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If this is not available, then the last non-missing value prior to the","text_display":"\nmissing value on or prior to Day 1). If this is not available, then the last non-missing value prior to the","confidence":1,"confidence_rate":1},{"cnt":[[305,395],[1800,395],[1800,440],[305,440]],"region":{"top_left_x":305,"top_left_y":395,"width":1496,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aedba6bd847946fcbf321011d55ac59b","type":"text","conversion_output":true,"text":"first dose of double-blind study medication (including unscheduled assessments) will be used as","text_display":" first dose of double-blind study medication (including unscheduled assessments) will be used as","confidence":1,"confidence_rate":1},{"cnt":[[305,443],[453,443],[453,483],[305,483]],"region":{"top_left_x":305,"top_left_y":442,"width":149,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ff93d06d39a45199e2efeeeafaf73ef","type":"text","conversion_output":true,"text":"baseline.","text_display":" baseline.","confidence":1,"confidence_rate":1},{"cnt":[[301,552],[1695,552],[1695,621],[301,621]],"region":{"top_left_x":300,"top_left_y":552,"width":1396,"height":69},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac50799439b04cdd869b537c150ef209","type":"section_header","conversion_output":false,"children_ids":["090926fac4f94dfa8d8030c37978315b"],"text":"","text_display":""},{"cnt":[[305,556],[1691,556],[1691,614],[305,614]],"region":{"top_left_x":305,"top_left_y":556,"width":1386,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"090926fac4f94dfa8d8030c37978315b","type":"text","conversion_output":true,"parent_id":"ac50799439b04cdd869b537c150ef209","text":"6.3. Retests, Unscheduled Visits and Early Termination Data","text_display":"\n\n\\subsection*{6.3. 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Primary Efficacy Variable \\& Derivation}","confidence":1,"confidence_rate":1},{"cnt":[[305,730],[1949,730],[1949,776],[305,776]],"region":{"top_left_x":305,"top_left_y":730,"width":1644,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94d5ad3dfedb4bd896640cf4ded985e9","type":"text","conversion_output":true,"text":"The primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C. Baseline LDL-C is","text_display":"\n\nThe primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C. Baseline LDL-C is","confidence":1,"confidence_rate":1},{"cnt":[[307,776],[1949,776],[1949,823],[307,823]],"region":{"top_left_x":307,"top_left_y":775,"width":1642,"height":48},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1be5ee65b53b4e25be3fd367d50a2e50","type":"text","conversion_output":true,"text":"defined as the mean of the LDL-C values from Week-1 (Visit S3) and predose Day 1/Week 0 (Visit T1)","text_display":" defined as the mean of the LDL-C values from Week-1 (Visit S3) and predose Day 1/Week 0 (Visit T1)","confidence":0.9078912734985352,"confidence_rate":0.9990888054807056},{"cnt":[[309,821],[1089,821],[1089,870],[309,870]],"region":{"top_left_x":309,"top_left_y":820,"width":781,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6dd75f31724a4a959176149a307669d2","type":"text","conversion_output":true,"text":"(last two non-missing values on or prior to Day 1).","text_display":" (last two non-missing values on or prior to Day 1).","confidence":0.9795362949371338,"confidence_rate":0.999630854084545},{"cnt":[[309,915],[1949,915],[1949,960],[309,960]],"region":{"top_left_x":309,"top_left_y":915,"width":1640,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51d376fe69ec452796a3b3d3c115d0b8","type":"text","conversion_output":true,"text":"In cases where triglycerides (TG) is \\(>400 mg / dL\\) or LDL-C is \\(\\leq 50 mg / dL\\), a measured LDL (LDL-M) will be","text_display":"\n\nIn cases where triglycerides (TG) is \\(>400 mg / dL\\) or LDL-C is \\(\\leq 50 mg / dL\\), a measured LDL (LDL-M) will be","confidence":0.965550888213329,"confidence_rate":0.9997150286452896},{"cnt":[[309,962],[1949,962],[1949,1008],[309,1008]],"region":{"top_left_x":309,"top_left_y":962,"width":1640,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3bebe1a226f545c8b4ab3b64931838c0","type":"text","conversion_output":true,"text":"used instead of LDL-C for the analysis of that time point. 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If both values are available, the LDL-M will be","confidence":1,"confidence_rate":1},{"cnt":[[309,1010],[397,1010],[397,1051],[309,1051]],"region":{"top_left_x":309,"top_left_y":1009,"width":89,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85903b3fd5b847e5bb08cfa06aa8217a","type":"text","conversion_output":true,"text":"used.","text_display":" used.","confidence":1,"confidence_rate":1},{"cnt":[[305,1113],[1248,1113],[1248,1171],[305,1171]],"region":{"top_left_x":305,"top_left_y":1112,"width":944,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e130621e2684e7db95f19506c4801ab","type":"section_header","conversion_output":false,"children_ids":["05da1f61315d45cd89829adbaa96af13"],"text":"","text_display":""},{"cnt":[[309,1117],[1244,1117],[1244,1164],[309,1164]],"region":{"top_left_x":309,"top_left_y":1117,"width":935,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05da1f61315d45cd89829adbaa96af13","type":"text","conversion_output":true,"parent_id":"7e130621e2684e7db95f19506c4801ab","text":"17.1.2. 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The alternative hypothesis, \\(H _{1}\\), will","text_display":" placebo in mean percent change from baseline to Week 12 in LDL-C. The alternative hypothesis, \\(H _{1}\\), will","confidence":1,"confidence_rate":1},{"cnt":[[305,1311],[1278,1311],[1278,1360],[305,1360]],"region":{"top_left_x":305,"top_left_y":1310,"width":974,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1284cf551a9d44eab97805974b25d5d2","type":"text","conversion_output":true,"text":"be that bempedoic acid \\(180 mg /\\) day is different from placebo:","text_display":" be that bempedoic acid \\(180 mg /\\) day is different from placebo:","confidence":1,"confidence_rate":1},{"cnt":[[425,1358],[610,1358],[610,1463],[425,1463]],"region":{"top_left_x":425,"top_left_y":1357,"width":186,"height":107},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a407867f928409ca3b1a080376c9b42","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& H_{0}: \\mu_{p}=\\mu_{b} \\\\\n& H_{1}: \\mu_{p} \\neq \\mu_{b}\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& H_{0}: \\mu_{p}=\\mu_{b} \\\\\n& H_{1}: \\mu_{p} \\neq \\mu_{b}\n\\end{aligned}\n\\]","confidence":0.9873046875,"confidence_rate":0.9998531534660081},{"cnt":[[305,1465],[1884,1465],[1884,1515],[305,1515]],"region":{"top_left_x":305,"top_left_y":1465,"width":1580,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5286c9179adb41228824eda82d1caadb","type":"text","conversion_output":true,"text":"where \\(\\mu_{p}\\) and \\(\\mu_{b}\\) denote the mean percent change from baseline to Week 12 in LDL-C on placebo and","text_display":"\nwhere \\(\\mu_{p}\\) and \\(\\mu_{b}\\) denote the mean percent change from baseline to Week 12 in LDL-C on placebo and","confidence":0.9765737056732178,"confidence_rate":0.9998072945694774},{"cnt":[[305,1512],[960,1512],[960,1562],[305,1562]],"region":{"top_left_x":305,"top_left_y":1512,"width":656,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2603755002fd4a7ebc874f5cb5d94bb7","type":"text","conversion_output":true,"text":"bempedoic acid \\(180 mg /\\) day respectively.","text_display":" bempedoic acid \\(180 mg /\\) day respectively.","confidence":1,"confidence_rate":1},{"cnt":[[305,1581],[1897,1581],[1897,1629],[305,1629]],"region":{"top_left_x":305,"top_left_y":1581,"width":1593,"height":48},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61aef365aacc458eaadb695cc14fee0e","type":"text","conversion_output":true,"text":"The primary efficacy endpoint will be analyzed using analysis of covariance (ANCOVA), with treatment","text_display":"\n\nThe primary efficacy endpoint will be analyzed using analysis of covariance (ANCOVA), with treatment","confidence":1,"confidence_rate":1},{"cnt":[[305,1629],[1841,1629],[1841,1676],[305,1676]],"region":{"top_left_x":305,"top_left_y":1628,"width":1537,"height":48},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e51b4cc91682437a83673ab26500ca9b","type":"text","conversion_output":true,"text":"group and randomization stratification factors (CV risk and baseline statin intensity) as factors and","text_display":" group and randomization stratification factors (CV risk and baseline statin intensity) as factors and","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[305,1676],[1828,1676],[1828,1721],[305,1721]],"region":{"top_left_x":305,"top_left_y":1675,"width":1524,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d01a74f02a6846dda4fdf5702f7c3ec6","type":"text","conversion_output":true,"text":"baseline LDL-C as a covariate. 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AEs that occurred on day 1 will be only be determined as TEAE if the site indicated it occurred","text_display":" 30 days. AEs that occurred on day 1 will be only be determined as TEAE if the site indicated it occurred","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[305,675],[780,675],[780,715],[305,715]],"region":{"top_left_x":305,"top_left_y":674,"width":475,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05f4b8c4bb074bc2b5d8402a0c8a74d6","type":"text","conversion_output":true,"text":"after first dose on the AE CRF.","text_display":" after first dose on the AE CRF.","confidence":1,"confidence_rate":1},{"cnt":[[305,743],[1869,743],[1869,788],[305,788]],"region":{"top_left_x":305,"top_left_y":743,"width":1565,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3645a9a5444e43fa91fb472a0627b10c","type":"text","conversion_output":true,"text":"See Appendix 2 for handling of partial dates for AEs. In the case where it is not possible to define an","text_display":"\n\nSee Appendix 2 for handling of partial dates for AEs. In the case where it is not possible to define an","confidence":0.99853515625,"confidence_rate":0.9999867936215969},{"cnt":[[305,786],[1865,786],[1865,836],[305,836]],"region":{"top_left_x":305,"top_left_y":786,"width":1560,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"048954c4a15c4bbd9057ae7198a96a65","type":"text","conversion_output":true,"text":"AE as treatment emergent or not, the AE will be classified by the worst case scenario, i.e. treatment","text_display":" AE as treatment emergent or not, the AE will be classified by the worst case scenario, i.e. treatment","confidence":0.5529292921426077,"confidence_rate":0.9945286785371626},{"cnt":[[305,838],[477,838],[477,883],[305,883]],"region":{"top_left_x":305,"top_left_y":837,"width":172,"height":47},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ebcc297d81c84940a7af35e60f40758d","type":"text","conversion_output":true,"text":"emergent.","text_display":" emergent.","confidence":1,"confidence_rate":1},{"cnt":[[305,902],[1878,902],[1878,947],[305,947]],"region":{"top_left_x":305,"top_left_y":902,"width":1573,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"185183ce21a44abeb6524d1da417bba6","type":"text","conversion_output":true,"text":"An overall summary of number of patients within each of the categories described in the sub-section","text_display":"\n\nAn overall summary of number of patients within each of the categories described in the sub-section","confidence":1,"confidence_rate":1},{"cnt":[[305,950],[1811,950],[1811,995],[305,995]],"region":{"top_left_x":305,"top_left_y":949,"width":1507,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"edfee319b6314b718bc39a9fbe5d8e8c","type":"text","conversion_output":true,"text":"below, will be provided as specified in the templates. Listings will include TEAEs and Non-TEAEs.","text_display":" below, will be provided as specified in the templates. Listings will include TEAEs and Non-TEAEs.","confidence":1,"confidence_rate":1},{"cnt":[[367,1053],[735,1053],[735,1109],[367,1109]],"region":{"top_left_x":367,"top_left_y":1052,"width":368,"height":57},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f95bf5990b8f41ad838026b42c8d9c99","type":"section_header","conversion_output":false,"children_ids":["d5c23d27e2e7440b94c4a6ef1ea82fe2"],"text":"","text_display":""},{"cnt":[[374,1057],[730,1057],[730,1102],[374,1102]],"region":{"top_left_x":373,"top_left_y":1057,"width":358,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5c23d27e2e7440b94c4a6ef1ea82fe2","type":"text","conversion_output":true,"parent_id":"f95bf5990b8f41ad838026b42c8d9c99","text":"18.1.1. All TEAEs","text_display":"\n\n\\subsection*{18.1.1. 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TEAEs will also be","text_display":" broken down further by maximum severity and relationship to study medication. TEAEs will also be","confidence":1,"confidence_rate":1},{"cnt":[[305,1250],[1901,1250],[1901,1300],[305,1300]],"region":{"top_left_x":305,"top_left_y":1250,"width":1597,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06b98a4bec734809b90b8a31c97db2bf","type":"text","conversion_output":true,"text":"presented by PT in descending frequency. Adverse events by the subgroups in Section 17.2.4 with the","text_display":" presented by PT in descending frequency. 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If a subject reports a TEAE more than once within that SOC/ PT, the AE with the","text_display":" scenario, ie, as severe. 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If a subject reports the same AE more","confidence":1,"confidence_rate":1},{"cnt":[[305,2045],[1841,2045],[1841,2090],[305,2090]],"region":{"top_left_x":305,"top_left_y":2045,"width":1537,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f09a59c30444ce2a2167f6d37ad40db","type":"text","conversion_output":true,"text":"than once within that SOC/ PT, the AE with the worst case relationship to study medication will be","text_display":" than once within that SOC/ PT, the AE with the worst case relationship to study medication will be","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[305,2093],[1102,2093],[1102,2138],[305,2138]],"region":{"top_left_x":305,"top_left_y":2092,"width":798,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8899fbc8c5804aff8fe1057995b14ee9","type":"text","conversion_output":true,"text":"used in the corresponding relationship summaries.","text_display":" used in the corresponding relationship summaries.","confidence":1,"confidence_rate":1},{"cnt":[[367,2196],[1476,2196],[1476,2249],[367,2249]],"region":{"top_left_x":367,"top_left_y":2195,"width":1109,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1936b94ef8f94754b04c93e55bfe9289","type":"section_header","conversion_output":false,"children_ids":["748fd00acc8245e1b97f7bd52a5c384d"],"text":"","text_display":""},{"cnt":[[374,2200],[1472,2200],[1472,2245],[374,2245]],"region":{"top_left_x":373,"top_left_y":2200,"width":1099,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"748fd00acc8245e1b97f7bd52a5c384d","type":"text","conversion_output":true,"parent_id":"1936b94ef8f94754b04c93e55bfe9289","text":"18.1.4. 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TEAEs Leading to Discontinuation of Study Medication}","confidence":0.9166318297884573,"confidence_rate":0.9986616751015399},{"cnt":[[305,2299],[1790,2299],[1790,2346],[305,2346]],"region":{"top_left_x":305,"top_left_y":2298,"width":1485,"height":49},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4714e4d4d22a48d984e3b27a3d0f1498","type":"text","conversion_output":true,"text":"TEAEs leading to permanent discontinuation of study medication will be identified by using the","text_display":"\n\nTEAEs leading to permanent discontinuation of study medication will be identified by using 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For TEAEs leading to discontinuation of study medication, summaries of","text_display":" on the AE eCRF page. For TEAEs leading to discontinuation of study medication, summaries of","confidence":1,"confidence_rate":1},{"cnt":[[309,443],[1532,443],[1532,488],[309,488]],"region":{"top_left_x":309,"top_left_y":442,"width":1223,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3eed9fa4e884b08b2d86242d3d4449f","type":"text","conversion_output":true,"text":"incidence rates (frequencies and percentages) by SOC and PT will be prepared.","text_display":" incidence rates (frequencies and percentages) by SOC and PT will be prepared.","confidence":1,"confidence_rate":1},{"cnt":[[367,546],[952,546],[952,604],[367,604]],"region":{"top_left_x":367,"top_left_y":545,"width":585,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0aee1bd7e59d4d97a9db43fec394f06f","type":"section_header","conversion_output":false,"children_ids":["00684ab46b194817bf2cb08cb3ee13b7"],"text":"","text_display":""},{"cnt":[[374,552],[947,552],[947,597],[374,597]],"region":{"top_left_x":373,"top_left_y":552,"width":575,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00684ab46b194817bf2cb08cb3ee13b7","type":"text","conversion_output":true,"parent_id":"0aee1bd7e59d4d97a9db43fec394f06f","text":"18.1.5. Serious Adverse Events","text_display":"\n\n\\subsection*{18.1.5. Serious Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[307,653],[1871,653],[1871,698],[307,698]],"region":{"top_left_x":307,"top_left_y":653,"width":1565,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8f03ef993d84f7fba03d055f8ebd688","type":"text","conversion_output":true,"text":"Serious adverse events (SAEs) are those events recorded as \"Serious\" on the Adverse Events page of","text_display":"\n\nSerious adverse events (SAEs) are those events recorded as \"Serious\" on the Adverse Events page of","confidence":1,"confidence_rate":1},{"cnt":[[307,696],[1841,696],[1841,743],[307,743]],"region":{"top_left_x":307,"top_left_y":696,"width":1535,"height":48},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41f9c405adeb42b9932cfc88c38f9822","type":"text","conversion_output":true,"text":"the (e)CRF. A summary of serious TEAEs by SOC and PT will be prepared. Serious TEAEs will also be","text_display":" the (e)CRF. A summary of serious TEAEs by SOC and PT will be prepared. Serious TEAEs will also be","confidence":0.99853515625,"confidence_rate":0.9999856283612877},{"cnt":[[305,743],[965,743],[965,788],[305,788]],"region":{"top_left_x":305,"top_left_y":743,"width":660,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17580e0bcd8a40edb4e8e7b9821c6ab2","type":"text","conversion_output":true,"text":"presented by PT in descending frequency.","text_display":" presented by PT in descending frequency.","confidence":0.99462890625,"confidence_rate":0.9998803278294501},{"cnt":[[365,846],[1240,846],[1240,909],[365,909]],"region":{"top_left_x":365,"top_left_y":846,"width":875,"height":63},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8b0c784e7eb4edeb0c82d845f8e5066","type":"section_header","conversion_output":false,"children_ids":["75d48e0b42744c0da33b99887c01b608"],"text":"","text_display":""},{"cnt":[[374,851],[1235,851],[1235,904],[374,904]],"region":{"top_left_x":373,"top_left_y":850,"width":863,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75d48e0b42744c0da33b99887c01b608","type":"text","conversion_output":true,"parent_id":"a8b0c784e7eb4edeb0c82d845f8e5066","text":"18.1.6. 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cause) will be tabulated and listed.","text_display":" no known other cause) will be tabulated and listed.","confidence":1,"confidence_rate":1},{"cnt":[[305,1719],[1106,1719],[1106,1764],[305,1764]],"region":{"top_left_x":305,"top_left_y":1718,"width":802,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d2fac67feee843bdb4212365c0f3b278","type":"text","conversion_output":true,"text":"Laboratory abnormalities in parameters of interest","text_display":"\n\nLaboratory abnormalities in parameters of interest","confidence":1,"confidence_rate":1},{"cnt":[[365,1783],[862,1783],[862,1833],[365,1833]],"region":{"top_left_x":365,"top_left_y":1783,"width":497,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8923f8d01ff404baa7e406e90a2d3e5","type":"text","conversion_output":true,"text":"ALT or AST ( \\(>3 x\\) ULN , >5xULN)","text_display":"\nALT or AST ( \\(>3 x\\) ULN , 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\\min / 1.73 m 2,15-<30 mL / \\min / 1.73 m 2\\) )","confidence":0.6654100873422498,"confidence_rate":0.9942790784820035},{"cnt":[[370,2256],[1016,2256],[1016,2305],[370,2305]],"region":{"top_left_x":369,"top_left_y":2255,"width":648,"height":51},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a5b8470d56f446684439af516a27d8a","type":"text","conversion_output":true,"text":"Hgb (decrease from baseline for \\(\\geq 2 g / dL\\) )","text_display":"\nHgb (decrease from baseline for \\(\\geq 2 g / dL\\) )","confidence":0.99853515625,"confidence_rate":0.9999728537447163},{"cnt":[[370,2325],[591,2325],[591,2374],[370,2374]],"region":{"top_left_x":369,"top_left_y":2324,"width":222,"height":51},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8dff57790d6945659fcb732fa1c910a8","type":"text","conversion_output":true,"text":"Hgb ( \\(<8 g / dL\\) )","text_display":"\nHgb ( \\(<8 g / dL\\) 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All concentration data will also be presented in a listing.","text_display":" PK Analysis Set as defined in section 5.4. 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unknown or 31st December if day and month are unknown), then: If stop date < study med start date, then not TEAE If stop date >= study med start date and <=study med end date + 30, then TEAE \\\\\n\\hline & Missing & Assumed TEAE \\\\\n\\hline & & \\\\\n\\hline Missing & Known & If stop date < study med start date, then not TEAE If stop date >= study med start date and <=study med end date + 30, then TEAE \\\\\n\\hline & Partial & \\begin{tabular}{l}\nImpute stop date as latest possible date (i.e. last day of month if day unknown or 31st December if day and month are unknown), then: \\\\\nIf stop date < study med start date and <=study med end date +30 , then not TEAE\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline START DATE & STOP DATE & ACTION \\\\\n\\hline Known & Known & If start date < study med start date, then not TEAE If start date >= study med start date and <=study med end date + 30, then TEAE \\\\\n\\hline & Partial & If start date < study med start date, then not TEAE If start date >= study med start date and <=study med end date + 30, then TEAE \\\\\n\\hline & Missing & If start date < study med start date, then not TEAE If start date >= study med start date and <=study med end date + 30 , then TEAE \\\\\n\\hline Partial, but known components show that it cannot be on or after study med start date & Known & Not TEAE \\\\\n\\hline & Partial & Not TEAE \\\\\n\\hline & Missing & Not TEAE \\\\\n\\hline Partial, could be on or after study med start date & Known & If stop date < study med start date, then not TEAE If stop date >= study med start date and <=study med end date + 30, then TEAE \\\\\n\\hline & Partial & Impute stop date as latest possible date (i.e. last day of month if day unknown or 31st December if day and month are unknown), then: If stop date < study med start date, then not TEAE If stop date >= study med start date and <=study med end date + 30, then TEAE \\\\\n\\hline & Missing & Assumed TEAE \\\\\n\\hline & & \\\\\n\\hline Missing & Known & If stop date < study med start date, then not TEAE If stop date >= study med start date and <=study med end date + 30, then TEAE \\\\\n\\hline & Partial & \\begin{tabular}{l}\nImpute stop date as latest possible date (i.e. last day of month if day unknown or 31st December if day and month are unknown), then: \\\\\nIf stop date < study med start date and <=study med end date +30 , then not TEAE\n\\end{tabular} 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start date < study med start date, then not TEAE If start date >= study med start date and <=study med end date + 30, then TEAE","text_display":"If start date < study med start date, then not TEAE If start date >= study med start date and <=study med end date + 30, then TEAE","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1041,666],[1825,666],[1825,707],[1041,707]],"region":{"top_left_x":1041,"top_left_y":666,"width":785,"height":42},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2bfaa05ee08473288d05fe55f7fc14b","type":"text","conversion_output":false,"parent_id":"1936f30ba26d4ff9a576b7bca1886028","text":"If start date < study med start date, then not TEAE","text_display":"If start date < study med start date, then not 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study med start date, then not TEAE If start date >= study med start date and <=study med end date + 30, then TEAE","text_display":"If start date < study med start date, then not TEAE If start date >= study med start date and <=study med end date + 30, then TEAE","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999887697222805},{"cnt":[[1041,809],[1825,809],[1825,850],[1041,850]],"region":{"top_left_x":1041,"top_left_y":809,"width":785,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85073a348c914101be9455de275d66cb","type":"text","conversion_output":false,"parent_id":"adb6007bb14c42158aad12701bad492b","text":"If start date < study med start date, then not TEAE","text_display":"If start date < study med start date, then not 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Medications:","confidence":0.9926895997509746,"confidence_rate":0.9998561426588423},{"cnt":[[305,670],[1944,670],[1944,2260],[305,2260]],"region":{"top_left_x":305,"top_left_y":670,"width":1640,"height":1591},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9c4d5a01b8c244b6bc14527a7f3439ef","type":"table","conversion_output":true,"children_ids":["6900c7deacc04a22b29452617855c8f2","dcd10941ffe741e5b485d52e5c91090e","40b6bb2198404c0fbfa5233f70abdc2d","2aa1ee3e8a0e4e93b883da1cbd9899ab","6a20191e212f4213a91f8dbdad770ea5","eb6aa864301b435aa2efd3031c9b3304","14193f9148344a4cb1a2334872779882","f5f38c370948492ebb444e4840d43c56","41f02eb8bceb49399ac3dce1d2155dab","e8365c9520544f7baf52a933a5da3927","38cd9d85d23a48d5a5f17f9d210bf49d","36c3387a3e9b4ec6a9352e3859e675b7","73b21340a37c4a89b51c5c6248e7b74c","f05063feb7644f1880b0129feb427613","0ff4984c7828410cb858f66f9a5153f4","60920a43d26f48c4b1fa5838196f6c8c","9979bf092fd8464bb19384d11637134a","b0b237a4aff14a8cb8bf7363f758c32c","d0354a29e54a4b1f877f4cb2e0196cfa","33b98605c76d4b93beab0835128487f3","f3d1d0192d324290aa4aff60d4769a79","94a120f3719b441fa3a3856b3adb93fb","a2256e3d6a954b099ee88bce1df2364a","2fdc4eb97b0048b1b8faf94054f548d8"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline START DATE & STOP DATE & ACTION \\\\\n\\hline Known & Known & \\begin{tabular}{l}\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post study\n\\end{tabular} \\\\\n\\hline & Partial & \\begin{tabular}{l}\nImpute stop date as latest possible date (i.e. last day of month if day unknown or \\(31^{\\text {st }}\\) December if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular} \\\\\n\\hline & Missing & \\begin{tabular}{l}\nIf stop date is missing could never be assumed a prior medication \\\\\nIf start date <= end of treatment, assign as concomitant \\\\\nIf start date > end of treatment, assign as post treatment\n\\end{tabular} \\\\\n\\hline Partial & Known & \\begin{tabular}{l}\nImpute start date as earliest possible date (i.e. first day of month if day unknown or \\(1^{\\text {st }}\\) January if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular} \\\\\n\\hline & Partial & \\begin{tabular}{l}\nImpute start date as earliest possible date (i.e. first day of month if day unknown or \\(1^{\\text {st }}\\) January if day and month are unknown) and impute stop date as latest possible date (i.e. last day of month if day unknown or \\(31{ }^{\\text {st }}\\) December if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline START DATE & STOP DATE & ACTION \\\\\n\\hline Known & Known & \\begin{tabular}{l}\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post study\n\\end{tabular} \\\\\n\\hline & Partial & \\begin{tabular}{l}\nImpute stop date as latest possible date (i.e. last day of month if day unknown or \\(31^{\\text {st }}\\) December if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular} \\\\\n\\hline & Missing & \\begin{tabular}{l}\nIf stop date is missing could never be assumed a prior medication \\\\\nIf start date <= end of treatment, assign as concomitant \\\\\nIf start date > end of treatment, assign as post treatment\n\\end{tabular} \\\\\n\\hline Partial & Known & \\begin{tabular}{l}\nImpute start date as earliest possible date (i.e. first day of month if day unknown or \\(1^{\\text {st }}\\) January if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular} \\\\\n\\hline & Partial & \\begin{tabular}{l}\nImpute start date as earliest possible date (i.e. first day of month if day unknown or \\(1^{\\text {st }}\\) January if day and month are unknown) and impute stop date as latest possible date (i.e. last day of month if day unknown or \\(31{ }^{\\text {st }}\\) December if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","confidence":0.71533203125,"confidence_rate":0.9999532616992121},{"cnt":[[324,670],[537,670],[537,2262],[324,2262]],"region":{"top_left_x":324,"top_left_y":670,"width":213,"height":1592},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6900c7deacc04a22b29452617855c8f2","type":"table_column","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"","text_display":""},{"cnt":[[591,670],[716,670],[716,2262],[591,2262]],"region":{"top_left_x":590,"top_left_y":670,"width":127,"height":1592},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dcd10941ffe741e5b485d52e5c91090e","type":"table_column","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"","text_display":""},{"cnt":[[836,670],[1877,670],[1877,2262],[836,2262]],"region":{"top_left_x":835,"top_left_y":670,"width":1043,"height":1592},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40b6bb2198404c0fbfa5233f70abdc2d","type":"table_column","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"","text_display":""},{"cnt":[[305,692],[1944,692],[1944,783],[305,783]],"region":{"top_left_x":305,"top_left_y":691,"width":1640,"height":92},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2aa1ee3e8a0e4e93b883da1cbd9899ab","type":"table_row","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"","text_display":""},{"cnt":[[305,809],[1942,809],[1942,1032],[305,1032]],"region":{"top_left_x":305,"top_left_y":808,"width":1638,"height":224},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a20191e212f4213a91f8dbdad770ea5","type":"table_row","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"","text_display":""},{"cnt":[[305,1036],[1942,1036],[1942,1348],[305,1348]],"region":{"top_left_x":305,"top_left_y":1035,"width":1638,"height":313},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb6aa864301b435aa2efd3031c9b3304","type":"table_row","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"","text_display":""},{"cnt":[[305,1352],[1942,1352],[1942,1491],[305,1491]],"region":{"top_left_x":305,"top_left_y":1352,"width":1638,"height":139},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14193f9148344a4cb1a2334872779882","type":"table_row","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"","text_display":""},{"cnt":[[305,1541],[1944,1541],[1944,1855],[305,1855]],"region":{"top_left_x":305,"top_left_y":1540,"width":1640,"height":315},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f5f38c370948492ebb444e4840d43c56","type":"table_row","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"","text_display":""},{"cnt":[[305,1857],[1942,1857],[1942,2257],[305,2257]],"region":{"top_left_x":305,"top_left_y":1856,"width":1638,"height":402},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41f02eb8bceb49399ac3dce1d2155dab","type":"table_row","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"","text_display":""},{"cnt":[[327,696],[528,696],[528,728],[327,728]],"region":{"top_left_x":326,"top_left_y":695,"width":203,"height":34},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8365c9520544f7baf52a933a5da3927","type":"simple_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"START DATE","text_display":"START DATE","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[595,696],[693,696],[693,776],[595,776]],"region":{"top_left_x":595,"top_left_y":695,"width":98,"height":82},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38cd9d85d23a48d5a5f17f9d210bf49d","type":"complex_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","children_ids":["348113ec91684ef6955272cc159e739a","7fac458d3baf4827bf9b3fd41e7e9c41"],"text":"STOP DATE","text_display":"STOP DATE","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[595,696],[688,696],[688,728],[595,728]],"region":{"top_left_x":595,"top_left_y":695,"width":94,"height":34},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"348113ec91684ef6955272cc159e739a","type":"text","conversion_output":false,"parent_id":"38cd9d85d23a48d5a5f17f9d210bf49d","text":"STOP","text_display":"STOP","confidence":1,"confidence_rate":1},{"cnt":[[600,744],[688,744],[688,776],[600,776]],"region":{"top_left_x":599,"top_left_y":743,"width":90,"height":34},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7fac458d3baf4827bf9b3fd41e7e9c41","type":"text","conversion_output":false,"parent_id":"38cd9d85d23a48d5a5f17f9d210bf49d","text":"DATE","text_display":" DATE","confidence":1,"confidence_rate":1},{"cnt":[[842,696],[974,696],[974,731],[842,731]],"region":{"top_left_x":842,"top_left_y":695,"width":133,"height":36},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"36c3387a3e9b4ec6a9352e3859e675b7","type":"simple_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"ACTION","text_display":"ACTION","cell_row":0,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[327,813],[433,813],[433,845],[327,845]],"region":{"top_left_x":326,"top_left_y":812,"width":107,"height":34},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73b21340a37c4a89b51c5c6248e7b74c","type":"simple_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"Known","text_display":"Known","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[600,813],[701,813],[701,845],[600,845]],"region":{"top_left_x":599,"top_left_y":812,"width":103,"height":34},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f05063feb7644f1880b0129feb427613","type":"simple_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"Known","text_display":"Known","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[842,811],[1866,811],[1866,1029],[842,1029]],"region":{"top_left_x":842,"top_left_y":810,"width":1025,"height":220},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ff4984c7828410cb858f66f9a5153f4","type":"complex_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","children_ids":["27a9917f06cb469c8e40cc7c53aea821","ca3062ea2f564ab2b32e705cc388e24c","1193b01fbfe24a6786b73a45ebd74685","25bcd0aa9f744a1c92fe603e94bed336","b039cd6552214beea2fa13061126ab14"],"text":"\\begin{tabular}{l}\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post study\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post study\n\\end{tabular}","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.998046875,"confidence_rate":0.9999923514877521},{"cnt":[[844,813],[1559,813],[1559,852],[844,852]],"region":{"top_left_x":844,"top_left_y":812,"width":715,"height":40},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27a9917f06cb469c8e40cc7c53aea821","type":"text","conversion_output":false,"parent_id":"0ff4984c7828410cb858f66f9a5153f4","text":"If stop date < study med start date, assign as prior","text_display":"If stop date < study med start date, assign as prior","confidence":1,"confidence_rate":1},{"cnt":[[844,856],[1862,856],[1862,897],[844,897]],"region":{"top_left_x":844,"top_left_y":856,"width":1018,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca3062ea2f564ab2b32e705cc388e24c","type":"text","conversion_output":false,"parent_id":"0ff4984c7828410cb858f66f9a5153f4","text":"If stop date >= study med start date and start date <= end of treatment,","text_display":"\nIf stop date >= study med start date and start date <= end of treatment,","confidence":0.998046875,"confidence_rate":0.9999746102595223},{"cnt":[[846,902],[1163,902],[1163,941],[846,941]],"region":{"top_left_x":846,"top_left_y":901,"width":317,"height":40},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1193b01fbfe24a6786b73a45ebd74685","type":"text","conversion_output":false,"parent_id":"0ff4984c7828410cb858f66f9a5153f4","text":"assign as concomitant","text_display":" assign as concomitant","confidence":1,"confidence_rate":1},{"cnt":[[844,947],[1845,947],[1845,988],[844,988]],"region":{"top_left_x":844,"top_left_y":947,"width":1001,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25bcd0aa9f744a1c92fe603e94bed336","type":"text","conversion_output":false,"parent_id":"0ff4984c7828410cb858f66f9a5153f4","text":"If stop date >= study med start date and start date > end of treatment,","text_display":"\nIf stop date >= study med start date and start date > end of treatment,","confidence":0.9990236759185791,"confidence_rate":0.9999871474379078},{"cnt":[[846,990],[1130,990],[1130,1027],[846,1027]],"region":{"top_left_x":846,"top_left_y":990,"width":285,"height":38},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b039cd6552214beea2fa13061126ab14","type":"text","conversion_output":false,"parent_id":"0ff4984c7828410cb858f66f9a5153f4","text":"assign as post study","text_display":" assign as post study","confidence":1,"confidence_rate":1},{"cnt":[[600,1040],[697,1040],[697,1075],[600,1075]],"region":{"top_left_x":599,"top_left_y":1040,"width":98,"height":35},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"60920a43d26f48c4b1fa5838196f6c8c","type":"simple_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"Partial","text_display":"Partial","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[842,1038],[1868,1038],[1868,1348],[842,1348]],"region":{"top_left_x":842,"top_left_y":1038,"width":1027,"height":310},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9979bf092fd8464bb19384d11637134a","type":"complex_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","children_ids":["dd109da4014a408984a166c17b801d3a","d51aae5dc08840699a4cc12529492cf9","7ff28650d76047b1944a46549b562235","eb3c97e2fd7b46c4b9ba5390eea55234","50f5b0f6b9674790960d4d9638666e4b","27defc3b42574f0290add9a9972dc52c","1fc9bbfdda024a6db0a8f88c15f42be2"],"text":"\\begin{tabular}{l}\nImpute stop date as latest possible date (i.e. last day of month if day unknown or \\(31^{\\text {st }}\\) December if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nImpute stop date as latest possible date (i.e. last day of month if day unknown or \\(31^{\\text {st }}\\) December if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.71533203125,"confidence_rate":0.9993883850159524},{"cnt":[[846,1040],[1814,1040],[1814,1079],[846,1079]],"region":{"top_left_x":846,"top_left_y":1040,"width":969,"height":40},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dd109da4014a408984a166c17b801d3a","type":"text","conversion_output":false,"parent_id":"9979bf092fd8464bb19384d11637134a","text":"Impute stop date as latest possible date (i.e. last day of month if day","text_display":"Impute stop date as latest possible date (i.e. last day of month if day","confidence":1,"confidence_rate":1},{"cnt":[[846,1077],[1780,1077],[1780,1123],[846,1123]],"region":{"top_left_x":846,"top_left_y":1077,"width":934,"height":46},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d51aae5dc08840699a4cc12529492cf9","type":"text","conversion_output":false,"parent_id":"9979bf092fd8464bb19384d11637134a","text":"unknown or \\(31^{\\text {st }}\\) December if day and month are unknown), then:","text_display":" unknown or \\(31^{\\text {st }}\\) December if day and month are unknown), then:","confidence":0.71533203125,"confidence_rate":0.9958726341124323},{"cnt":[[846,1129],[1559,1129],[1559,1168],[846,1168]],"region":{"top_left_x":846,"top_left_y":1129,"width":713,"height":40},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ff28650d76047b1944a46549b562235","type":"text","conversion_output":false,"parent_id":"9979bf092fd8464bb19384d11637134a","text":"If stop date < study med start date, assign as prior","text_display":"\nIf stop date < study med start date, assign as prior","confidence":1,"confidence_rate":1},{"cnt":[[844,1175],[1862,1175],[1862,1214],[844,1214]],"region":{"top_left_x":844,"top_left_y":1174,"width":1018,"height":40},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb3c97e2fd7b46c4b9ba5390eea55234","type":"text","conversion_output":false,"parent_id":"9979bf092fd8464bb19384d11637134a","text":"If stop date >= study med start date and start date <= end of treatment,","text_display":"\nIf stop date >= study med start date and start date <= end of treatment,","confidence":0.98974609375,"confidence_rate":0.9998661538970539},{"cnt":[[846,1220],[1163,1220],[1163,1257],[846,1257]],"region":{"top_left_x":846,"top_left_y":1220,"width":317,"height":37},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50f5b0f6b9674790960d4d9638666e4b","type":"text","conversion_output":false,"parent_id":"9979bf092fd8464bb19384d11637134a","text":"assign as concomitant","text_display":" assign as concomitant","confidence":1,"confidence_rate":1},{"cnt":[[846,1263],[1845,1263],[1845,1304],[846,1304]],"region":{"top_left_x":846,"top_left_y":1263,"width":999,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27defc3b42574f0290add9a9972dc52c","type":"text","conversion_output":false,"parent_id":"9979bf092fd8464bb19384d11637134a","text":"If stop date >= study med start date and start date > end of treatment,","text_display":"\nIf stop date >= study med start date and start date > end of treatment,","confidence":0.9990236759185791,"confidence_rate":0.9999871474379078},{"cnt":[[844,1307],[1199,1307],[1199,1343],[844,1343]],"region":{"top_left_x":844,"top_left_y":1306,"width":356,"height":38},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1fc9bbfdda024a6db0a8f88c15f42be2","type":"text","conversion_output":false,"parent_id":"9979bf092fd8464bb19384d11637134a","text":"assign as post treatment","text_display":" assign as post treatment","confidence":1,"confidence_rate":1},{"cnt":[[600,1359],[712,1359],[712,1395],[600,1395]],"region":{"top_left_x":599,"top_left_y":1358,"width":114,"height":38},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0b237a4aff14a8cb8bf7363f758c32c","type":"simple_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"Missing","text_display":"Missing","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[842,1354],[1775,1354],[1775,1489],[842,1489]],"region":{"top_left_x":842,"top_left_y":1354,"width":934,"height":135},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0354a29e54a4b1f877f4cb2e0196cfa","type":"complex_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","children_ids":["8dd8ad25e5214e628f8b3272a3a43401","8fd961cd739e44c3a1463de4b4396599","05d7a107068a497e85ff6108c5f354ed"],"text":"\\begin{tabular}{l}\nIf stop date is missing could never be assumed a prior medication \\\\\nIf start date <= end of treatment, assign as concomitant \\\\\nIf start date > end of treatment, assign as post treatment\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nIf stop date is missing could never be assumed a prior medication \\\\\nIf start date <= end of treatment, assign as concomitant \\\\\nIf start date > end of treatment, assign as post treatment\n\\end{tabular}","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[846,1356],[1771,1356],[1771,1395],[846,1395]],"region":{"top_left_x":846,"top_left_y":1356,"width":926,"height":40},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8dd8ad25e5214e628f8b3272a3a43401","type":"text","conversion_output":false,"parent_id":"d0354a29e54a4b1f877f4cb2e0196cfa","text":"If stop date is missing could never be assumed a prior medication","text_display":"If stop date is missing could never be assumed a prior medication","confidence":1,"confidence_rate":1},{"cnt":[[846,1402],[1635,1402],[1635,1443],[846,1443]],"region":{"top_left_x":846,"top_left_y":1401,"width":789,"height":43},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8fd961cd739e44c3a1463de4b4396599","type":"text","conversion_output":false,"parent_id":"d0354a29e54a4b1f877f4cb2e0196cfa","text":"If start date <= end of treatment, assign as concomitant","text_display":"\nIf start date <= end of treatment, assign as concomitant","confidence":1,"confidence_rate":1},{"cnt":[[844,1445],[1654,1445],[1654,1486],[844,1486]],"region":{"top_left_x":844,"top_left_y":1445,"width":811,"height":42},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05d7a107068a497e85ff6108c5f354ed","type":"text","conversion_output":false,"parent_id":"d0354a29e54a4b1f877f4cb2e0196cfa","text":"If start date > end of treatment, assign as post treatment","text_display":"\nIf start date > end of treatment, assign as post 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start date as earliest possible date (i.e. first day of month if day unknown or \\(1^{\\text {st }}\\) January if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nImpute start date as earliest possible date (i.e. first day of month if day unknown or \\(1^{\\text {st }}\\) January if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular}","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.98046875,"confidence_rate":0.9999575308135009},{"cnt":[[846,1545],[1853,1545],[1853,1586],[846,1586]],"region":{"top_left_x":846,"top_left_y":1544,"width":1008,"height":43},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41b82253afc94b5e91b9bc314601fa4c","type":"text","conversion_output":false,"parent_id":"94a120f3719b441fa3a3856b3adb93fb","text":"Impute start date as earliest possible date (i.e. first day of month if day","text_display":"Impute start date as earliest possible date (i.e. first day of month if day","confidence":1,"confidence_rate":1},{"cnt":[[846,1584],[1721,1584],[1721,1629],[846,1629]],"region":{"top_left_x":846,"top_left_y":1583,"width":876,"height":47},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb9b79c7ac384963869f45a60b4a5083","type":"text","conversion_output":false,"parent_id":"94a120f3719b441fa3a3856b3adb93fb","text":"unknown or \\(1^{\\text {st }}\\) January if day and month are unknown), then:","text_display":" unknown or \\(1^{\\text {st }}\\) January if day and month are unknown), then:","confidence":0.9990234375,"confidence_rate":0.9999876324859995},{"cnt":[[846,1631],[1559,1631],[1559,1673],[846,1673]],"region":{"top_left_x":846,"top_left_y":1631,"width":713,"height":42},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aaddc831f5994871b951ef2ebc51e25c","type":"text","conversion_output":false,"parent_id":"94a120f3719b441fa3a3856b3adb93fb","text":"If stop date < study med start date, assign as prior","text_display":"\nIf stop date < study med start date, assign as prior","confidence":1,"confidence_rate":1},{"cnt":[[844,1679],[1862,1679],[1862,1720],[844,1720]],"region":{"top_left_x":844,"top_left_y":1679,"width":1018,"height":42},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bbad196076f24486b65072494f05a11e","type":"text","conversion_output":false,"parent_id":"94a120f3719b441fa3a3856b3adb93fb","text":"If stop date >= study med start date and start date <= end of treatment,","text_display":"\nIf stop date >= study med start date and start date <= end of treatment,","confidence":0.998046875,"confidence_rate":0.9999746102595223},{"cnt":[[846,1722],[1163,1722],[1163,1764],[846,1764]],"region":{"top_left_x":846,"top_left_y":1722,"width":317,"height":42},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59767da168fa427589a2752880bc1b18","type":"text","conversion_output":false,"parent_id":"94a120f3719b441fa3a3856b3adb93fb","text":"assign as concomitant","text_display":" assign as concomitant","confidence":1,"confidence_rate":1},{"cnt":[[846,1768],[1845,1768],[1845,1807],[846,1807]],"region":{"top_left_x":846,"top_left_y":1767,"width":999,"height":40},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20849d5259c44bd49349afb72840fa78","type":"text","conversion_output":false,"parent_id":"94a120f3719b441fa3a3856b3adb93fb","text":"If stop date >= study med start date and start date > end of treatment,","text_display":"\nIf stop date >= study med start date and start date > end of treatment,","confidence":0.98046875,"confidence_rate":0.9997405007106642},{"cnt":[[844,1809],[1199,1809],[1199,1850],[844,1850]],"region":{"top_left_x":844,"top_left_y":1809,"width":356,"height":42},"line":68,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39a6826e80124a4f9a0d08806289b5a1","type":"text","conversion_output":false,"parent_id":"94a120f3719b441fa3a3856b3adb93fb","text":"assign as post treatment","text_display":" assign as post treatment","confidence":1,"confidence_rate":1},{"cnt":[[600,1861],[697,1861],[697,1894],[600,1894]],"region":{"top_left_x":599,"top_left_y":1861,"width":98,"height":33},"line":69,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2256e3d6a954b099ee88bce1df2364a","type":"simple_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","text":"Partial","text_display":"Partial","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[842,1859],[1875,1859],[1875,2253],[842,2253]],"region":{"top_left_x":842,"top_left_y":1858,"width":1033,"height":395},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2fdc4eb97b0048b1b8faf94054f548d8","type":"complex_cell","conversion_output":false,"parent_id":"9c4d5a01b8c244b6bc14527a7f3439ef","children_ids":["9d170aea6afc4efe9672c3f422f67d39","75f918db8bd943e0a331b3bf9c2349d2","4389d76ce6694df0aa97380340f70f9a","c8713b0e9c544107ab40b2456da8c4f3","6041f11be1e844b8ad50939e9ca2c48f","e26655fc82f443b0afef8a336d9334d9","cfbdfef29523497da67d7580bccea516","f932e0efb0584f248495396e133313d8","5a3914ea085b4dae9e69cf6706a594ed"],"text":"\\begin{tabular}{l}\nImpute start date as earliest possible date (i.e. first day of month if day unknown or \\(1^{\\text {st }}\\) January if day and month are unknown) and impute stop date as latest possible date (i.e. last day of month if day unknown or \\(31{ }^{\\text {st }}\\) December if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nImpute start date as earliest possible date (i.e. first day of month if day unknown or \\(1^{\\text {st }}\\) January if day and month are unknown) and impute stop date as latest possible date (i.e. last day of month if day unknown or \\(31{ }^{\\text {st }}\\) December if day and month are unknown), then: \\\\\nIf stop date < study med start date, assign as prior \\\\\nIf stop date >= study med start date and start date <= end of treatment, assign as concomitant \\\\\nIf stop date >= study med start date and start date > end of treatment, assign as post treatment\n\\end{tabular}","cell_row":5,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9699673962313682,"confidence_rate":0.9999608305979243},{"cnt":[[844,1861],[1853,1861],[1853,1902],[844,1902]],"region":{"top_left_x":844,"top_left_y":1861,"width":1010,"height":42},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d170aea6afc4efe9672c3f422f67d39","type":"text","conversion_output":false,"parent_id":"2fdc4eb97b0048b1b8faf94054f548d8","text":"Impute start date as earliest possible date (i.e. first day of month if day","text_display":"Impute start date as earliest possible date (i.e. first day of month if day","confidence":1,"confidence_rate":1},{"cnt":[[846,1900],[1871,1900],[1871,1945],[846,1945]],"region":{"top_left_x":846,"top_left_y":1899,"width":1025,"height":47},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75f918db8bd943e0a331b3bf9c2349d2","type":"text","conversion_output":false,"parent_id":"2fdc4eb97b0048b1b8faf94054f548d8","text":"unknown or \\(1^{\\text {st }}\\) January if day and month are unknown) and impute stop","text_display":" unknown or \\(1^{\\text {st }}\\) January if day and month are unknown) and impute stop","confidence":0.9990234375,"confidence_rate":0.9999888973383643},{"cnt":[[846,1943],[1871,1943],[1871,1989],[846,1989]],"region":{"top_left_x":846,"top_left_y":1943,"width":1025,"height":46},"line":73,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4389d76ce6694df0aa97380340f70f9a","type":"text","conversion_output":false,"parent_id":"2fdc4eb97b0048b1b8faf94054f548d8","text":"date as latest possible date (i.e. last day of month if day unknown or \\(31{ }^{\\text {st }}\\)","text_display":" date as latest possible date (i.e. last day of month if day unknown or \\(31{ }^{\\text {st }}\\)","confidence":0.9699673962313682,"confidence_rate":0.9996649701989537},{"cnt":[[844,1989],[1541,1989],[1541,2030],[844,2030]],"region":{"top_left_x":844,"top_left_y":1988,"width":698,"height":42},"line":74,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8713b0e9c544107ab40b2456da8c4f3","type":"text","conversion_output":false,"parent_id":"2fdc4eb97b0048b1b8faf94054f548d8","text":"December if day and month are unknown), then:","text_display":" December if day and month are unknown), 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start date and start date <= end of treatment,","confidence":0.99951171875,"confidence_rate":0.9999936571565041},{"cnt":[[846,2125],[1163,2125],[1163,2162],[846,2162]],"region":{"top_left_x":846,"top_left_y":2125,"width":317,"height":38},"line":77,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfbdfef29523497da67d7580bccea516","type":"text","conversion_output":false,"parent_id":"2fdc4eb97b0048b1b8faf94054f548d8","text":"assign as concomitant","text_display":" assign as concomitant","confidence":1,"confidence_rate":1},{"cnt":[[846,2169],[1845,2169],[1845,2210],[846,2210]],"region":{"top_left_x":846,"top_left_y":2168,"width":999,"height":42},"line":78,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f932e0efb0584f248495396e133313d8","type":"text","conversion_output":false,"parent_id":"2fdc4eb97b0048b1b8faf94054f548d8","text":"If stop date >= study med start date and start date > end of treatment,","text_display":"\nIf stop date >= study 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THERAPEUTICS, INC.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1182,198],[1901,198],[1901,230],[1182,230]],"region":{"top_left_x":1181,"top_left_y":197,"width":721,"height":33},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb778875b4044432878ab08e0d170ea7","type":"page_info","conversion_output":false,"text":"STATISTICAL ANALYSIS PLAN: PROTOCOL 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1680,236],[1901,236],[1901,277],[1680,277]],"region":{"top_left_x":1680,"top_left_y":236,"width":222,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75d0b9511e2a4a9e975cead6dccbe816","type":"page_info","conversion_output":false,"text":"Page 42 of 48","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[333,262],[707,262],[707,303],[333,303]],"region":{"top_left_x":333,"top_left_y":262,"width":374,"height":41},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af5e5b2a5fa443d9a70e8b77f64a79db","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[303,352],[1536,352],[1536,526],[303,526]],"region":{"top_left_x":302,"top_left_y":352,"width":1235,"height":175},"line":6,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"ec22834c4039412fa8a389f82f2a2061","type":"section_header","conversion_output":false,"children_ids":["dd340347aee945d1a5f101ac84d178e7","fbe7b0bbf15345549e91c54fb70a9a7b"],"text":"","text_display":""},{"cnt":[[309,357],[1532,357],[1532,410],[309,410]],"region":{"top_left_x":309,"top_left_y":356,"width":1223,"height":55},"line":7,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"dd340347aee945d1a5f101ac84d178e7","type":"text","conversion_output":true,"parent_id":"ec22834c4039412fa8a389f82f2a2061","text":"APPENDIX 3. List of DMC Tables, Listings, and Figures","text_display":"\n\n\\section*{APPENDIX 3. List of DMC Tables, Listings, and Figures","confidence":0.989772547618486,"confidence_rate":0.9998227723940755},{"cnt":[[309,477],[483,477],[483,522],[309,522]],"region":{"top_left_x":309,"top_left_y":476,"width":175,"height":47},"line":8,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"fbe7b0bbf15345549e91c54fb70a9a7b","type":"text","conversion_output":true,"parent_id":"ec22834c4039412fa8a389f82f2a2061","text":"TABLES","text_display":" \\\\ TABLES}","confidence":1,"confidence_rate":1},{"cnt":[[290,604],[1951,604],[1951,2548],[290,2548]],"region":{"top_left_x":290,"top_left_y":603,"width":1661,"height":1946},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9261d386f9f54d1ea46ddd49f448987d","type":"table","conversion_output":true,"children_ids":["4e551ddc65514070853744130a5af888","6f2be49f5de2483dbbee260bb40f5be6","06d0d8fbba7b435ab4bc820479b5538f","c91caee6fcee4cf192bd3378413f81cd","c271d1cb894544eca9567f7328e1f2c6","1259050831b34f1f8f4a3b24647408ea","e8c319897de94128904171b963657f24","cc3157b525ed4b7ea7e89b15960aae36","0c688533ed55472196f929a8eac48d03","830de63c5b9042b8ab94fc8e02986427","cb08e923557c42ff9b3df92b29bad03d","b75e1c7c47e74c64a0b643e40492d5c0","65763a1f408040dd849ea979ef0c3db6","2f4d885d185a4e54b6e53751a4f5574f","e5fdb952cae84eae917d810f05735e34","a18c17dc35cc4cf8ad998286d49af85a","a6d575a5ee71442782cc43c2ae818395","634b122c39774779b67e814dd4d0ce18","710ad3124ed8425d80bef825a4f7f651","8793d08a7f5a437cba5866d794733a5a","7f9124d02e8e4373bdd0b60dd4851c8a","eef16ce8ff524d29966521b57ad8e46a","f4a2ea78b6d04234bddd8d2b25c55976","51d07ad5348f44a5b27687f6fd4bfee9","5ca249e611ae491db4ce13e242bde5b3","fa7eaa93452a49ef9900c30ced4b236c","5484eb51c1654f5495ebb0ed8e8596d6","1d3acc76353d486ca5405b3894e8138b","b3a640ca38d243d582bf3d239fac7549","2f9b74ca07934c218bf2cf4c350f87b9","71f5623dde724f49899987309f382985","7e8995cb52d748c7b8e98458db2c60e5","7a8c3e15ba4e456da326fda08ad2279f","151f9f3d5848479da21cb1ca79bdd85f","70174527a886438bb898e95473f609bd","92b533b973e645d0b8c0bdd9c7d1e960","de9bbd2a6a154982bbba1a40d3dda7c0","7550314842984aa0b183549da629c3ed","6017f5a52b7847e680e639ecd2830c79","49cf0d8b87344a1f99081e54f85eb991","35e315a3a54a48d681407613d969a19f","651d0d97cdbb480982cbe80ab3a88980","8067079f252d4ca1b04600866fb075a9","da2d6e15a0d04e90ba6a917fc60464cd","09f97f51283049abb607c887caef579e","c69b6ce56bb74561b602797e6e0fb878","557da1ce3f1e42a59bc78dc595cf5f83","822965e5d07f46b4b196494651e23e63","28345c2cb1e74ad18a154c35c2c30014","ad499bdc89e6487681102296b170cf5f","ca1d5c4d7b91421d9e8151a92fea6ab2","a3a44adb7ea54a34bd2392de926e36d1","487d0c5de610454bbc7e085cc9ede8de","a78e2a4e717e45018a6c5603b0addaf4"],"text":"\\begin{tabular}{|l|l|}\n\\hline 14.1.1.1 & Patient Disposition - All Patients \\\\\n\\hline 14.1.2.1a & Demographic and Other Baseline Characteristics - Full Analysis Set \\\\\n\\hline 14.1.3.1 & Medical/Surgical History - Full Analysis Set \\\\\n\\hline 14.1.3.3 & Targeted Cardiovascular History/Risk Factors - Full Analysis Set \\\\\n\\hline 14.1.5.1 & Study Drug Compliance - Safety Analysis Set \\\\\n\\hline 14.3.1.1 & Overview of Treatment-Emergent Adverse Events - Safety Analysis Set \\\\\n\\hline 14.3.1.2 & Treatment-Emergent Adverse Events by Maximum Severity, System Organ Class and Preferred Term - Safety Analysis Set \\\\\n\\hline 14.3.1.3 & Serious Treatment-Emergent Adverse Events by Maximum Severity, System Organ Class and Preferred Term - Safety Analysis Set \\\\\n\\hline 14.3.1.4 & Related Treatment-Emergent Adverse Events by Maximum Severity, System Organ Class and Preferred Term - Safety Analysis Set \\\\\n\\hline 14.3.1.5 & Related Serious Treatment-Emergent Adverse Events by Maximum Severity, System Organ Class and Preferred Term - Safety Analysis Set \\\\\n\\hline 14.3.1.6 & Treatment-Emergent Adverse Events That Led to Discontinuation of Study Drug by Maximum Severity, System Organ Class and Preferred Term - Safety Analysis Set \\\\\n\\hline 14.3.1.8 & Treatment-Emergent AESIs by Maximum Severity, System Organ Class and Preferred Term - Safety Analysis Set \\\\\n\\hline 14.3.1.15 & Investigator-reported Major Cardiac Events (MACE) by Event Type - Safety Analysis Set \\\\\n\\hline 14.3.1.16 & Adjudicated Major Cardiac Events (MACE) by Event Type - Safety Analysis Set \\\\\n\\hline 14.3.2.8 & Laboratory Parameters of Interest: Observed and Change from Baseline - Safety Analysis Set \\\\\n\\hline 14.3.2.9 & Laboratory Parameters of Interest: Laboratory Abnormalities - Safety Analysis Set \\\\\n\\hline & \\\\\n\\hline ![](https://cdn.mathpix.com/cropped/de3477dd-40d9-4af3-84f5-5eecb300914b-42.jpg?height=44\\&width=103\\&top_left_y=2469\\&top_left_x=307) & Version Number: \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline 14.1.1.1 & Patient Disposition - All Patients \\\\\n\\hline 14.1.2.1a & Demographic and Other Baseline Characteristics - Full Analysis Set \\\\\n\\hline 14.1.3.1 & Medical/Surgical History - Full Analysis Set \\\\\n\\hline 14.1.3.3 & Targeted Cardiovascular History/Risk Factors - Full Analysis Set \\\\\n\\hline 14.1.5.1 & Study Drug Compliance - Safety Analysis Set \\\\\n\\hline 14.3.1.1 & Overview of Treatment-Emergent Adverse Events - Safety Analysis Set \\\\\n\\hline 14.3.1.2 & Treatment-Emergent Adverse Events by Maximum Severity, System Organ Class and Preferred Term - Safety Analysis Set \\\\\n\\hline 14.3.1.3 & Serious Treatment-Emergent Adverse Events by Maximum Severity, System Organ Class and Preferred Term - Safety Analysis Set \\\\\n\\hline 14.3.1.4 & Related Treatment-Emergent Adverse Events by Maximum Severity, System Organ Class and Preferred Term - Safety Analysis Set \\\\\n\\hline 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