\\end{tabular} \\\\\n\\hline Immunosuppressant & & Cyclosporine - oral/IV only (Neoral \\({ }^{(R)}\\), Sandimmune \\({ }^{\\text {® }}\\) ) \\\\\n\\hline Other & \\begin{tabular}{l}\nSt John's Wort \\\\\nEnzalutamide (Xtandi \\({ }^{\\circledR}\\) ) \\\\\nModafinil (Provigil \\({ }^{\\text {® }}\\) )\n\\end{tabular} & Buprenorphine (Cizol º, Subutex º, Suboxone \\({ }^{\\text {® }}\\) ), Quinine, armodafinil (Nuvigil \\({ }^{ TM }\\) ) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline & Strong/Moderate CYP3A4 Inducers & Strong/Moderate CYP3A4 Inhibitors \\\\\n\\hline Antidepressant/ Antianxiety & \\begin{tabular}{l}\nBarbiturates \\\\\n- Amobarbital (Amytal \\({ }^{\\text {® }}\\) ) \\\\\n- Aprobarbital (Alurate \\({ }^{\\text {® }}\\) ) \\\\\n- Butalbital (Fiorinal \\({ }^{ R }\\), Fioricet \\({ }^{\\text {® }}\\) ) \\\\\n- Butabarbital (Busodium \\({ }^{\\circledR}\\), Butisol \\({ }^{\\text {® }}\\) ) \\\\\n- Mephobarbital (Mebaral \\({ }^{\\text {® }}\\) ) \\\\\n- 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Calan SR \\({ }^{\\circledR}\\) ) \\\\\n\\hline Glucocorticoid (Systemic) & \\begin{tabular}{l}\nBetamethasone (Celestone \\({ }^{\\text {® }}\\) ) \\\\\nDexamethasone (Baycadron \\({ }^{\\circledR}\\), DexPak \\({ }^{\\text {® }}\\) ) \\\\\nHydrocortisone (Cortef \\({ }^{\\text {® }}\\) ) Methylprednisolone (Medrol \\({ }^{\\text {® }}\\) ) Prednisolone (Prelone \\({ }^{\\circledR}\\) ) Prednisone (Deltasone \\({ }^{\\circledR}\\) ) Triamcinolone (Kenalog \\({ }^{\\circledR}\\) )\n\\end{tabular} & \\\\\n\\hline Antibiotics & Rifabutin (Mycobutin \\({ }^{\\text {R }}\\) ) Rifampicin/ Rifampin (Rifadin \\({ }^{®}\\), Rifater \\({ }^{®}\\), Rimactane \\({ }^{\\text {® }}\\) ) & Erythromycin ( Benzamycin \\({ }^{\\text {® }}\\), EryTab \\({ }^{\\text {® }}\\) ) Clarithromycin (Biaxin \\({ }^{\\text {® }}\\) ) Telithromycin (Ketek \\({ }^{\\circledR}\\) ) \\\\\n\\hline Antifungal & & Fluconazole (Diflucan \\({ }^{\\text {® }}\\), Trican \\({ }^{\\text {® }}\\) ) Itraconazole (Sporanox \\({ 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}^{\\oplus}\\), Propulsid \\({ }^{\\oplus}\\) ) \\\\\nPimozide (Orap \\({ }^{®}\\) )\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Drugs with Narrow Therapeutic Margins & \\begin{tabular}{l} \nWarfarin (Coumadin \\({ }^{\\oplus}\\) ) \\\\\nDigoxin (Digitek \\({ }^{\\oplus}\\), Lanoxin \\(^{®}\\), Digox \\(^{\\oplus}\\) ) \\\\\nCisapride (Prepulsid \\({ }^{\\oplus}\\), Propulsid \\({ }^{\\oplus}\\) ) \\\\\nPimozide (Orap \\({ }^{®}\\) )\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.022383290925900814,"confidence_rate":0.9867107801125701},{"cnt":[[309,511],[1867,511],[1867,561],[309,561]],"region":{"top_left_x":309,"top_left_y":511,"width":1558,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62d333c9164d45dc91871f4b64b8fd53","type":"text","conversion_output":true,"text":"The following medications are allowed during the study; however, they are prohibited 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Triptan & \\begin{tabular}{l}\nAlmotriptan (Axert \\({ }^{( B )}\\) ) \\\\\nEletriptan (Relpax \\({ }^{\\text {® }}\\) ) \\\\\nFrovatriptan (Frova \\({ }^{\\text {® }}\\) ) \\\\\nNaratriptan (Amerge \\({ }^{\\circledR}\\) ) \\\\\nRizatriptan (Maxalt \\({ }^{\\text {® }}\\) ) \\\\\nSumatriptan (Imitrex \\({ }^{\\text {® }}\\) ) \\\\\nZolmitriptan (Zomig \\({ }^{\\text {® }}\\) )\n\\end{tabular} \\\\\n\\hline Ergot Derivative & \\begin{tabular}{l}\nDihydroergotamine (DHE \\(45^{\\circ}\\), Migranal \\({ }^{\\circ}\\) ) \\\\\nErgotamine (Cafergot \\({ }^{®}\\), Ergomar \\({ }^{®}\\), Wigraine \\({ }^{®}\\) )\n\\end{tabular} \\\\\n\\hline Opioid & \\begin{tabular}{l}\nTramadol (eg, Ultracet \\({ }^{( R )}\\), Ultram \\({ }^{( R )}\\) ) \\\\\nButorphanol (Stadol \\({ }^{\\circledR}\\) ) \\\\\nCodeine-containing analgesics (eg, Tylenol with Codeine \\#3 \\({ }^{\\text {® }}\\) ) \\\\\nHydrocodone (Zohydro ER™)/Hydrocodone-containing analgesics (eg, Vicodin \\({ }^{\\text {® }}\\) ) \\\\\nOxycodone (Oxycontin \\({ }^{\\text {® }}\\), Roxicodone \\({ }^{\\text {® }}\\) )/Oxycodone-containing analgesics (eg, Percocet ) \\\\\nMorphine (MS Contin \\({ }^{\\circledR}\\) )\n\\end{tabular} \\\\\n\\hline NSAID & \\begin{tabular}{l}\nAspirin \\\\\nCombination medicines with NSAIDs (eg, Excedrin \\({ }^{\\text {® }}\\) ) \\\\\nDiclofenac (Arthrotec \\({ }^{(\\text {® })}\\), Cataflam \\({ }^{\\text {® }}\\), Voltaren \\({ }^{\\text {® }}\\) ) \\\\\nIbuprofen (eg, Advil \\({ }^{\\circledR}\\), Excedrin IB \\({ }^{\\circledR}\\), Motrin \\({ }^{\\circledR}\\) ) \\\\\nKetoprofen (eg, Orudis \\({ }^{\\text {® }}\\) ) \\\\\nNaproxen (eg, Aleve \\({ }^{\\text {® }}\\), Naprosyn \\({ }^{\\text {® }}\\) )\n\\end{tabular} \\\\\n\\hline Analgesic & Acetaminophen (eg, Tylenol \\({ }^{\\text {® }}\\) or any combination drug Tylenol \\({ }^{\\text {® }}\\) ) \\\\\n\\hline Antiemetic agent & \\begin{tabular}{l}\nChlorpromazine (Thorazine \\({ }^{(B)}\\) ) \\\\\nHydroxyzine (Vistaril \\({ 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Triptan & \\begin{tabular}{l}\nAlmotriptan (Axert \\({ }^{( B )}\\) ) \\\\\nEletriptan (Relpax \\({ }^{\\text {® }}\\) ) \\\\\nFrovatriptan (Frova \\({ }^{\\text {® }}\\) ) \\\\\nNaratriptan (Amerge \\({ }^{\\circledR}\\) ) \\\\\nRizatriptan (Maxalt \\({ }^{\\text {® }}\\) ) \\\\\nSumatriptan (Imitrex \\({ }^{\\text {® }}\\) ) \\\\\nZolmitriptan (Zomig \\({ }^{\\text {® }}\\) )\n\\end{tabular} \\\\\n\\hline Ergot Derivative & \\begin{tabular}{l}\nDihydroergotamine (DHE \\(45^{\\circ}\\), Migranal \\({ }^{\\circ}\\) ) \\\\\nErgotamine (Cafergot \\({ }^{®}\\), Ergomar \\({ }^{®}\\), Wigraine \\({ }^{®}\\) )\n\\end{tabular} \\\\\n\\hline Opioid & \\begin{tabular}{l}\nTramadol (eg, Ultracet \\({ }^{( R )}\\), Ultram \\({ }^{( R )}\\) ) \\\\\nButorphanol (Stadol \\({ }^{\\circledR}\\) ) \\\\\nCodeine-containing analgesics (eg, Tylenol with Codeine \\#3 \\({ }^{\\text {® }}\\) ) \\\\\nHydrocodone (Zohydro ER™)/Hydrocodone-containing analgesics (eg, Vicodin \\({ }^{\\text {® }}\\) ) 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