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The","confidence":1,"confidence_rate":1},{"cnt":[[245,1332],[1846,1332],[1846,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1332,"width":1602,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e8908f9a07c4487bb29ac96b3121461","type":"text","conversion_output":true,"text":"estimated overall duration of the study (first patient first visit [FPFV] to last patient last visit [LPLV]) is","text_display":" estimated overall duration of the study (first patient first visit [FPFV] to last patient last visit [LPLV]) is","confidence":1,"confidence_rate":1},{"cnt":[[245,1377],[655,1377],[655,1424],[245,1424]],"region":{"top_left_x":244,"top_left_y":1377,"width":412,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e68179b2f6c4a54a60a72ffd6ec5477","type":"text","conversion_output":true,"text":"approximately 21 months.","text_display":" approximately 21 months.","confidence":1,"confidence_rate":1},{"cnt":[[243,1435],[973,1435],[973,1489],[243,1489]],"region":{"top_left_x":242,"top_left_y":1435,"width":732,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"064af467436f4b32bea9ba8b6dd03621","type":"section_header","conversion_output":false,"children_ids":["b20fdfc6bc3d4c0fad112ecd769900b3"],"text":"","text_display":""},{"cnt":[[247,1439],[969,1439],[969,1487],[247,1487]],"region":{"top_left_x":247,"top_left_y":1439,"width":722,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b20fdfc6bc3d4c0fad112ecd769900b3","type":"text","conversion_output":true,"parent_id":"064af467436f4b32bea9ba8b6dd03621","text":"Diagnosis and criteria for patient eligibility:","text_display":"\n\n\\section*{Diagnosis and criteria for patient eligibility:}","confidence":1,"confidence_rate":1},{"cnt":[[245,1491],[1371,1491],[1371,1538],[245,1538]],"region":{"top_left_x":244,"top_left_y":1491,"width":1127,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa28002cbc6c47d5a17397a03d085c60","type":"text","conversion_output":true,"text":"The study will enroll adult male and female patients with hyperlipidemia","text_display":"\n\nThe study will enroll adult male and female patients with hyperlipidemia","confidence":1,"confidence_rate":1},{"cnt":[[245,1543],[1373,1543],[1373,1588],[245,1588]],"region":{"top_left_x":244,"top_left_y":1542,"width":1129,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14378eff36a24e45bdfd82ad7efe21ce","type":"text","conversion_output":true,"text":"Each patient must meet the following criteria to be eligible for this study:","text_display":"\nEach patient must meet the following criteria to be eligible for this study:","confidence":1,"confidence_rate":1},{"cnt":[[245,1590],[526,1590],[526,1639],[245,1639]],"region":{"top_left_x":244,"top_left_y":1589,"width":283,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f582e969849e44629840f079994c9387","type":"section_header","conversion_output":false,"children_ids":["e63d3de56ca544d18f08a1e5cf69ee2f"],"text":"","text_display":""},{"cnt":[[247,1594],[522,1594],[522,1635],[247,1635]],"region":{"top_left_x":247,"top_left_y":1594,"width":276,"height":41},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e63d3de56ca544d18f08a1e5cf69ee2f","type":"text","conversion_output":true,"parent_id":"f582e969849e44629840f079994c9387","text":"Inclusion Criteria","text_display":"\n\n\\section*{Inclusion Criteria}","confidence":1,"confidence_rate":1},{"cnt":[[249,1646],[1474,1646],[1474,1695],[249,1695]],"region":{"top_left_x":249,"top_left_y":1645,"width":1225,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90bb3f53249a4379b806431f53ee7eee","type":"text","conversion_output":true,"text":"1. Provision of written informed consent prior to any study-specific procedure","text_display":"\n1. Provision of written informed consent prior to any study-specific procedure","confidence":1,"confidence_rate":1},{"cnt":[[245,1702],[1828,1702],[1828,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1701,"width":1585,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df3f3f7d28a54b4d9d596be7f76e4ee1","type":"text","conversion_output":true,"text":"2. Age \\(\\geq 18\\) years or legal age of majority depending on regional law, whichever is greater at Week - 5","text_display":"\n2. Age \\(\\geq 18\\) years or legal age of majority depending on regional law, whichever is greater at Week - 5","confidence":0.5532069206237793,"confidence_rate":0.9945333010696953},{"cnt":[[309,1745],[466,1745],[466,1790],[309,1790]],"region":{"top_left_x":309,"top_left_y":1744,"width":158,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2fa0ee09eca4567a6d422118f230d76","type":"text","conversion_output":true,"text":"(Visit S1)","text_display":" (Visit S1)","confidence":1,"confidence_rate":1},{"cnt":[[245,1800],[990,1800],[990,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1800,"width":747,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b95ac132ca84c709f54a62a39c97680","type":"text","conversion_output":true,"text":"3. Men and nonpregnant, nonlactating women.","text_display":"\n3. Men and nonpregnant, nonlactating women.","confidence":1,"confidence_rate":1},{"cnt":[[245,1852],[672,1852],[672,1895],[245,1895]],"region":{"top_left_x":244,"top_left_y":1851,"width":429,"height":44},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bb28ba9c49d4bb8aae80400e21d8fc2","type":"text","conversion_output":true,"text":"4. Women must be either:","text_display":"\n4. Women must be either:","confidence":1,"confidence_rate":1},{"cnt":[[309,1912],[1755,1912],[1755,1957],[309,1957]],"region":{"top_left_x":309,"top_left_y":1912,"width":1447,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac5832626c88445fbfba8fbf7fc28e3c","type":"text","conversion_output":true,"text":"- Naturally postmenopausal (as reported by the patient, defined as greater than 55 years and","text_display":"\n- Naturally postmenopausal (as reported by the patient, defined as greater than 55 years and","confidence":1,"confidence_rate":1},{"cnt":[[367,1955],[1876,1955],[1876,2000],[367,2000]],"region":{"top_left_x":367,"top_left_y":1955,"width":1509,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e24d655414114a40b2dd13de474b386a","type":"text","conversion_output":true,"text":"\\(\\geq 1\\) year without menses, \\(<55\\) years and \\(\\geq 1\\) year without menses with follicle-stimulating hormone","text_display":" \\(\\geq 1\\) year without menses, \\(<55\\) years and \\(\\geq 1\\) year without menses with follicle-stimulating hormone","confidence":0.9970703125,"confidence_rate":0.9999717889802962},{"cnt":[[370,1998],[1865,1998],[1865,2043],[370,2043]],"region":{"top_left_x":369,"top_left_y":1998,"width":1496,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43aba0a12dcf407f8906fccdeb6c282c","type":"text","conversion_output":true,"text":"(FSH) \\(\\geq 40.0 IU / L\\) ), or surgically sterile including hysterectomy, bilateral oophorectomy, or tubal","text_display":" (FSH) \\(\\geq 40.0 IU / L\\) ), or surgically sterile including hysterectomy, bilateral oophorectomy, or tubal","confidence":0.9912109375,"confidence_rate":0.9999204724046169},{"cnt":[[370,2041],[548,2041],[548,2088],[370,2088]],"region":{"top_left_x":369,"top_left_y":2041,"width":179,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69a00de04f0a48ee954bf038e7f930e2","type":"text","conversion_output":true,"text":"ligation or;","text_display":" ligation or;","confidence":1,"confidence_rate":1},{"cnt":[[309,2101],[1813,2101],[1813,2146],[309,2146]],"region":{"top_left_x":309,"top_left_y":2101,"width":1505,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"add4f1c273674d6c834ac79d629abe11","type":"text","conversion_output":true,"text":"- Women of childbearing potential must be willing to use 2 acceptable methods of birth control","text_display":"\n- Women of childbearing potential must be willing to use 2 acceptable methods of birth control","confidence":1,"confidence_rate":1},{"cnt":[[370,2144],[1833,2144],[1833,2189],[370,2189]],"region":{"top_left_x":369,"top_left_y":2144,"width":1464,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f3938be55d843638b56bab869a33e97","type":"text","conversion_output":true,"text":"(unless they have agreed to follow the definition of true abstinence). The minimal requirement","text_display":" (unless they have agreed to follow the definition of true abstinence). The minimal requirement","confidence":1,"confidence_rate":1},{"cnt":[[370,2187],[1828,2187],[1828,2232],[370,2232]],"region":{"top_left_x":369,"top_left_y":2187,"width":1460,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eaf6b581933c4140830392ec4870958f","type":"text","conversion_output":true,"text":"for adequate contraception should be started on Day 1, continuing during the study period, and","text_display":" for adequate contraception should be started on Day 1, continuing during the study period, and","confidence":1,"confidence_rate":1},{"cnt":[[372,2230],[1869,2230],[1869,2277],[372,2277]],"region":{"top_left_x":371,"top_left_y":2230,"width":1499,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f531895e5748452eb2680199bd517944","type":"text","conversion_output":true,"text":"for at least 30 days after the last dose of study drug. Acceptable methods of birth control include:","text_display":" for at least 30 days after the last dose of study drug. Acceptable methods of birth control include:","confidence":1,"confidence_rate":1},{"cnt":[[370,2275],[1815,2275],[1815,2322],[370,2322]],"region":{"top_left_x":369,"top_left_y":2275,"width":1447,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"972713cbb202495bb7c9545b266a08e4","type":"text","conversion_output":true,"text":"oral, implantable, injectable, or topical birth control medications; placement of an intrauterine","text_display":" oral, implantable, injectable, or topical birth control medications; placement of an intrauterine","confidence":1,"confidence_rate":1},{"cnt":[[370,2320],[1869,2320],[1869,2365],[370,2365]],"region":{"top_left_x":369,"top_left_y":2320,"width":1501,"height":46},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00268058d19c477b9c27aa4356f0d97b","type":"text","conversion_output":true,"text":"device (IUD) with or without hormones; barrier methods including condom or occlusive 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true abstinence when this is in line with the preferred and usual lifestyle of the subject","text_display":" patient; or true abstinence when this is in line with the preferred and usual lifestyle of the subject","confidence":1,"confidence_rate":1},{"cnt":[[370,2449],[1878,2449],[1878,2499],[370,2499]],"region":{"top_left_x":369,"top_left_y":2449,"width":1509,"height":50},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd74cc804d9f437b82be6f61387304cb","type":"text","conversion_output":true,"text":"(periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], declaration","text_display":" (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], 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Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,174],[814,174],[814,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":571,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3076885689bf40849d8bc0457bca61aa","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"924fb0e74e2e4b0cb600af0cb5f3f972","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 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Fasting LDL-C (minimum of 10 hours) value at Week -5 (Visit S1) \\(\\geq 100 mg / dL (2.6 mmol / L )\\) and","text_display":"\n5. Fasting LDL-C (minimum of 10 hours) value at Week -5 (Visit S1) \\(\\geq 100 mg / dL (2.6 mmol / L )\\) and","confidence":0.5945140847334711,"confidence_rate":0.9956028242196963},{"cnt":[[305,494],[1366,494],[1366,539],[305,539]],"region":{"top_left_x":305,"top_left_y":494,"width":1062,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ce9627998fd4b9888033f26ce4fe9d1","type":"text","conversion_output":true,"text":"fasting LDL-C value at Week -1 (Visit S3) \\(\\geq 70 mg / dL (1.8 mmol / L )\\)","text_display":" fasting LDL-C value at Week -1 (Visit S3) \\(\\geq 70 mg / dL (1.8 mmol / L )\\)","confidence":0.7186253053733935,"confidence_rate":0.9959291087567077},{"cnt":[[245,546],[978,546],[978,595],[245,595]],"region":{"top_left_x":244,"top_left_y":545,"width":734,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8685c1442eb4e0098660865065d6998","type":"text","conversion_output":true,"text":"6. Have high CV risk that is defined as either:","text_display":"\n6. Have high CV risk that is defined as either:","confidence":1,"confidence_rate":1},{"cnt":[[305,604],[1796,604],[1796,651],[305,651]],"region":{"top_left_x":305,"top_left_y":603,"width":1492,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"617cd1ff36bd4473b45c378b89838c63","type":"text","conversion_output":true,"text":"- Diagnosis of HeFH. Diagnosis must be made by either genotyping or by clinical assessment","text_display":"\n- Diagnosis of HeFH. Diagnosis must be made by either genotyping or by clinical assessment","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[370,649],[1760,649],[1760,694],[370,694]],"region":{"top_left_x":369,"top_left_y":648,"width":1391,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13d8695b9cf34564a0e8feb6ce6fbfe2","type":"text","conversion_output":true,"text":"using either the World Health Organization (WHO) criteria/Dutch Lipid Clinical Network","text_display":" using either the World Health Organization (WHO) criteria/Dutch Lipid Clinical Network","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[370,692],[1867,692],[1867,741],[370,741]],"region":{"top_left_x":369,"top_left_y":691,"width":1498,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d8995db98b740179af3622de250d5e1","type":"text","conversion_output":true,"text":"Criteria with a score that is \\(>8\\) points (see Appendix 4) or the Simon Broome Register Diagnostic","text_display":" Criteria with a score that is \\(>8\\) points (see Appendix 4) or the Simon Broome Register Diagnostic","confidence":0.9346644573379308,"confidence_rate":0.9993505217402584},{"cnt":[[370,735],[1830,735],[1830,784],[370,784]],"region":{"top_left_x":369,"top_left_y":734,"width":1462,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b667d3da83364094a738fa48e509aff0","type":"text","conversion_output":true,"text":"Criteria with an assessment of 'Definite HeFH' (see Appendix 5). 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In the case of PCSK9 inhibitor use, the patient must have received","text_display":" a consistent time each day. In the case of PCSK9 inhibitor use, the patient must have received","confidence":1,"confidence_rate":1},{"cnt":[[305,623],[1809,623],[1809,672],[305,672]],"region":{"top_left_x":305,"top_left_y":623,"width":1504,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"54f769b443684ee78864bb1bd5764d25","type":"text","conversion_output":true,"text":"3 stable doses. It is important that lipid values are measured at PCSK9i trough levels. Therefore,","text_display":" 3 stable doses. It is important that lipid values are measured at PCSK9i trough levels. Therefore,","confidence":1,"confidence_rate":1},{"cnt":[[305,666],[1828,666],[1828,715],[305,715]],"region":{"top_left_x":305,"top_left_y":666,"width":1524,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6467911f34e54facaa9136ad0a0bef15","type":"text","conversion_output":true,"text":"study visits should be scheduled in accordance with the patient's PCSK9i injection regimen so that","text_display":" study visits should be scheduled in accordance with the patient's PCSK9i injection regimen so that","confidence":1,"confidence_rate":1},{"cnt":[[305,713],[1800,713],[1800,758],[305,758]],"region":{"top_left_x":305,"top_left_y":713,"width":1496,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f335d1ce29af434dbe82ceb19e49d3e9","type":"text","conversion_output":true,"text":"measurement of lipid values for all visits occurs before the PCSK9i injection but not greater than","text_display":" measurement of lipid values for all visits occurs before the PCSK9i injection but not greater than","confidence":1,"confidence_rate":1},{"cnt":[[305,756],[1876,756],[1876,804],[305,804]],"region":{"top_left_x":305,"top_left_y":756,"width":1571,"height":48},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1e3811cdf2a4b2982afb28168a2d676","type":"text","conversion_output":true,"text":"48 hours before the next scheduled PCSK9i injection. Patients who have discontinued investigational","text_display":" 48 hours before the next scheduled PCSK9i injection. Patients who have discontinued investigational","confidence":1,"confidence_rate":1},{"cnt":[[305,799],[1811,799],[1811,849],[305,849]],"region":{"top_left_x":305,"top_left_y":799,"width":1507,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"626559aafc0f4b9993e078d061890634","type":"text","conversion_output":true,"text":"or commercial PCSK9 inhibitor must have had their last dose at least 4 months prior to Screening","text_display":" or commercial PCSK9 inhibitor must have had their last dose at least 4 months prior to Screening","confidence":1,"confidence_rate":1},{"cnt":[[305,844],[449,844],[449,887],[305,887]],"region":{"top_left_x":305,"top_left_y":844,"width":145,"height":44},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"76008e70ee584d809be2baeb3b987220","type":"text","conversion_output":true,"text":"Visit S1.","text_display":" Visit S1.","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[544,898],[544,943],[245,943]],"region":{"top_left_x":244,"top_left_y":898,"width":300,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ede9f8bca62640679596d95bf952a31d","type":"text","conversion_output":true,"text":"Exclusion Criteria:","text_display":"\nExclusion Criteria:","confidence":1,"confidence_rate":1},{"cnt":[[245,950],[1691,950],[1691,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":949,"width":1447,"height":55},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93540c06aac64df5acd3b4caed022063","type":"text","conversion_output":true,"text":"1. Total fasting (minimum of 10 hours) \\(TG \\geq 500 mg / dL (5.6 mmol / L )\\) at Week -5 (Visit S1)","text_display":"\n1. Total fasting (minimum of 10 hours) \\(TG \\geq 500 mg / dL (5.6 mmol / L )\\) at Week -5 (Visit S1)","confidence":0.7873995304107666,"confidence_rate":0.9978870187082609},{"cnt":[[305,1005],[1815,1005],[1815,1055],[305,1055]],"region":{"top_left_x":305,"top_left_y":1005,"width":1511,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af88ef9f692947a18a0b427902863d64","type":"text","conversion_output":true,"text":"Note: TG may be repeated 1 time between Visits S1 and S2. For those patients who have a repeat","text_display":"\n\nNote: TG may be repeated 1 time between Visits S1 and S2. For those patients who have a repeat","confidence":0.9931719303131104,"confidence_rate":0.9999328308087444},{"cnt":[[305,1051],[1190,1051],[1190,1098],[305,1098]],"region":{"top_left_x":305,"top_left_y":1050,"width":886,"height":48},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cbf8c335509e4a10be48e99cd2cbb3d3","type":"text","conversion_output":true,"text":"TG, the repeat value will be used to determine eligibility.","text_display":" TG, the repeat value will be used to determine eligibility.","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[245,1104],[1811,1104],[1811,1154],[245,1154]],"region":{"top_left_x":244,"top_left_y":1104,"width":1568,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c9b801036c84fb89b5a7bb7e719f094","type":"text","conversion_output":true,"text":"2. Renal dysfunction or nephritic syndrome or a history of nephritis, including estimated glomerular","text_display":"\n2. Renal dysfunction or nephritic syndrome or a history of nephritis, including estimated glomerular","confidence":1,"confidence_rate":1},{"cnt":[[305,1147],[1807,1147],[1807,1197],[305,1197]],"region":{"top_left_x":305,"top_left_y":1147,"width":1502,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"833b8f2e449046df8a04a348bb8d7d1a","type":"text","conversion_output":true,"text":"filtration rate (eGFR) (using central laboratory determined Modification of Diet in Renal Disease","text_display":" filtration rate (eGFR) (using central laboratory determined Modification of Diet in Renal Disease","confidence":1,"confidence_rate":1},{"cnt":[[305,1188],[1493,1188],[1493,1244],[305,1244]],"region":{"top_left_x":305,"top_left_y":1188,"width":1189,"height":56},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98f3cf4e284743fba3b2869d6ddbe1ae","type":"text","conversion_output":true,"text":"[MDRD] formula) \\(<30 mL / min / 1.73 m^{2}\\) at Week -5 (Visit S1) (Levey 2006).","text_display":" [MDRD] formula) \\(<30 mL / min / 1.73 m^{2}\\) at Week -5 (Visit S1) (Levey 2006).","confidence":0.5352726997807622,"confidence_rate":0.9932297725802274},{"cnt":[[305,1246],[1863,1246],[1863,1296],[305,1296]],"region":{"top_left_x":305,"top_left_y":1246,"width":1558,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28a651d4e96142ffb0c4692a64d37f43","type":"text","conversion_output":true,"text":"Note: At the discretion of the investigator, the screening period may be extended up to 4 weeks for a","text_display":"\nNote: At the discretion of the investigator, the screening period may be extended up to 4 weeks for a","confidence":1,"confidence_rate":1},{"cnt":[[305,1291],[1863,1291],[1863,1343],[305,1343]],"region":{"top_left_x":305,"top_left_y":1291,"width":1558,"height":52},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"157587faef0e493e95ac8471555828de","type":"text","conversion_output":true,"text":"single repeat eGFR. For those patients who have a repeat eGFR, the repeat value should be obtained","text_display":" single repeat eGFR. For those patients who have a repeat eGFR, the repeat value should be obtained","confidence":1,"confidence_rate":1},{"cnt":[[305,1336],[1334,1336],[1334,1386],[305,1386]],"region":{"top_left_x":305,"top_left_y":1336,"width":1030,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1a02772b67f436f9f0d9f37a28a7ad0","type":"text","conversion_output":true,"text":"between Visits S1 and S2 and will be used to determine eligibility.","text_display":" between Visits S1 and S2 and will be used to determine eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[245,1384],[857,1384],[857,1437],[245,1437]],"region":{"top_left_x":244,"top_left_y":1383,"width":614,"height":55},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f16478ed7804eee98115f6521d52317","type":"text","conversion_output":true,"text":"3. Body mass index (BMI) \\(\\geq 50 kg / m ^{2}\\)","text_display":"\n3. Body mass index (BMI) \\(\\geq 50 kg / m ^{2}\\)","confidence":0.99951171875,"confidence_rate":0.9999902320377446},{"cnt":[[243,1439],[1828,1439],[1828,1493],[243,1493]],"region":{"top_left_x":242,"top_left_y":1439,"width":1587,"height":55},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"120bb3548f3c4a20833c7079c20b0b8d","type":"text","conversion_output":true,"text":"4. Recent (within 3 months prior to the screening visit [Week - 5 (Visit S1)] or between screening and","text_display":"\n4. Recent (within 3 months prior to the screening visit [Week - 5 (Visit S1)] or between screening and","confidence":0.4157187076254093,"confidence_rate":0.9922624228371438},{"cnt":[[305,1487],[1781,1487],[1781,1536],[305,1536]],"region":{"top_left_x":305,"top_left_y":1486,"width":1477,"height":51},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d68e8d414444b119b19cfe881be7db1","type":"text","conversion_output":true,"text":"randomization visits) MI, unstable angina leading to hospitalization, uncontrolled, symptomatic","text_display":" randomization visits) MI, unstable angina leading to hospitalization, uncontrolled, symptomatic","confidence":1,"confidence_rate":1},{"cnt":[[305,1532],[1876,1532],[1876,1579],[305,1579]],"region":{"top_left_x":305,"top_left_y":1531,"width":1571,"height":49},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00fb75be35f04f79bc229484f76b7894","type":"text","conversion_output":true,"text":"cardiac arrhythmia (or medication for an arrhythmia that was started or dose changed within 3 months","text_display":" cardiac arrhythmia (or medication for an arrhythmia that was started or dose changed within 3 months","confidence":1,"confidence_rate":1},{"cnt":[[305,1577],[1837,1577],[1837,1624],[305,1624]],"region":{"top_left_x":305,"top_left_y":1576,"width":1532,"height":49},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b9014cb2b5e4372a1eeab5ca0c65f8f","type":"text","conversion_output":true,"text":"of screening), CABG, PCI, carotid surgery or stenting, cerebrovascular accident, transient ischemic","text_display":" of screening), CABG, PCI, carotid surgery or stenting, cerebrovascular accident, transient ischemic","confidence":1,"confidence_rate":1},{"cnt":[[305,1620],[1865,1620],[1865,1669],[305,1669]],"region":{"top_left_x":305,"top_left_y":1619,"width":1560,"height":51},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"908e176d1b6041cc95cdabc27ef5a4eb","type":"text","conversion_output":true,"text":"attack (TIA), endovascular procedure or surgical intervention for peripheral vascular disease or plans","text_display":" attack (TIA), endovascular procedure or surgical intervention for peripheral vascular disease or plans","confidence":1,"confidence_rate":1},{"cnt":[[305,1663],[1757,1663],[1757,1712],[305,1712]],"region":{"top_left_x":305,"top_left_y":1662,"width":1453,"height":51},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17d20104706a4066bd94bd5a8dd16917","type":"text","conversion_output":true,"text":"to undergo a major surgical or interventional procedure (eg, PCI, CABG, carotid or peripheral","text_display":" to undergo a major surgical or interventional procedure (eg, PCI, CABG, carotid or peripheral","confidence":1,"confidence_rate":1},{"cnt":[[305,1706],[1785,1706],[1785,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1705,"width":1481,"height":51},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"630ffc3d029043f9a0abf3034956f8c7","type":"text","conversion_output":true,"text":"revascularization). Patients with implantable pacemakers or automatic implantable cardioverter","text_display":" revascularization). Patients with implantable pacemakers or automatic implantable cardioverter","confidence":1,"confidence_rate":1},{"cnt":[[305,1749],[1863,1749],[1863,1800],[305,1800]],"region":{"top_left_x":305,"top_left_y":1748,"width":1558,"height":53},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fed50e3ee9924b37ae41f2b6564ad238","type":"text","conversion_output":true,"text":"defibrillators may be considered if deemed by the Investigator to be stable for the previous 3 months.","text_display":" defibrillators may be considered if deemed by the Investigator to be stable for the previous 3 months.","confidence":1,"confidence_rate":1},{"cnt":[[245,1805],[1876,1805],[1876,1854],[245,1854]],"region":{"top_left_x":244,"top_left_y":1804,"width":1632,"height":51},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"063aa55389b94772acf57b7a1fb2996f","type":"text","conversion_output":true,"text":"5. Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) \\(\\geq 160 mmHg\\) and diastolic","text_display":"\n5. Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) \\(\\geq 160 mmHg\\) and diastolic","confidence":0.9990234375,"confidence_rate":0.999991276469766},{"cnt":[[305,1850],[1377,1850],[1377,1901],[305,1901]],"region":{"top_left_x":305,"top_left_y":1849,"width":1073,"height":53},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"631dc8597f874c3e98a08d0b9e7639c6","type":"text","conversion_output":true,"text":"blood pressure \\(( DBP ) \\geq 100 mmHg\\) after sitting quietly for 5 minutes.","text_display":" blood pressure \\(( DBP ) \\geq 100 mmHg\\) after sitting quietly for 5 minutes.","confidence":0.984375,"confidence_rate":0.9998079653072647},{"cnt":[[305,1904],[1818,1904],[1818,1953],[305,1953]],"region":{"top_left_x":305,"top_left_y":1903,"width":1513,"height":50},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"880fb8ba3eb24bd09e8c2d6cc109ad42","type":"text","conversion_output":true,"text":"Note: If the initial blood pressure (BP) values meet or exceed the specified level, an additional BP","text_display":"\nNote: If the initial blood pressure (BP) values meet or exceed the specified level, an additional BP","confidence":1,"confidence_rate":1},{"cnt":[[305,1949],[1835,1949],[1835,1996],[305,1996]],"region":{"top_left_x":305,"top_left_y":1948,"width":1530,"height":48},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"71ac77c2294d4f9d8ec209eacd9eca2f","type":"text","conversion_output":true,"text":"assessment may be completed. If the systolic or the diastolic values continue to meet or exceed the","text_display":" assessment may be completed. If the systolic or the diastolic values continue to meet or exceed the","confidence":1,"confidence_rate":1},{"cnt":[[305,1989],[1858,1989],[1858,2039],[305,2039]],"region":{"top_left_x":305,"top_left_y":1989,"width":1554,"height":50},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a22693fccc846958c53a6b742377c31","type":"text","conversion_output":true,"text":"threshold, the patient may not continue screening. However, at the discretion of the Investigator, the","text_display":" threshold, the patient may not continue screening. However, at the discretion of the Investigator, the","confidence":1,"confidence_rate":1},{"cnt":[[305,2037],[1807,2037],[1807,2084],[305,2084]],"region":{"top_left_x":305,"top_left_y":2036,"width":1502,"height":48},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a235fe105784b2091970bc12f8915f3","type":"text","conversion_output":true,"text":"screening period (between Visits S1 and S2) may be extended up to 4 weeks to allow for a repeat","text_display":" screening period (between Visits S1 and S2) may be extended up to 4 weeks to allow for a repeat","confidence":1,"confidence_rate":1},{"cnt":[[305,2080],[1815,2080],[1815,2129],[305,2129]],"region":{"top_left_x":305,"top_left_y":2079,"width":1511,"height":51},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b67b5eb9d86c4ad8beb80432bec953f4","type":"text","conversion_output":true,"text":"qualifying BP assessment following adjustment of BP medication(s), provided that the patient has","text_display":" qualifying BP assessment following adjustment of BP medication(s), provided that the patient has","confidence":1,"confidence_rate":1},{"cnt":[[305,2123],[1865,2123],[1865,2172],[305,2172]],"region":{"top_left_x":305,"top_left_y":2122,"width":1560,"height":51},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1cbaac1883dd4f7991e178c252aad940","type":"text","conversion_output":true,"text":"been on a stable dose of the BP medication for a minimum of 2 weeks prior to randomization and the","text_display":" been on a stable dose of the BP medication for a minimum of 2 weeks prior to randomization and the","confidence":0.900390625,"confidence_rate":0.9990106163475762},{"cnt":[[305,2168],[1222,2168],[1222,2215],[305,2215]],"region":{"top_left_x":305,"top_left_y":2167,"width":918,"height":49},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5fe7b274db34997b0f9881a9b7f53b5","type":"text","conversion_output":true,"text":"repeat BP measurements do not meet the exclusion criteria.","text_display":" repeat BP measurements do not meet the exclusion criteria.","confidence":1,"confidence_rate":1},{"cnt":[[245,2219],[1149,2219],[1149,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2219,"width":906,"height":52},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4405c4f3f8714149944c61c50d8210b2","type":"text","conversion_output":true,"text":"6. Hemoglobin \\(A _{1 C }\\left( HbA _{1 C }\\right) \\geq 10 \\%\\) at Week -5 (Visit S 1\\()\\)","text_display":"\n6. Hemoglobin \\(A _{1 C }\\left( HbA _{1 C }\\right) \\geq 10 \\%\\) at Week -5 (Visit S 1\\()\\)","confidence":0.3826645005314719,"confidence_rate":0.9888924212985284},{"cnt":[[245,2273],[1884,2273],[1884,2325],[245,2325]],"region":{"top_left_x":244,"top_left_y":2273,"width":1641,"height":52},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd431cf586c5441b842320ae0c8cd185","type":"text","conversion_output":true,"text":"7. Uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) \\(>1.5 \\times\\) the upper limit of","text_display":"\n7. Uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) \\(>1.5 \\times\\) the upper limit of","confidence":1,"confidence_rate":1},{"cnt":[[305,2320],[1833,2320],[1833,2370],[305,2370]],"region":{"top_left_x":305,"top_left_y":2320,"width":1528,"height":50},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97fd679d9bc646c5a411a43660e245b9","type":"text","conversion_output":true,"text":"normal (ULN) at Week -5 (Visit S1). Patients stabilized on thyroid replacement therapy for at least","text_display":" normal (ULN) at Week -5 (Visit S1). Patients stabilized on thyroid replacement therapy for at least","confidence":0.7769641876220703,"confidence_rate":0.9975763934167281},{"cnt":[[305,2363],[990,2363],[990,2413],[305,2413]],"region":{"top_left_x":305,"top_left_y":2363,"width":686,"height":50},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be312fdd5abe4eea8c6d1ba4a8245c3f","type":"text","conversion_output":true,"text":"6 weeks prior to randomization are allowed.","text_display":" 6 weeks prior to randomization are allowed.","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[245,2417],[924,2417],[924,2469],[245,2469]],"region":{"top_left_x":244,"top_left_y":2416,"width":680,"height":53},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0fcd568fd63a4c79bba50684b52a9aa7","type":"text","conversion_output":true,"text":"8. Liver disease or dysfunction, including:","text_display":"\n8. Liver disease or dysfunction, including:","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2623],[245,2623]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":46},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f432f3f49976418b896bba97f73e22ee","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[941,2578],[1179,2578],[1179,2628],[941,2628]],"region":{"top_left_x":941,"top_left_y":2578,"width":239,"height":50},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b3add9e280740249e87970db4c91fd2","type":"page_info","conversion_output":false,"text":"Page 7 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-008","page":8,"lines":[{"cnt":[[245,129],[535,129],[535,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":291,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"330c4e94413a4efc940f1ce9f3258c9d","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77f53a4c030349499f452c293c79392d","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,174],[814,174],[814,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":571,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a591083c0fb94292bd96e37193549a1d","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c2d4c72fab14a2bbb169063f947a691","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,254],[1710,254],[1710,303],[309,303]],"region":{"top_left_x":309,"top_left_y":253,"width":1402,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"046f029baf7442e3bec83ff00a27e35a","type":"text","conversion_output":true,"text":"- Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies","text_display":"\n- Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies","confidence":0.9912335698027164,"confidence_rate":0.9999063333082645},{"cnt":[[372,301],[939,301],[939,346],[372,346]],"region":{"top_left_x":371,"top_left_y":300,"width":568,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"313789259b124db8b777206e8c255d65","type":"text","conversion_output":true,"text":"(HCV-AB) at Week -5 (Visit S1); or","text_display":" (HCV-AB) at Week -5 (Visit S1); or","confidence":0.9244612944312394,"confidence_rate":0.9979880754717259},{"cnt":[[309,357],[1775,357],[1775,402],[309,402]],"region":{"top_left_x":309,"top_left_y":356,"width":1466,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a9af0df6e3742b485983c5b2d7cc3c4","type":"text","conversion_output":true,"text":"- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \\(\\geq 2 \\times\\) ULN, and/or total","text_display":"\n- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \\(\\geq 2 \\times\\) ULN, and/or total","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[370,402],[1669,402],[1669,445],[370,445]],"region":{"top_left_x":369,"top_left_y":401,"width":1301,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3988d44f5ace43e992683f2f6d83aa32","type":"text","conversion_output":true,"text":"bilirubin (TB) \\(\\geq 2 \\times\\) ULN at Week -5 (Visit S1). If TB \\(\\geq 1.2 \\times ULN\\), a reflex indirect","text_display":" bilirubin (TB) \\(\\geq 2 \\times\\) ULN at Week -5 (Visit S1). If TB \\(\\geq 1.2 \\times ULN\\), a reflex indirect","confidence":0.34462734665649675,"confidence_rate":0.9887310859221653},{"cnt":[[370,443],[1854,443],[1854,492],[370,492]],"region":{"top_left_x":369,"top_left_y":442,"width":1486,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c47368ecf27f46779767959e19263219","type":"text","conversion_output":true,"text":"(unconjugated) bilirubin will be obtained and if consistent with Gilbert's disease or if the patient","text_display":" (unconjugated) bilirubin will be obtained and if consistent with Gilbert's disease or if the patient","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[370,490],[1519,490],[1519,535],[370,535]],"region":{"top_left_x":369,"top_left_y":489,"width":1150,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fb0a818e55cc4acebfc3d2c7a9d824ac","type":"text","conversion_output":true,"text":"has a history of Gilbert's Disease, the patient may be enrolled in the study.","text_display":" has a history of Gilbert's Disease, the patient may be enrolled in the study.","confidence":1,"confidence_rate":1},{"cnt":[[370,544],[1858,544],[1858,591],[370,591]],"region":{"top_left_x":369,"top_left_y":543,"width":1490,"height":48},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38aa1babebaf4e98b0b9d5edece4ad95","type":"text","conversion_output":true,"text":"Note: At the discretion of the investigator, a single repeat of ALT and/or AST may be completed","text_display":"\nNote: At the discretion of the investigator, a single repeat of ALT and/or AST may be completed","confidence":1,"confidence_rate":1},{"cnt":[[370,589],[1841,589],[1841,634],[370,634]],"region":{"top_left_x":369,"top_left_y":588,"width":1473,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2fb85f367a5c49a5aed5c07c2a7c1e3c","type":"text","conversion_output":true,"text":"prior to randomization. For those patients who have a repeat ALT and/or AST, the repeat value","text_display":" prior to randomization. For those patients who have a repeat ALT and/or AST, the repeat value","confidence":1,"confidence_rate":1},{"cnt":[[370,632],[1880,632],[1880,677],[370,677]],"region":{"top_left_x":369,"top_left_y":631,"width":1511,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e37210a4f8242679e2c636e34326418","type":"text","conversion_output":true,"text":"will be used to determine eligibility. Also, if test for hepatitis C antibody is positive, but reflexive","text_display":" will be used to determine eligibility. Also, if test for hepatitis C antibody is positive, but reflexive","confidence":0.9477791786193848,"confidence_rate":0.9995337284096505},{"cnt":[[370,675],[1588,675],[1588,720],[370,720]],"region":{"top_left_x":369,"top_left_y":674,"width":1219,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f36379225f3466b829c26a174b1397f","type":"text","conversion_output":true,"text":"test for Hepatitis C ribonucleic acid (RNA) is negative, patient can be enrolled.","text_display":" test for Hepatitis C ribonucleic acid (RNA) is negative, patient can be enrolled.","confidence":0.99609375,"confidence_rate":0.9999544905783626},{"cnt":[[245,722],[1818,722],[1818,776],[245,776]],"region":{"top_left_x":244,"top_left_y":721,"width":1574,"height":55},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25deb4eecd0d426e834fc07513782bb1","type":"text","conversion_output":true,"text":"9. Gastrointestinal conditions or procedures (including weight loss surgery; eg, Lap-Band \\({ }^{\\circledR}\\) or gastric","text_display":"\n9. Gastrointestinal conditions or procedures (including weight loss surgery; eg, Lap-Band \\({ }^{\\circledR}\\) or gastric","confidence":0.8538672924041748,"confidence_rate":0.9986506591068441},{"cnt":[[305,773],[922,773],[922,819],[305,819]],"region":{"top_left_x":305,"top_left_y":773,"width":617,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6cbda54abe44c4688c578daebb2e899","type":"text","conversion_output":true,"text":"bypass) that may affect drug absorption","text_display":" bypass) that may affect drug absorption","confidence":1,"confidence_rate":1},{"cnt":[[249,827],[1846,827],[1846,874],[249,874]],"region":{"top_left_x":249,"top_left_y":827,"width":1597,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da523ef492e045569777bf25e271d0a8","type":"text","conversion_output":true,"text":"10. Hematologic or coagulation disorders or a hemoglobin ( Hgb ) level \\(<10.0 g / dL ( 100 g / L\\) ) at Week -5","text_display":"\n10. Hematologic or coagulation disorders or a hemoglobin ( Hgb ) level \\(<10.0 g / dL ( 100 g / L\\) ) at Week -5","confidence":0.2650993252796126,"confidence_rate":0.9896005099398071},{"cnt":[[305,872],[466,872],[466,917],[305,917]],"region":{"top_left_x":305,"top_left_y":872,"width":162,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57f6317087684f9e8521dfe2953aaf2c","type":"text","conversion_output":true,"text":"(Visit S1)","text_display":" (Visit S1)","confidence":1,"confidence_rate":1},{"cnt":[[249,924],[1798,924],[1798,973],[249,973]],"region":{"top_left_x":249,"top_left_y":923,"width":1550,"height":51},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"71320ca47fb549a0add2025c9e2082be","type":"text","conversion_output":true,"text":"11. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past","text_display":"\n11. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past","confidence":1,"confidence_rate":1},{"cnt":[[305,971],[1841,971],[1841,1016],[305,1016]],"region":{"top_left_x":305,"top_left_y":971,"width":1537,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc1a47d40e0c4abab8857925dcd0b25c","type":"text","conversion_output":true,"text":"5 years. Nonmetastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ","text_display":" 5 years. Nonmetastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ","confidence":1,"confidence_rate":1},{"cnt":[[305,1014],[494,1014],[494,1055],[305,1055]],"region":{"top_left_x":305,"top_left_y":1014,"width":190,"height":41},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f4e9f4df5624653b07a07484ec9a428","type":"text","conversion_output":true,"text":"are allowed","text_display":" are allowed","confidence":1,"confidence_rate":1},{"cnt":[[249,1068],[1880,1068],[1880,1113],[249,1113]],"region":{"top_left_x":249,"top_left_y":1067,"width":1631,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc031c472b474fc797ea6fd61e75338b","type":"text","conversion_output":true,"text":"12. Unexplained creatine kinase (CK) \\(>3 \\times\\) ULN at screening up to randomization (ie, not associated with","text_display":"\n12. Unexplained creatine kinase (CK) \\(>3 \\times\\) ULN at screening up to randomization (ie, not associated with","confidence":0.99853515625,"confidence_rate":0.9999866735644114},{"cnt":[[305,1113],[1833,1113],[1833,1158],[305,1158]],"region":{"top_left_x":305,"top_left_y":1112,"width":1528,"height":47},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"129845ac17e8427394868306ba8c1eed","type":"text","conversion_output":true,"text":"recent trauma or physically strenuous activity). Patients with an explained CK elevation must have","text_display":" recent trauma or physically strenuous activity). Patients with an explained CK elevation must have","confidence":1,"confidence_rate":1},{"cnt":[[305,1156],[1102,1156],[1102,1201],[305,1201]],"region":{"top_left_x":305,"top_left_y":1155,"width":798,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3737bf756ed741ccbb5acbbadb73be39","type":"text","conversion_output":true,"text":"single repeat CK \\(\\leq 3 \\times\\) ULN prior to randomization.","text_display":" single repeat CK \\(\\leq 3 \\times\\) ULN prior to randomization.","confidence":0.99755859375,"confidence_rate":0.9999563511072518},{"cnt":[[249,1210],[1777,1210],[1777,1257],[249,1257]],"region":{"top_left_x":249,"top_left_y":1209,"width":1528,"height":48},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39f173e6637642f4a6f0969c442c301b","type":"text","conversion_output":true,"text":"13. History within the last 2 years of drug, alcohol, amphetamine and derivatives, or cocaine abuse.","text_display":"\n13. History within the last 2 years of drug, alcohol, amphetamine and derivatives, or cocaine abuse.","confidence":1,"confidence_rate":1},{"cnt":[[305,1255],[1846,1255],[1846,1300],[305,1300]],"region":{"top_left_x":305,"top_left_y":1254,"width":1541,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31d8cf8a73fc4d03b46a4db5c4aeeb98","type":"text","conversion_output":true,"text":"Patients with amphetamine derivatives prescribed by and under the care of a health care practitioner","text_display":" Patients with amphetamine derivatives prescribed by and under the care of a health care practitioner","confidence":1,"confidence_rate":1},{"cnt":[[305,1298],[1102,1298],[1102,1343],[305,1343]],"region":{"top_left_x":305,"top_left_y":1297,"width":798,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4058c5ab66974c4fa5d8f1ac6eae0d6b","type":"text","conversion_output":true,"text":"can be enrolled after evaluation by the Investigator.","text_display":" can be enrolled after evaluation by the Investigator.","confidence":1,"confidence_rate":1},{"cnt":[[247,1351],[1852,1351],[1852,1399],[247,1399]],"region":{"top_left_x":247,"top_left_y":1351,"width":1605,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a7eb1eb79bd4c02b075f25cc0dbf73b","type":"text","conversion_output":true,"text":"14. Blood donation, blood transfusion, participation in a clinical study with multiple blood draws, major","text_display":"\n14. Blood donation, blood transfusion, participation in a clinical study with multiple blood draws, major","confidence":1,"confidence_rate":1},{"cnt":[[305,1396],[1596,1396],[1596,1442],[305,1442]],"region":{"top_left_x":305,"top_left_y":1396,"width":1292,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"746d85d7fb884a8c921f7ecd4d925c40","type":"text","conversion_output":true,"text":"trauma, or surgery with or without blood loss within 30 days prior to randomization","text_display":" trauma, or surgery with or without blood loss within 30 days prior to randomization","confidence":1,"confidence_rate":1},{"cnt":[[249,1450],[1583,1450],[1583,1497],[249,1497]],"region":{"top_left_x":249,"top_left_y":1450,"width":1335,"height":48},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0be3ddf4ce244cb8e3fc65988431507","type":"text","conversion_output":true,"text":"15. 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An adjunctive","text_display":"\n\nPatients may continue to use stable doses of TG-lowering medications during the study. 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confirmed TG \\(>1000 mg / dL (11.3 mmol / L )\\) may initiate standard-of-care","confidence":0.7921945555135608,"confidence_rate":0.9978252815319937},{"cnt":[[365,443],[1695,443],[1695,488],[365,488]],"region":{"top_left_x":365,"top_left_y":442,"width":1331,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e065fc1623e4d3a8cc4cbbebd874c17","type":"text","conversion_output":true,"text":"therapy (however, gemfibrozil may not be added) to lower TG using a patient-specific","text_display":" therapy (however, gemfibrozil may not be added) to lower TG using a patient-specific","confidence":1,"confidence_rate":1},{"cnt":[[365,486],[1824,486],[1824,533],[365,533]],"region":{"top_left_x":365,"top_left_y":485,"width":1460,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2d794620aea4be1a39072e0fcf50d24","type":"text","conversion_output":true,"text":"prescription. The initiation of this medication will be documented on the case report form as a","text_display":" prescription. The initiation of this medication will be documented on the case report form as a","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[365,529],[1876,529],[1876,578],[365,578]],"region":{"top_left_x":365,"top_left_y":528,"width":1511,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8082eb9c11014de0a83461e512499d3c","type":"text","conversion_output":true,"text":"concomitant medication with the associated start date. These medications will not be provided by","text_display":" concomitant medication with the associated start date. These medications will not be provided by","confidence":1,"confidence_rate":1},{"cnt":[[365,574],[561,574],[561,621],[365,621]],"region":{"top_left_x":365,"top_left_y":573,"width":196,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64de6ef3fd324704bda9b1c594055599","type":"text","conversion_output":true,"text":"the sponsor.","text_display":" the sponsor.","confidence":1,"confidence_rate":1},{"cnt":[[305,625],[1880,625],[1880,675],[305,675]],"region":{"top_left_x":305,"top_left_y":625,"width":1575,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89d11bf02c154e718861f158b36a7ff4","type":"text","conversion_output":true,"text":"- Patients continuing to exceed the TG threshold after maximizing the standard-of-care triglyceride-","text_display":"\n- Patients continuing to exceed the TG threshold after maximizing the standard-of-care triglyceride","confidence":1,"confidence_rate":1},{"cnt":[[365,670],[1813,670],[1813,718],[365,718]],"region":{"top_left_x":365,"top_left_y":670,"width":1449,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20e9cd18248a420ca2484985dec0cca7","type":"text","conversion_output":true,"text":"lowering therapy will be discontinued from IMP treatment and will be asked to continue to be","text_display":"lowering therapy will be discontinued from IMP treatment and will be asked to continue to be","confidence":1,"confidence_rate":1},{"cnt":[[365,713],[1330,713],[1330,763],[365,763]],"region":{"top_left_x":365,"top_left_y":713,"width":965,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bec7743877f94eafb98c9bd2bb1e8177","type":"text","conversion_output":true,"text":"followed for safety using the protocol-specified visit schedule.","text_display":" followed for safety using the protocol-specified visit schedule.","confidence":1,"confidence_rate":1},{"cnt":[[243,765],[1689,765],[1689,814],[243,814]],"region":{"top_left_x":242,"top_left_y":764,"width":1447,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0468dff80e3b495da4cb6da9fe0a5f59","type":"text","conversion_output":true,"text":"Monitoring and Management of Potential AEs and Adverse Events of Special Interest (AESI)","text_display":"\nMonitoring and Management of Potential AEs and Adverse Events of Special Interest (AESI)","confidence":1,"confidence_rate":1},{"cnt":[[245,816],[1407,816],[1407,864],[245,864]],"region":{"top_left_x":244,"top_left_y":816,"width":1164,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8ebeb2aa32f417ea50a81222424d3e0","type":"text","conversion_output":true,"text":"Adverse Events Associated with Experience with Bempedoic Acid to Date:","text_display":"\nAdverse Events Associated with Experience with Bempedoic Acid to Date:","confidence":1,"confidence_rate":1},{"cnt":[[245,868],[475,868],[475,909],[245,909]],"region":{"top_left_x":244,"top_left_y":867,"width":231,"height":42},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5264f3174e244fd7b197c780c8122fec","type":"text","conversion_output":true,"text":"Potential AEs:","text_display":"\nPotential AEs:","confidence":1,"confidence_rate":1},{"cnt":[[305,920],[1729,920],[1729,965],[305,965]],"region":{"top_left_x":305,"top_left_y":919,"width":1425,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bd905b0a75c40bca17870bce85e6aeb","type":"text","conversion_output":true,"text":"Based on findings in nonclinical models, potential AEs include reversible hypoglycemia and","text_display":"\nBased on findings in nonclinical models, potential AEs include reversible hypoglycemia and","confidence":1,"confidence_rate":1},{"cnt":[[305,962],[1863,962],[1863,1008],[305,1008]],"region":{"top_left_x":305,"top_left_y":962,"width":1558,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc0a4d11873e43599f9a9a544ddf4061","type":"text","conversion_output":true,"text":"metabolic acidosis. Patients will be educated on the signs and symptoms of hypoglycemia and asked","text_display":" metabolic acidosis. Patients will be educated on the signs and symptoms of hypoglycemia and asked","confidence":1,"confidence_rate":1},{"cnt":[[305,1005],[1869,1005],[1869,1053],[305,1053]],"region":{"top_left_x":305,"top_left_y":1005,"width":1565,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5eba213200154091946505a157e94685","type":"text","conversion_output":true,"text":"to report the experienced signs and symptoms to the investigator. Investigator confirmed occurrences","text_display":" to report the experienced signs and symptoms to the investigator. Investigator confirmed occurrences","confidence":1,"confidence_rate":1},{"cnt":[[305,1051],[1848,1051],[1848,1098],[305,1098]],"region":{"top_left_x":305,"top_left_y":1050,"width":1543,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"508aa2a62f5c470abc1d048e3563860d","type":"text","conversion_output":true,"text":"of hypoglycemia will be reported as AEs. Potential cases of reversible hypoglycemia and metabolic","text_display":" of hypoglycemia will be reported as AEs. Potential cases of reversible hypoglycemia and metabolic","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,1094],[1755,1094],[1755,1141],[305,1141]],"region":{"top_left_x":305,"top_left_y":1093,"width":1451,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43711ecade18403d9b3d9027615d2b81","type":"text","conversion_output":true,"text":"acidosis will be identified by routine safety monitoring of AEs and clinical safety laboratories.","text_display":" acidosis will be identified by routine safety monitoring of AEs and clinical safety laboratories.","confidence":1,"confidence_rate":1},{"cnt":[[245,1143],[621,1143],[621,1192],[245,1192]],"region":{"top_left_x":244,"top_left_y":1142,"width":377,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3e30ae045d4477d9e3c499fe52b5f22","type":"text","conversion_output":true,"text":"Musculoskeletal Safety:","text_display":"\nMusculoskeletal Safety:","confidence":1,"confidence_rate":1},{"cnt":[[305,1195],[1824,1195],[1824,1244],[305,1244]],"region":{"top_left_x":305,"top_left_y":1194,"width":1520,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c9ad9f87f824289b59b5fb8cb222113","type":"text","conversion_output":true,"text":"Patients with CK abnormalities will also be reviewed for any other lab changes, such as creatinine,","text_display":"\nPatients with CK abnormalities will also be reviewed for any other lab changes, such as creatinine,","confidence":1,"confidence_rate":1},{"cnt":[[305,1240],[1828,1240],[1828,1287],[305,1287]],"region":{"top_left_x":305,"top_left_y":1239,"width":1524,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a461765efe34e07b7739823c71b8c77","type":"text","conversion_output":true,"text":"and any reported AEs or SAEs. Musculoskeletal events will be identified and evaluated by routine","text_display":" and any reported AEs or SAEs. Musculoskeletal events will be identified and evaluated by routine","confidence":1,"confidence_rate":1},{"cnt":[[305,1283],[965,1283],[965,1330],[305,1330]],"region":{"top_left_x":305,"top_left_y":1282,"width":660,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8345c41453704348bc929d9ce6589002","type":"text","conversion_output":true,"text":"safety monitoring of PE findings and AEs.","text_display":" safety monitoring of PE findings and AEs.","confidence":1,"confidence_rate":1},{"cnt":[[245,1332],[707,1332],[707,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1332,"width":463,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0af8f6932afe4590bc0833b99e2f95a6","type":"text","conversion_output":true,"text":"Diabetes and Hyperglycemia:","text_display":"\nDiabetes and Hyperglycemia:","confidence":1,"confidence_rate":1},{"cnt":[[305,1384],[1841,1384],[1841,1433],[305,1433]],"region":{"top_left_x":305,"top_left_y":1383,"width":1537,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfcdd7085f5d4e19868ee26d7e802b68","type":"text","conversion_output":true,"text":"Cases of new onset of diabetes will be recorded as AEs. Clinical laboratories, including \\(HbA _{1 C }\\) and","text_display":"\nCases of new onset of diabetes will be recorded as AEs. Clinical laboratories, including \\(HbA _{1 C }\\) and","confidence":1,"confidence_rate":1},{"cnt":[[305,1429],[1815,1429],[1815,1476],[305,1476]],"region":{"top_left_x":305,"top_left_y":1428,"width":1511,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ac6dacaeb204b9e81f0d60b6566c5bc","type":"text","conversion_output":true,"text":"glucose will also be evaluated across treatment groups during this study and all ongoing studies to","text_display":" glucose will also be evaluated across treatment groups during this study and all ongoing studies to","confidence":1,"confidence_rate":1},{"cnt":[[305,1474],[1051,1474],[1051,1521],[305,1521]],"region":{"top_left_x":305,"top_left_y":1473,"width":746,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49fec3b074dd40f4ba558884dff9bb63","type":"text","conversion_output":true,"text":"identify potential cases of new onset of diabetes","text_display":" identify potential cases of new onset of diabetes","confidence":1,"confidence_rate":1},{"cnt":[[245,1525],[617,1525],[617,1571],[245,1571]],"region":{"top_left_x":244,"top_left_y":1525,"width":373,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d0805c5e98247c49709df58ab7b7bfa","type":"text","conversion_output":true,"text":"Neurocognitive Events:","text_display":"\nNeurocognitive Events:","confidence":1,"confidence_rate":1},{"cnt":[[303,1573],[1828,1573],[1828,1622],[303,1622]],"region":{"top_left_x":302,"top_left_y":1572,"width":1527,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04a7df12804f46f5a280b33ea015e0f1","type":"text","conversion_output":true,"text":"Neurocognitive events will be identified and evaluated by routine safety monitoring of PE findings","text_display":"\nNeurocognitive events will be identified and evaluated by routine safety monitoring of PE findings","confidence":1,"confidence_rate":1},{"cnt":[[305,1620],[453,1620],[453,1661],[305,1661]],"region":{"top_left_x":305,"top_left_y":1619,"width":149,"height":42},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5526fb43d29f458395663d70c40b88d0","type":"text","conversion_output":true,"text":"and AEs.","text_display":" and AEs.","confidence":1,"confidence_rate":1},{"cnt":[[245,1667],[552,1667],[552,1717],[245,1717]],"region":{"top_left_x":244,"top_left_y":1667,"width":309,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2ab8fd12fef4821b11772e4bedf6665","type":"text","conversion_output":true,"text":"Clinical Endpoints:","text_display":"\nClinical Endpoints:","confidence":1,"confidence_rate":1},{"cnt":[[305,1719],[1880,1719],[1880,1768],[305,1768]],"region":{"top_left_x":305,"top_left_y":1718,"width":1575,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6922eaa1f22487087b2fc6665a5a25a","type":"text","conversion_output":true,"text":"Clinical endpoints will be monitored and adjudicated by an independent expert CEC for this study and","text_display":"\nClinical endpoints will be monitored and adjudicated by an independent expert CEC for this study and","confidence":1,"confidence_rate":1},{"cnt":[[305,1764],[1137,1764],[1137,1811],[305,1811]],"region":{"top_left_x":305,"top_left_y":1763,"width":832,"height":49},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3c2670885e04c518bbaf94bd5485414","type":"text","conversion_output":true,"text":"other ongoing studies in the bempedoic acid program.","text_display":" other ongoing studies in the bempedoic acid program.","confidence":1,"confidence_rate":1},{"cnt":[[305,1813],[1749,1813],[1749,1863],[305,1863]],"region":{"top_left_x":305,"top_left_y":1813,"width":1444,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"079304f2f993416bae6f9350ed5d5e5a","type":"text","conversion_output":true,"text":"Routine cardiovascular monitoring will include review of cardiovascular AEs, SAEs, (both as","text_display":"\nRoutine cardiovascular monitoring will include review of cardiovascular AEs, SAEs, (both as","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,1858],[1188,1858],[1188,1906],[305,1906]],"region":{"top_left_x":305,"top_left_y":1858,"width":884,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd04045955ec4010990c7e5b0cc97830","type":"text","conversion_output":true,"text":"adjudicated by the CEC), standard vital signs, and ECGs.","text_display":" adjudicated by the CEC), standard vital signs, and ECGs.","confidence":1,"confidence_rate":1},{"cnt":[[245,1908],[1618,1908],[1618,1957],[245,1957]],"region":{"top_left_x":244,"top_left_y":1907,"width":1374,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8edf90d1ff0a413dba308c9b0a64a6d7","type":"text","conversion_output":true,"text":"Additional details regarding safety monitoring are included in Section 11.1.6.3.1 through","text_display":"\nAdditional details regarding safety monitoring are included in Section 11.1.6.3.1 through","confidence":1,"confidence_rate":1},{"cnt":[[245,1955],[511,1955],[511,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1955,"width":268,"height":41},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce3ec8a151214918b97d0dd98de86714","type":"text","conversion_output":true,"text":"Section 11.1.6.4.","text_display":" Section 11.1.6.4.","confidence":0.99951171875,"confidence_rate":0.9999778002237774},{"cnt":[[245,2002],[1697,2002],[1697,2052],[245,2052]],"region":{"top_left_x":244,"top_left_y":2002,"width":1454,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afb70cc928f94d20a9f626605d30a0be","type":"text","conversion_output":true,"text":"Further details on occurrence and monitoring are available in the Investigator's Brochure (IB).","text_display":"\nFurther details on occurrence and monitoring are available in the Investigator's Brochure (IB).","confidence":0.9985356330871582,"confidence_rate":0.9999853457059158},{"cnt":[[245,2062],[578,2062],[578,2108],[245,2108]],"region":{"top_left_x":244,"top_left_y":2062,"width":334,"height":46},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33cc34b7c90144f39b831bdd1a03bdfc","type":"section_header","conversion_output":false,"children_ids":["f5ca96e7162d44459beac25c33befc19"],"text":"","text_display":""},{"cnt":[[249,2067],[574,2067],[574,2103],[249,2103]],"region":{"top_left_x":249,"top_left_y":2066,"width":325,"height":38},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f5ca96e7162d44459beac25c33befc19","type":"text","conversion_output":true,"parent_id":"33cc34b7c90144f39b831bdd1a03bdfc","text":"Statistical methods:","text_display":"\n\n\\section*{Statistical 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LDL-C.","confidence":1,"confidence_rate":1},{"cnt":[[245,2221],[1820,2221],[1820,2271],[245,2271]],"region":{"top_left_x":244,"top_left_y":2221,"width":1576,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"777f935247a54b5fae549c275842363c","type":"text","conversion_output":true,"text":"The sample size of 500 randomized patients in the bempedoic acid 180 mg group and 250 randomized","text_display":"\nThe sample size of 500 randomized patients in the bempedoic acid 180 mg group and 250 randomized","confidence":0.99853515625,"confidence_rate":0.9999869115349181},{"cnt":[[245,2269],[1841,2269],[1841,2314],[245,2314]],"region":{"top_left_x":244,"top_left_y":2268,"width":1598,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bb7204e9b0648d889637c084fd0f05e","type":"text","conversion_output":true,"text":"patients in the placebo group is expected to provide more than \\(95 \\%\\) power to detect a difference of \\(15 \\%\\)","text_display":" patients in the placebo group is expected to provide more than \\(95 \\%\\) power to detect a difference of \\(15 \\%\\)","confidence":0.9980480668600649,"confidence_rate":0.9999820750171311},{"cnt":[[245,2312],[1841,2312],[1841,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2311,"width":1598,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f41976afbdc0492599588ee924845797","type":"text","conversion_output":true,"text":"in the percent change from baseline to Week 12 in LDL-C between the bempedoic acid treatment group","text_display":" in the percent change from baseline to Week 12 in LDL-C between the bempedoic acid treatment 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A gatekeeping or stepdown approach will be used to test the primary efficacy endpoint and","text_display":" error rate. A gatekeeping or stepdown approach will be used to test the primary efficacy endpoint and","confidence":1,"confidence_rate":1},{"cnt":[[247,1835],[1830,1835],[1830,1880],[247,1880]],"region":{"top_left_x":247,"top_left_y":1834,"width":1584,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bc307435a224641a4817d553d410d89","type":"text","conversion_output":true,"text":"then specific secondary efficacy endpoints sequentially in order to preserve the study-wise Type I error","text_display":" then specific secondary efficacy endpoints sequentially in order to preserve the study-wise Type I error","confidence":0.998046875,"confidence_rate":0.9999820640614399},{"cnt":[[245,1878],[1381,1878],[1381,1923],[245,1923]],"region":{"top_left_x":244,"top_left_y":1877,"width":1138,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"daf6a04298c641ae8e15eb22cb321102","type":"text","conversion_output":true,"text":"rate. 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If the primary endpoint","text_display":" Statistical significance at each step is required in order to test the next hypothesis. 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percent change from baseline to Weeks 12, 24, and 52 in HDL-C, non-HDL-C, TG,","text_display":"\nand 52 in LDL-C; percent change from baseline to Weeks 12, 24, and 52 in HDL-C, non-HDL-C, TG,","confidence":1,"confidence_rate":1},{"cnt":[[245,296],[1830,296],[1830,346],[245,346]],"region":{"top_left_x":244,"top_left_y":296,"width":1587,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ecb2d6f9d1cc4c5b9930367b1d3f5c2c","type":"text","conversion_output":true,"text":"TC, apoB, and hs-CRP will each be analyzed using ANCOVA with treatment group, CV risk (ASCVD","text_display":" TC, apoB, and hs-CRP will each be analyzed using ANCOVA with treatment group, CV risk (ASCVD","confidence":0.99755859375,"confidence_rate":0.9999748004067751},{"cnt":[[245,344],[1876,344],[1876,389],[245,389]],"region":{"top_left_x":244,"top_left_y":343,"width":1632,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc4f660cfef2470f8b0f22b3c2b40570","type":"text","conversion_output":true,"text":"only; HeFH with or without ASCVD) and baseline statin intensity (high intensity, moderate intensity, low","text_display":" only; HeFH with or without ASCVD) and baseline statin intensity (high intensity, moderate intensity, low","confidence":1,"confidence_rate":1},{"cnt":[[245,385],[1850,385],[1850,432],[245,432]],"region":{"top_left_x":244,"top_left_y":384,"width":1606,"height":48},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea4e119b5b394aa58ce55faf21ffa75f","type":"text","conversion_output":true,"text":"intensity) as factors and the relevant baseline as a covariate. Baseline for HDL-C, non-HDL-C, TG, and","text_display":" intensity) as factors and the relevant baseline as a covariate. 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Each","text_display":" Baseline for apoB and hs-CRP will be defined as the predose Day 1/Week 0 (Visit T1) value. 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For each lipid parameter and analysis time point, the","confidence":1,"confidence_rate":1},{"cnt":[[245,692],[1852,692],[1852,739],[245,739]],"region":{"top_left_x":244,"top_left_y":691,"width":1608,"height":49},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16affd77cee14dbfb0cc06c608d863dc","type":"text","conversion_output":true,"text":"LSM and SE will be provided for both treatment groups, along with the placebo-corrected LSM, its 95\\%","text_display":" LSM and SE will be provided for both treatment groups, along with the placebo-corrected LSM, its 95\\%","confidence":0.97216796875,"confidence_rate":0.999731210586585},{"cnt":[[245,735],[655,735],[655,784],[245,784]],"region":{"top_left_x":244,"top_left_y":734,"width":412,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"455c11be33cf428eb88480195d02b5d7","type":"text","conversion_output":true,"text":"CI and associated p-value.","text_display":" CI and associated p-value.","confidence":0.5711495876312256,"confidence_rate":0.9831703750006145},{"cnt":[[245,791],[1871,791],[1871,836],[245,836]],"region":{"top_left_x":244,"top_left_y":790,"width":1628,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd9455cc25f34d63aed0879dac2a9ef0","type":"text","conversion_output":true,"text":"For all continuous efficacy endpoints (percent change from baseline in LDL-C, HDL-C, non-HDL-C, TC,","text_display":"\nFor all continuous efficacy endpoints (percent change from baseline in LDL-C, HDL-C, non-HDL-C, TC,","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,834],[1818,834],[1818,881],[245,881]],"region":{"top_left_x":244,"top_left_y":833,"width":1574,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b57599848d434de591325a672cadbe35","type":"text","conversion_output":true,"text":"TG, apoB, and hs-CRP; change from baseline in LDL-C; to Weeks 12, 24, and 52, as appropriate), the","text_display":" TG, apoB, and hs-CRP; change from baseline in LDL-C; to Weeks 12, 24, and 52, as appropriate), the","confidence":0.9970715045928955,"confidence_rate":0.9999715266981888},{"cnt":[[245,879],[1820,879],[1820,924],[245,924]],"region":{"top_left_x":244,"top_left_y":878,"width":1576,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c809da83a384c82a81c96d92c4a95bd","type":"text","conversion_output":true,"text":"ANCOVA assumption of normality will be assessed. If non-normality of the data is found at any time","text_display":" ANCOVA assumption of normality will be assessed. If non-normality of the data is found at any time","confidence":1,"confidence_rate":1},{"cnt":[[245,924],[1723,924],[1723,969],[245,969]],"region":{"top_left_x":244,"top_left_y":923,"width":1480,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dbbf2d6b6ad347fd83f094ed7157b795","type":"text","conversion_output":true,"text":"point for any parameter, either the data will be transformed so that it is normally distributed or a","text_display":" point for any parameter, either the data will be transformed so that it is normally distributed or a","confidence":1,"confidence_rate":1},{"cnt":[[245,967],[1257,967],[1257,1012],[245,1012]],"region":{"top_left_x":244,"top_left_y":966,"width":1013,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cd5d90eac0ee4294a78911f66835db03","type":"text","conversion_output":true,"text":"nonparametric test will be used instead of the planned ANCOVA.","text_display":" nonparametric test will be used instead of the planned ANCOVA.","confidence":1,"confidence_rate":1},{"cnt":[[245,1021],[1815,1021],[1815,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1020,"width":1572,"height":48},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04eec4591e7345f390c6caaccb43a666","type":"text","conversion_output":true,"text":"In addition, a summary of percent change from baseline to Week 12 LDL-C using the FAS, excluding","text_display":"\nIn addition, a summary of percent change from baseline to Week 12 LDL-C using the FAS, excluding","confidence":1,"confidence_rate":1},{"cnt":[[245,1066],[1846,1066],[1846,1111],[245,1111]],"region":{"top_left_x":244,"top_left_y":1065,"width":1602,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e9a6030832b46c88dd3646e90d8149b","type":"text","conversion_output":true,"text":"patients who received additional lipid-lowering therapy by that time point (by Week 12 for the Week 12","text_display":" patients who received additional lipid-lowering therapy by that time point (by Week 12 for the Week 12","confidence":1,"confidence_rate":1},{"cnt":[[245,1109],[1760,1109],[1760,1154],[245,1154]],"region":{"top_left_x":244,"top_left_y":1108,"width":1516,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ae2eb2d04184ba5ac9021a95b1b27fe","type":"text","conversion_output":true,"text":"time point), will be provided. Percent change from baseline to Weeks 24 and 52 on LDL-C will be","text_display":" time point), will be provided. Percent change from baseline to Weeks 24 and 52 on LDL-C will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1152],[1858,1152],[1858,1199],[245,1199]],"region":{"top_left_x":244,"top_left_y":1151,"width":1615,"height":48},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b7e57439bd3542c38522e2671395816c","type":"text","conversion_output":true,"text":"analyzed similarly, with patients in the FAS who did not receive additional LDL or triglyceride-lowering","text_display":" analyzed similarly, with patients in the FAS who did not receive additional LDL or triglyceride-lowering","confidence":1,"confidence_rate":1},{"cnt":[[245,1197],[1841,1197],[1841,1244],[245,1244]],"region":{"top_left_x":244,"top_left_y":1196,"width":1598,"height":48},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da4c39e9318c4258b0611d955603e559","type":"text","conversion_output":true,"text":"therapy by that time point (by Week 24 for the Week 24 analysis by Week 52 for the Week 52 analysis)","text_display":" therapy by that time point (by Week 24 for the Week 24 analysis by Week 52 for the Week 52 analysis)","confidence":1,"confidence_rate":1},{"cnt":[[245,1242],[1826,1242],[1826,1287],[245,1287]],"region":{"top_left_x":244,"top_left_y":1241,"width":1583,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c662c5ab35f40f9837d89b0bebfb69d","type":"text","conversion_output":true,"text":"included in the analyses. Output from each time point will include the LSM and SE for each treatment","text_display":" included in the analyses. Output from each time point will include the LSM and SE for each treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,1285],[1246,1285],[1246,1332],[245,1332]],"region":{"top_left_x":244,"top_left_y":1284,"width":1003,"height":49},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b7676dfc6e6c400b88b62a2a5c539968","type":"text","conversion_output":true,"text":"group, as well as the placebo-correct LSM, \\(95 \\% CI\\), and p-value.","text_display":" group, as well as the placebo-correct LSM, \\(95 \\% CI\\), and p-value.","confidence":0.5915191173553467,"confidence_rate":0.9929296904321123},{"cnt":[[245,1336],[1270,1336],[1270,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1336,"width":1026,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd16c7b2ebe845cd88d9e49360a37b71","type":"text","conversion_output":true,"text":"Additional post-randomization adjunctive lipid-modifying therapy","text_display":"\nAdditional post-randomization adjunctive lipid-modifying therapy","confidence":1,"confidence_rate":1},{"cnt":[[245,1386],[1811,1386],[1811,1433],[245,1433]],"region":{"top_left_x":244,"top_left_y":1385,"width":1568,"height":49},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d180801c1cb5472d8ccbff138a415bbc","type":"text","conversion_output":true,"text":"The number and percent of patients in each treatment group requiring additional (post-randomization)","text_display":"\nThe number and percent of patients in each treatment group requiring additional (post-randomization)","confidence":1,"confidence_rate":1},{"cnt":[[245,1431],[1850,1431],[1850,1476],[245,1476]],"region":{"top_left_x":244,"top_left_y":1430,"width":1606,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c67ec0e458846a4bf97e2b7fd2dad5c","type":"text","conversion_output":true,"text":"adjunctive lipid-modifying therapy will be summarized. Medications and the reasons for their additional","text_display":" adjunctive lipid-modifying therapy will be summarized. Medications and the reasons for their additional","confidence":1,"confidence_rate":1},{"cnt":[[245,1474],[1532,1474],[1532,1521],[245,1521]],"region":{"top_left_x":244,"top_left_y":1473,"width":1288,"height":49},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24effe5cafd34d6298a294fa8db05688","type":"text","conversion_output":true,"text":"treatment (hyperlipidemia vs. hypertriglyceridemia) will be summarized separately.","text_display":" treatment (hyperlipidemia vs. hypertriglyceridemia) will be summarized separately.","confidence":1,"confidence_rate":1},{"cnt":[[243,1521],[505,1521],[505,1575],[243,1575]],"region":{"top_left_x":242,"top_left_y":1521,"width":263,"height":54},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e174f16ec3bf4f26b9549310c6e4dc33","type":"section_header","conversion_output":false,"children_ids":["a7c4c86147304f3dbda441b95fe6958a"],"text":"","text_display":""},{"cnt":[[249,1525],[501,1525],[501,1571],[249,1571]],"region":{"top_left_x":249,"top_left_y":1525,"width":252,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7c4c86147304f3dbda441b95fe6958a","type":"text","conversion_output":true,"parent_id":"e174f16ec3bf4f26b9549310c6e4dc33","text":"Safety Analyses","text_display":"\n\n\\section*{Safety Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[247,1577],[1880,1577],[1880,1624],[247,1624]],"region":{"top_left_x":247,"top_left_y":1576,"width":1633,"height":49},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca858ab6e83f4028a40b96b9885354fd","type":"text","conversion_output":true,"text":"The summarization of AEs will include TEAEs, defined as AEs with an onset date on or after initiation of","text_display":"\n\nThe summarization of AEs will include TEAEs, defined as AEs with an onset date on or after initiation of","confidence":1,"confidence_rate":1},{"cnt":[[245,1622],[1772,1622],[1772,1669],[245,1669]],"region":{"top_left_x":244,"top_left_y":1622,"width":1529,"height":48},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb2b7d49b49649cca6bd63b10fbcb969","type":"text","conversion_output":true,"text":"study treatment. TEAEs and SAEs will be summarized by system organ class (SOC), severity, and","text_display":" study treatment. TEAEs and SAEs will be summarized by system organ class (SOC), severity, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1667],[1760,1667],[1760,1712],[245,1712]],"region":{"top_left_x":244,"top_left_y":1667,"width":1516,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fab5b18edd37400f86c3e5ab3b797c10","type":"text","conversion_output":true,"text":"relationship to study drug for each treatment group. These AE summaries will include cumulative","text_display":" relationship to study drug for each treatment group. These AE summaries will include cumulative","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[245,1710],[1732,1710],[1732,1755],[245,1755]],"region":{"top_left_x":244,"top_left_y":1710,"width":1488,"height":46},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a102045a30014b6096ac26bf9adcaa7f","type":"text","conversion_output":true,"text":"incidence (percent of patients experiencing the AE) and patient-year adjusted incidence rates. If","text_display":" incidence (percent of patients experiencing the AE) and patient-year adjusted incidence rates. If","confidence":1,"confidence_rate":1},{"cnt":[[245,1753],[1858,1753],[1858,1800],[245,1800]],"region":{"top_left_x":244,"top_left_y":1753,"width":1615,"height":48},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7bb015975c634bf5b9532c01c278d9d0","type":"text","conversion_output":true,"text":"appropriate, absolute and relative risk differences will be calculated using both cumulative incidence and","text_display":" appropriate, absolute and relative risk differences will be calculated using both cumulative incidence and","confidence":0.99755859375,"confidence_rate":0.9999779786988527},{"cnt":[[245,1798],[1869,1798],[1869,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1798,"width":1626,"height":48},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01da88f289124be892a052ff392e4618","type":"text","conversion_output":true,"text":"incidence rates. Deaths, withdrawal from study treatment due to AEs, and withdrawal from the study due","text_display":" incidence rates. Deaths, withdrawal from study treatment due to AEs, and withdrawal from the study due","confidence":1,"confidence_rate":1},{"cnt":[[245,1843],[1059,1843],[1059,1888],[245,1888]],"region":{"top_left_x":244,"top_left_y":1843,"width":816,"height":46},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3216675666cc4bbb954da934afaf8509","type":"text","conversion_output":true,"text":"to AEs will each be summarized by treatment group.","text_display":" to AEs will each be summarized by treatment group.","confidence":1,"confidence_rate":1},{"cnt":[[245,1897],[1815,1897],[1815,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1897,"width":1572,"height":48},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5e256bceea049c2b2b77411ff2d7a02","type":"text","conversion_output":true,"text":"Clinical safety laboratories, including hematology, blood chemistry, coagulation, \\(HbA _{1 C }\\), glucose, and","text_display":"\nClinical safety laboratories, including hematology, blood chemistry, coagulation, \\(HbA _{1 C }\\), glucose, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1938],[1824,1938],[1824,1987],[245,1987]],"region":{"top_left_x":244,"top_left_y":1937,"width":1581,"height":51},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1cd338feea5d40e89283412462d98509","type":"text","conversion_output":true,"text":"urinalysis; PE findings; vital signs; ECG readings; and weight will be summarized by the value and by","text_display":" urinalysis; PE findings; vital signs; ECG readings; and weight will be summarized by the value and by","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,1985],[1571,1985],[1571,2030],[245,2030]],"region":{"top_left_x":244,"top_left_y":1985,"width":1327,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1a9a022a4974d3c9f6c0bf87e6ca562","type":"text","conversion_output":true,"text":"change from baseline in the value (where appropriate) at each postbaseline time point.","text_display":" change from baseline in the value (where appropriate) at each postbaseline time point.","confidence":1,"confidence_rate":1},{"cnt":[[243,2032],[483,2032],[483,2086],[243,2086]],"region":{"top_left_x":242,"top_left_y":2032,"width":242,"height":55},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3c1df5bfed447e2a66068f7633a3bcf","type":"section_header","conversion_output":false,"children_ids":["2d8537dd3f894d469a859dfe2b7856c6"],"text":"","text_display":""},{"cnt":[[245,2037],[483,2037],[483,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2036,"width":240,"height":46},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d8537dd3f894d469a859dfe2b7856c6","type":"text","conversion_output":true,"parent_id":"a3c1df5bfed447e2a66068f7633a3bcf","text":"Hepatic Safety","text_display":"\n\n\\section*{Hepatic Safety}","confidence":1,"confidence_rate":1},{"cnt":[[245,2084],[1878,2084],[1878,2133],[245,2133]],"region":{"top_left_x":244,"top_left_y":2083,"width":1634,"height":51},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6cdb0a4fc56546739a0d4548d37ecd27","type":"text","conversion_output":true,"text":"Liver-associated enzymes and TB will be summarized by the value and change from baseline in the value,","text_display":"\n\nLiver-associated enzymes and TB will be summarized by the value and change from baseline in the value,","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[245,2131],[1811,2131],[1811,2176],[245,2176]],"region":{"top_left_x":244,"top_left_y":2131,"width":1568,"height":46},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00cfea6b966d4d7281848131cb622cda","type":"text","conversion_output":true,"text":"by treatment group and visit. In addition, the number and percent of patients with abnormal values for","text_display":" by treatment group and visit. In addition, the number and percent of patients with abnormal values for","confidence":1,"confidence_rate":1},{"cnt":[[245,2174],[1781,2174],[1781,2219],[245,2219]],"region":{"top_left_x":244,"top_left_y":2174,"width":1538,"height":46},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"851e01faf0a648ee9fa405a484c627b1","type":"text","conversion_output":true,"text":"ALT, AST, and TB will be summarized. These summaries of patients with abnormal values will be","text_display":" ALT, AST, and TB will be summarized. These summaries of patients with abnormal values will be","confidence":1,"confidence_rate":1},{"cnt":[[245,2217],[1837,2217],[1837,2264],[245,2264]],"region":{"top_left_x":244,"top_left_y":2217,"width":1593,"height":48},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f04a4d399614c3ead4842f5bb508d4d","type":"text","conversion_output":true,"text":"performed overall; by normal baseline; and by abnormal baseline for each of ALT, AST, and TB. Hy's","text_display":" performed overall; by normal baseline; and by abnormal baseline for each of ALT, AST, and TB. 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In the case of","text_display":" will also be applied to the data; any potential Hy's law cases will be listed separately. 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Study 1002-047 Study Design","text_display":"\nFigure 1. 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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS","text_display":"\n\n\\section*{3. 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Abbreviation or Specialist Term & Explanation \\\\\n\\hline ACL & Adenosine triphosphate-citrate lyase \\\\\n\\hline ACS & Acyl-CoA synthetase \\\\\n\\hline ADR & Adverse drug reaction \\\\\n\\hline AE & Adverse event \\\\\n\\hline AESI & Adverse events of special interest \\\\\n\\hline ALB & Albumin \\\\\n\\hline ALK-P & Alkaline phosphatase \\\\\n\\hline ALT & Alanine aminotransferase \\\\\n\\hline ANCOVA & Analysis of covariance \\\\\n\\hline apoB & Apolipoprotein B \\\\\n\\hline ASCVD & Atherosclerotic cardiovascular diseases \\\\\n\\hline AST & Aspartate aminotransferase \\\\\n\\hline ATP & Adenosine triphosphate \\\\\n\\hline AUC & Area under the concentration-time curve \\\\\n\\hline \\(AUC _{0-24}\\) & Area under the curve during 24 hours \\\\\n\\hline BMI & Body mass index \\\\\n\\hline BP & Blood pressure \\\\\n\\hline BUN & Blood urea nitrogen \\\\\n\\hline Ca & Calcium \\\\\n\\hline CABG & Coronary artery bypass graft \\\\\n\\hline CEC & Clinical Event Committee \\\\\n\\hline CETP & Cholesterol ester transfer protein \\\\\n\\hline CFR & Code of Federal Regulations \\\\\n\\hline CHD & Coronary heart disease \\\\\n\\hline CI & Confidence interval \\\\\n\\hline CK & Creatine kinase \\\\\n\\hline Cl & Chloride \\\\\n\\hline \\(C _{\\text {max }}\\) & Time to peak maximum concentrations \\\\\n\\hline CMV & Cytomegalovirus \\\\\n\\hline CNS & Central nervous system \\\\\n\\hline CoA & Acetyl-coenzyme A \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 1: Abbreviations and Specialist Terms}\n\\begin{tabular}{|l|l|}\n\\hline Abbreviation or Specialist Term & Explanation \\\\\n\\hline ACL & Adenosine triphosphate-citrate lyase \\\\\n\\hline ACS & Acyl-CoA synthetase \\\\\n\\hline ADR & Adverse drug reaction \\\\\n\\hline AE & Adverse event \\\\\n\\hline AESI & Adverse events of special interest \\\\\n\\hline ALB & Albumin \\\\\n\\hline ALK-P & Alkaline phosphatase \\\\\n\\hline ALT & 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In the United","confidence":1,"confidence_rate":1},{"cnt":[[245,1551],[1800,1551],[1800,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1551,"width":1557,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3103f58056c84c37a5c0541640f25159","type":"text","conversion_output":true,"text":"States (US), based on 2011 death rate data, more than 2150 Americans die from CV diseases","text_display":" States (US), based on 2011 death rate data, more than 2150 Americans die from CV diseases","confidence":1,"confidence_rate":1},{"cnt":[[245,1601],[1828,1601],[1828,1652],[245,1652]],"region":{"top_left_x":244,"top_left_y":1600,"width":1585,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f2ce29618304eb1b4fd1128bcbe84cc","type":"text","conversion_output":true,"text":"daily, an average of 1 death every 40 seconds. Approximately 155,000 Americans dying from","text_display":" daily, an average of 1 death every 40 seconds. Approximately 155,000 Americans dying from","confidence":0.9326171875,"confidence_rate":0.9993026386183655},{"cnt":[[245,1650],[1811,1650],[1811,1699],[245,1699]],"region":{"top_left_x":244,"top_left_y":1650,"width":1568,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd6c957bb7e54a23984be268fc809d29","type":"text","conversion_output":true,"text":"CV disease are less than 65 years of age. In 2011, \\(34 \\%\\) of deaths due to CV disease occurred","text_display":" CV disease are less than 65 years of age. In 2011, \\(34 \\%\\) of deaths due to CV disease occurred","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1697],[1841,1697],[1841,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1697,"width":1598,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c766e433d72c43a78d503c354d12192d","type":"text","conversion_output":true,"text":"prior to the age of 75 years, less than the current 78.7-year average life expectancy (Mozffarian","text_display":" prior to the age of 75 years, less than the current 78.7-year average life expectancy (Mozffarian","confidence":0.5657622814178467,"confidence_rate":0.994590102805102},{"cnt":[[245,1749],[359,1749],[359,1794],[245,1794]],"region":{"top_left_x":244,"top_left_y":1748,"width":115,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40e9831c0c94462b9f8a7444329254a7","type":"text","conversion_output":true,"text":"2015).","text_display":" 2015).","confidence":1,"confidence_rate":1},{"cnt":[[245,1818],[1714,1818],[1714,1867],[245,1867]],"region":{"top_left_x":244,"top_left_y":1817,"width":1471,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef8589f992db4db7b186346552013de3","type":"text","conversion_output":true,"text":"Patients with documented ASCVD are at very high risk for events and require intensive","text_display":"\n\nPatients with documented ASCVD are at very high risk for events and require intensive","confidence":1,"confidence_rate":1},{"cnt":[[245,1865],[1777,1865],[1777,1914],[245,1914]],"region":{"top_left_x":244,"top_left_y":1864,"width":1533,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0caa76d3d1942a69c073ec32cfcc00b","type":"text","conversion_output":true,"text":"pharmacologic intervention (Stone 2014). For a variety of reasons, many with ASCVD are","text_display":" pharmacologic intervention (Stone 2014). For a variety of reasons, many with ASCVD are","confidence":1,"confidence_rate":1},{"cnt":[[245,1912],[1843,1912],[1843,1962],[245,1962]],"region":{"top_left_x":244,"top_left_y":1912,"width":1600,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d240c15c89574b9198b7c503831b2881","type":"text","conversion_output":true,"text":"unable to attain aggressive LDL-C treatment goals despite the addition of lipid-lowering agents","text_display":" unable to attain aggressive LDL-C treatment goals despite the addition of lipid-lowering agents","confidence":1,"confidence_rate":1},{"cnt":[[245,1964],[1160,1964],[1160,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1963,"width":917,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2b6fb47446a49d688ac32d34966d607","type":"text","conversion_output":true,"text":"to maximally tolerated statin therapy (Jacobson 2014).","text_display":" to maximally tolerated statin therapy (Jacobson 2014).","confidence":1,"confidence_rate":1},{"cnt":[[245,2032],[1762,2032],[1762,2082],[245,2082]],"region":{"top_left_x":244,"top_left_y":2032,"width":1518,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cba108539d94082afa09c5cccae793b","type":"text","conversion_output":true,"text":"Familial hypercholesterolemia refers to individuals with extremely elevated LDL-C due to","text_display":"\n\nFamilial hypercholesterolemia refers to individuals with extremely elevated LDL-C due to","confidence":1,"confidence_rate":1},{"cnt":[[245,2080],[1742,2080],[1742,2129],[245,2129]],"region":{"top_left_x":244,"top_left_y":2079,"width":1499,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b0b3d9b55664e3ca397cd0430bb3657","type":"text","conversion_output":true,"text":"underlying genetic mutations of the LDL receptor (LDLR), apolipoprotein B (apoB), and","text_display":" underlying genetic mutations of the LDL receptor (LDLR), apolipoprotein B (apoB), and","confidence":0.99853515625,"confidence_rate":0.9999837121583983},{"cnt":[[245,2127],[1818,2127],[1818,2179],[245,2179]],"region":{"top_left_x":244,"top_left_y":2126,"width":1574,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69df0b330a5044e58060652f00d6547d","type":"text","conversion_output":true,"text":"proprotein convertase subtilisin/kexin type 9 (PCSK9) (FH Foundation 2015). In adult HeFH","text_display":" proprotein convertase subtilisin/kexin type 9 (PCSK9) (FH Foundation 2015). In adult HeFH","confidence":0.9497785568237305,"confidence_rate":0.9994796665351886},{"cnt":[[245,2176],[1785,2176],[1785,2226],[245,2226]],"region":{"top_left_x":244,"top_left_y":2176,"width":1542,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"312eb0345f7d41329ea8d628698f0a43","type":"text","conversion_output":true,"text":"patients, LDL-C usually exceeds \\(190 mg / dL (4.9 mmol / L )\\) and can be as high as \\(400 mg / dL\\)","text_display":" patients, LDL-C usually exceeds \\(190 mg / dL (4.9 mmol / L )\\) and can be as high as \\(400 mg / dL","confidence":0.8173828125,"confidence_rate":0.9981172163928896},{"cnt":[[245,2226],[1663,2226],[1663,2275],[245,2275]],"region":{"top_left_x":244,"top_left_y":2225,"width":1419,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c4f1c7105814cb18824e5d96666910b","type":"text","conversion_output":true,"text":"\\((10.4 mmol / L ) . HeFH\\) is the most common form of the disease with a prevalence of","text_display":" (10.4 mmol / L ) . HeFH\\) is the most common form of the disease with a prevalence of","confidence":0.8804759330087109,"confidence_rate":0.9985866365763824},{"cnt":[[245,2275],[1755,2275],[1755,2325],[245,2325]],"region":{"top_left_x":244,"top_left_y":2275,"width":1512,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a36b4809994246d492e839a3324e3764","type":"text","conversion_output":true,"text":"approximately 1 in 300 to 500 persons worldwide and as high as 1 in 100 persons in some","text_display":" approximately 1 in 300 to 500 persons worldwide and as high as 1 in 100 persons in some","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[245,2325],[1742,2325],[1742,2374],[245,2374]],"region":{"top_left_x":244,"top_left_y":2324,"width":1499,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd0ea7b855744ae894cc1386ea97256b","type":"text","conversion_output":true,"text":"populations (NORD 2015). Patients with HeFH inherit a genetic mutation from 1 parent.","text_display":" populations (NORD 2015). Patients with HeFH inherit a genetic mutation from 1 parent.","confidence":0.7880859375,"confidence_rate":0.9975973542442153},{"cnt":[[245,2372],[1734,2372],[1734,2421],[245,2421]],"region":{"top_left_x":244,"top_left_y":2371,"width":1490,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8f652637eaf4fcca214c741e297fbe4","type":"text","conversion_output":true,"text":"Inheritance is generally via an autosomal-dominant mechanism (Robinson 2013). HeFH","text_display":" Inheritance is generally via an autosomal-dominant mechanism (Robinson 2013). HeFH","confidence":1,"confidence_rate":1},{"cnt":[[245,2419],[1800,2419],[1800,2469],[245,2469]],"region":{"top_left_x":244,"top_left_y":2419,"width":1557,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"686eb3bf5ae24f4280b0c14d7f8a2efc","type":"text","conversion_output":true,"text":"increases the risk of atherosclerosis leading to CV events. The mean age for the onset of CV","text_display":" increases the risk of atherosclerosis leading to CV events. The mean age for the onset of CV","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":41},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a94db16c0ae4402ba9fc33c033bdb97","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[932,2580],[1190,2580],[1190,2628],[932,2628]],"region":{"top_left_x":932,"top_left_y":2580,"width":259,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35e5abe5dcdc434bbab70dd22663b120","type":"page_info","conversion_output":false,"text":"Page 25 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-026","page":26,"lines":[{"cnt":[[245,129],[537,129],[537,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":294,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac4844a1dd564db3a98fd88693cbb9a0","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e19e5e1840cc407eb3da58275af69f63","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,174],[814,174],[814,226],[245,226]],"region":{"top_left_x":244,"top_left_y":174,"width":571,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fedfac28385d4690ae09d955e5400065","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c63bedc4f8914996a9d6cfec5aeba28c","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1792,254],[1792,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1548,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2c3bdb443d8480ba2f8f5d5872e31f2","type":"text","conversion_output":true,"text":"disease is relatively young, at 42 to 46 years in men and 51 to 52 years in women (Robinson","text_display":"\ndisease is relatively young, at 42 to 46 years in men and 51 to 52 years in women (Robinson","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1790,301],[1790,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1546,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45cf8ed30be048b3b6032f1b23aa3f10","type":"text","conversion_output":true,"text":"2013). The cumulative risk of experiencing a coronary event by the age of 60 years without","text_display":" 2013). The cumulative risk of experiencing a coronary event by the age of 60 years without","confidence":0.9990236759185791,"confidence_rate":0.9999900326925697},{"cnt":[[245,350],[1777,350],[1777,397],[245,397]],"region":{"top_left_x":244,"top_left_y":350,"width":1533,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d290a1f9b3f49a6a24d43b804abbfb2","type":"text","conversion_output":true,"text":"effective treatment is at least \\(50 \\%\\) in men and approximately \\(30 \\%\\) in women with a marked","text_display":" effective treatment is at least \\(50 \\%\\) in men and approximately \\(30 \\%\\) in women with a marked","confidence":1,"confidence_rate":1},{"cnt":[[245,400],[1824,400],[1824,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1581,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80cb82eadcf24ba688052b91ccbba38e","type":"text","conversion_output":true,"text":"increase in postmenopausal women. Before effective treatment with statins became available,","text_display":" increase in postmenopausal women. Before effective treatment with statins became available,","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1863,447],[1863,496],[245,496]],"region":{"top_left_x":244,"top_left_y":446,"width":1619,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7a1552adba64b1ca7c8d3a394687ecf","type":"text","conversion_output":true,"text":"mortality from coronary disease was increased by nearly 100 -fold in young adults 20 to 39 years","text_display":" mortality from coronary disease was increased by nearly 100 -fold in young adults 20 to 39 years","confidence":0.9443628787994385,"confidence_rate":0.9994797282865289},{"cnt":[[245,494],[1790,494],[1790,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1546,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34a59a701a3e48989b4a5e7d4296046c","type":"text","conversion_output":true,"text":"of age, and approximately 4 -fold for patients aged 40 to 59 years (Neil 2008). The National","text_display":" of age, and approximately 4 -fold for patients aged 40 to 59 years (Neil 2008). The National","confidence":0.9956073760986328,"confidence_rate":0.9999584697320352},{"cnt":[[245,546],[1755,546],[1755,595],[245,595]],"region":{"top_left_x":244,"top_left_y":545,"width":1512,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdb7f3528b1c46078d1a78da335b4f14","type":"text","conversion_output":true,"text":"Lipid Association (NLA) recommends achievement of \\(\\geq 50 \\%\\) reduction in LDL-C in adult","text_display":" Lipid Association (NLA) recommends achievement of \\(\\geq 50 \\%\\) reduction in LDL-C in adult","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[245,593],[1781,593],[1781,642],[245,642]],"region":{"top_left_x":244,"top_left_y":592,"width":1538,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07e1abf4775b4705b92f38686fdc9947","type":"text","conversion_output":true,"text":"patients using statins. HeFH patients at even higher risk for CV disease (such as those with","text_display":" patients using statins. HeFH patients at even higher risk for CV disease (such as those with","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,642],[1843,642],[1843,690],[245,690]],"region":{"top_left_x":244,"top_left_y":642,"width":1600,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b038e94a04c34b999dfeeea275d2eed1","type":"text","conversion_output":true,"text":"established ASCVD, diabetes, smoking, family history, and other risk factors) have a treatment","text_display":" established ASCVD, diabetes, smoking, family history, and other risk factors) have a treatment","confidence":1,"confidence_rate":1},{"cnt":[[245,690],[1871,690],[1871,741],[245,741]],"region":{"top_left_x":244,"top_left_y":689,"width":1628,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b6ff7f6cac3402799a50d4e426eb6d5","type":"text","conversion_output":true,"text":"goal of \\(\\leq 70 mg / dL (1.8 mmol / L )\\). Those unable to achieve these treatment goals with maximally","text_display":" goal of \\(\\leq 70 mg / dL (1.8 mmol / L )\\). Those unable to achieve these treatment goals with maximally","confidence":0.99560546875,"confidence_rate":0.9999599624780234},{"cnt":[[245,739],[1867,739],[1867,788],[245,788]],"region":{"top_left_x":244,"top_left_y":739,"width":1623,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe01f9b682014f6ab73b192e936446ff","type":"text","conversion_output":true,"text":"tolerated statin therapy require additional lipid-lowering therapy and still may be unable to reach","text_display":" tolerated statin therapy require additional lipid-lowering therapy and still may be unable to reach","confidence":1,"confidence_rate":1},{"cnt":[[245,786],[651,786],[651,836],[245,836]],"region":{"top_left_x":244,"top_left_y":786,"width":407,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af03a37884684dd5927acc8a0d720bfe","type":"text","conversion_output":true,"text":"LDL-C treatment goals.","text_display":" LDL-C treatment goals.","confidence":1,"confidence_rate":1},{"cnt":[[245,855],[1695,855],[1695,907],[245,907]],"region":{"top_left_x":244,"top_left_y":855,"width":1452,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"387523d61b8f4e2b92a41874dda09ed8","type":"text","conversion_output":true,"text":"Lowering LDL-C is the primary therapeutic lipid target in ASCVD and HeFH patients","text_display":"\n\nLowering LDL-C is the primary therapeutic lipid target in ASCVD and HeFH patients","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[245,907],[1779,907],[1779,956],[245,956]],"region":{"top_left_x":244,"top_left_y":906,"width":1535,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db9e50dafef64ecfab46e49c787d3414","type":"text","conversion_output":true,"text":"(Goldberg 2011). LDL-C is largely accepted as a valid surrogate endpoint of CV events by","text_display":" (Goldberg 2011). LDL-C is largely accepted as a valid surrogate endpoint of CV events by","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1768,954],[1768,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":953,"width":1525,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c133f0d33c1544e8a1893c80a6dc700f","type":"text","conversion_output":true,"text":"clinicians and regulatory authorities (Stone 2014). Long-term elevations in LDL-C lead to","text_display":" clinicians and regulatory authorities (Stone 2014). Long-term elevations in LDL-C lead to","confidence":1,"confidence_rate":1},{"cnt":[[245,1003],[1867,1003],[1867,1053],[245,1053]],"region":{"top_left_x":244,"top_left_y":1003,"width":1623,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21a41a502ed44852a837f2cbac43526b","type":"text","conversion_output":true,"text":"progressive accumulation of atherosclerotic lesions in the walls of arteries that require long-term","text_display":" progressive accumulation of atherosclerotic lesions in the walls of arteries that require long-term","confidence":1,"confidence_rate":1},{"cnt":[[245,1053],[1867,1053],[1867,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1052,"width":1623,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43099797bb7b4a0498671a2748af3eaf","type":"text","conversion_output":true,"text":"management. While lifestyle changes are the primary intervention, these measures rarely reduce","text_display":" management. While lifestyle changes are the primary intervention, these measures rarely reduce","confidence":1,"confidence_rate":1},{"cnt":[[245,1100],[1863,1100],[1863,1149],[245,1149]],"region":{"top_left_x":244,"top_left_y":1100,"width":1619,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"684ce5798df1464eb53c23722aad848d","type":"text","conversion_output":true,"text":"plasma LDL-C by >15\\%. Particularly in ASCVD and HeFH patients, pharmacologic treatments","text_display":" plasma LDL-C by >15\\%. Particularly in ASCVD and HeFH patients, pharmacologic treatments","confidence":0.8596713542938232,"confidence_rate":0.9983578160692111},{"cnt":[[245,1147],[1858,1147],[1858,1199],[245,1199]],"region":{"top_left_x":244,"top_left_y":1147,"width":1615,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a9093a4db214176a5f59aa2012046dc","type":"text","conversion_output":true,"text":"are required to adequately treat hyperlipidemia (Pollex 2008). Evidence supporting LDL-C as a","text_display":" are required to adequately treat hyperlipidemia (Pollex 2008). Evidence supporting LDL-C as a","confidence":1,"confidence_rate":1},{"cnt":[[245,1199],[1742,1199],[1742,1246],[245,1246]],"region":{"top_left_x":244,"top_left_y":1198,"width":1499,"height":49},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e38542d97a144f2da7a462cbcf21f137","type":"text","conversion_output":true,"text":"therapeutic target and surrogate for CV outcomes comes from interventional studies with","text_display":" therapeutic target and surrogate for CV outcomes comes from interventional studies with","confidence":1,"confidence_rate":1},{"cnt":[[245,1246],[1846,1246],[1846,1296],[245,1296]],"region":{"top_left_x":244,"top_left_y":1246,"width":1602,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b88eb505fb6471f871ec12764792150","type":"text","conversion_output":true,"text":"LDL-C-lowering therapies, epidemiological studies, genetic variants (both gain of function and","text_display":" LDL-C-lowering therapies, epidemiological studies, genetic variants (both gain of function and","confidence":1,"confidence_rate":1},{"cnt":[[245,1293],[1869,1293],[1869,1343],[245,1343]],"region":{"top_left_x":244,"top_left_y":1293,"width":1626,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5766fb7bd3cd4ff694ff7cd98175f204","type":"text","conversion_output":true,"text":"loss of function). Large randomized clinical studies aimed at lowering LDL-C show a consistent,","text_display":" loss of function). Large randomized clinical studies aimed at lowering LDL-C show a consistent,","confidence":1,"confidence_rate":1},{"cnt":[[245,1343],[1867,1343],[1867,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1342,"width":1623,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34727d7a666b404d93426085342e8294","type":"text","conversion_output":true,"text":"log-linear relationship between LDL-C reduction and CV risk reduction, independent of the way","text_display":" log-linear relationship between LDL-C reduction and CV risk reduction, independent of the way","confidence":1,"confidence_rate":1},{"cnt":[[245,1392],[1841,1392],[1841,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1392,"width":1598,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd0b2d764aaf445697a44eda6741928e","type":"text","conversion_output":true,"text":"LDL-C lowering was achieved based on mechanism of action (Kathiresan 2008; Baigent 2010;","text_display":" LDL-C lowering was achieved based on mechanism of action (Kathiresan 2008; Baigent 2010;","confidence":1,"confidence_rate":1},{"cnt":[[245,1439],[1843,1439],[1843,1489],[245,1489]],"region":{"top_left_x":244,"top_left_y":1439,"width":1600,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09bd1091f1af4afaa2d4da982663e195","type":"text","conversion_output":true,"text":"Robinson 2005; Stamler 1986). A published patient-level meta-analysis including 26 trials and","text_display":" Robinson 2005; Stamler 1986). A published patient-level meta-analysis including 26 trials and","confidence":1,"confidence_rate":1},{"cnt":[[245,1489],[1854,1489],[1854,1538],[245,1538]],"region":{"top_left_x":244,"top_left_y":1488,"width":1611,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbca5ba20abc48f8a65b2e6d7b3b10d1","type":"text","conversion_output":true,"text":"more than 160,000 participants, showed a consistent relationship between LDL-C reduction and","text_display":" more than 160,000 participants, showed a consistent relationship between LDL-C reduction and","confidence":1,"confidence_rate":1},{"cnt":[[245,1536],[1837,1536],[1837,1586],[245,1586]],"region":{"top_left_x":244,"top_left_y":1536,"width":1593,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d7c970023e24198af492cbb81ae2dc0","type":"text","conversion_output":true,"text":"CV outcomes (Baigent 2010). This analysis showed that with a \\(1 mmol / L\\) reduction in LDL-C","text_display":" CV outcomes (Baigent 2010). This analysis showed that with a \\(1 mmol / L\\) reduction in LDL-C","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,1586],[1622,1586],[1622,1635],[245,1635]],"region":{"top_left_x":244,"top_left_y":1585,"width":1379,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66a70ef1f5334bc49148e6206f1431a9","type":"text","conversion_output":true,"text":"associated with a \\(22 \\%\\) reduction in the 5 -year incidence of major coronary events,","text_display":" associated with a \\(22 \\%\\) reduction in the 5 -year incidence of major coronary events,","confidence":0.9951171875,"confidence_rate":0.9999473694239973},{"cnt":[[245,1635],[1760,1635],[1760,1684],[245,1684]],"region":{"top_left_x":244,"top_left_y":1634,"width":1516,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b5776c96f2c431d9b04e005820bd5a4","type":"text","conversion_output":true,"text":"revascularizations, and ischemic strokes. Intensive statin therapy relative to low/moderate","text_display":" revascularizations, and ischemic strokes. Intensive statin therapy relative to low/moderate","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[245,1684],[1798,1684],[1798,1732],[245,1732]],"region":{"top_left_x":244,"top_left_y":1684,"width":1555,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d968bee21878413c84cbe161cd02cc90","type":"text","conversion_output":true,"text":"intensity statin treatment produces greater benefit in patients at high CV risk (Cannon 2004).","text_display":" intensity statin treatment produces greater benefit in patients at high CV risk (Cannon 2004).","confidence":1,"confidence_rate":1},{"cnt":[[245,1732],[1843,1732],[1843,1781],[245,1781]],"region":{"top_left_x":244,"top_left_y":1731,"width":1600,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82b5b54f4a084d4a947597ae64df7d6a","type":"text","conversion_output":true,"text":"Unfortunately, some patients are unable to take high intensity statins due to dosing limits based","text_display":" Unfortunately, some patients are unable to take high intensity statins due to dosing limits based","confidence":1,"confidence_rate":1},{"cnt":[[245,1781],[1867,1781],[1867,1830],[245,1830]],"region":{"top_left_x":244,"top_left_y":1781,"width":1623,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8d2801096cd4c5481265dcb21133816","type":"text","conversion_output":true,"text":"on co-morbidities, contraindications, and/or tolerance (Jacobson 2014). Nonstatin therapies may","text_display":" on co-morbidities, contraindications, and/or tolerance (Jacobson 2014). Nonstatin therapies may","confidence":1,"confidence_rate":1},{"cnt":[[245,1830],[1837,1830],[1837,1880],[245,1880]],"region":{"top_left_x":244,"top_left_y":1830,"width":1593,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66fbf947c267424ba2b7e5f01de0eecf","type":"text","conversion_output":true,"text":"provide additional lowering of CV risk as demonstrated in the IMPROVE-IT trial which added","text_display":" provide additional lowering of CV risk as demonstrated in the IMPROVE-IT trial which added","confidence":1,"confidence_rate":1},{"cnt":[[245,1878],[965,1878],[965,1927],[245,1927]],"region":{"top_left_x":244,"top_left_y":1877,"width":721,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67685e22c6434682a44d1c706572d218","type":"text","conversion_output":true,"text":"ezetimibe to statin therapy (Cannon 2015).","text_display":" ezetimibe to statin therapy (Cannon 2015).","confidence":1,"confidence_rate":1},{"cnt":[[245,1946],[1755,1946],[1755,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1946,"width":1512,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85b3518841f742469e7b970b1db6b2be","type":"text","conversion_output":true,"text":"Patients with ASCVD and HeFH on maximally tolerated lipid-lowering therapy including","text_display":"\n\nPatients with ASCVD and HeFH on maximally tolerated lipid-lowering therapy including","confidence":0.99560546875,"confidence_rate":0.9999505156560203},{"cnt":[[245,1998],[1880,1998],[1880,2047],[245,2047]],"region":{"top_left_x":244,"top_left_y":1998,"width":1636,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d2f7705297e490bb78458f0380469fc","type":"text","conversion_output":true,"text":"maximally tolerated doses of statins who require additional lipid-lowering therapy have an unmet","text_display":" maximally tolerated doses of statins who require additional lipid-lowering therapy have an unmet","confidence":1,"confidence_rate":1},{"cnt":[[245,2045],[1798,2045],[1798,2095],[245,2095]],"region":{"top_left_x":244,"top_left_y":2045,"width":1555,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"585889555e4b490faa5b378a180f288b","type":"text","conversion_output":true,"text":"medical need. ETC-1002 may offer a once daily option for these patients. The oral route of","text_display":" medical need. ETC-1002 may offer a once daily option for these patients. The oral route of","confidence":1,"confidence_rate":1},{"cnt":[[245,2093],[1824,2093],[1824,2142],[245,2142]],"region":{"top_left_x":244,"top_left_y":2092,"width":1581,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33c023c55a344f4985ea7031781e9c2a","type":"text","conversion_output":true,"text":"administration may be preferable to injectable biologic therapy for some patients. Bempedoic","text_display":" administration may be preferable to injectable biologic therapy for some patients. Bempedoic","confidence":1,"confidence_rate":1},{"cnt":[[245,2142],[1828,2142],[1828,2191],[245,2191]],"region":{"top_left_x":244,"top_left_y":2141,"width":1585,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4172c5bdcc7242538f0b55a88869407e","type":"text","conversion_output":true,"text":"acid has been well tolerated to date and Phase 2 data demonstrate significant LDL-C lowering,","text_display":" acid has been well tolerated to date and Phase 2 data demonstrate significant LDL-C lowering,","confidence":1,"confidence_rate":1},{"cnt":[[245,2191],[1184,2191],[1184,2241],[245,2241]],"region":{"top_left_x":244,"top_left_y":2191,"width":940,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06f70d73c4b74d41b12980083eb522c1","type":"text","conversion_output":true,"text":"prompting further evaluation in Phase 3 clinical studies.","text_display":" prompting further evaluation in Phase 3 clinical studies.","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":41},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"300d0a42dbd3405c90082b1bc4a48acb","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[932,2580],[1190,2580],[1190,2628],[932,2628]],"region":{"top_left_x":932,"top_left_y":2580,"width":259,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9adcee9d8c22435898beaf2ce5f118ed","type":"page_info","conversion_output":false,"text":"Page 26 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-027","page":27,"lines":[{"cnt":[[245,129],[535,129],[535,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":291,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"340f40f310c84f44900c50cf3b20cc79","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"525b268abec74e11a072f90bc7499f0d","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,221],[245,221]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"622f0ba05686485e992cf9cfbe56dd1f","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7f7e174e6d3435b81b0378696754a4e","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[241,249],[1119,249],[1119,312],[241,312]],"region":{"top_left_x":240,"top_left_y":249,"width":880,"height":63},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ce5d683f1174663911cb502936dcb11","type":"section_header","conversion_output":false,"children_ids":["ecdf9ab582aa41ecb6c0eb5c92bfc6fc"],"text":"","text_display":""},{"cnt":[[245,254],[1113,254],[1113,312],[245,312]],"region":{"top_left_x":244,"top_left_y":253,"width":869,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecdf9ab582aa41ecb6c0eb5c92bfc6fc","type":"text","conversion_output":true,"parent_id":"8ce5d683f1174663911cb502936dcb11","text":"4.2. Background on Bempedoic Acid","text_display":"\n\n\\subsection*{4.2. Background on Bempedoic Acid}","confidence":0.79052734375,"confidence_rate":0.9938334330521561},{"cnt":[[243,365],[823,365],[823,410],[243,410]],"region":{"top_left_x":242,"top_left_y":365,"width":581,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e94514da34044e3fac4959546ea87040","type":"section_header","conversion_output":false,"children_ids":["e5b56733e453445c8818f079339de272"],"text":"","text_display":""},{"cnt":[[247,370],[819,370],[819,406],[247,406]],"region":{"top_left_x":247,"top_left_y":369,"width":572,"height":38},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5b56733e453445c8818f079339de272","type":"text","conversion_output":true,"parent_id":"e94514da34044e3fac4959546ea87040","text":"4.2.1. Mechanism of Action","text_display":"\n\n\\subsection*{4.2.1. Mechanism of Action}","confidence":0.9482421875,"confidence_rate":0.9982871029658854},{"cnt":[[247,447],[1779,447],[1779,492],[247,492]],"region":{"top_left_x":247,"top_left_y":446,"width":1532,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7781e802b244408b6f6820f48b56f7e","type":"text","conversion_output":true,"text":"Bempedoic acid is a first-in-class small molecule inhibitor of ACL, an enzyme upstream of","text_display":"\n\nBempedoic acid is a first-in-class small molecule inhibitor of ACL, an enzyme upstream of","confidence":1,"confidence_rate":1},{"cnt":[[245,494],[1835,494],[1835,544],[245,544]],"region":{"top_left_x":244,"top_left_y":494,"width":1591,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afb952b72ccc425bbdee28b4cd00a68d","type":"text","conversion_output":true,"text":"HMG-CoA in the cholesterol biosynthesis pathway. Bempedoic acid is a prodrug that requires","text_display":" HMG-CoA in the cholesterol biosynthesis pathway. Bempedoic acid is a prodrug that requires","confidence":1,"confidence_rate":1},{"cnt":[[247,544],[1807,544],[1807,591],[247,591]],"region":{"top_left_x":247,"top_left_y":543,"width":1560,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b7ea3bcf7f54136ba6a87091a7175d1","type":"text","conversion_output":true,"text":"activation in liver to ETC-1002-co-enzyme A (ETC-1002-CoA), which mediates competitive","text_display":" activation in liver to ETC-1002-co-enzyme A (ETC-1002-CoA), which mediates competitive","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[247,593],[1876,593],[1876,638],[247,638]],"region":{"top_left_x":247,"top_left_y":592,"width":1629,"height":47},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d70a66b5eb2471c895c7b2d920dabbb","type":"text","conversion_output":true,"text":"inhibition of ACL. Inhibition of ACL by ETC-1002-CoA decreases cholesterol synthesis in liver","text_display":" inhibition of ACL. Inhibition of ACL by ETC-1002-CoA decreases cholesterol synthesis in liver","confidence":1,"confidence_rate":1},{"cnt":[[247,640],[1824,640],[1824,690],[247,690]],"region":{"top_left_x":247,"top_left_y":640,"width":1578,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93386e02a76040b6919c4b65cdb4f871","type":"text","conversion_output":true,"text":"leading to increased LDLR expression and LDL particle clearance from the blood. Therefore,","text_display":" leading to increased LDLR expression and LDL particle clearance from the blood. Therefore,","confidence":1,"confidence_rate":1},{"cnt":[[247,690],[1772,690],[1772,737],[247,737]],"region":{"top_left_x":247,"top_left_y":689,"width":1526,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07130135173f4e77af5794920e068bd6","type":"text","conversion_output":true,"text":"inhibition of ACL by ETC-1002-CoA reduces LDL-C via the same pathway as HMG-CoA","text_display":" inhibition of ACL by ETC-1002-CoA reduces LDL-C via the same pathway as HMG-CoA","confidence":1,"confidence_rate":1},{"cnt":[[245,739],[758,739],[758,784],[245,784]],"region":{"top_left_x":244,"top_left_y":739,"width":515,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e7480b4ec4a48cdbcea039600a73173","type":"text","conversion_output":true,"text":"reductase inhibition by statins.","text_display":" reductase inhibition by statins.","confidence":1,"confidence_rate":1},{"cnt":[[245,808],[1837,808],[1837,853],[245,853]],"region":{"top_left_x":244,"top_left_y":807,"width":1593,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58fb8725de0f4d39b89259dc407c87f1","type":"text","conversion_output":true,"text":"An important differentiating feature of bempedoic acid is that, unlike statins, it does not inhibit","text_display":"\n\nAn important differentiating feature of bempedoic acid is that, unlike statins, it does not inhibit","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,855],[1790,855],[1790,904],[245,904]],"region":{"top_left_x":244,"top_left_y":855,"width":1546,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdf6bca619db41b7abeb7b421ed0a09c","type":"text","conversion_output":true,"text":"cholesterol synthesis in skeletal muscle. The enzyme required to convert bempedoic acid to","text_display":" cholesterol synthesis in skeletal muscle. The enzyme required to convert bempedoic acid to","confidence":1,"confidence_rate":1},{"cnt":[[245,902],[1841,902],[1841,952],[245,952]],"region":{"top_left_x":244,"top_left_y":902,"width":1598,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef66c8b489504959988910bb7b66fffb","type":"text","conversion_output":true,"text":"ETC-1002-CoA is not present in skeletal muscle. Therefore, bempedoic acid is not anticipated","text_display":" ETC-1002-CoA is not present in skeletal muscle. Therefore, bempedoic acid is not anticipated","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1824,954],[1824,999],[245,999]],"region":{"top_left_x":244,"top_left_y":953,"width":1581,"height":47},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9dbcc349fcde457b8fd5bdfb6776881d","type":"text","conversion_output":true,"text":"to mediate the adverse effects associated with inhibition of biological intermediates within the","text_display":" to mediate the adverse effects associated with inhibition of biological intermediates within the","confidence":1,"confidence_rate":1},{"cnt":[[245,1001],[1850,1001],[1850,1051],[245,1051]],"region":{"top_left_x":244,"top_left_y":1001,"width":1606,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cb9f586e2ae458982233adb9b121be5","type":"text","conversion_output":true,"text":"cholesterol biosynthesis pathway in skeletal muscle; however, the safety of bempedoic acid and","text_display":" cholesterol biosynthesis pathway in skeletal muscle; however, the safety of bempedoic acid and","confidence":1,"confidence_rate":1},{"cnt":[[245,1051],[1422,1051],[1422,1098],[245,1098]],"region":{"top_left_x":244,"top_left_y":1050,"width":1179,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"487242a7dd264099bc7415ae80638619","type":"text","conversion_output":true,"text":"its metabolites regarding human skeletal muscle is not yet established.","text_display":" its metabolites regarding human skeletal muscle is not yet established.","confidence":1,"confidence_rate":1},{"cnt":[[245,1139],[855,1139],[855,1192],[245,1192]],"region":{"top_left_x":244,"top_left_y":1138,"width":612,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24858b72722f4e4994f381cd954a53bf","type":"section_header","conversion_output":false,"children_ids":["df145b1e62cf4a9a8912bd80b40c97d4"],"text":"","text_display":""},{"cnt":[[249,1143],[853,1143],[853,1188],[249,1188]],"region":{"top_left_x":249,"top_left_y":1142,"width":604,"height":47},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df145b1e62cf4a9a8912bd80b40c97d4","type":"text","conversion_output":true,"parent_id":"24858b72722f4e4994f381cd954a53bf","text":"4.2.2. 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In these studies, bempedoic acid lowered LDL-C and","text_display":" predictive rodent models of dyslipidemia. In these studies, bempedoic acid lowered LDL-C and","confidence":1,"confidence_rate":1},{"cnt":[[245,1319],[1826,1319],[1826,1364],[245,1364]],"region":{"top_left_x":244,"top_left_y":1319,"width":1583,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d090e853ab1946bd8b5588abf7732c23","type":"text","conversion_output":true,"text":"triglycerides (TGs) and increased high-density lipoprotein cholesterol (HDL-C). In a study of","text_display":" triglycerides (TGs) and increased high-density lipoprotein cholesterol (HDL-C). 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No significant central nervous system (CNS),","text_display":" up to 52 weeks in duration have been completed. No significant central nervous system (CNS),","confidence":1,"confidence_rate":1},{"cnt":[[245,1702],[1790,1702],[1790,1749],[245,1749]],"region":{"top_left_x":244,"top_left_y":1701,"width":1546,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e47e3822679b4ba2afbfff53a75aa028","type":"text","conversion_output":true,"text":"respiratory, or CV liabilities were identified. Target organs identified in repeat-dose studies","text_display":" respiratory, or CV liabilities were identified. Target organs identified in repeat-dose studies","confidence":1,"confidence_rate":1},{"cnt":[[245,1749],[1755,1749],[1755,1798],[245,1798]],"region":{"top_left_x":244,"top_left_y":1748,"width":1512,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05e8320417664600b1b3831029032a8f","type":"text","conversion_output":true,"text":"were liver in rats and liver and kidney in monkeys, and changes were reversible following","text_display":" were liver in rats and liver and kidney in monkeys, and changes were reversible following","confidence":1,"confidence_rate":1},{"cnt":[[245,1798],[1858,1798],[1858,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1798,"width":1615,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af09e29f42124be6ae8127e22bf57b7a","type":"text","conversion_output":true,"text":"cessation of treatment. Changes in clinical laboratory parameters indicative of hepatic and renal","text_display":" cessation of treatment. Changes in clinical laboratory parameters indicative of hepatic and renal","confidence":1,"confidence_rate":1},{"cnt":[[245,1848],[1768,1848],[1768,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1847,"width":1525,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36dd4ff62a5a43acb8d26af18bdf0b86","type":"text","conversion_output":true,"text":"function were observed in animals at doses lower than those associated with frank toxicity.","text_display":" function were observed in animals at doses lower than those associated with frank toxicity.","confidence":1,"confidence_rate":1},{"cnt":[[245,1895],[1833,1895],[1833,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1894,"width":1589,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e4f1799f73f460d94dbce87e28babb6","type":"text","conversion_output":true,"text":"Routine clinical laboratory parameters will continue to be monitored carefully in clinical trials.","text_display":" Routine clinical laboratory parameters will continue to be monitored carefully in clinical trials.","confidence":1,"confidence_rate":1},{"cnt":[[245,1964],[1727,1964],[1727,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1963,"width":1484,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6549b30590d4614bf707f6943aae72a","type":"text","conversion_output":true,"text":"Bempedoic acid is nonmutagenic and nonclastogenic in both in vitro and in vivo genetic","text_display":"\n\nBempedoic acid is nonmutagenic and nonclastogenic in both in vitro and in vivo genetic","confidence":1,"confidence_rate":1},{"cnt":[[245,2013],[556,2013],[556,2060],[245,2060]],"region":{"top_left_x":244,"top_left_y":2013,"width":313,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41a4c5799f6a42d7be3c5eefd77303fc","type":"text","conversion_output":true,"text":"toxicology assays.","text_display":" toxicology assays.","confidence":1,"confidence_rate":1},{"cnt":[[245,2084],[1755,2084],[1755,2133],[245,2133]],"region":{"top_left_x":244,"top_left_y":2083,"width":1512,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d2c7729b0494102819d889bf39ecbb0","type":"text","conversion_output":true,"text":"In the pivotal 26-week rat study, the no-observed-adverse-effect level (NOAEL) dose was","text_display":"\n\nIn the pivotal 26-week rat study, the no-observed-adverse-effect level (NOAEL) dose was","confidence":0.99609375,"confidence_rate":0.9999574585209889},{"cnt":[[245,2131],[1777,2131],[1777,2179],[245,2179]],"region":{"top_left_x":244,"top_left_y":2131,"width":1533,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6fb6a02fe1c4561a15924e3df50a771","type":"text","conversion_output":true,"text":"\\(30 mg / kg /\\) day in rats and the corresponding area under the curve during 24 hours ( \\(AUC _{0-24}\\) )","text_display":" \\(30 mg / kg /\\) day in rats and the corresponding area under the curve during 24 hours ( \\(AUC _{0-24}\\) )","confidence":0.989769458770752,"confidence_rate":0.9999121129827991},{"cnt":[[245,2183],[1871,2183],[1871,2230],[245,2230]],"region":{"top_left_x":244,"top_left_y":2182,"width":1628,"height":49},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"771df7ef186d4e5baf20b993d6c077fc","type":"text","conversion_output":true,"text":"values of the sum of ETC-1002 and ESP 15228 were up to \\(528 \\mu g \\cdot hr / mL\\). In the pivotal 52 -week","text_display":" values of the sum of ETC-1002 and ESP 15228 were up to \\(528 \\mu g \\cdot hr / mL\\). 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In addition,","text_display":" cytochrome P450 (CYP) enzymes at clinically relevant plasma concentrations. In addition,","confidence":1,"confidence_rate":1},{"cnt":[[245,2449],[1549,2449],[1549,2494],[245,2494]],"region":{"top_left_x":244,"top_left_y":2449,"width":1306,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efb9ee2328554cfca04b4a908110e244","type":"text","conversion_output":true,"text":"ETC-1002 bempedoic acid does not appear to inhibit major drug transporters.","text_display":" ETC-1002 bempedoic acid does not appear to inhibit major drug transporters.","confidence":1,"confidence_rate":1},{"cnt":[[245,2582],[462,2582],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2582,"width":218,"height":37},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6e3f5476e6d4eb19f872e5121d42291","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[932,2582],[1190,2582],[1190,2628],[932,2628]],"region":{"top_left_x":932,"top_left_y":2582,"width":259,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ca67763547b4a48acc4f496fc664395","type":"page_info","conversion_output":false,"text":"Page 27 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-028","page":28,"lines":[{"cnt":[[245,129],[535,129],[535,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":291,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25b53a17afbc4342b47314f040a6c4bd","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0774ac6b72bd456280a9451f9e73e9a3","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6a8c39432ee4faca0727ead9cd0f047","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7d7d05623fc4db08b4dd15af05b56a3","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1858,254],[1858,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1615,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fca7266c8136436e9fb9e641677a5e56","type":"text","conversion_output":true,"text":"Please refer to the most recent Investigator's Brochure (IB) for additional information regarding","text_display":"\n\nPlease refer to the most recent Investigator's Brochure (IB) for additional information regarding","confidence":0.9990234375,"confidence_rate":0.9999904212258001},{"cnt":[[245,301],[1420,301],[1420,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1177,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49f45c71561f4277b1446db66ef03391","type":"text","conversion_output":true,"text":"pharmacology, pharmacokinetics (PK), and nonclinical safety studies.","text_display":" pharmacology, pharmacokinetics (PK), and nonclinical safety studies.","confidence":1,"confidence_rate":1},{"cnt":[[241,391],[956,391],[956,445],[241,445]],"region":{"top_left_x":240,"top_left_y":391,"width":717,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7236701355a8494bb39fcc214fb90ec0","type":"section_header","conversion_output":false,"children_ids":["0fa6c0367c6f408c848b09b6c67ca2aa"],"text":"","text_display":""},{"cnt":[[245,391],[952,391],[952,440],[245,440]],"region":{"top_left_x":244,"top_left_y":391,"width":708,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fa6c0367c6f408c848b09b6c67ca2aa","type":"text","conversion_output":true,"parent_id":"7236701355a8494bb39fcc214fb90ec0","text":"4.2.3. 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This efficacy was observed across a range of patient","confidence":1,"confidence_rate":1},{"cnt":[[245,713],[1785,713],[1785,767],[245,767]],"region":{"top_left_x":244,"top_left_y":713,"width":1542,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb6c658a94cd437daf871e3dc5e477f0","type":"text","conversion_output":true,"text":"populations, including those with primary hyperlipidemia and mixed dyslipidemia, some of","text_display":" populations, including those with primary hyperlipidemia and mixed dyslipidemia, some of","confidence":1,"confidence_rate":1},{"cnt":[[245,765],[1742,765],[1742,814],[245,814]],"region":{"top_left_x":244,"top_left_y":764,"width":1499,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5b936ed6bd04bf0a5002a7437a2b43e","type":"text","conversion_output":true,"text":"whom also reported type 2 diabetes mellitus (T2DM), CHD, and/or statin intolerance. In","text_display":" whom also reported type 2 diabetes mellitus (T2DM), CHD, and/or statin intolerance. In","confidence":1,"confidence_rate":1},{"cnt":[[245,812],[1858,812],[1858,862],[245,862]],"region":{"top_left_x":244,"top_left_y":812,"width":1615,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d25b4cca78141a7b0cfec74c1cb8ba0","type":"text","conversion_output":true,"text":"addition, a positive benefit/risk profile is shown across a range of low and moderate dose statins","text_display":" addition, a positive benefit/risk profile is shown across a range of low and moderate dose statins","confidence":1,"confidence_rate":1},{"cnt":[[245,859],[496,859],[496,904],[245,904]],"region":{"top_left_x":244,"top_left_y":859,"width":253,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b979e8abc70a4b1a98618755145609a5","type":"text","conversion_output":true,"text":"and ezetimibe.","text_display":" and ezetimibe.","confidence":1,"confidence_rate":1},{"cnt":[[245,930],[1841,930],[1841,982],[245,982]],"region":{"top_left_x":244,"top_left_y":930,"width":1598,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e7f6645fd974272b7681bf8e8e9b8ac","type":"text","conversion_output":true,"text":"In both single- and multiple-dose studies, bempedoic acid is well absorbed (with a time to peak","text_display":"\n\nIn both single- and multiple-dose studies, bempedoic acid is well absorbed (with a time to peak","confidence":1,"confidence_rate":1},{"cnt":[[245,980],[1725,980],[1725,1029],[245,1029]],"region":{"top_left_x":244,"top_left_y":979,"width":1482,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed1f94f3ad024e11a4524feb805ff281","type":"text","conversion_output":true,"text":"maximum concentration \\(\\left[ C _{\\max }\\right]\\) of approximately \\(<4\\) hours). The \\(C _{\\max }\\) of ETC-1002 and","text_display":" maximum concentration \\(\\left[ C _{\\max }\\right]\\) of approximately \\(<4\\) hours). The \\(C _{\\max }\\) of ETC-1002 and","confidence":0.9892673492431641,"confidence_rate":0.9999108249590068},{"cnt":[[245,1027],[1854,1027],[1854,1076],[245,1076]],"region":{"top_left_x":244,"top_left_y":1026,"width":1611,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a08d40e0e2124304b9c8f6a6a945c918","type":"text","conversion_output":true,"text":"ESP15228 increased in proportion to increasing dose; and the area under the concentration-time","text_display":" ESP15228 increased in proportion to increasing dose; and the area under the concentration-time","confidence":0.9970703125,"confidence_rate":0.9999703642024339},{"cnt":[[245,1076],[1725,1076],[1725,1126],[245,1126]],"region":{"top_left_x":244,"top_left_y":1076,"width":1482,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3a69515320e4a38af654d5834b6203b","type":"text","conversion_output":true,"text":"curve (AUC) showed slightly more than dose-proportional increases for ETC-1002 with","text_display":" curve (AUC) showed slightly more than dose-proportional increases for ETC-1002 with","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[245,1126],[1876,1126],[1876,1175],[245,1175]],"region":{"top_left_x":244,"top_left_y":1125,"width":1632,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"898919fb9d904170b19286143df90e24","type":"text","conversion_output":true,"text":"increasing dose, but proportional increases in AUC were observed with ESP15228. The terminal","text_display":" increasing dose, but proportional increases in AUC were observed with ESP15228. The terminal","confidence":1,"confidence_rate":1},{"cnt":[[245,1173],[1751,1173],[1751,1222],[245,1222]],"region":{"top_left_x":244,"top_left_y":1173,"width":1507,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38d36906f06e4cc28713c58027913867","type":"text","conversion_output":true,"text":"elimination half-life ( \\(t _{\\frac{1}{2}}\\) ) ranged from 15 to 27 hours for ETC-1002 and 20 to 33 hours for","text_display":" elimination half-life ( \\(t _{\\frac{1}{2}}\\) ) ranged from 15 to 27 hours for ETC-1002 and 20 to 33 hours for","confidence":0.6647003747741564,"confidence_rate":0.9967892685749458},{"cnt":[[245,1220],[440,1220],[440,1265],[245,1265]],"region":{"top_left_x":244,"top_left_y":1220,"width":197,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b090e3a3734b40caa8f04dfeda6f7457","type":"text","conversion_output":true,"text":"ESP15228.","text_display":" ESP15228.","confidence":0.99853515625,"confidence_rate":0.9998952970758412},{"cnt":[[245,1291],[1833,1291],[1833,1343],[245,1343]],"region":{"top_left_x":244,"top_left_y":1291,"width":1589,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"018afee5325e489a8451ac612b9d6435","type":"text","conversion_output":true,"text":"A study to assess the effect of a high-fat, high-calorie meal on the bioavailability of ETC-1002","text_display":"\n\nA study to assess the effect of a high-fat, high-calorie meal on the bioavailability of ETC-1002","confidence":1,"confidence_rate":1},{"cnt":[[245,1341],[1766,1341],[1766,1390],[245,1390]],"region":{"top_left_x":244,"top_left_y":1340,"width":1523,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b33fd95c6794f158d0761166e5503f6","type":"text","conversion_output":true,"text":"following administration of \\(180- mg\\) tablet relative to the fasted state, the bioavailability of","text_display":" following administration of \\(180- mg\\) tablet relative to the fasted state, the bioavailability of","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[247,1388],[1861,1388],[1861,1437],[247,1437]],"region":{"top_left_x":247,"top_left_y":1387,"width":1614,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10776513c6394e3e8cd0a18500010b9d","type":"text","conversion_output":true,"text":"\\(180- mg\\) capsules relative to one \\(180- mg\\) tablet in the fasted state, and the bioavailability of three","text_display":" \\(180- mg\\) capsules relative to one \\(180- mg\\) tablet in the fasted state, and the bioavailability of three","confidence":1,"confidence_rate":1},{"cnt":[[247,1437],[1835,1437],[1835,1487],[247,1487]],"region":{"top_left_x":247,"top_left_y":1437,"width":1588,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fee694165ebe4609b600360b85d59601","type":"text","conversion_output":true,"text":"\\(60- mg\\) tablets relative to one \\(180- mg\\) tablet has completed (1002-016). A high-fat meal has no","text_display":" \\(60- mg\\) tablets relative to one \\(180- mg\\) tablet has completed (1002-016). A high-fat meal has no","confidence":0.9985356330871582,"confidence_rate":0.9999860435245741},{"cnt":[[245,1487],[1858,1487],[1858,1536],[245,1536]],"region":{"top_left_x":244,"top_left_y":1486,"width":1615,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a94d00ccb434bb2ba560b8ebb6bdaad","type":"text","conversion_output":true,"text":"effect on the PK of ETC-1002 \\(180- mg\\) tablet; ETC-1002 PK are equivalent whether taken in the","text_display":" effect on the PK of ETC-1002 \\(180- mg\\) tablet; ETC-1002 PK are equivalent whether taken in the","confidence":0.9985356330871582,"confidence_rate":0.9999856330429514},{"cnt":[[245,1534],[1725,1534],[1725,1583],[245,1583]],"region":{"top_left_x":244,"top_left_y":1533,"width":1482,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dec5d94e23d042f4a07788a89d9e5374","type":"text","conversion_output":true,"text":"fasting or fed state. The evaluation of the tablet formulation that will be used in Phase 3","text_display":" fasting or fed state. The evaluation of the tablet formulation that will be used in Phase 3","confidence":1,"confidence_rate":1},{"cnt":[[245,1583],[1803,1583],[1803,1635],[245,1635]],"region":{"top_left_x":244,"top_left_y":1583,"width":1559,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0e1302852d54c39b7dd28d8629938b8","type":"text","conversion_output":true,"text":"demonstrates similar PK characteristics to the capsule formulation utilized in Phases 1 and 2.","text_display":" demonstrates similar PK characteristics to the capsule formulation utilized in Phases 1 and 2.","confidence":0.99658203125,"confidence_rate":0.9999661013334881},{"cnt":[[245,1633],[1865,1633],[1865,1682],[245,1682]],"region":{"top_left_x":244,"top_left_y":1632,"width":1621,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"309a1e81e1674cf4aaf0956d8ffd509d","type":"text","conversion_output":true,"text":"The PK following three \\(60- mg\\) tablets was similar to one \\(180- mg\\) tablet. Only the \\(180- mg\\) tablet","text_display":" The PK following three \\(60- mg\\) tablets was similar to one \\(180- mg\\) tablet. Only the \\(180- mg\\) tablet","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[245,1680],[741,1680],[741,1729],[245,1729]],"region":{"top_left_x":244,"top_left_y":1680,"width":498,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1816613645bc4fd193e4845e65f30bd0","type":"text","conversion_output":true,"text":"is planned for use in Phase 3.","text_display":" is planned for use in Phase 3.","confidence":1,"confidence_rate":1},{"cnt":[[245,1749],[1846,1749],[1846,1798],[245,1798]],"region":{"top_left_x":244,"top_left_y":1748,"width":1602,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8557a68a0ff248e58eecf216bd6ad7bd","type":"text","conversion_output":true,"text":"Two studies evaluated clinical drug-drug interaction using bempedoic acid 240 mg and showed","text_display":"\n\nTwo studies evaluated clinical drug-drug interaction using bempedoic acid 240 mg and showed","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,1798],[1848,1798],[1848,1850],[245,1850]],"region":{"top_left_x":244,"top_left_y":1798,"width":1604,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea6f0a76bfec4874aaed8e8f268168ed","type":"text","conversion_output":true,"text":"less than a 2-fold increase in the exposure of atorvastatin 10 mg , simvastatin 20 mg , pravastatin","text_display":" less than a 2-fold increase in the exposure of atorvastatin 10 mg , simvastatin 20 mg , pravastatin","confidence":0.848853003949614,"confidence_rate":0.9985635830928921},{"cnt":[[245,1848],[1828,1848],[1828,1897],[245,1897]],"region":{"top_left_x":244,"top_left_y":1847,"width":1585,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce316ed8569a404391f8eba280fcecfa","type":"text","conversion_output":true,"text":"40 mg , and rosuvastatin 10 mg (Studies 1002-007 and 1002-012). Likewise, when bempedoic","text_display":" 40 mg , and rosuvastatin 10 mg (Studies 1002-007 and 1002-012). Likewise, when bempedoic","confidence":1,"confidence_rate":1},{"cnt":[[245,1895],[1820,1895],[1820,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1894,"width":1576,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3322186362e44ff90740359b51253b8","type":"text","conversion_output":true,"text":"acid 180 mg was dosed in combination with high-dose statins (atorvastatin 80 mg , pravastatin","text_display":" acid 180 mg was dosed in combination with high-dose statins (atorvastatin 80 mg , pravastatin","confidence":1,"confidence_rate":1},{"cnt":[[245,1944],[1807,1944],[1807,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1944,"width":1563,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4a252d93f7c4739881c849f63723068","type":"text","conversion_output":true,"text":"80 mg , rosuvastatin 40 mg , and simvastatin 40 mg ), mean exposure of these statins increased","text_display":" 80 mg , rosuvastatin 40 mg , and simvastatin 40 mg ), mean exposure of these statins increased","confidence":0.9975600242614746,"confidence_rate":0.9999777915436084},{"cnt":[[245,1994],[1111,1994],[1111,2043],[245,2043]],"region":{"top_left_x":244,"top_left_y":1993,"width":867,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfadd88a605443b987ed1cebc7847c96","type":"text","conversion_output":true,"text":"between approximately 1.4- and 2-fold (1002-037).","text_display":" between approximately 1.4- and 2-fold (1002-037).","confidence":0.5346336364746094,"confidence_rate":0.9884711656148819},{"cnt":[[245,2062],[1828,2062],[1828,2112],[245,2112]],"region":{"top_left_x":244,"top_left_y":2062,"width":1585,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3218abe0636f46d99d49379df552b8f2","type":"text","conversion_output":true,"text":"No drug interaction occurred between daily ETC-1002 180 mg and metformin in patients with","text_display":"\n\nNo drug interaction occurred between daily ETC-1002 180 mg and metformin in patients with","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[245,2110],[1863,2110],[1863,2159],[245,2159]],"region":{"top_left_x":244,"top_left_y":2109,"width":1619,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68e1909bf6ad4647b1eb1d6f99d90d96","type":"text","conversion_output":true,"text":"T2DM. A Phase 2 study showed no effect of ezetimibe 10 mg on steady-state trough ETC-1002","text_display":" T2DM. A Phase 2 study showed no effect of ezetimibe 10 mg on steady-state trough ETC-1002","confidence":1,"confidence_rate":1},{"cnt":[[245,2159],[1695,2159],[1695,2211],[245,2211]],"region":{"top_left_x":244,"top_left_y":2159,"width":1452,"height":52},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8290d3266d0c44abb098853f40f4d22c","type":"text","conversion_output":true,"text":"plasma concentrations in 40 patients with hypercholesterolemia randomized to receive","text_display":" plasma concentrations in 40 patients with hypercholesterolemia randomized to receive","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[245,2209],[1828,2209],[1828,2258],[245,2258]],"region":{"top_left_x":244,"top_left_y":2208,"width":1585,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be8755fce5a842808b147982c7bcd51f","type":"text","conversion_output":true,"text":"ETC-1002 plus ezetimibe (Study 1002-008). Results of a drug interaction study in 19 patients","text_display":" ETC-1002 plus ezetimibe (Study 1002-008). Results of a drug interaction study in 19 patients","confidence":1,"confidence_rate":1},{"cnt":[[245,2256],[1712,2256],[1712,2307],[245,2307]],"region":{"top_left_x":244,"top_left_y":2255,"width":1469,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f665283807dd45dfac12c15cfad62d02","type":"text","conversion_output":true,"text":"( 16 evaluable for PK) with the oral contraceptive Ortho-Novum 1/35 in healthy women","text_display":" ( 16 evaluable for PK) with the oral contraceptive Ortho-Novum 1/35 in healthy women","confidence":0.8486586511135101,"confidence_rate":0.9982179133548633},{"cnt":[[245,2305],[1858,2305],[1858,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2305,"width":1615,"height":52},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13090181e1fb416699d781f4fb6c0a59","type":"text","conversion_output":true,"text":"demonstrate no effect of daily ETC-1002 180 mg on ethinyl estradiol or norethindrone exposure","text_display":" demonstrate no effect of daily ETC-1002 180 mg on ethinyl estradiol or norethindrone exposure","confidence":1,"confidence_rate":1},{"cnt":[[245,2355],[556,2355],[556,2404],[245,2404]],"region":{"top_left_x":244,"top_left_y":2354,"width":313,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3b5295de94341a3a4649af116902a68","type":"text","conversion_output":true,"text":"(Study 1002-017).","text_display":" (Study 1002-017).","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":41},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c12ae28a3fdb454ca2eeb7a4edccf7ec","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[932,2580],[1192,2580],[1192,2628],[932,2628]],"region":{"top_left_x":932,"top_left_y":2580,"width":261,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e9048fdc53d4a8f94b824238a3233fb","type":"page_info","conversion_output":false,"text":"Page 28 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-029","page":29,"lines":[{"cnt":[[245,129],[535,129],[535,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":291,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8be54095c2284c5dbd2e236097aa1068","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3a255b422b3422aa1269ef82817b71f","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"430015be98284f729aa9d27a38524bc5","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4787f8aa562c42009e23f253fbfc0398","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1824,254],[1824,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1581,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0de554e7408a49339e2d4d4bd0a93919","type":"text","conversion_output":true,"text":"The results of the thorough QT/QTc (TQT) study (1002-022) showed no significant change in","text_display":"\n\nThe results of the thorough QT/QTc (TQT) study (1002-022) showed no significant change in","confidence":0.67919921875,"confidence_rate":0.9958931287581628},{"cnt":[[245,301],[1850,301],[1850,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1606,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b9e582ae0154f4eaa37a7d0514853de","type":"text","conversion_output":true,"text":"QTc. Following daily bempedoic acid 240 mg for 9 days, bempedoic acid does not prolong QT","text_display":" QTc. Following daily bempedoic acid 240 mg for 9 days, bempedoic acid does not prolong QT","confidence":1,"confidence_rate":1},{"cnt":[[245,352],[1850,352],[1850,397],[245,397]],"region":{"top_left_x":244,"top_left_y":352,"width":1606,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"640060c86bab478e8b8b92e6e8d8630d","type":"text","conversion_output":true,"text":"interval duration and has no clinically significant effect on heart rate and PR and QRS intervals.","text_display":" interval duration and has no clinically significant effect on heart rate and PR and QRS intervals.","confidence":1,"confidence_rate":1},{"cnt":[[245,421],[1850,421],[1850,468],[245,468]],"region":{"top_left_x":244,"top_left_y":421,"width":1606,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e31ea0d3772a4f35b7534dc7571896f7","type":"text","conversion_output":true,"text":"Occurrences of treatment-emergent adverse events (TEAEs), withdrawals due to adverse events","text_display":"\n\nOccurrences of treatment-emergent adverse events (TEAEs), withdrawals due to adverse events","confidence":1,"confidence_rate":1},{"cnt":[[247,468],[1854,468],[1854,518],[247,518]],"region":{"top_left_x":247,"top_left_y":468,"width":1608,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cda35547dc474fe4ad93151b53723a68","type":"text","conversion_output":true,"text":"(AEs), and treatment-related AEs were similar across groups receiving bempedoic acid, placebo","text_display":" (AEs), and treatment-related AEs were similar across groups receiving bempedoic acid, placebo","confidence":1,"confidence_rate":1},{"cnt":[[245,518],[1846,518],[1846,565],[245,565]],"region":{"top_left_x":244,"top_left_y":517,"width":1602,"height":49},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb0bf4296ecd4021a2746c248acf835d","type":"text","conversion_output":true,"text":"or an active comparator, ezetimibe. Across the 15 clinical studies, the most frequently reported","text_display":" or an active comparator, ezetimibe. 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The event was assessed by the investigator as severe and as","text_display":" subject in Clinical Study 1002-008. The event was assessed by the investigator as severe and as","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1781,954],[1781,1003],[245,1003]],"region":{"top_left_x":244,"top_left_y":953,"width":1538,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b671a21e37b40769b01d98c2ef37969","type":"text","conversion_output":true,"text":"possibly related to study treatment. The rationale for the investigator assessment was that a","text_display":" possibly related to study treatment. The rationale for the investigator assessment was that a","confidence":1,"confidence_rate":1},{"cnt":[[245,1003],[1848,1003],[1848,1051],[245,1051]],"region":{"top_left_x":244,"top_left_y":1003,"width":1604,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb2039cfd1f3442bb647116a24b6c823","type":"text","conversion_output":true,"text":"relationship to bempedoic acid could not be ruled out given the temporal nature of the event. A","text_display":" relationship to bempedoic acid could not be ruled out given the temporal nature of the event. 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Statin intensity categories and randomization strata are defined in Table 2 and","text_display":" total of 6 strata. Statin intensity categories and randomization strata are defined in Table 2 and","confidence":1,"confidence_rate":1},{"cnt":[[245,1796],[1560,1796],[1560,1846],[245,1846]],"region":{"top_left_x":244,"top_left_y":1796,"width":1316,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b7ac9c8d081425489b606b5b9aba395","type":"text","conversion_output":true,"text":"Table 3 below, respectively. Intensity category is based on average daily dose.","text_display":" Table 3 below, respectively. 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Eligible patients who are taking allowed concomitant medications","text_display":" eligibility will be evaluated. Eligible patients who are taking allowed concomitant medications","confidence":1,"confidence_rate":1},{"cnt":[[245,1053],[1858,1053],[1858,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1052,"width":1615,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88c4d6812f934eee90eb73459499a7ae","type":"text","conversion_output":true,"text":"must be on stable regimens as defined in Section 8.2. At the investigator's discretion, screening","text_display":" must be on stable regimens as defined in Section 8.2. At the investigator's discretion, screening","confidence":1,"confidence_rate":1},{"cnt":[[245,1100],[1824,1100],[1824,1149],[245,1149]],"region":{"top_left_x":244,"top_left_y":1100,"width":1581,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7239a97c204044b188ff528dfb302c31","type":"text","conversion_output":true,"text":"(time between visits S1 and S2) may be extended for an additional 4 weeks if needed to adjust","text_display":" (time between visits S1 and S2) may be extended for an additional 4 weeks if needed to adjust","confidence":0.998046875,"confidence_rate":0.9999806434067887},{"cnt":[[245,1147],[1826,1147],[1826,1199],[245,1199]],"region":{"top_left_x":244,"top_left_y":1147,"width":1583,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"632552894e1b4ddaa1130f8b9115d008","type":"text","conversion_output":true,"text":"background medical therapy or for other reasons as specified in the protocol. 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Eligible patients will return at Week-1 (Visit S3) for lipid and safety","text_display":" (patient only) placebo. 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Patients will be stratified on CV risk (HeFH and ASCVD","text_display":" IWRS at Week 0 (Visit T1). 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Women must be either:","confidence":1,"confidence_rate":1},{"cnt":[[374,915],[1871,915],[1871,965],[374,965]],"region":{"top_left_x":373,"top_left_y":915,"width":1499,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f9250c58c4a44588864e568377e898b","type":"text","conversion_output":true,"text":"- Naturally postmenopausal (as reported by the patient, defined as greater than 55 years","text_display":"\n- Naturally postmenopausal (as reported by the patient, defined as greater than 55 years","confidence":1,"confidence_rate":1},{"cnt":[[434,967],[1796,967],[1796,1012],[434,1012]],"region":{"top_left_x":433,"top_left_y":966,"width":1364,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ec805edc8ea491295668eea220c5ea9","type":"text","conversion_output":true,"text":"and \\(\\geq 1\\) year without menses, \\(<55\\) years and \\(\\geq 1\\) year without menses with follicle-","text_display":" and \\(\\geq 1\\) year without menses, \\(<55\\) years and \\(\\geq 1\\) year without menses with follicle","confidence":1,"confidence_rate":1},{"cnt":[[434,1014],[1867,1014],[1867,1061],[434,1061]],"region":{"top_left_x":433,"top_left_y":1014,"width":1434,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53c786f1d6894a388ba970778d7aad3b","type":"text","conversion_output":true,"text":"stimulating hormone (FSH) \\(\\geq 40.0 IU / L\\) ), or surgically sterile including hysterectomy,","text_display":"stimulating hormone (FSH) \\(\\geq 40.0 IU / L\\) ), or surgically sterile including hysterectomy,","confidence":0.740234375,"confidence_rate":0.996935435801243},{"cnt":[[434,1061],[1171,1061],[1171,1111],[434,1111]],"region":{"top_left_x":433,"top_left_y":1061,"width":738,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10704f5cbf0d4e82a2cdae3c2d82f9cf","type":"text","conversion_output":true,"text":"bilateral oophorectomy, or tubal ligation or;","text_display":" bilateral oophorectomy, or tubal ligation or;","confidence":1,"confidence_rate":1},{"cnt":[[374,1134],[1876,1134],[1876,1182],[374,1182]],"region":{"top_left_x":373,"top_left_y":1134,"width":1503,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"965a5200f8804c05a383de0cdbaae8fc","type":"text","conversion_output":true,"text":"- Women of childbearing potential must be willing to use 2 acceptable methods of birth","text_display":"\n- Women of childbearing potential must be willing to use 2 acceptable methods of birth","confidence":1,"confidence_rate":1},{"cnt":[[434,1182],[1792,1182],[1792,1231],[434,1231]],"region":{"top_left_x":433,"top_left_y":1181,"width":1359,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be5041d9e498429b8a6232136830693f","type":"text","conversion_output":true,"text":"control (unless they have agreed to follow the definition of true abstinence). The","text_display":" control (unless they have agreed to follow the definition of true abstinence). 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Acceptable methods of birth control include: oral, implantable,","text_display":" of study drug. Acceptable methods of birth control include: oral, implantable,","confidence":1,"confidence_rate":1},{"cnt":[[434,1377],[1811,1377],[1811,1424],[434,1424]],"region":{"top_left_x":433,"top_left_y":1377,"width":1379,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f36e6a693d54121a6654a76495d6f77","type":"text","conversion_output":true,"text":"injectable or topical birth control medications; placement of an intrauterine device","text_display":" injectable or topical birth control medications; placement of an intrauterine device","confidence":1,"confidence_rate":1},{"cnt":[[434,1427],[1863,1427],[1863,1474],[434,1474]],"region":{"top_left_x":433,"top_left_y":1426,"width":1430,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96b1550a322946aaa67c01fce0f95f1d","type":"text","conversion_output":true,"text":"(IUD) with or without hormones; barrier methods including condom or occlusive cap","text_display":" (IUD) with or without hormones; barrier methods including condom or occlusive cap","confidence":1,"confidence_rate":1},{"cnt":[[434,1474],[1878,1474],[1878,1523],[434,1523]],"region":{"top_left_x":433,"top_left_y":1473,"width":1445,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b439cf810aec49ff8f3f35538286f767","type":"text","conversion_output":true,"text":"with spermicidal foam or spermicidal jelly; vasectomized male partner who is the sole","text_display":" with spermicidal foam or spermicidal jelly; vasectomized male partner who is the sole","confidence":1,"confidence_rate":1},{"cnt":[[434,1523],[1835,1523],[1835,1571],[434,1571]],"region":{"top_left_x":433,"top_left_y":1523,"width":1402,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78bbbc37148a49ec90d8a71d187bccaf","type":"text","conversion_output":true,"text":"partner for this patient; or true abstinence when this is in line with the preferred and","text_display":" partner for this patient; or true abstinence when this is in line with the preferred and","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[434,1573],[1669,1573],[1669,1620],[434,1620]],"region":{"top_left_x":433,"top_left_y":1572,"width":1237,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2af6448cb84140ac892500f0ac7e47c5","type":"text","conversion_output":true,"text":"usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation,","text_display":" usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation,","confidence":0.99755859375,"confidence_rate":0.9999701907937938},{"cnt":[[434,1620],[1863,1620],[1863,1669],[434,1669]],"region":{"top_left_x":433,"top_left_y":1619,"width":1430,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"732ce12c8d064f7bafb21b09c0765d41","type":"text","conversion_output":true,"text":"symptothermal, postovulation methods], declaration of abstinence for the duration of","text_display":" symptothermal, postovulation methods], declaration of abstinence for the duration of","confidence":1,"confidence_rate":1},{"cnt":[[434,1669],[1618,1669],[1618,1717],[434,1717]],"region":{"top_left_x":433,"top_left_y":1669,"width":1185,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f8dbc4293b64edfae74794189b48c9a","type":"text","conversion_output":true,"text":"the trial, and withdrawal are not acceptable methods of contraception).","text_display":" the trial, and withdrawal are not acceptable methods of contraception).","confidence":1,"confidence_rate":1},{"cnt":[[372,1738],[1841,1738],[1841,1785],[372,1785]],"region":{"top_left_x":371,"top_left_y":1738,"width":1471,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"714385746c604bd2b4ef2642576358df","type":"text","conversion_output":true,"text":"There are no protocol-specific birth control requirements for men with partners who are","text_display":"\n\nThere are no protocol-specific birth control requirements for men with partners who are","confidence":1,"confidence_rate":1},{"cnt":[[370,1788],[793,1788],[793,1833],[370,1833]],"region":{"top_left_x":369,"top_left_y":1787,"width":424,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1287031c39264d8c9c45892e34c113ac","type":"text","conversion_output":true,"text":"able to become pregnant.","text_display":" able to become pregnant.","confidence":1,"confidence_rate":1},{"cnt":[[309,1856],[1721,1856],[1721,1904],[309,1904]],"region":{"top_left_x":309,"top_left_y":1856,"width":1412,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4e15d963c2e4d25929232328b8b56c9","type":"text","conversion_output":true,"text":"5. Fasting LDL-C (minimum of 10 hours) value at Week -5 (Visit S1) \\(\\geq 100 mg / dL\\)","text_display":"\n5. Fasting LDL-C (minimum of 10 hours) value at Week -5 (Visit S1) \\(\\geq 100 mg / dL","confidence":0.990234375,"confidence_rate":0.9998933358906693},{"cnt":[[372,1904],[1837,1904],[1837,1953],[372,1953]],"region":{"top_left_x":371,"top_left_y":1903,"width":1466,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f66c764b0a84d27943af4ba0115582d","type":"text","conversion_output":true,"text":"\\((2.6 mmol / L )\\) and fasting LDL-C value at Week-1 (Visit S3) \\(\\geq 70 mg / dL (1.8 mmol / L )\\).","text_display":" (2.6 mmol / L )\\) and fasting LDL-C value at Week-1 (Visit S3) \\(\\geq 70 mg / dL (1.8 mmol / L )\\).","confidence":0.41545726810231526,"confidence_rate":0.9915083419269765},{"cnt":[[309,1972],[1098,1972],[1098,2022],[309,2022]],"region":{"top_left_x":309,"top_left_y":1972,"width":789,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"249dbc8258d249a9ae2185cb30bf45d8","type":"text","conversion_output":true,"text":"6. Have high CV risk that is defined as either:","text_display":"\n6. Have high CV risk that is defined as either:","confidence":1,"confidence_rate":1},{"cnt":[[372,2045],[1790,2045],[1790,2095],[372,2095]],"region":{"top_left_x":371,"top_left_y":2045,"width":1419,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ba045a6fee34fc989b9e90bd6947757","type":"text","conversion_output":true,"text":"- Diagnosis of HeFH. Diagnosis must be made by either genotyping or by clinical","text_display":"\n- Diagnosis of HeFH. Diagnosis must be made by either genotyping or by clinical","confidence":0.99658203125,"confidence_rate":0.999959241028889},{"cnt":[[434,2093],[1841,2093],[1841,2142],[434,2142]],"region":{"top_left_x":433,"top_left_y":2092,"width":1409,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"861f87471ce7434eab83662c53ded21a","type":"text","conversion_output":true,"text":"assessment using either the World Health Organization (WHO) criteria/Dutch Lipid","text_display":" assessment using either the World Health Organization (WHO) criteria/Dutch Lipid","confidence":0.9990234375,"confidence_rate":0.9999885054819704},{"cnt":[[434,2142],[1762,2142],[1762,2189],[434,2189]],"region":{"top_left_x":433,"top_left_y":2141,"width":1329,"height":49},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23878669ef1c4746b19e81e38cd40b79","type":"text","conversion_output":true,"text":"Clinical Network Criteria with a score that is \\(>8\\) points (see Appendix 4) or the","text_display":" Clinical Network Criteria with a score that is \\(>8\\) points (see Appendix 4) or the","confidence":0.9926943592781754,"confidence_rate":0.9999166800894272},{"cnt":[[434,2191],[1833,2191],[1833,2241],[434,2241]],"region":{"top_left_x":433,"top_left_y":2191,"width":1400,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a4e1254cafa4482a7e67d2d075090e4","type":"text","conversion_output":true,"text":"Simon Broome Register Diagnostic Criteria with an assessment of 'Definite HeFH'","text_display":" Simon Broome Register Diagnostic Criteria with an assessment of 'Definite HeFH'","confidence":1,"confidence_rate":1},{"cnt":[[434,2239],[1693,2239],[1693,2288],[434,2288]],"region":{"top_left_x":433,"top_left_y":2238,"width":1260,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac8b0f7c2c6645968a970025ae5a4b27","type":"text","conversion_output":true,"text":"(see Appendix 5). Patients with a diagnosis of HeFH may or may not have","text_display":" (see Appendix 5). Patients with a diagnosis of HeFH may or may not have","confidence":0.9970703125,"confidence_rate":0.999964220305538},{"cnt":[[434,2290],[1149,2290],[1149,2340],[434,2340]],"region":{"top_left_x":433,"top_left_y":2290,"width":717,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0f16f5b23db427d99eb12bfacb2ff06","type":"text","conversion_output":true,"text":"established CHD or CHD risk equivalents.","text_display":" established CHD or CHD risk 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Total fasting (minimum of 10 hours) triglyceride \\(\\geq 500 mg / dL (5.6 mmol / L )\\) at Week -5","confidence":0.9742450714111328,"confidence_rate":0.9997538756366805},{"cnt":[[372,993],[539,993],[539,1038],[372,1038]],"region":{"top_left_x":371,"top_left_y":992,"width":169,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26c941357d9a4307a66e444e14818bb6","type":"text","conversion_output":true,"text":"(Visit S1)","text_display":" (Visit S1)","confidence":1,"confidence_rate":1},{"cnt":[[370,1061],[1792,1061],[1792,1106],[370,1106]],"region":{"top_left_x":369,"top_left_y":1061,"width":1423,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aca782eef49a4a23ae2021dc8f18218d","type":"text","conversion_output":true,"text":"Note: TG may be repeated 1 time between Visits S1 and S2. For those patients who","text_display":"\n\nNote: TG may be repeated 1 time between Visits S1 and S2. For those patients who","confidence":0.7335283756256104,"confidence_rate":0.9964847272153186},{"cnt":[[370,1109],[1560,1109],[1560,1154],[370,1154]],"region":{"top_left_x":369,"top_left_y":1108,"width":1191,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7030d864e0bc4f2483a30b44a52c3430","type":"text","conversion_output":true,"text":"have a repeat TG, the repeat value will be used to determine eligibility.","text_display":" have a repeat TG, the repeat value will be used to determine eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[307,1177],[1811,1177],[1811,1227],[307,1227]],"region":{"top_left_x":307,"top_left_y":1177,"width":1505,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dc89242de174c2d812eee3013dc27c4","type":"text","conversion_output":true,"text":"2. Renal dysfunction or nephritic syndrome or a history of nephritis, including estimated","text_display":"\n2. 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For those patients who have a repeat eGFR, the repeat","text_display":" 4 weeks for a single repeat eGFR. 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Body mass index (BMI) \\(\\geq 50 kg / m ^{2}\\)","text_display":"\n3. Body mass index (BMI) \\(\\geq 50 kg / m ^{2}\\)","confidence":1,"confidence_rate":1},{"cnt":[[307,1676],[1785,1676],[1785,1725],[307,1725]],"region":{"top_left_x":307,"top_left_y":1675,"width":1479,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62b599bab83f42d5b9de738ee2abf1b4","type":"text","conversion_output":true,"text":"4. Recent (within 3 months prior to the screening visit [Week -5 (Visit S1)] or between","text_display":"\n4. 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Patients with implantable pacemakers or automatic implantable","text_display":" revascularization). Patients with implantable pacemakers or automatic implantable","confidence":1,"confidence_rate":1},{"cnt":[[370,2067],[1826,2067],[1826,2116],[370,2116]],"region":{"top_left_x":369,"top_left_y":2066,"width":1458,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c852be2da8074e1c8aa8ea649c8f2a3d","type":"text","conversion_output":true,"text":"cardioverter defibrillators may be considered if deemed by the Investigator to be stable","text_display":" cardioverter defibrillators may be considered if deemed by the Investigator to be stable","confidence":1,"confidence_rate":1},{"cnt":[[370,2114],[814,2114],[814,2163],[370,2163]],"region":{"top_left_x":369,"top_left_y":2114,"width":446,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7c2a7cf63234d6599f700cd2865c9fe","type":"text","conversion_output":true,"text":"for the previous 3 months.","text_display":" for the previous 3 months.","confidence":1,"confidence_rate":1},{"cnt":[[309,2183],[1858,2183],[1858,2232],[309,2232]],"region":{"top_left_x":309,"top_left_y":2182,"width":1550,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff1c7df8e52b49f9a44f27bd185886b3","type":"text","conversion_output":true,"text":"5. Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) \\(\\geq 160 mmHg\\)","text_display":"\n5. Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) \\(\\geq 160 mmHg\\)","confidence":1,"confidence_rate":1},{"cnt":[[370,2230],[1747,2230],[1747,2279],[370,2279]],"region":{"top_left_x":369,"top_left_y":2230,"width":1378,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ad036e5b2aa43a38e203b6863e01afd","type":"text","conversion_output":true,"text":"and diastolic blood pressure (DBP) \\(\\geq 100 mmHg\\) after sitting quietly for 5 minutes","text_display":" and diastolic blood pressure (DBP) \\(\\geq 100 mmHg\\) after sitting quietly for 5 minutes","confidence":0.9912109375,"confidence_rate":0.9999050806973419},{"cnt":[[370,2303],[1785,2303],[1785,2350],[370,2350]],"region":{"top_left_x":369,"top_left_y":2303,"width":1417,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e42c586fb4724ed0a783e6cf49a773c0","type":"text","conversion_output":true,"text":"Note: If the initial blood pressure (BP) values meet or exceed the specified level, an","text_display":"\n\nNote: If the initial blood pressure (BP) values meet or exceed the specified level, an","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[370,2350],[1751,2350],[1751,2400],[370,2400]],"region":{"top_left_x":369,"top_left_y":2350,"width":1382,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d2a1fda9f6947af945382a5497d4b34","type":"text","conversion_output":true,"text":"additional BP assessment may be completed. If the systolic or the diastolic values","text_display":" additional BP assessment may be completed. If the systolic or the diastolic values","confidence":1,"confidence_rate":1},{"cnt":[[370,2400],[1725,2400],[1725,2447],[370,2447]],"region":{"top_left_x":369,"top_left_y":2399,"width":1357,"height":49},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3576291d02043b7a0c9963c2ec645e3","type":"text","conversion_output":true,"text":"continue to meet or exceed the threshold, the patient may not continue screening.","text_display":" continue to meet or exceed the threshold, the patient may not continue screening.","confidence":1,"confidence_rate":1},{"cnt":[[370,2449],[1813,2449],[1813,2496],[370,2496]],"region":{"top_left_x":369,"top_left_y":2449,"width":1445,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e1db28e867c4268b4b9c660a16e556c","type":"text","conversion_output":true,"text":"However, at the discretion of the Investigator, the screening period (between Visits S1","text_display":" However, at the 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Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52010c704bde42438b374d365e90b454","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7152a7957ba046e390b62c7ad8123800","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 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adjustment of BP medication(s), provided that the patient has been on a stable","confidence":1,"confidence_rate":1},{"cnt":[[370,350],[1790,350],[1790,400],[370,400]],"region":{"top_left_x":369,"top_left_y":350,"width":1421,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9b0ae8e34a64b56b3a4d1397e8a9006","type":"text","conversion_output":true,"text":"dose of the BP medication for a minimum of 2 weeks prior to randomization and the","text_display":" dose of the BP medication for a minimum of 2 weeks prior to randomization and the","confidence":0.9985356330871582,"confidence_rate":0.9999835345159404},{"cnt":[[370,400],[1366,400],[1366,449],[370,449]],"region":{"top_left_x":369,"top_left_y":399,"width":998,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6f800b871de4265a79720c6c2076282","type":"text","conversion_output":true,"text":"repeat BP measurements do not meet the exclusion 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Patients stabilized on thyroid","confidence":0.991714471951127,"confidence_rate":0.9999032599840021},{"cnt":[[370,636],[1648,636],[1648,685],[370,685]],"region":{"top_left_x":369,"top_left_y":635,"width":1279,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6401351e00e4158a201a13389d46440","type":"text","conversion_output":true,"text":"replacement therapy for at least 6 weeks prior to randomization are allowed.","text_display":" replacement therapy for at least 6 weeks prior to randomization are allowed.","confidence":1,"confidence_rate":1},{"cnt":[[309,705],[1042,705],[1042,754],[309,754]],"region":{"top_left_x":309,"top_left_y":704,"width":733,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"628ef3238c50476984ea4bf8aff931da","type":"text","conversion_output":true,"text":"8. Liver disease or dysfunction, including:","text_display":"\n8. Liver disease or dysfunction, including:","confidence":1,"confidence_rate":1},{"cnt":[[370,776],[1712,776],[1712,827],[370,827]],"region":{"top_left_x":369,"top_left_y":775,"width":1344,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"019029ba17c047828460df8be6ec7556","type":"text","conversion_output":true,"text":"- Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C","text_display":"\n- Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C","confidence":0.9960966110229492,"confidence_rate":0.9999528803019436},{"cnt":[[432,825],[1235,825],[1235,874],[432,874]],"region":{"top_left_x":431,"top_left_y":825,"width":805,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"303404a971ee487f9fce6e382ead4208","type":"text","conversion_output":true,"text":"antibodies (HCV-AB) at Week -5 (Visit S1); or","text_display":" antibodies (HCV-AB) at Week -5 (Visit S1); or","confidence":0.98974609375,"confidence_rate":0.9997938844505811},{"cnt":[[372,898],[1762,898],[1762,947],[372,947]],"region":{"top_left_x":371,"top_left_y":898,"width":1391,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9382c20a89846d994177ad69bf76205","type":"text","conversion_output":true,"text":"- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \\(\\geq 2 \\times\\) ULN,","text_display":"\n- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \\(\\geq 2 \\times\\) ULN,","confidence":0.9985356330871582,"confidence_rate":0.9999823442504918},{"cnt":[[434,945],[1837,945],[1837,995],[434,995]],"region":{"top_left_x":433,"top_left_y":945,"width":1404,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff69e0bd1e6a410fa2c0d7c2f2a7bab1","type":"text","conversion_output":true,"text":"and/or total bilirubin (TB) \\(\\geq 1.2 \\times\\) ULN at Week -5 (Visit S1). If TB \\(\\geq 1.2 \\times\\) ULN, a","text_display":" and/or total bilirubin (TB) \\(\\geq 1.2 \\times\\) ULN at Week -5 (Visit S1). If TB \\(\\geq 1.2 \\times\\) ULN, a","confidence":0.8917891886185786,"confidence_rate":0.998728303625765},{"cnt":[[434,993],[1740,993],[1740,1042],[434,1042]],"region":{"top_left_x":433,"top_left_y":992,"width":1308,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e60d6ab3d22f42d68a9cafeaf0aa379e","type":"text","conversion_output":true,"text":"reflex indirect (unconjugated) bilirubin will be obtained and if consistent with","text_display":" reflex indirect (unconjugated) bilirubin will be obtained and if consistent with","confidence":1,"confidence_rate":1},{"cnt":[[434,1042],[1880,1042],[1880,1091],[434,1091]],"region":{"top_left_x":433,"top_left_y":1041,"width":1447,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64f51646ea4c4a628b568101bdf67c26","type":"text","conversion_output":true,"text":"Gilbert's disease or if the patient has a history of Gilbert's Disease, the patient may be","text_display":" Gilbert's disease or if the patient has a history of Gilbert's Disease, the patient may be","confidence":0.998535871389322,"confidence_rate":0.9999845769453121},{"cnt":[[434,1091],[793,1091],[793,1141],[434,1141]],"region":{"top_left_x":433,"top_left_y":1091,"width":360,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64ddb2ea516540c79fac69430fa69247","type":"text","conversion_output":true,"text":"enrolled in the study.","text_display":" enrolled in the study.","confidence":1,"confidence_rate":1},{"cnt":[[370,1160],[1809,1160],[1809,1210],[370,1210]],"region":{"top_left_x":369,"top_left_y":1160,"width":1440,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbfc34fad2b241458cd09403c9989796","type":"text","conversion_output":true,"text":"Note: At the discretion of the investigator, a single repeat of ALT and/or AST may be","text_display":"\n\nNote: At the discretion of the investigator, a single repeat of ALT and/or AST may be","confidence":1,"confidence_rate":1},{"cnt":[[370,1212],[1785,1212],[1785,1257],[370,1257]],"region":{"top_left_x":369,"top_left_y":1211,"width":1417,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"710046748d1a41c590f8148629ab601d","type":"text","conversion_output":true,"text":"completed prior to randomization. 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Hematologic or coagulation disorders or a hemoglobin (Hgb) level \\(<10.0 g / dL (100 g / L )\\)","text_display":"\n10. Hematologic or coagulation disorders or a hemoglobin (Hgb) level \\(<10.0 g / dL (100 g / L )\\)","confidence":0.7663909545602476,"confidence_rate":0.9973949397122648},{"cnt":[[370,1592],[735,1592],[735,1639],[370,1639]],"region":{"top_left_x":369,"top_left_y":1591,"width":366,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"668e588b263b4fc7bd9f761781641822","type":"text","conversion_output":true,"text":"at Week -5 (Visit S1)","text_display":" at Week -5 (Visit S1)","confidence":0.99365234375,"confidence_rate":0.999755111210052},{"cnt":[[309,1659],[1854,1659],[1854,1710],[309,1710]],"region":{"top_left_x":309,"top_left_y":1658,"width":1546,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9840876683f245828521b4560863aad8","type":"text","conversion_output":true,"text":"11. 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Unexplained creatine kinase (CK) \\(>3 \\times\\) ULN at screening up to randomization (ie, not","confidence":0.9829335138201714,"confidence_rate":0.9998168912652375},{"cnt":[[370,1876],[1717,1876],[1717,1927],[370,1927]],"region":{"top_left_x":369,"top_left_y":1875,"width":1348,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7d229fc91a544e9afbd596ac5f33f1f","type":"text","conversion_output":true,"text":"associated with recent trauma or physically strenuous activity). Patients with an","text_display":" associated with recent trauma or physically strenuous activity). Patients with an","confidence":1,"confidence_rate":1},{"cnt":[[370,1925],[1824,1925],[1824,1974],[370,1974]],"region":{"top_left_x":369,"top_left_y":1925,"width":1456,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1cfddbbfe0a4707a1882a4461a4e693","type":"text","conversion_output":true,"text":"explained CK elevation must have single repeat CK \\(\\leq 3 \\times\\) ULN prior to randomization.","text_display":" explained CK elevation must have single repeat CK \\(\\leq 3 \\times\\) ULN prior to randomization.","confidence":0.98388671875,"confidence_rate":0.9998174940519831},{"cnt":[[312,1994],[1858,1994],[1858,2043],[312,2043]],"region":{"top_left_x":311,"top_left_y":1993,"width":1548,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e68bfeafaae4c7da42636cbe0865e76","type":"text","conversion_output":true,"text":"13. 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Blood donation, blood transfusion for any reason, participation in a clinical study with","text_display":"\n14. 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To discontinue the patient from the","text_display":" NOT automatically discontinue the patient from the study. To discontinue the patient from the","confidence":1,"confidence_rate":1},{"cnt":[[245,1336],[1772,1336],[1772,1386],[245,1386]],"region":{"top_left_x":244,"top_left_y":1336,"width":1529,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51e8169614b34d5ea1c779e5c833e7ed","type":"text","conversion_output":true,"text":"study, the appropriate clinical site personnel will need to register the 'discontinuation' visit","text_display":" study, the appropriate clinical site personnel will need to register the 'discontinuation' visit","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,1388],[432,1388],[432,1433],[245,1433]],"region":{"top_left_x":244,"top_left_y":1387,"width":188,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45b2b74f869b440682c01972d431f5ba","type":"text","conversion_output":true,"text":"separately.","text_display":" separately.","confidence":1,"confidence_rate":1},{"cnt":[[245,1457],[1674,1457],[1674,1506],[245,1506]],"region":{"top_left_x":244,"top_left_y":1456,"width":1430,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb69705aa1b642d8bc2bf69fac459480","type":"text","conversion_output":true,"text":"Blinding of treatment must be maintained for all patients unless, in the opinion of the","text_display":"\n\nBlinding of treatment must be maintained for all patients unless, in the opinion of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1504],[1785,1504],[1785,1553],[245,1553]],"region":{"top_left_x":244,"top_left_y":1503,"width":1542,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bc6530ed27342fba1bd185bd3abc78b","type":"text","conversion_output":true,"text":"Investigator, the safety of the patient may be at risk. Only under the rarest of circumstances","text_display":" Investigator, the safety of the patient may be at risk. 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In the","confidence":1,"confidence_rate":1},{"cnt":[[245,1650],[1841,1650],[1841,1699],[245,1699]],"region":{"top_left_x":244,"top_left_y":1650,"width":1598,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20bc2249d3304bcfaae743f2a64dab9a","type":"text","conversion_output":true,"text":"event that the blind needs to be broken prior to completion of the study, the Investigator should","text_display":" event that the blind needs to be broken prior to completion of the study, the Investigator should","confidence":1,"confidence_rate":1},{"cnt":[[245,1697],[1772,1697],[1772,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1697,"width":1529,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7db77a186f8841e789149f8c7cea1dae","type":"text","conversion_output":true,"text":"contact the appropriate Medical Monitor by telephone. 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for individual laboratory measures for LDL-C, TG, TC, HDL-C,","confidence":1,"confidence_rate":1},{"cnt":[[245,2325],[1798,2325],[1798,2374],[245,2374]],"region":{"top_left_x":244,"top_left_y":2324,"width":1555,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfd514c4705f40fd9a77c79d3124da7e","type":"text","conversion_output":true,"text":"non-HDL, apoB, and hs-CRP, including any plasma concentration of bempedoic acid and its","text_display":" non-HDL, apoB, and hs-CRP, including any plasma concentration of bempedoic acid and its","confidence":1,"confidence_rate":1},{"cnt":[[245,2372],[1708,2372],[1708,2419],[245,2419]],"region":{"top_left_x":244,"top_left_y":2371,"width":1465,"height":49},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a817f4da9c104aa2adf2876bf14387e5","type":"text","conversion_output":true,"text":"metabolite that may inadvertently suggest treatment assignment will not be available 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IMP may be taken","text_display":" (once every 24 hours) at approximately the same time each day with water. IMP may be taken","confidence":1,"confidence_rate":1},{"cnt":[[247,1590],[1837,1590],[1837,1635],[247,1635]],"region":{"top_left_x":247,"top_left_y":1589,"width":1590,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9506cd183dfc4aa7b04f9825a1e43e2b","type":"text","conversion_output":true,"text":"with or without food. On clinic visit days, patients will be instructed to delay ingestion of IMP","text_display":" with or without food. On clinic visit days, patients will be instructed to delay ingestion of IMP","confidence":1,"confidence_rate":1},{"cnt":[[247,1637],[1835,1637],[1835,1687],[247,1687]],"region":{"top_left_x":247,"top_left_y":1637,"width":1588,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed73be6c185a46e0901ae8c41a2438f7","type":"text","conversion_output":true,"text":"until all study procedures have been completed. If a patient arrives at clinic on Visits T4 or T5","text_display":" until all study procedures have been completed. If a patient arrives at clinic on Visits T4 or T5","confidence":1,"confidence_rate":1},{"cnt":[[247,1687],[1876,1687],[1876,1734],[247,1734]],"region":{"top_left_x":247,"top_left_y":1686,"width":1629,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06256c04e50b473c8bc262514dc12d20","type":"text","conversion_output":true,"text":"or T7 without having fasted or having taken IMP before arriving at the clinic, reschedule the visit","text_display":" or T7 without having fasted or having taken IMP before arriving at the clinic, reschedule the visit","confidence":1,"confidence_rate":1},{"cnt":[[249,1736],[1841,1736],[1841,1781],[249,1781]],"region":{"top_left_x":249,"top_left_y":1735,"width":1593,"height":47},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41d23c491722485a9dad752c6bc64b72","type":"text","conversion_output":true,"text":"(the next day or as soon as possible) so that the fasting and dosing requirements have been met.","text_display":" (the next day or as soon as possible) so that the fasting and dosing requirements have been met.","confidence":1,"confidence_rate":1},{"cnt":[[247,1783],[1678,1783],[1678,1830],[247,1830]],"region":{"top_left_x":247,"top_left_y":1783,"width":1431,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b634207b4fcb4149924d7c309cb5bd3e","type":"text","conversion_output":true,"text":"Patients will be instructed to return all packaging and unused IMP at each clinic visit.","text_display":" Patients will be instructed to return all packaging and unused IMP at each clinic visit.","confidence":1,"confidence_rate":1},{"cnt":[[247,1852],[1841,1852],[1841,1901],[247,1901]],"region":{"top_left_x":247,"top_left_y":1851,"width":1595,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4994b3766a7445ac8da8059305465b88","type":"text","conversion_output":true,"text":"If the patient forgets to take IMP at the usual time on nonclinic visit days, it may be taken up to","text_display":"\n\nIf the patient forgets to take IMP at the usual time on nonclinic visit days, it may be taken up to","confidence":1,"confidence_rate":1},{"cnt":[[249,1901],[1867,1901],[1867,1949],[249,1949]],"region":{"top_left_x":249,"top_left_y":1901,"width":1618,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f437f39d1cf41ef8e0296e82e79b1dd","type":"text","conversion_output":true,"text":"12 hours later the same day. After that time, the patient should not take IMP that day and should","text_display":" 12 hours later the same day. After that time, the patient should not take IMP that day and should","confidence":1,"confidence_rate":1},{"cnt":[[245,1951],[1848,1951],[1848,1998],[245,1998]],"region":{"top_left_x":244,"top_left_y":1950,"width":1604,"height":49},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"001e141ce87e42008c3e689fc0c66620","type":"text","conversion_output":true,"text":"resume ingestion of IMP the following day. If a patient fails to take IMP, details describing the","text_display":" resume ingestion of IMP the following day. If a patient fails to take IMP, details describing the","confidence":1,"confidence_rate":1},{"cnt":[[245,1998],[1841,1998],[1841,2047],[245,2047]],"region":{"top_left_x":244,"top_left_y":1998,"width":1598,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a9d132a431f495d88ee80060709d70b","type":"text","conversion_output":true,"text":"reasons for nondosing should be documented in the patient's medical records and eCRF. Extra","text_display":" reasons for nondosing should be documented in the patient's medical records and eCRF. Extra","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[247,2047],[1841,2047],[1841,2095],[247,2095]],"region":{"top_left_x":247,"top_left_y":2047,"width":1595,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47a2231c3fa9486ba1410a28395d292e","type":"text","conversion_output":true,"text":"IMP (7 extra days per bottle) is provided and can be used, if needed, prior to the next visit or to","text_display":" IMP (7 extra days per bottle) is provided and can be used, if needed, prior to the next visit or to","confidence":0.99462890625,"confidence_rate":0.9999482170145101},{"cnt":[[245,2097],[1450,2097],[1450,2144],[245,2144]],"region":{"top_left_x":244,"top_left_y":2096,"width":1207,"height":49},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"746c476972b64e7c8d5db9c232b0b954","type":"text","conversion_output":true,"text":"replace a dose of IMP that cannot be used because it is lost or damaged.","text_display":" replace a dose of IMP that cannot be used because it is lost or damaged.","confidence":1,"confidence_rate":1},{"cnt":[[245,2582],[462,2582],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2582,"width":218,"height":37},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36a07071c37a442c823fec7d616f52ca","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[932,2582],[1192,2582],[1192,2628],[932,2628]],"region":{"top_left_x":932,"top_left_y":2582,"width":261,"height":46},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8d989c7da5744e3b076815b95c26d74","type":"page_info","conversion_output":false,"text":"Page 47 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-048","page":48,"lines":[{"cnt":[[245,129],[535,129],[535,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":291,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2eb7a1ed50b74a50aa423074a9fdfe11","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f220f136c934635a64ba2ce17194167","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,221],[245,221]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02502cf2d8604d939cd36fb5801319fc","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1876,176],[1876,221],[1388,221]],"region":{"top_left_x":1387,"top_left_y":176,"width":489,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"047d1d544df04e24adc64cc0c71b0afb","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[243,251],[1472,251],[1472,312],[243,312]],"region":{"top_left_x":242,"top_left_y":251,"width":1230,"height":61},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50e9b22c423f484896fe2c57c00ad3a7","type":"section_header","conversion_output":false,"children_ids":["e279c0a869ee4db794e9337c6b96192a"],"text":"","text_display":""},{"cnt":[[245,254],[1467,254],[1467,312],[245,312]],"region":{"top_left_x":244,"top_left_y":253,"width":1224,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e279c0a869ee4db794e9337c6b96192a","type":"text","conversion_output":true,"parent_id":"50e9b22c423f484896fe2c57c00ad3a7","text":"9.3. Investigational Medicinal Product Accountability","text_display":"\n\n\\subsection*{9.3. 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must be maintained.","confidence":1,"confidence_rate":1},{"cnt":[[245,460],[1790,460],[1790,509],[245,509]],"region":{"top_left_x":244,"top_left_y":459,"width":1546,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1599956fb02444b3b2081e41d55b190b","type":"text","conversion_output":true,"text":"IMP records or logs must comply with applicable regulations, local law, and guidelines, and","text_display":"\n\nIMP records or logs must comply with applicable regulations, local law, and guidelines, and","confidence":1,"confidence_rate":1},{"cnt":[[245,511],[509,511],[509,552],[245,552]],"region":{"top_left_x":244,"top_left_y":511,"width":266,"height":42},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb913665466549a3a179eb6351ffa42d","type":"text","conversion_output":true,"text":"should include:","text_display":" should 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Reason for withdrawal, date of the discontinuation, and date of the last","text_display":" should be completed. Reason for withdrawal, date of the discontinuation, and date of the last","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[245,812],[1850,812],[1850,859],[245,859]],"region":{"top_left_x":244,"top_left_y":812,"width":1606,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8f29744db8e49ef9b052c5033cdd841","type":"text","conversion_output":true,"text":"dose of study drug should be recorded in the appropriate section of the eCRF. Additionally, the","text_display":" dose of study drug should be recorded in the appropriate section of the eCRF. 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Accommodations for early or late visits in special circumstances will be considered","text_display":" the protocol. Accommodations for early or late visits in special circumstances will be considered","confidence":1,"confidence_rate":1},{"cnt":[[245,1074],[1729,1074],[1729,1124],[245,1124]],"region":{"top_left_x":244,"top_left_y":1074,"width":1486,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7ca0692303a4f15ba5e0eb8d7270817","type":"text","conversion_output":true,"text":"by the Sponsor to prevent early withdrawal. Written notice (regardless of cause) is to be","text_display":" by the Sponsor to prevent early withdrawal. Written notice (regardless of cause) is to be","confidence":1,"confidence_rate":1},{"cnt":[[245,1121],[1876,1121],[1876,1173],[245,1173]],"region":{"top_left_x":244,"top_left_y":1121,"width":1632,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13aad820026a47a189849893c2ddaa8e","type":"text","conversion_output":true,"text":"provided within 48 hours of the withdrawal to the Sponsor personnel or the Medical Monitor. At","text_display":" provided within 48 hours of the withdrawal to the Sponsor personnel or the Medical Monitor. At","confidence":1,"confidence_rate":1},{"cnt":[[245,1173],[1811,1173],[1811,1222],[245,1222]],"region":{"top_left_x":244,"top_left_y":1173,"width":1568,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"131e72ef8f3640cf8a8209fd43c486a1","type":"text","conversion_output":true,"text":"the time of discontinuation, every effort should be made to ensure all relevant procedures and","text_display":" the time of discontinuation, every effort should be made to ensure all relevant procedures and","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[245,1220],[1807,1220],[1807,1270],[245,1270]],"region":{"top_left_x":244,"top_left_y":1220,"width":1563,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c1fb6a0f7da4e5899394f060d4dece8","type":"text","conversion_output":true,"text":"evaluations scheduled for the final study visit are performed. Except in the case of a medical","text_display":" evaluations scheduled for the final study visit are performed. Except in the case of a medical","confidence":1,"confidence_rate":1},{"cnt":[[245,1268],[1841,1268],[1841,1317],[245,1317]],"region":{"top_left_x":244,"top_left_y":1267,"width":1598,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fc4737b5d97479493dcee76111315b6","type":"text","conversion_output":true,"text":"emergency, the procedures and assessments detailed in Section 10.2.10 will be performed upon","text_display":" emergency, the procedures and assessments detailed in Section 10.2.10 will be performed upon","confidence":1,"confidence_rate":1},{"cnt":[[245,1317],[788,1317],[788,1364],[245,1364]],"region":{"top_left_x":244,"top_left_y":1316,"width":545,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f59c5ce6c7245699ea91774b6a73e78","type":"text","conversion_output":true,"text":"the discontinuation of the study.","text_display":" the discontinuation of the study.","confidence":1,"confidence_rate":1},{"cnt":[[245,1388],[1841,1388],[1841,1437],[245,1437]],"region":{"top_left_x":244,"top_left_y":1387,"width":1598,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d93b655352c4bd286a5e26216525ae7","type":"text","conversion_output":true,"text":"Patients choosing to withdraw from the study early should be encouraged to return for all study","text_display":"\n\nPatients choosing to withdraw from the study early should be encouraged to return for all study","confidence":1,"confidence_rate":1},{"cnt":[[245,1435],[1798,1435],[1798,1485],[245,1485]],"region":{"top_left_x":244,"top_left_y":1435,"width":1555,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50fee686482747da8a6bd08b1041c7e1","type":"text","conversion_output":true,"text":"scheduled clinic visit even if they are no longer taking IMP. Patients who withdraw from all","text_display":" scheduled clinic visit even if they are no longer taking IMP. Patients who withdraw from all","confidence":1,"confidence_rate":1},{"cnt":[[245,1485],[1680,1485],[1680,1532],[245,1532]],"region":{"top_left_x":244,"top_left_y":1484,"width":1437,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0fd4ceda3014eaaa22808d514773a53","type":"text","conversion_output":true,"text":"aspects of the study will be asked to consent to clinical visits or phone calls for safety","text_display":" aspects of the study will be asked to consent to clinical visits or phone calls for safety","confidence":1,"confidence_rate":1},{"cnt":[[245,1532],[1863,1532],[1863,1581],[245,1581]],"region":{"top_left_x":244,"top_left_y":1531,"width":1619,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9481c2b8bf104ec5a4b23db0afe13038","type":"text","conversion_output":true,"text":"assessments, including AEs, concomitant medication, and current health status through Week 52","text_display":" assessments, including AEs, concomitant medication, and current health status through Week 52","confidence":1,"confidence_rate":1},{"cnt":[[245,1581],[428,1581],[428,1631],[245,1631]],"region":{"top_left_x":244,"top_left_y":1581,"width":184,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ccc5201a6024fef81957c33945753e9","type":"text","conversion_output":true,"text":"(Visit T7).","text_display":" (Visit T7).","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":41},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bfe277046684bd6a39280189e154a40","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[932,2580],[1188,2580],[1188,2628],[932,2628]],"region":{"top_left_x":932,"top_left_y":2580,"width":257,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92c7e001faa64ddaa13d70648b6d1f25","type":"page_info","conversion_output":false,"text":"Page 57 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-058","page":58,"lines":[{"cnt":[[245,127],[537,127],[537,174],[245,174]],"region":{"top_left_x":244,"top_left_y":126,"width":294,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53a7916b4e56478eac2badadf8b5d57b","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3e4db148f3c43b5a17d4d95b090f946","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,221],[245,221]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a70f8512292149f3b7d9f727ffab4c26","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,221],[1388,221]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3415aa3d639484488f39628c9bf9707","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[245,314],[1051,314],[1051,367],[245,367]],"region":{"top_left_x":244,"top_left_y":313,"width":807,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"442677c810a746b69c33271ba22924aa","type":"section_header","conversion_output":false,"children_ids":["6f3d9f783e38455bacc5bb9e15b071de"],"text":"","text_display":""},{"cnt":[[249,318],[1046,318],[1046,363],[249,363]],"region":{"top_left_x":249,"top_left_y":317,"width":798,"height":47},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f3d9f783e38455bacc5bb9e15b071de","type":"text","conversion_output":true,"parent_id":"442677c810a746b69c33271ba22924aa","text":"11. 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Safety Parameters}","confidence":0.99462890625,"confidence_rate":0.999807676713188},{"cnt":[[245,518],[1798,518],[1798,565],[245,565]],"region":{"top_left_x":244,"top_left_y":517,"width":1555,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d956cd9b57b45769463821fc0ee6176","type":"text","conversion_output":true,"text":"At all clinic visits, investigators will review all safety information including vital signs, AEs,","text_display":"\n\nAt all clinic visits, investigators will review all safety information including vital signs, AEs,","confidence":1,"confidence_rate":1},{"cnt":[[247,567],[1828,567],[1828,612],[247,612]],"region":{"top_left_x":247,"top_left_y":567,"width":1582,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0547bfe595b04710aaae2bae093bec28","type":"text","conversion_output":true,"text":"concomitant medications, and ECG reports and will ensure that the collected data are recorded","text_display":" concomitant medications, and ECG reports and will ensure that the collected data are recorded","confidence":1,"confidence_rate":1},{"cnt":[[247,614],[1833,614],[1833,664],[247,664]],"region":{"top_left_x":247,"top_left_y":614,"width":1586,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e06913f4b78414d9d9ed5c6e4a5422f","type":"text","conversion_output":true,"text":"into the appropriate eCRF. 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All surgeries","text_display":" start date (month and year) and whether the condition is ongoing or resolved. All surgeries","confidence":1,"confidence_rate":1},{"cnt":[[245,1031],[879,1031],[879,1076],[245,1076]],"region":{"top_left_x":244,"top_left_y":1031,"width":635,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"272b0834214c4741a23bb136711f6ee1","type":"text","conversion_output":true,"text":"regardless of date should be reported.","text_display":" regardless of date should be reported.","confidence":1,"confidence_rate":1},{"cnt":[[245,1117],[638,1117],[638,1171],[245,1171]],"region":{"top_left_x":244,"top_left_y":1117,"width":395,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbaed5ac35254f77a988e488ea8a65e1","type":"section_header","conversion_output":false,"children_ids":["5d6e8e86ff41424fa0d656a64c6ea066"],"text":"","text_display":""},{"cnt":[[249,1121],[634,1121],[634,1167],[249,1167]],"region":{"top_left_x":249,"top_left_y":1121,"width":385,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d6e8e86ff41424fa0d656a64c6ea066","type":"text","conversion_output":true,"parent_id":"cbaed5ac35254f77a988e488ea8a65e1","text":"11.1.2. 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Additional clinical and laboratory information will be collected and carefully","confidence":1,"confidence_rate":1},{"cnt":[[245,2286],[1848,2286],[1848,2331],[245,2331]],"region":{"top_left_x":244,"top_left_y":2285,"width":1604,"height":47},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82f2d912ea3943e793f99ee673abe1d0","type":"text","conversion_output":true,"text":"documented in order to better characterize the ECG abnormality and rule out alternative causes.","text_display":" documented in order to better characterize the ECG abnormality and rule out alternative causes.","confidence":1,"confidence_rate":1},{"cnt":[[245,2333],[1843,2333],[1843,2383],[245,2383]],"region":{"top_left_x":244,"top_left_y":2333,"width":1600,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6164fe150bca4da89799293dbb301ac4","type":"text","conversion_output":true,"text":"ECG findings determined to be a clinically significant change from baseline should be reported","text_display":" ECG findings determined to be a clinically significant change from baseline should be reported","confidence":0.99609375,"confidence_rate":0.9999604664448944},{"cnt":[[245,2380],[797,2380],[797,2430],[245,2430]],"region":{"top_left_x":244,"top_left_y":2380,"width":554,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7502c93197748bb8e57df553b89cae7","type":"text","conversion_output":true,"text":"as an AE regardless of causality.","text_display":" as an AE regardless of causality.","confidence":0.81298828125,"confidence_rate":0.9945664317410641},{"cnt":[[245,2451],[1687,2451],[1687,2499],[245,2499]],"region":{"top_left_x":244,"top_left_y":2451,"width":1443,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba43315201f24267a1d291e6db5c1bfa","type":"text","conversion_output":true,"text":"Unscheduled ECG assessments will be completed at the 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Collection schedule, schedule of laboratory","text_display":" and tests will include those listed in Table 5. Collection schedule, schedule of laboratory","confidence":1,"confidence_rate":1},{"cnt":[[245,533],[1841,533],[1841,582],[245,582]],"region":{"top_left_x":244,"top_left_y":532,"width":1598,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb5605ad7b7c4587b32960c7e34fd27f","type":"text","conversion_output":true,"text":"parameters by visit, and instructions are in the Clinical Laboratory Manual provided by Central","text_display":" parameters by visit, and instructions are in the Clinical Laboratory Manual provided by Central","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,580],[449,580],[449,629],[245,629]],"region":{"top_left_x":244,"top_left_y":580,"width":206,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"702afa3ae50c45199dd1a047eb2d0d3e","type":"text","conversion_output":true,"text":"Laboratory.","text_display":" 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Clinical Laboratory Test \\\\\n\\hline \\begin{tabular}{l}\nHematology \\\\\n- Hematocrit (Hct) \\\\\n- Hemoglobin (Hgb) \\\\\n- Mean corpuscular hemoglobin (MCH) \\\\\n- Mean corpuscular hemoglobin concentration (MCHC) \\\\\n- Mean corpuscular volume (MCV) \\\\\n- Platelet count \\\\\n- Red blood (RBC) cell count \\\\\n- White blood (WBC) cell count with differential (absolute and \\%)\n\\end{tabular} & \\begin{tabular}{l}\nBlood Chemistry (serum, fasting) \\\\\n- Albumin (Alb) \\\\\n- Alkaline phosphatase (ALK-P) \\\\\n- Alanine aminotransferase (ALT; SGPT) \\\\\n- Aspartate aminotransferase (AST; SGOT) \\\\\n- Blood urea nitrogen (BUN) \\\\\n- Calcium (Ca) \\\\\n- Carbon dioxide ( \\(CO _{2}\\) ) \\\\\n- Chloride (Cl) \\\\\n- Creatinine \\\\\n- Creatine kinase (CK) \\\\\n- Glucose \\\\\n- Lactate dehydrogenase (LDH) \\\\\n- Phosphorus \\\\\n- Potassium (K) \\\\\n- Sodium (Na) \\\\\n- Total and direct bilirubin (TB) \\({ }^{ a }\\) \\\\\n- Total protein \\\\\n- Uric 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for management of the abnormality is required","confidence":1,"confidence_rate":1},{"cnt":[[372,851],[1772,851],[1772,900],[372,900]],"region":{"top_left_x":371,"top_left_y":850,"width":1402,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8aa43daa9fe14db0849d4d4af389bc35","type":"text","conversion_output":true,"text":"- at the discretion of the investigator should the abnormality be deemed clinically","text_display":"\n- at the discretion of the investigator should the abnormality be deemed clinically","confidence":1,"confidence_rate":1},{"cnt":[[434,900],[617,900],[617,947],[434,947]],"region":{"top_left_x":433,"top_left_y":900,"width":184,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bbaa848a9ae47e38c10fd11a63d2a39","type":"text","conversion_output":true,"text":"significant","text_display":" significant","confidence":1,"confidence_rate":1},{"cnt":[[245,967],[1755,967],[1755,1016],[245,1016]],"region":{"top_left_x":244,"top_left_y":966,"width":1512,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4ded4c7ab4a4fb6a02730afde782665","type":"text","conversion_output":true,"text":"All clinically significant laboratory abnormalities occurring during the study that were not","text_display":"\n\nAll clinically significant laboratory abnormalities occurring during the study that were not","confidence":1,"confidence_rate":1},{"cnt":[[245,1018],[1783,1018],[1783,1068],[245,1068]],"region":{"top_left_x":244,"top_left_y":1018,"width":1540,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1a2115e0be84ef0965e91f7dc1255a5","type":"text","conversion_output":true,"text":"present at baseline should be followed and evaluated with additional tests if necessary, until","text_display":" present at baseline should be followed and evaluated with additional tests if necessary, until","confidence":1,"confidence_rate":1},{"cnt":[[245,1066],[1871,1066],[1871,1115],[245,1115]],"region":{"top_left_x":244,"top_left_y":1065,"width":1628,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6626d6c04da043d69506ab92322e394d","type":"text","conversion_output":true,"text":"diagnosis of the underlying cause or resolution. Specific monitoring and management guidelines","text_display":" diagnosis of the underlying cause or resolution. Specific monitoring and management guidelines","confidence":1,"confidence_rate":1},{"cnt":[[245,1113],[1394,1113],[1394,1162],[245,1162]],"region":{"top_left_x":244,"top_left_y":1112,"width":1151,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03b12f3a65a54e209b800f7721956d00","type":"text","conversion_output":true,"text":"for laboratories of special interest are outlined in the sections below.","text_display":" for laboratories of special interest are outlined in the sections below.","confidence":0.99658203125,"confidence_rate":0.9999555357502582},{"cnt":[[245,1199],[1562,1199],[1562,1257],[245,1257]],"region":{"top_left_x":244,"top_left_y":1198,"width":1318,"height":59},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a97d346fa7644b0a359697de4fca89d","type":"section_header","conversion_output":false,"children_ids":["3ccff738607f483297d97ccd565c7805"],"text":"","text_display":""},{"cnt":[[249,1203],[1558,1203],[1558,1253],[249,1253]],"region":{"top_left_x":249,"top_left_y":1203,"width":1309,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ccff738607f483297d97ccd565c7805","type":"text","conversion_output":true,"parent_id":"9a97d346fa7644b0a359697de4fca89d","text":"11.1.6.3.1. Monitoring and Management of Elevated Liver Function Tests","text_display":"\n\n\\subsection*{11.1.6.3.1. Monitoring and Management of Elevated Liver Function Tests}","confidence":0.71875,"confidence_rate":0.9956064574796468},{"cnt":[[245,1285],[1837,1285],[1837,1334],[245,1334]],"region":{"top_left_x":244,"top_left_y":1284,"width":1593,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f321ec0a8794e6384671c9d806800ef","type":"text","conversion_output":true,"text":"If at any time after randomization a patient experiences a new ALT and/or AST \\(>3 \\times\\) ULN, the","text_display":"\n\nIf at any time after randomization a patient experiences a new ALT and/or AST \\(>3 \\times\\) ULN, the","confidence":0.97021484375,"confidence_rate":0.9996914991920045},{"cnt":[[245,1334],[1760,1334],[1760,1384],[245,1384]],"region":{"top_left_x":244,"top_left_y":1334,"width":1516,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f516698bf38e490c877c25d8e5c22920","type":"text","conversion_output":true,"text":"patient will undergo repeat confirmatory liver function test (LFT) assessment as soon as is","text_display":" patient will undergo repeat confirmatory liver function test (LFT) assessment as soon as is","confidence":1,"confidence_rate":1},{"cnt":[[245,1384],[1815,1384],[1815,1431],[245,1431]],"region":{"top_left_x":244,"top_left_y":1383,"width":1572,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e236af9de0c146a5af64e62115b50ff0","type":"text","conversion_output":true,"text":"reasonably possible, preferably within 3 to 7 days of the laboratory result becoming available.","text_display":" reasonably possible, preferably within 3 to 7 days of the laboratory result becoming available.","confidence":1,"confidence_rate":1},{"cnt":[[245,1452],[1854,1452],[1854,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1452,"width":1611,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c5cde2636ea493f87b7d332570b59ca","type":"text","conversion_output":true,"text":"Repeat LFT assessment will include: 1) measurement of ALT, AST, alkaline phosphatase, total","text_display":"\n\nRepeat LFT assessment will include: 1) measurement of ALT, AST, alkaline phosphatase, total","confidence":1,"confidence_rate":1},{"cnt":[[245,1500],[1783,1500],[1783,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1499,"width":1540,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49b89207d58046ab8e71ad4783b76487","type":"text","conversion_output":true,"text":"and direct bilirubin, prothrombin time (PT)/international normalized ratio (INR), eosinophil","text_display":" and direct bilirubin, prothrombin time (PT)/international normalized ratio (INR), eosinophil","confidence":1,"confidence_rate":1},{"cnt":[[245,1549],[1850,1549],[1850,1596],[245,1596]],"region":{"top_left_x":244,"top_left_y":1549,"width":1606,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70db8bf75ea54877bc93b2d3729d90f9","type":"text","conversion_output":true,"text":"count, CK, antihepatitis A virus (total), HBsAg (confirmation of screening measurement), HCV","text_display":" count, CK, antihepatitis A virus (total), HBsAg (confirmation of screening measurement), HCV","confidence":0.9834458513651043,"confidence_rate":0.9998279251184843},{"cnt":[[245,1598],[1738,1598],[1738,1646],[245,1646]],"region":{"top_left_x":244,"top_left_y":1598,"width":1495,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4927954e2bcb4be38ab0538062e68bc8","type":"text","conversion_output":true,"text":"(confirmation of screening measurement), and anti-cytomegalovirus/immunoglobulin M;","text_display":" (confirmation of screening measurement), and anti-cytomegalovirus/immunoglobulin M;","confidence":0.99658203125,"confidence_rate":0.9999610936733531},{"cnt":[[245,1646],[1781,1646],[1781,1695],[245,1695]],"region":{"top_left_x":244,"top_left_y":1645,"width":1538,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec3c36f04588492baac2415ac7e8f667","type":"text","conversion_output":true,"text":"2) history of concomitant medication use; 3) history of exposure to environmental chemical","text_display":" 2) history of concomitant medication use; 3) history of exposure to environmental chemical","confidence":0.9795019626617432,"confidence_rate":0.9997820128378004},{"cnt":[[245,1697],[1854,1697],[1854,1745],[245,1745]],"region":{"top_left_x":244,"top_left_y":1697,"width":1611,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21c5cea6e4724c6ea02b9fe42e21cb40","type":"text","conversion_output":true,"text":"agents, including ethanol; and 4) query for related symptoms. 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acidosis","confidence":1,"confidence_rate":1},{"cnt":[[434,1470],[1519,1470],[1519,1517],[434,1517]],"region":{"top_left_x":433,"top_left_y":1469,"width":1086,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80c3aac115574cc0bee5dec4917abf23","type":"text","conversion_output":true,"text":"- Follow symptoms and CK until the abnormality has resolved","text_display":"\n- Follow symptoms and CK until the abnormality has resolved","confidence":1,"confidence_rate":1},{"cnt":[[434,1540],[1704,1540],[1704,1588],[434,1588]],"region":{"top_left_x":433,"top_left_y":1540,"width":1271,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f5f6774649144beb9b4271c6d8fb5f1","type":"text","conversion_output":true,"text":"- If based on the above evaluation an alternative explanation is suspected,","text_display":"\n- If based on the above evaluation an alternative explanation is suspected,","confidence":1,"confidence_rate":1},{"cnt":[[494,1590],[1824,1590],[1824,1635],[494,1635]],"region":{"top_left_x":494,"top_left_y":1589,"width":1331,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62518d0a70d349b183dda068ea899964","type":"text","conversion_output":true,"text":"consideration can be given to resuming IMP once CK returns to baseline levels","text_display":" consideration can be given to resuming IMP once CK returns to baseline levels","confidence":1,"confidence_rate":1},{"cnt":[[434,1661],[1863,1661],[1863,1708],[434,1708]],"region":{"top_left_x":433,"top_left_y":1660,"width":1430,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77d12aacc1a74cca92361f090ac2023c","type":"text","conversion_output":true,"text":"- If no alternative explanation exists, consideration should be given to withdrawing","text_display":"\n- If no alternative explanation exists, consideration 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recent","confidence":1,"confidence_rate":1},{"cnt":[[432,1830],[1837,1830],[1837,1878],[432,1878]],"region":{"top_left_x":431,"top_left_y":1830,"width":1406,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb3d43ce39bd46228b267071d051248f","type":"text","conversion_output":true,"text":"trauma or physically strenuous activity) CK abnormality as listed below, the patient","text_display":" trauma or physically strenuous activity) CK abnormality as listed below, the patient","confidence":1,"confidence_rate":1},{"cnt":[[434,1878],[1485,1878],[1485,1927],[434,1927]],"region":{"top_left_x":433,"top_left_y":1877,"width":1052,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a153cfcd1e64a6a951b09eacd2fc301","type":"text","conversion_output":true,"text":"should be withdrawn and given no further doses of study drug:","text_display":" should be withdrawn and given no further doses of study 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evaluations as outlined","confidence":1,"confidence_rate":1},{"cnt":[[494,2071],[612,2071],[612,2112],[494,2112]],"region":{"top_left_x":494,"top_left_y":2071,"width":119,"height":41},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dec94134d4143e9a8a55284d70a8821","type":"text","conversion_output":true,"text":"above.","text_display":" above.","confidence":1,"confidence_rate":1},{"cnt":[[372,2144],[1738,2144],[1738,2189],[372,2189]],"region":{"top_left_x":371,"top_left_y":2144,"width":1368,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0eb50022db714ab0a91d24d10fbfff2b","type":"text","conversion_output":true,"text":"- If the patient is withdrawn from IMP treatment, the patient should be asked to","text_display":"\n- If the patient is withdrawn from IMP treatment, the patient should be asked to","confidence":1,"confidence_rate":1},{"cnt":[[434,2191],[1807,2191],[1807,2239],[434,2239]],"region":{"top_left_x":433,"top_left_y":2191,"width":1374,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc423f38f7a34a29837f147b25a94f39","type":"text","conversion_output":true,"text":"continue being followed for safety using the protocol-specified visit schedule (see","text_display":" continue being followed for safety using the protocol-specified visit schedule (see","confidence":1,"confidence_rate":1},{"cnt":[[434,2239],[660,2239],[660,2288],[434,2288]],"region":{"top_left_x":433,"top_left_y":2238,"width":227,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c1c120ff3fe49ffa9e9a778ae523cb2","type":"text","conversion_output":true,"text":"Appendix 1).","text_display":" Appendix 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Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,221],[245,221]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e51a034be37e45e5bc239faa924a4210","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1876,176],[1876,221],[1388,221]],"region":{"top_left_x":1387,"top_left_y":176,"width":489,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09962cb8c00b4fd68047a4cd51825f02","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[245,249],[1876,249],[1876,305],[245,305]],"region":{"top_left_x":244,"top_left_y":249,"width":1632,"height":57},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d98076b1785a4a64a531ca7908aa9288","type":"section_header","conversion_output":false,"children_ids":["3cc9e7d58d6648a090cbf756fafaad0a"],"text":"","text_display":""},{"cnt":[[247,254],[1871,254],[1871,303],[247,303]],"region":{"top_left_x":247,"top_left_y":253,"width":1625,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cc9e7d58d6648a090cbf756fafaad0a","type":"text","conversion_output":true,"parent_id":"d98076b1785a4a64a531ca7908aa9288","text":"11.1.6.4. 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For each occurrence of patient-reported signs and","text_display":" with hypoglycemia to the investigator. For each occurrence of patient-reported signs and","confidence":1,"confidence_rate":1},{"cnt":[[245,597],[1846,597],[1846,645],[245,645]],"region":{"top_left_x":244,"top_left_y":597,"width":1602,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b462fc2b92c74d0cabdb0be7037a153b","type":"text","conversion_output":true,"text":"symptoms associated with hypoglycemia, the investigator will discuss these symptoms with the","text_display":" symptoms associated with hypoglycemia, the investigator will discuss these symptoms with the","confidence":1,"confidence_rate":1},{"cnt":[[245,649],[1815,649],[1815,694],[245,694]],"region":{"top_left_x":244,"top_left_y":648,"width":1572,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c38176123a241cea16f0eea873f2b00","type":"text","conversion_output":true,"text":"patient and assess whether they are attributable to hypoglycemia or to another potential cause.","text_display":" patient and assess whether they are attributable to hypoglycemia or to another potential cause.","confidence":1,"confidence_rate":1},{"cnt":[[245,696],[1725,696],[1725,741],[245,741]],"region":{"top_left_x":244,"top_left_y":696,"width":1482,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d22046b3818490683dda696f23dc709","type":"text","conversion_output":true,"text":"All investigator-confirmed occurrences of hypoglycemia will be recorded as an AE. All","text_display":" All investigator-confirmed occurrences of hypoglycemia will be recorded as an AE. All","confidence":1,"confidence_rate":1},{"cnt":[[245,743],[1837,743],[1837,793],[245,793]],"region":{"top_left_x":244,"top_left_y":743,"width":1593,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3879742d6566477e8f4d073e93e8bb3e","type":"text","conversion_output":true,"text":"occurrences of signs and symptoms that are not confirmed by the investigator to be attributable","text_display":" occurrences of signs and symptoms that are not confirmed by the investigator to be attributable","confidence":0.9951193332672119,"confidence_rate":0.9999510750360345},{"cnt":[[245,795],[1343,795],[1343,840],[245,840]],"region":{"top_left_x":244,"top_left_y":794,"width":1099,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29d544a888c4442281c36f0fd9dde986","type":"text","conversion_output":true,"text":"to hypoglycemia will be reported using the appropriate diagnosis.","text_display":" to hypoglycemia will be reported using the appropriate diagnosis.","confidence":1,"confidence_rate":1},{"cnt":[[245,862],[1858,862],[1858,909],[245,909]],"region":{"top_left_x":244,"top_left_y":861,"width":1615,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05a35eabe3ba4212bfa722218cc21c6a","type":"text","conversion_output":true,"text":"Clinical laboratories will be assessed to determine any signs of anion gap metabolic acidosis. 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If","confidence":1,"confidence_rate":1},{"cnt":[[247,911],[1790,911],[1790,956],[247,956]],"region":{"top_left_x":247,"top_left_y":910,"width":1543,"height":47},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3b319fd44514a4d80a0afc47b584f2c","type":"text","conversion_output":true,"text":"laboratories are consistent with metabolic acidosis, immediate follow up with the patient for","text_display":" laboratories are consistent with metabolic acidosis, immediate follow up with the patient for","confidence":1,"confidence_rate":1},{"cnt":[[245,958],[1824,958],[1824,1008],[245,1008]],"region":{"top_left_x":244,"top_left_y":958,"width":1581,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9229f03bfa2c4341ac827087f2218a1c","type":"text","conversion_output":true,"text":"further medical evaluation of the acidosis will occur. 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Post-randomization, LDL-C results will be masked to","text_display":"defined LDL-C threshold criteria. Post-randomization, LDL-C results will be masked to","confidence":1,"confidence_rate":1},{"cnt":[[247,1229],[1833,1229],[1833,1274],[247,1274]],"region":{"top_left_x":247,"top_left_y":1228,"width":1586,"height":47},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7ddd9b344d34146a1cd056f807b605e","type":"text","conversion_output":true,"text":"investigators in order to maintain the blind; however, the following thresholds have been set to","text_display":" investigators in order to maintain the blind; however, the following thresholds have been set to","confidence":1,"confidence_rate":1},{"cnt":[[245,1276],[1837,1276],[1837,1323],[245,1323]],"region":{"top_left_x":244,"top_left_y":1276,"width":1593,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17855bef9d9e42a5a436adcb16a2d774","type":"text","conversion_output":true,"text":"notify investigators and provide an opportunity to adjust the patient's standard 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The patient's LDL-C will be re-","text_display":" \\(\\geq 40 mg\\) /day and the fibrate, gemfibrozil. 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For each AE, the following information will be recorded:","text_display":" investigational drug. 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single cause should be reported as a single","confidence":1,"confidence_rate":1},{"cnt":[[245,374],[1682,374],[1682,423],[245,423]],"region":{"top_left_x":244,"top_left_y":373,"width":1439,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de7ab6066446411190d92bef7ca5e5b9","type":"text","conversion_output":true,"text":"AE (eg, fever, elevated WBC, cough, abnormal chest x-ray, etc, can all be reported as","text_display":" AE (eg, fever, elevated WBC, cough, abnormal chest x-ray, etc, can all be reported as","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[245,421],[496,421],[496,471],[245,471]],"region":{"top_left_x":244,"top_left_y":421,"width":253,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4e283465c7a4bbdaaf4fa7adc5dd78f","type":"text","conversion_output":true,"text":"\"pneumonia\").","text_display":" 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The question of","text_display":" treatment in order that he/she may judge the true nature and severity of the AE. 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Typically, the event should resolve when the study","text_display":" no other more probable cause. Typically, the event should resolve when the study","confidence":1,"confidence_rate":1},{"cnt":[[434,352],[1222,352],[1222,402],[434,402]],"region":{"top_left_x":433,"top_left_y":352,"width":790,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bb7d5b174f044fd8f0f0dc1491ee62b","type":"text","conversion_output":true,"text":"drug is discontinued and recur on re-challenge.","text_display":" drug is discontinued and recur on re-challenge.","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1248,443],[1248,494],[245,494]],"region":{"top_left_x":244,"top_left_y":442,"width":1005,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"501d52ad488c4d44b5f6d539a358102b","type":"section_header","conversion_output":false,"children_ids":["8e1fd0ff109d4178938c86eafd36b130"],"text":"","text_display":""},{"cnt":[[249,443],[1244,443],[1244,492],[249,492]],"region":{"top_left_x":249,"top_left_y":442,"width":995,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e1fd0ff109d4178938c86eafd36b130","type":"text","conversion_output":true,"parent_id":"501d52ad488c4d44b5f6d539a358102b","text":"11.2.6. Monitoring and Follow-up of Adverse Events","text_display":"\n\n\\subsection*{11.2.6. Monitoring and Follow-up of Adverse Events}","confidence":0.8310546875,"confidence_rate":0.9966409329310494},{"cnt":[[245,524],[1865,524],[1865,571],[245,571]],"region":{"top_left_x":244,"top_left_y":524,"width":1621,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d5d636a63ca415bb307c49e5ebf0ac3","type":"text","conversion_output":true,"text":"Patients having AEs will be monitored with relevant clinical assessments and laboratory tests, as","text_display":"\n\nPatients having AEs will be monitored with relevant clinical assessments and laboratory tests, as","confidence":1,"confidence_rate":1},{"cnt":[[245,574],[1867,574],[1867,621],[245,621]],"region":{"top_left_x":244,"top_left_y":573,"width":1623,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0368d5fa66fc49088cd0cfbe53f16454","type":"text","conversion_output":true,"text":"determined by the Investigator. All follow-up results are to be reported to the Sponsor personnel","text_display":" determined by the Investigator. All follow-up results are to be reported to the Sponsor personnel","confidence":1,"confidence_rate":1},{"cnt":[[245,623],[1820,623],[1820,668],[245,668]],"region":{"top_left_x":244,"top_left_y":623,"width":1576,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33feb666fab74944a8b48814c43dcd8a","type":"text","conversion_output":true,"text":"or the authorized Medical Monitor. Any actions taken and follow up results must be recorded","text_display":" or the authorized Medical Monitor. Any actions taken and follow up results must be recorded","confidence":1,"confidence_rate":1},{"cnt":[[245,670],[1837,670],[1837,718],[245,718]],"region":{"top_left_x":244,"top_left_y":670,"width":1593,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71b3d185d2a34bfc8a242ef827a2046a","type":"text","conversion_output":true,"text":"either on the appropriate page of the eCRF or in appropriate follow-up written correspondence,","text_display":" either on the appropriate page of the eCRF or in appropriate follow-up written correspondence,","confidence":1,"confidence_rate":1},{"cnt":[[245,718],[1815,718],[1815,767],[245,767]],"region":{"top_left_x":244,"top_left_y":717,"width":1572,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82384b114cda4a2db9981117b09420ae","type":"text","conversion_output":true,"text":"as well as in the patient's source documentation. Follow-up laboratory results should be filed","text_display":" as well as in the patient's source documentation. Follow-up laboratory results should be filed","confidence":1,"confidence_rate":1},{"cnt":[[245,769],[930,769],[930,814],[245,814]],"region":{"top_left_x":244,"top_left_y":769,"width":687,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c5981bd0ae54fccaa9db4255cac4cd0","type":"text","conversion_output":true,"text":"with the patient's source documentation.","text_display":" with the patient's source documentation.","confidence":1,"confidence_rate":1},{"cnt":[[245,838],[1689,838],[1689,883],[245,883]],"region":{"top_left_x":244,"top_left_y":837,"width":1445,"height":47},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e44d8d55e7c4911a8a8c65cf93c7a52","type":"text","conversion_output":true,"text":"For all AEs that require the patient to be discontinued from the study, relevant clinical","text_display":"\n\nFor all AEs that require the patient to be discontinued from the study, relevant clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,885],[1841,885],[1841,932],[245,932]],"region":{"top_left_x":244,"top_left_y":885,"width":1598,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01e756b7a57140e6ade7e17c551ad4a1","type":"text","conversion_output":true,"text":"assessments and laboratory tests must be repeated at appropriate intervals until final resolution,","text_display":" assessments and laboratory tests must be repeated at appropriate intervals until final resolution,","confidence":1,"confidence_rate":1},{"cnt":[[245,932],[1493,932],[1493,982],[245,982]],"region":{"top_left_x":244,"top_left_y":932,"width":1250,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ef9f4c378f54e2d83af9101c08ea7e0","type":"text","conversion_output":true,"text":"stabilization of the event(s), or until the patient is lost to follow-up or dies.","text_display":" stabilization of the event(s), or until the patient is lost to follow-up or dies.","confidence":1,"confidence_rate":1},{"cnt":[[245,1001],[1815,1001],[1815,1051],[245,1051]],"region":{"top_left_x":244,"top_left_y":1001,"width":1572,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02bfd8f4e1864e15900f899e6444b304","type":"text","conversion_output":true,"text":"Patients with AEs that are ongoing at study completion or study withdrawal must be followed","text_display":"\n\nPatients with AEs that are ongoing at study completion or study withdrawal must be followed","confidence":1,"confidence_rate":1},{"cnt":[[245,1053],[1858,1053],[1858,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1052,"width":1615,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0d46ddabdb944ebbfeb532b8c4ab6a0","type":"text","conversion_output":true,"text":"until resolution or for 30 days after the last study visit, whichever comes first (see Section 11.3).","text_display":" until resolution or for 30 days after the last study visit, whichever comes first (see Section 11.3).","confidence":0.99853515625,"confidence_rate":0.9999865513043565},{"cnt":[[243,1139],[1111,1139],[1111,1192],[243,1192]],"region":{"top_left_x":242,"top_left_y":1138,"width":869,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c83c66cc0fb4a9dbf91d42760aea60e","type":"section_header","conversion_output":false,"children_ids":["c609d32d3ce44ce6b32dfc96dcaeea4e"],"text":"","text_display":""},{"cnt":[[249,1143],[1106,1143],[1106,1188],[249,1188]],"region":{"top_left_x":249,"top_left_y":1142,"width":858,"height":47},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c609d32d3ce44ce6b32dfc96dcaeea4e","type":"text","conversion_output":true,"parent_id":"9c83c66cc0fb4a9dbf91d42760aea60e","text":"11.2.7. Treatment-Emergent Adverse Events","text_display":"\n\n\\subsection*{11.2.7. Treatment-Emergent Adverse Events}","confidence":0.88720703125,"confidence_rate":0.9974017092905554},{"cnt":[[245,1222],[1588,1222],[1588,1274],[245,1274]],"region":{"top_left_x":244,"top_left_y":1222,"width":1344,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b95a2e2fce184e51b56f7f5388309bd5","type":"text","conversion_output":true,"text":"TEAE are defined as AEs that begin or worsen after the first dose of study drug.","text_display":"\n\nTEAE are defined as AEs that begin or worsen after the first dose of study drug.","confidence":1,"confidence_rate":1},{"cnt":[[243,1311],[1081,1311],[1081,1360],[243,1360]],"region":{"top_left_x":242,"top_left_y":1310,"width":839,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6dfac68889ac411b97a45b1f9f1e6733","type":"section_header","conversion_output":false,"children_ids":["39c52e7519934f82aca2d3972feb160c"],"text":"","text_display":""},{"cnt":[[249,1315],[1076,1315],[1076,1354],[249,1354]],"region":{"top_left_x":249,"top_left_y":1314,"width":828,"height":40},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39c52e7519934f82aca2d3972feb160c","type":"text","conversion_output":true,"parent_id":"6dfac68889ac411b97a45b1f9f1e6733","text":"11.2.7.1. Definition of Serious Adverse Event","text_display":"\n\n\\subsection*{11.2.7.1. Definition of Serious Adverse Event}","confidence":0.9951171875,"confidence_rate":0.9999021093440684},{"cnt":[[245,1394],[1704,1394],[1704,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1394,"width":1460,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"581cd6f68497449b96c8f9d56fc36804","type":"text","conversion_output":true,"text":"An SAE is defined as any AE occurring at any dose that results in any of the following","text_display":"\n\nAn SAE is defined as any AE occurring at any dose that results in any of the following","confidence":1,"confidence_rate":1},{"cnt":[[245,1448],[423,1448],[423,1485],[245,1485]],"region":{"top_left_x":244,"top_left_y":1448,"width":180,"height":37},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b41e1f3420d64402814cc220cb7aa8b0","type":"text","conversion_output":true,"text":"outcomes:","text_display":" outcomes:","confidence":1,"confidence_rate":1},{"cnt":[[357,1517],[690,1517],[690,1558],[357,1558]],"region":{"top_left_x":356,"top_left_y":1516,"width":334,"height":42},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df8ed3e98dd24d0584227c79329050f6","type":"text","conversion_output":true,"text":"- Results in death","text_display":"\n- Results in death","confidence":1,"confidence_rate":1},{"cnt":[[357,1586],[720,1586],[720,1635],[357,1635]],"region":{"top_left_x":356,"top_left_y":1585,"width":364,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"579bf8da42994b9c8e5311becf4f1054","type":"text","conversion_output":true,"text":"- Is life threatening","text_display":"\n- Is life threatening","confidence":1,"confidence_rate":1},{"cnt":[[357,1659],[1712,1659],[1712,1708],[357,1708]],"region":{"top_left_x":356,"top_left_y":1658,"width":1357,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b6bd5b912534452ad87e7de33d16107","type":"text","conversion_output":true,"text":"- Requires in-patient hospitalization or prolongation of existing hospitalization","text_display":"\n- Requires in-patient hospitalization or prolongation of existing hospitalization","confidence":1,"confidence_rate":1},{"cnt":[[357,1727],[1871,1727],[1871,1777],[357,1777]],"region":{"top_left_x":356,"top_left_y":1727,"width":1516,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49676ecf88014913afb1cd5bd3c59d4c","type":"text","conversion_output":true,"text":"- Results in persistent or significant disability/incapacity, or substantial disruption of the","text_display":"\n- Results in persistent or significant disability/incapacity, or substantial disruption of the","confidence":1,"confidence_rate":1},{"cnt":[[417,1779],[1076,1779],[1076,1824],[417,1824]],"region":{"top_left_x":416,"top_left_y":1778,"width":661,"height":47},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a661b73b042b42f78f52e6b161cc6515","type":"text","conversion_output":true,"text":"ability to conduct normal life functions","text_display":" ability to conduct normal life functions","confidence":1,"confidence_rate":1},{"cnt":[[357,1848],[1025,1848],[1025,1897],[357,1897]],"region":{"top_left_x":356,"top_left_y":1847,"width":669,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"913a15a8a6af45fd8fb10c8fccbe02a4","type":"text","conversion_output":true,"text":"- Is a congenital anomaly/birth defect","text_display":"\n- Is a congenital anomaly/birth defect","confidence":1,"confidence_rate":1},{"cnt":[[357,1921],[892,1921],[892,1970],[357,1970]],"region":{"top_left_x":356,"top_left_y":1920,"width":536,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3065a539d4fd4ad28d71a5b290ef7a28","type":"text","conversion_output":true,"text":"- An important medical event","text_display":"\n- An important medical event","confidence":1,"confidence_rate":1},{"cnt":[[245,1989],[1734,1989],[1734,2039],[245,2039]],"region":{"top_left_x":244,"top_left_y":1989,"width":1490,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2e87c9de33f4f2fb2c8043a3ff3ab56","type":"text","conversion_output":true,"text":"NOTE: Hospitalization is defined as a formal inpatient admission. This will not include","text_display":"\n\nNOTE: Hospitalization is defined as a formal inpatient admission. This will not include","confidence":1,"confidence_rate":1},{"cnt":[[245,2039],[1815,2039],[1815,2086],[245,2086]],"region":{"top_left_x":244,"top_left_y":2038,"width":1572,"height":49},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f76885ec938b497caabdab89cf518c95","type":"text","conversion_output":true,"text":"admissions under \"23-hour Observational Status\", an Emergency Room visit without hospital","text_display":" admissions under \"23-hour Observational Status\", an Emergency Room visit without hospital","confidence":1,"confidence_rate":1},{"cnt":[[245,2088],[1790,2088],[1790,2136],[245,2136]],"region":{"top_left_x":244,"top_left_y":2088,"width":1546,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b8d560e861b4e399ec688eea2052df6","type":"text","conversion_output":true,"text":"admission or an Urgent Care visit and therefore, such events will not be recorded as an SAE","text_display":" admission or an Urgent Care visit and therefore, such events will not be recorded as an SAE","confidence":1,"confidence_rate":1},{"cnt":[[245,2136],[1826,2136],[1826,2185],[245,2185]],"region":{"top_left_x":244,"top_left_y":2135,"width":1583,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ecd56e6ca4d04c68b90e1034fc3c894e","type":"text","conversion_output":true,"text":"under this criterion. Admission to the hospital for social or situational reasons (eg, no place to","text_display":" under this criterion. 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Examples of such medical events include allergic","text_display":" outcomes listed in this definition. 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The CEC will","text_display":"\n\nAny clinical endpoints that meet SAE criteria will be reported as SAEs. The CEC will","confidence":1,"confidence_rate":1},{"cnt":[[245,468],[1815,468],[1815,518],[245,518]],"region":{"top_left_x":244,"top_left_y":468,"width":1572,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a03684abbe9a404b8924c4f138a51cc0","type":"text","conversion_output":true,"text":"adjudicate clinical endpoints in a blinded fashion, but the DMC will review clinical endpoints","text_display":" adjudicate clinical endpoints in a blinded fashion, but the DMC will review clinical endpoints","confidence":1,"confidence_rate":1},{"cnt":[[245,518],[829,518],[829,561],[245,561]],"region":{"top_left_x":244,"top_left_y":517,"width":586,"height":44},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f89341c3dec485993948574e14df806","type":"text","conversion_output":true,"text":"and SAEs in an unblinded fashion.","text_display":" and SAEs in an unblinded fashion.","confidence":1,"confidence_rate":1},{"cnt":[[243,606],[1308,606],[1308,660],[243,660]],"region":{"top_left_x":242,"top_left_y":605,"width":1067,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5095534137145c58e5cdce6614e918e","type":"section_header","conversion_output":false,"children_ids":["bd25e4ea1a534c37a193716347b9ada6"],"text":"","text_display":""},{"cnt":[[247,610],[1306,610],[1306,655],[247,655]],"region":{"top_left_x":247,"top_left_y":610,"width":1060,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd25e4ea1a534c37a193716347b9ada6","type":"text","conversion_output":true,"parent_id":"e5095534137145c58e5cdce6614e918e","text":"11.2.7.2. Events not Qualifying as Serious Adverse Events","text_display":"\n\n\\subsection*{11.2.7.2. Events not Qualifying as Serious Adverse Events}","confidence":0.9951171875,"confidence_rate":0.9999210551747466},{"cnt":[[245,688],[1777,688],[1777,737],[245,737]],"region":{"top_left_x":244,"top_left_y":687,"width":1533,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e02a1baea3241dcae04eabb9ae8a893","type":"text","conversion_output":true,"text":"The following is not considered an SAE and therefore does not need to be reported as such:","text_display":"\n\nThe following is not considered an SAE and therefore does not need to be reported as such:","confidence":1,"confidence_rate":1},{"cnt":[[372,773],[1833,773],[1833,819],[372,819]],"region":{"top_left_x":371,"top_left_y":773,"width":1462,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"630fe91b2d3d4db89e2b4547ef434a93","type":"text","conversion_output":true,"text":"- Overdose of either Esperion study drug or concomitant medication unless the event","text_display":"\n- Overdose of either Esperion study drug or concomitant medication unless the event","confidence":1,"confidence_rate":1},{"cnt":[[434,821],[1854,821],[1854,870],[434,870]],"region":{"top_left_x":433,"top_left_y":820,"width":1422,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10c7183a9a98454893bde87f3de3f2f2","type":"text","conversion_output":true,"text":"meets SAE criteria (eg, hospitalization). However, the event should still be captured","text_display":" meets SAE criteria (eg, hospitalization). However, the event should still be captured","confidence":1,"confidence_rate":1},{"cnt":[[434,870],[1274,870],[1274,917],[434,917]],"region":{"top_left_x":433,"top_left_y":870,"width":842,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdf5fa94b7fd46bb8a2cd3128c4a89f7","type":"text","conversion_output":true,"text":"as a nonserious AE on the appropriate eCRF page","text_display":" as a nonserious AE on the appropriate eCRF page","confidence":0.97216796875,"confidence_rate":0.9994573264910387},{"cnt":[[243,954],[1871,954],[1871,1010],[243,1010]],"region":{"top_left_x":242,"top_left_y":953,"width":1630,"height":57},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f39eeab8fe94c65ab2a398811c301df","type":"section_header","conversion_output":false,"children_ids":["9b15c268048b46b8acdf8605a0f4fb0e"],"text":"","text_display":""},{"cnt":[[247,958],[1867,958],[1867,1008],[247,1008]],"region":{"top_left_x":247,"top_left_y":958,"width":1620,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b15c268048b46b8acdf8605a0f4fb0e","type":"text","conversion_output":true,"parent_id":"6f39eeab8fe94c65ab2a398811c301df","text":"11.2.7.3. Clinical Laboratory Assessments as Adverse Events and Serious Adverse Events","text_display":"\n\n\\subsection*{11.2.7.3. Clinical Laboratory Assessments as Adverse Events and Serious Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[247,1040],[1871,1040],[1871,1087],[247,1087]],"region":{"top_left_x":247,"top_left_y":1039,"width":1625,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"503c82a1bf31404b8d506298629e0ed3","type":"text","conversion_output":true,"text":"It is the responsibility of the investigator to assess the clinical significance of all abnormal values","text_display":"\n\nIt is the responsibility of the investigator to assess the clinical significance of all abnormal values","confidence":1,"confidence_rate":1},{"cnt":[[245,1087],[1871,1087],[1871,1137],[245,1137]],"region":{"top_left_x":244,"top_left_y":1087,"width":1628,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"043f0f8539fb4532aa392ba1f561437b","type":"text","conversion_output":true,"text":"as defined by the list of reference ranges from the central (or local where appropriate) laboratory.","text_display":" as defined by the list of reference ranges from the central (or local where appropriate) laboratory.","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[245,1137],[1790,1137],[1790,1184],[245,1184]],"region":{"top_left_x":244,"top_left_y":1136,"width":1546,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ca5a7a58d484f76bd0e9132470698e4","type":"text","conversion_output":true,"text":"In some cases, significant changes in lab values within the normal range will require similar","text_display":" In some cases, significant changes in lab values within the normal range will require similar","confidence":1,"confidence_rate":1},{"cnt":[[243,1186],[1656,1186],[1656,1235],[243,1235]],"region":{"top_left_x":242,"top_left_y":1185,"width":1415,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43d5dee6ddb8461a8336cce611f91a0b","type":"text","conversion_output":true,"text":"judgment. 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Patients who become","confidence":1,"confidence_rate":1},{"cnt":[[245,2329],[1714,2329],[1714,2378],[245,2378]],"region":{"top_left_x":244,"top_left_y":2328,"width":1471,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5472685bd341481aa860ca7d88f79de8","type":"text","conversion_output":true,"text":"pregnant will discontinue IMP immediately and complete the End of Study evaluations.","text_display":" pregnant will discontinue IMP immediately and complete the End of Study evaluations.","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":41},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7be5db7fad7e4f629b95ab453b085ee5","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[932,2580],[1190,2580],[1190,2628],[932,2628]],"region":{"top_left_x":932,"top_left_y":2580,"width":259,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18efdee82df24edf9cb44b52fa8b2da8","type":"page_info","conversion_output":false,"text":"Page 72 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-073","page":73,"lines":[{"cnt":[[245,129],[535,129],[535,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":291,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5a2cb91b30543528df3a1b1af0f1225","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3dc85616f0446979cc727c68010c704","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,221],[245,221]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36ffc277f37642c5ba2c86d5ce85efc7","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1876,176],[1876,221],[1388,221]],"region":{"top_left_x":1387,"top_left_y":176,"width":489,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06cecdaddd3c461e9304d6048c3b0bc9","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,251],[1156,251],[1156,314],[245,314]],"region":{"top_left_x":244,"top_left_y":251,"width":912,"height":63},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c48c019f2fa4de9a8ec1d3c5b518b2a","type":"section_header","conversion_output":false,"children_ids":["a7ad676da3c24d0293239f03836c5158"],"text":"","text_display":""},{"cnt":[[249,254],[1154,254],[1154,312],[249,312]],"region":{"top_left_x":249,"top_left_y":253,"width":905,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7ad676da3c24d0293239f03836c5158","type":"text","conversion_output":true,"parent_id":"9c48c019f2fa4de9a8ec1d3c5b518b2a","text":"11.4. Adverse Events of Special Interest","text_display":"\n\n\\subsection*{11.4. Adverse Events of Special Interest}","confidence":0.99951171875,"confidence_rate":0.9999891467144949},{"cnt":[[245,346],[1772,346],[1772,393],[245,393]],"region":{"top_left_x":244,"top_left_y":345,"width":1529,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d29f834d7cd2476a97fe356162bf7ec7","type":"text","conversion_output":true,"text":"Adverse events of special interest (AESI) include metabolic acidosis (clinical laboratories),","text_display":"\n\nAdverse events of special interest (AESI) include metabolic acidosis (clinical laboratories),","confidence":1,"confidence_rate":1},{"cnt":[[245,391],[1669,391],[1669,440],[245,440]],"region":{"top_left_x":244,"top_left_y":391,"width":1426,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b57a0f7fa5f4f40bd68d4990a3bb1f5","type":"text","conversion_output":true,"text":"hepatic, muscular (AE and CK evaluation), new onset diabetes/hyperglycemia, renal,","text_display":" hepatic, muscular (AE and CK evaluation), new onset diabetes/hyperglycemia, renal,","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1760,443],[1760,488],[245,488]],"region":{"top_left_x":244,"top_left_y":442,"width":1516,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9c310aae389488f863b1f59bd260b31","type":"text","conversion_output":true,"text":"cardiovascular, and neurocognitive/neurologic events. Based on previous experience with","text_display":" cardiovascular, and neurocognitive/neurologic events. Based on previous experience with","confidence":1,"confidence_rate":1},{"cnt":[[245,490],[1824,490],[1824,539],[245,539]],"region":{"top_left_x":244,"top_left_y":489,"width":1581,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2130067797b422b9fbf4ecc8e610c69","type":"text","conversion_output":true,"text":"ETC-1002, uric acid and hemoglobin will be closely monitored. Safety monitoring guidelines","text_display":" ETC-1002, uric acid and hemoglobin will be closely monitored. 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A total of 7 patients receiving bempedoic acid monotherapy","text_display":"off for End-of Phase 2. 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Patients who experience any of these","text_display":" difficulty concentrating and drowsiness. Patients who experience any of these","confidence":0.9990234375,"confidence_rate":0.9999880849533284},{"cnt":[[434,449],[1846,449],[1846,496],[434,496]],"region":{"top_left_x":433,"top_left_y":449,"width":1413,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77c9ae12646345d2b65396d6993d0e06","type":"text","conversion_output":true,"text":"symptoms will be instructed to report them to their study doctor. Diabetes/glycemic","text_display":" symptoms will be instructed to report them to their study doctor. Diabetes/glycemic","confidence":1,"confidence_rate":1},{"cnt":[[434,496],[1779,496],[1779,544],[434,544]],"region":{"top_left_x":433,"top_left_y":496,"width":1346,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87a394180b6a499aa62ffcdaf7e0d1f1","type":"text","conversion_output":true,"text":"monitoring plans are Section 11.1.6.4. Occurrence of metabolic acidosis will be","text_display":" monitoring plans are Section 11.1.6.4. 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The exact mechanism in the development of muscle events is unclear.","text_display":" products. The exact mechanism in the development of muscle events is unclear.","confidence":1,"confidence_rate":1},{"cnt":[[434,1048],[1863,1048],[1863,1094],[434,1094]],"region":{"top_left_x":433,"top_left_y":1048,"width":1430,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04a66b1184fa48a085fa6ee35e7866e2","type":"text","conversion_output":true,"text":"Bempedoic acid is a prodrug which needs to be converted by an acyl-CoA synthetase","text_display":" Bempedoic acid is a prodrug which needs to be converted by an acyl-CoA synthetase","confidence":1,"confidence_rate":1},{"cnt":[[434,1096],[1850,1096],[1850,1143],[434,1143]],"region":{"top_left_x":433,"top_left_y":1095,"width":1417,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c620b675cb4e438cbcd86a6486c52461","type":"text","conversion_output":true,"text":"(ACS) to a coenzyme A \\(( CoA )\\) ester (ETC-1002-CoA). 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The product information for statins mentions","text_display":" statins and is dose related. 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Hyperglycemia occurred in 10.8\\% ( \\(n =10\\) ) of the placebo treated patients","text_display":" reactions. Hyperglycemia occurred in 10.8\\% ( \\(n =10\\) ) of the placebo treated patients","confidence":0.749192962422967,"confidence_rate":0.9969328123763013},{"cnt":[[434,1652],[1755,1652],[1755,1699],[434,1699]],"region":{"top_left_x":433,"top_left_y":1652,"width":1323,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baaacfad3d3d497387542a1efdf58a95","type":"text","conversion_output":true,"text":"vs none of the bempedoic acid 180 mg treated patients in the Phase 2 program.","text_display":" vs none of the bempedoic acid 180 mg treated patients in the Phase 2 program.","confidence":1,"confidence_rate":1},{"cnt":[[434,1702],[1712,1702],[1712,1747],[434,1747]],"region":{"top_left_x":433,"top_left_y":1701,"width":1280,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00c0cf6bb7f74f92a3729ea887bd11c9","type":"text","conversion_output":true,"text":"Regardless, new onset diabetes through AE monitoring will be captured and","text_display":" Regardless, new onset diabetes through AE monitoring will be captured and","confidence":1,"confidence_rate":1},{"cnt":[[434,1749],[1781,1749],[1781,1796],[434,1796]],"region":{"top_left_x":433,"top_left_y":1748,"width":1349,"height":49},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fce2b4cbbeaa4819b8224a9c2183c98b","type":"text","conversion_output":true,"text":"summarized for this study and across all of the bempedoic acid studies. Clinical","text_display":" summarized for this study and across all of the bempedoic acid studies. Clinical","confidence":1,"confidence_rate":1},{"cnt":[[434,1796],[1800,1796],[1800,1846],[434,1846]],"region":{"top_left_x":433,"top_left_y":1796,"width":1368,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b70e0b31bec437191da11e7eddae299","type":"text","conversion_output":true,"text":"safety laboratories will also be evaluated during the studies including \\(HbA _{1 C }\\), and","text_display":" safety laboratories will also be evaluated during the studies including \\(HbA _{1 C }\\), and","confidence":0.99609375,"confidence_rate":0.9999623670608182},{"cnt":[[434,1848],[698,1848],[698,1893],[434,1893]],"region":{"top_left_x":433,"top_left_y":1847,"width":266,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1430edb8aac4bb4a93bfb1240fdd9ae","type":"text","conversion_output":true,"text":"fasting glucose.","text_display":" fasting glucose.","confidence":1,"confidence_rate":1},{"cnt":[[434,1916],[1863,1916],[1863,1962],[434,1962]],"region":{"top_left_x":433,"top_left_y":1916,"width":1430,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a73a12f8b5384087ab585daffec47e1d","type":"text","conversion_output":true,"text":"Renal: Nonclinical studies have demonstrated nephrotoxic effects on tubular cells of","text_display":"\n\nRenal: Nonclinical studies have demonstrated nephrotoxic effects on tubular cells of","confidence":0.9985356330871582,"confidence_rate":0.9999835345159404},{"cnt":[[434,1964],[1811,1964],[1811,2013],[434,2013]],"region":{"top_left_x":433,"top_left_y":1963,"width":1379,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bb956ced5ad45d89c1c0ca635772636","type":"text","conversion_output":true,"text":"some lipid-modifying agents. In the Phase 2 program, creatinine elevations \\(>25 \\%\\)","text_display":" some lipid-modifying agents. In the Phase 2 program, creatinine elevations \\(>25 \\%\\)","confidence":0.99853515625,"confidence_rate":0.999982954590827},{"cnt":[[434,2013],[1807,2013],[1807,2060],[434,2060]],"region":{"top_left_x":433,"top_left_y":2013,"width":1374,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93964537f6654df3af38f175da7ded18","type":"text","conversion_output":true,"text":"over baseline occurred in 1 subject in the bempedoic acid \\(80 mg , 2\\) in the 180 mg ,","text_display":" over baseline occurred in 1 subject in the bempedoic acid \\(80 mg , 2\\) in the 180 mg ,","confidence":0.9838943481445312,"confidence_rate":0.9998360057973453},{"cnt":[[434,2062],[1833,2062],[1833,2108],[434,2108]],"region":{"top_left_x":433,"top_left_y":2062,"width":1400,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe4f70ba043c429db2496a7f36860183","type":"text","conversion_output":true,"text":"1 in the \\(180 mg +\\) ezetimibe, 1 in the 240 mg , and 3 in the \\(240 mg +\\) baseline statin.","text_display":" 1 in the \\(180 mg +\\) ezetimibe, 1 in the 240 mg , and 3 in the \\(240 mg +\\) baseline statin.","confidence":0.9796291853126604,"confidence_rate":0.9998094518486778},{"cnt":[[434,2110],[1850,2110],[1850,2157],[434,2157]],"region":{"top_left_x":433,"top_left_y":2109,"width":1417,"height":49},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53aab065b3d94848b9d6ab605656eeb6","type":"text","conversion_output":true,"text":"In most cases, this elevation occurred at the end of the study and the values were not","text_display":" In most cases, this elevation occurred at the end of the study and the values were not","confidence":1,"confidence_rate":1},{"cnt":[[434,2159],[1811,2159],[1811,2206],[434,2206]],"region":{"top_left_x":433,"top_left_y":2159,"width":1379,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d8b5a015c00452b871d7795448585f7","type":"text","conversion_output":true,"text":"repeated and the events were not considered related. In 1 case, repeat values were","text_display":" repeated and the events were not considered related. In 1 case, repeat values were","confidence":1,"confidence_rate":1},{"cnt":[[434,2209],[1811,2209],[1811,2254],[434,2254]],"region":{"top_left_x":433,"top_left_y":2208,"width":1379,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a66c1ccbe384b2e86c9c3366f54e305","type":"text","conversion_output":true,"text":"obtained and the subject's creatinine was returning to baseline by Week 12. None","text_display":" obtained and the subject's creatinine was returning to baseline by Week 12. None","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[434,2256],[1751,2256],[1751,2305],[434,2305]],"region":{"top_left_x":433,"top_left_y":2255,"width":1318,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8d7fc48c2aa462988dfa561f3208951","type":"text","conversion_output":true,"text":"exceeded a serum creatinine \\(>1.8 mg / dL\\). No subjects withdrew due an AE of","text_display":" exceeded a serum creatinine \\(>1.8 mg / dL\\). No subjects withdrew due an AE of","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[434,2305],[1792,2305],[1792,2353],[434,2353]],"region":{"top_left_x":433,"top_left_y":2305,"width":1359,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a90fe5a333b4e0797128acfa110463f","type":"text","conversion_output":true,"text":"increased creatinine. In the Phase 3 program, repeat evaluation of creatinine will","text_display":" increased creatinine. In the Phase 3 program, repeat evaluation of creatinine will","confidence":1,"confidence_rate":1},{"cnt":[[434,2355],[1858,2355],[1858,2400],[434,2400]],"region":{"top_left_x":433,"top_left_y":2354,"width":1426,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c21293e97664ddb831d12e979253686","type":"text","conversion_output":true,"text":"occur and patients exceeding protocol-specified values will be withdrawn from study","text_display":" occur and patients exceeding protocol-specified values will be withdrawn from study","confidence":1,"confidence_rate":1},{"cnt":[[434,2402],[1695,2402],[1695,2449],[434,2449]],"region":{"top_left_x":433,"top_left_y":2401,"width":1263,"height":49},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f19f60b129a419eabffafbae17adb69","type":"text","conversion_output":true,"text":"medication (see Section 11.1.6.3.2). Patients will be monitored beyond the","text_display":" medication (see Section 11.1.6.3.2). Patients will be monitored beyond the","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[245,2582],[462,2582],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2582,"width":218,"height":37},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d439fe9529c4f95b9a3e70ec35ddba7","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[932,2582],[1188,2582],[1188,2628],[932,2628]],"region":{"top_left_x":932,"top_left_y":2582,"width":257,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80864a20feca42929b480c8682449c8f","type":"page_info","conversion_output":false,"text":"Page 74 of 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Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff82871e220d4ceca1d59873c66d6848","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6df49cbd7a064a7fbe714035299e8107","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[432,254],[1846,254],[1846,303],[432,303]],"region":{"top_left_x":431,"top_left_y":253,"width":1415,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60d952ba32614dd0bcd56eb959c9c8b5","type":"text","conversion_output":true,"text":"conclusion of the study if necessary to follow abnormal renal laboratory values until","text_display":"\nconclusion of the study if necessary to follow abnormal renal laboratory values until","confidence":1,"confidence_rate":1},{"cnt":[[434,301],[879,301],[879,346],[434,346]],"region":{"top_left_x":433,"top_left_y":300,"width":446,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f834ed4b385d4d4a80c7f0daf89bd7b6","type":"text","conversion_output":true,"text":"resolution or stabilization.","text_display":" resolution or 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bempedoic acid program.","confidence":1,"confidence_rate":1},{"cnt":[[434,468],[1742,468],[1742,518],[434,518]],"region":{"top_left_x":433,"top_left_y":468,"width":1310,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28f79e96010144b5aed90262fedae0b1","type":"text","conversion_output":true,"text":"The details of the monitoring program can be found in the charter of the CEC.","text_display":" The details of the monitoring program can be found in the charter of the CEC.","confidence":1,"confidence_rate":1},{"cnt":[[434,518],[1841,518],[1841,565],[434,565]],"region":{"top_left_x":433,"top_left_y":517,"width":1409,"height":49},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba175e6952e24cbebbee8e7800f17269","type":"text","conversion_output":true,"text":"Standard monitoring will include occurrence of CV AEs, SAEs, both as adjudicated","text_display":" Standard monitoring will include occurrence of CV AEs, SAEs, both as adjudicated","confidence":1,"confidence_rate":1},{"cnt":[[432,563],[1179,563],[1179,612],[432,612]],"region":{"top_left_x":431,"top_left_y":562,"width":749,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd4ab956bed04633b24c83595abcd74f","type":"text","conversion_output":true,"text":"by the CEC, standard vital signs, and ECGs.","text_display":" by the CEC, standard vital signs, and ECGs.","confidence":1,"confidence_rate":1},{"cnt":[[432,636],[1824,636],[1824,685],[432,685]],"region":{"top_left_x":431,"top_left_y":635,"width":1394,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"471e8f8cd9e64956b051db37d3a65d6f","type":"text","conversion_output":true,"text":"Neurocognitive Events: Theoretically, it is possible that lipid-lowering agents that","text_display":"\n\nNeurocognitive Events: Theoretically, it is possible that lipid-lowering agents 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loss) associated with","confidence":1,"confidence_rate":1},{"cnt":[[434,782],[1833,782],[1833,831],[434,831]],"region":{"top_left_x":433,"top_left_y":782,"width":1400,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09d71182b82a45e2b9c27a0350d01a2f","type":"text","conversion_output":true,"text":"the use of statin drugs (FDA 2012). The human brain has a significant requirement","text_display":" the use of statin drugs (FDA 2012). The human brain has a significant requirement","confidence":1,"confidence_rate":1},{"cnt":[[434,829],[1869,829],[1869,879],[434,879]],"region":{"top_left_x":433,"top_left_y":829,"width":1437,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08cfca2c1a6c4c6084d3e179ae059304","type":"text","conversion_output":true,"text":"for cholesterol (Dietschy 2001; Dietschy 2004) and dysregulation of brain cholesterol","text_display":" for cholesterol (Dietschy 2001; Dietschy 2004) and dysregulation of brain cholesterol","confidence":1,"confidence_rate":1},{"cnt":[[434,877],[1755,877],[1755,926],[434,926]],"region":{"top_left_x":433,"top_left_y":876,"width":1323,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2e3fe166e9b4c75834fe3f395a6e6e5","type":"text","conversion_output":true,"text":"homeostasis has been linked to chronic neurodegenerative disorders, including","text_display":" homeostasis has been linked to chronic neurodegenerative disorders, including","confidence":1,"confidence_rate":1},{"cnt":[[432,924],[1768,924],[1768,975],[432,975]],"region":{"top_left_x":431,"top_left_y":923,"width":1338,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f905e5538846491db5d85f1b4a171870","type":"text","conversion_output":true,"text":"Alzheimer's disease, Huntington's disease, Parkinson's disease, Niemann-Pick","text_display":" Alzheimer's disease, Huntington's disease, Parkinson's disease, Niemann-Pick","confidence":1,"confidence_rate":1},{"cnt":[[432,975],[1803,975],[1803,1025],[432,1025]],"region":{"top_left_x":431,"top_left_y":975,"width":1372,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceff36d3f93847e5a987c9cf50eaccf6","type":"text","conversion_output":true,"text":"type C disease and Smith-Lemli-Opitz syndrome (Goedeke 2014). In the Phase 2","text_display":" type C disease and Smith-Lemli-Opitz syndrome (Goedeke 2014). In the Phase 2","confidence":0.865234375,"confidence_rate":0.9983182197916044},{"cnt":[[432,1023],[1768,1023],[1768,1072],[432,1072]],"region":{"top_left_x":431,"top_left_y":1022,"width":1338,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a22d95e76d2747e0bbab24402cc7864f","type":"text","conversion_output":true,"text":"program, the only disorder in this system organ class (SOC) that occurred more","text_display":" program, the only disorder in this system organ class (SOC) that occurred more","confidence":1,"confidence_rate":1},{"cnt":[[434,1072],[1760,1072],[1760,1121],[434,1121]],"region":{"top_left_x":433,"top_left_y":1072,"width":1327,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af61c5e3a7234f5dae26b8a55b30efe2","type":"text","conversion_output":true,"text":"commonly in the bempedoic acid treated group was headache. For the ongoing","text_display":" commonly in the bempedoic acid treated group was headache. For the ongoing","confidence":1,"confidence_rate":1},{"cnt":[[434,1121],[1738,1121],[1738,1171],[434,1171]],"region":{"top_left_x":433,"top_left_y":1121,"width":1306,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba8ad8ce119e4fea97a91a60dad04d6a","type":"text","conversion_output":true,"text":"program, neurocognitive events will be evaluated by standard PE and adverse","text_display":" program, neurocognitive events will be evaluated by standard PE and adverse","confidence":1,"confidence_rate":1},{"cnt":[[434,1169],[1704,1169],[1704,1218],[434,1218]],"region":{"top_left_x":433,"top_left_y":1168,"width":1271,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f157e5319334bb7869da0f82110f7a0","type":"text","conversion_output":true,"text":"monitoring. Summarization of events will occur using prespecified Medical","text_display":" monitoring. Summarization of events will occur using prespecified Medical","confidence":1,"confidence_rate":1},{"cnt":[[434,1216],[1360,1216],[1360,1268],[434,1268]],"region":{"top_left_x":433,"top_left_y":1216,"width":927,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"638e078bdfa84b60af7a8e93e25ff5ed","type":"text","conversion_output":true,"text":"Dictionary for Regulatory Activities (MedDRA) terms.","text_display":" Dictionary for Regulatory Activities (MedDRA) terms.","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[1036,1306],[1036,1369],[245,1369]],"region":{"top_left_x":244,"top_left_y":1306,"width":792,"height":63},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"274830e6d5ff4345bb76bf3a028653ad","type":"section_header","conversion_output":false,"children_ids":["edbda68558c24e7aa4fa1b4ed98c700e"],"text":"","text_display":""},{"cnt":[[249,1311],[1033,1311],[1033,1364],[249,1364]],"region":{"top_left_x":249,"top_left_y":1310,"width":785,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edbda68558c24e7aa4fa1b4ed98c700e","type":"text","conversion_output":true,"parent_id":"274830e6d5ff4345bb76bf3a028653ad","text":"11.5. Data Monitoring Committee","text_display":"\n\n\\subsection*{11.5. 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In addition, data on SAEs and deaths, including","text_display":" the last patient has completed study treatment. In addition, data on SAEs and deaths, including","confidence":1,"confidence_rate":1},{"cnt":[[245,1495],[1790,1495],[1790,1545],[245,1545]],"region":{"top_left_x":244,"top_left_y":1495,"width":1546,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d847a9e5ba548dd9a6da04b223bbf36","type":"text","conversion_output":true,"text":"clinical endpoints, will be monitored by the DMC during this period. At each DMC review,","text_display":" clinical endpoints, will be monitored by the DMC during this period. At each DMC review,","confidence":1,"confidence_rate":1},{"cnt":[[245,1543],[1858,1543],[1858,1594],[245,1594]],"region":{"top_left_x":244,"top_left_y":1542,"width":1615,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fa75288a59e472d857935b9717b6a2d","type":"text","conversion_output":true,"text":"relevant unblinded safety and efficacy information from ongoing studies of bempedoic acid will","text_display":" relevant unblinded safety and efficacy information from ongoing studies of bempedoic acid will","confidence":1,"confidence_rate":1},{"cnt":[[245,1594],[1841,1594],[1841,1644],[245,1644]],"region":{"top_left_x":244,"top_left_y":1594,"width":1598,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b29f3e7228047d9b41a9b575b634fec","type":"text","conversion_output":true,"text":"be provided to the DMC by an independent unblinded statistician and programmer. Additional","text_display":" be provided to the DMC by an independent unblinded statistician and programmer. Additional","confidence":1,"confidence_rate":1},{"cnt":[[245,1641],[969,1641],[969,1691],[245,1691]],"region":{"top_left_x":244,"top_left_y":1641,"width":725,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17672176197642e885e153c80d048755","type":"text","conversion_output":true,"text":"details will be provided in a DMC Charter.","text_display":" details will be provided in a DMC Charter.","confidence":1,"confidence_rate":1},{"cnt":[[245,1729],[1128,1729],[1128,1794],[245,1794]],"region":{"top_left_x":244,"top_left_y":1729,"width":884,"height":65},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8bb895a41f14e5f828c95e3a8313c3c","type":"section_header","conversion_output":false,"children_ids":["bee3a37bccff44a685547e4c05a56c83"],"text":"","text_display":""},{"cnt":[[249,1736],[1124,1736],[1124,1790],[249,1790]],"region":{"top_left_x":249,"top_left_y":1735,"width":875,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bee3a37bccff44a685547e4c05a56c83","type":"text","conversion_output":true,"parent_id":"d8bb895a41f14e5f828c95e3a8313c3c","text":"11.6. Clinical Event Committee (CEC)","text_display":"\n\n\\subsection*{11.6. 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Any clinical","text_display":" hospitalization for heart failure (non-MACE) using standardized definitions. Any clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,2065],[1854,2065],[1854,2116],[245,2116]],"region":{"top_left_x":244,"top_left_y":2064,"width":1611,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"068589adc8674f19a1ab2f2f9782cea1","type":"text","conversion_output":true,"text":"endpoints that meet SAE criteria will be reported as SAEs. Additional details regarding clinical","text_display":" endpoints that meet SAE criteria will be reported as SAEs. Additional details regarding clinical","confidence":1,"confidence_rate":1},{"cnt":[[245,2114],[1833,2114],[1833,2163],[245,2163]],"region":{"top_left_x":244,"top_left_y":2114,"width":1589,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a76e01e0fde04628a6aa32ad988ae5dd","type":"text","conversion_output":true,"text":"endpoints and clinical endpoint definitions are outlined below and will be included in the CEC","text_display":" endpoints and clinical endpoint definitions are outlined below and will be included in the CEC","confidence":1,"confidence_rate":1},{"cnt":[[245,2161],[1766,2161],[1766,2211],[245,2211]],"region":{"top_left_x":244,"top_left_y":2161,"width":1523,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cae3ebac3ff43f48307ccd36723911b","type":"text","conversion_output":true,"text":"charter. The charter will also outline the committee's composition, meeting timelines, and","text_display":" charter. The charter will also outline the committee's composition, meeting timelines, and","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[245,2211],[1854,2211],[1854,2262],[245,2262]],"region":{"top_left_x":244,"top_left_y":2210,"width":1611,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1800ed15ce04714a51165c5a57f60f5","type":"text","conversion_output":true,"text":"members' roles and responsibilities. Clinical endpoints from this study and other studies within","text_display":" members' roles and responsibilities. Clinical endpoints from this study and other studies within","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[245,2260],[1757,2260],[1757,2310],[245,2310]],"region":{"top_left_x":244,"top_left_y":2260,"width":1514,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e28054071e094d59aeff5802bcb904e3","type":"text","conversion_output":true,"text":"the bempedoic acid Phase 3 development program will be aggregated to allow for a safety","text_display":" the bempedoic acid Phase 3 development program will be aggregated to allow for a safety","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[245,2310],[1106,2310],[1106,2359],[245,2359]],"region":{"top_left_x":244,"top_left_y":2309,"width":863,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a925bb041ee430ea48074f439ca1107","type":"text","conversion_output":true,"text":"assessment across the entire development program.","text_display":" assessment across the entire development program.","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":41},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5800e7e701b34ab7809064b32e11cbf7","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[932,2580],[1192,2580],[1192,2628],[932,2628]],"region":{"top_left_x":932,"top_left_y":2580,"width":261,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2ac2a24894b41ffa5a674b4c2acf95a","type":"page_info","conversion_output":false,"text":"Page 75 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-076","page":76,"lines":[{"cnt":[[245,129],[535,129],[535,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":291,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1121ff7d59264d34a6e9c4f8775747b8","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c55db4adfd644cf8b1c147f3ad26c99f","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,221],[245,221]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6e25c35eed64d2993f09c3309d64f82","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,221],[1388,221]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6250348606fc4ceb800b17d2c18fd1b8","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[245,249],[1085,249],[1085,312],[245,312]],"region":{"top_left_x":244,"top_left_y":249,"width":841,"height":63},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50d59ecd9e364facbb82fcc65ed9d3dc","type":"section_header","conversion_output":false,"children_ids":["57c95f19925748ce964acbc7e68b9b1d"],"text":"","text_display":""},{"cnt":[[249,254],[1081,254],[1081,312],[249,312]],"region":{"top_left_x":249,"top_left_y":253,"width":832,"height":59},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57c95f19925748ce964acbc7e68b9b1d","type":"text","conversion_output":true,"parent_id":"50d59ecd9e364facbb82fcc65ed9d3dc","text":"11.7. 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If these criteria have not been","text_display":"\nBlood draws for lipids (and glucose) must meet the criteria below. If these criteria have not been","confidence":1,"confidence_rate":1},{"cnt":[[245,930],[1854,930],[1854,978],[245,978]],"region":{"top_left_x":244,"top_left_y":930,"width":1611,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"857bb53aa73244dd99bb698bd7560d1b","type":"text","conversion_output":true,"text":"met, these blood samples will NOT be collected. If these criteria can be met by rescheduling","text_display":" met, these blood samples will NOT be collected. If these criteria can be met by rescheduling","confidence":1,"confidence_rate":1},{"cnt":[[245,980],[1835,980],[1835,1027],[245,1027]],"region":{"top_left_x":244,"top_left_y":979,"width":1591,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a928761c578449c8bbf5611c985bd246","type":"text","conversion_output":true,"text":"clinic visit to occur within 3 days, these blood samples will be collected at the rescheduled","text_display":" clinic visit to occur within 3 days, these blood samples will be collected at the rescheduled","confidence":0.9775390625,"confidence_rate":0.9997751042405244},{"cnt":[[245,1027],[529,1027],[529,1076],[245,1076]],"region":{"top_left_x":244,"top_left_y":1026,"width":285,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"122e477356054f048fb0c64fb0e57c29","type":"text","conversion_output":true,"text":"clinic visit only.","text_display":" clinic visit only.","confidence":1,"confidence_rate":1},{"cnt":[[370,1098],[1738,1098],[1738,1147],[370,1147]],"region":{"top_left_x":369,"top_left_y":1097,"width":1370,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5676565ed634823a8ba30aff8476116","type":"text","conversion_output":true,"text":"- Blood samples will be drawn after a minimum 10 -hour fast (water is allowed)","text_display":"\n- Blood samples will be drawn after a minimum 10 -hour fast (water is allowed)","confidence":0.56201171875,"confidence_rate":0.9933220186788685},{"cnt":[[245,1169],[1880,1169],[1880,1216],[245,1216]],"region":{"top_left_x":244,"top_left_y":1168,"width":1636,"height":49},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d657d7462cb64d069760f15523c052ae","type":"text","conversion_output":true,"text":"Patients are encouraged to be in a seated position during the blood collection. 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For each lipid parameter and analysis time point, the LSM and SE will be","text_display":" tertiary endpoints. 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If non-normality of the data is found","text_display":"\n\nThe ANCOVA assumption of normality will be assessed. If non-normality of the data is found","confidence":1,"confidence_rate":1},{"cnt":[[245,928],[1790,928],[1790,978],[245,978]],"region":{"top_left_x":244,"top_left_y":928,"width":1546,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbdf740845cd4477b9f39a14dee1b79a","type":"text","conversion_output":true,"text":"at any time point for any parameter, either the data will be transformed so that it is normally","text_display":" at any time point for any parameter, either the data will be transformed so that it is normally","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1714,975],[1714,1025],[245,1025]],"region":{"top_left_x":244,"top_left_y":975,"width":1471,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a79c9ed065948519424fb025c225f7f","type":"text","conversion_output":true,"text":"distributed or a nonparametric test will be considered instead of the planned ANCOVA.","text_display":" distributed or a nonparametric test will be considered instead of the planned ANCOVA.","confidence":1,"confidence_rate":1},{"cnt":[[245,1044],[1798,1044],[1798,1094],[245,1094]],"region":{"top_left_x":244,"top_left_y":1044,"width":1555,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b5565ebd80f4d90a39e053e52a6f3eb","type":"text","conversion_output":true,"text":"Percent change from baseline to Week 24 and to Week 52 LDL-C will be analyzed similarly","text_display":"\n\nPercent change from baseline to Week 24 and to Week 52 LDL-C will be analyzed similarly","confidence":1,"confidence_rate":1},{"cnt":[[245,1091],[1867,1091],[1867,1141],[245,1141]],"region":{"top_left_x":244,"top_left_y":1091,"width":1623,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d61c36cb9f04168bba6fc5d170f2fb7","type":"text","conversion_output":true,"text":"with patients in the FAS who did not receive additional lipid-lowering therapy by that time point","text_display":" with patients in the FAS who did not receive additional lipid-lowering therapy by that time point","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[245,1143],[1813,1143],[1813,1192],[245,1192]],"region":{"top_left_x":244,"top_left_y":1142,"width":1570,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4663a43a35ab446795b312cc88ad721e","type":"text","conversion_output":true,"text":"(by Week 24 for the Week 24 analysis; by Week 52 for the Week 52 analysis) included in the","text_display":" (by Week 24 for the Week 24 analysis; by Week 52 for the Week 52 analysis) included in the","confidence":1,"confidence_rate":1},{"cnt":[[245,1190],[1811,1190],[1811,1240],[245,1240]],"region":{"top_left_x":244,"top_left_y":1190,"width":1568,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce132cf3384d40358836dacade814032","type":"text","conversion_output":true,"text":"analyses. Only observed case data will be used (no imputation for missing data). Output from","text_display":" analyses. Only observed case data will be used (no imputation for missing data). Output from","confidence":1,"confidence_rate":1},{"cnt":[[245,1240],[1824,1240],[1824,1289],[245,1289]],"region":{"top_left_x":244,"top_left_y":1239,"width":1581,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e083dd308a76468dac730e0d27ffd4b6","type":"text","conversion_output":true,"text":"each time point will include the LSM and SE for each treatment group, as well as the placebo-","text_display":" each time point will include the LSM and SE for each treatment group, as well as the placebo","confidence":1,"confidence_rate":1},{"cnt":[[245,1285],[840,1285],[840,1334],[245,1334]],"region":{"top_left_x":244,"top_left_y":1284,"width":597,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2832698ee3d3468f91a95111bc1f2809","type":"text","conversion_output":true,"text":"correct LSM, \\(95 \\% CI\\), and p -value.","text_display":"correct LSM, \\(95 \\% CI\\), and p -value.","confidence":0.5846753120422363,"confidence_rate":0.9895316762050909},{"cnt":[[243,1375],[1699,1375],[1699,1508],[243,1508]],"region":{"top_left_x":242,"top_left_y":1375,"width":1458,"height":134},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ef166477b9a47c196606a6e61e2a78e","type":"section_header","conversion_output":false,"children_ids":["4ca6d5a903244d5e9863fbf1a6bbe5b2","d0164f3fe810445a9b12672855272d9a"],"text":"","text_display":""},{"cnt":[[249,1379],[1695,1379],[1695,1433],[249,1433]],"region":{"top_left_x":249,"top_left_y":1379,"width":1447,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ca6d5a903244d5e9863fbf1a6bbe5b2","type":"text","conversion_output":true,"parent_id":"6ef166477b9a47c196606a6e61e2a78e","text":"12.7. 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TEAEs and SAEs will be summarized by SOC,","confidence":1,"confidence_rate":1},{"cnt":[[245,1914],[1790,1914],[1790,1962],[245,1962]],"region":{"top_left_x":244,"top_left_y":1914,"width":1546,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a2635de8d1648ea9cd47a153b867122","type":"text","conversion_output":true,"text":"severity, and relationship to study drug for each treatment group. These AE summaries will","text_display":" severity, and relationship to study drug for each treatment group. These AE summaries will","confidence":1,"confidence_rate":1},{"cnt":[[245,1962],[1871,1962],[1871,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1961,"width":1628,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3788449f9a8b43c185194dd3fa93b29d","type":"text","conversion_output":true,"text":"include cumulative incidence (percent of patients experiencing the AE) and patient-year adjusted","text_display":" include cumulative incidence (percent of patients experiencing the AE) and patient-year adjusted","confidence":1,"confidence_rate":1},{"cnt":[[245,2011],[1800,2011],[1800,2060],[245,2060]],"region":{"top_left_x":244,"top_left_y":2010,"width":1557,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b014e28d85a4d228179864ce5aaef91","type":"text","conversion_output":true,"text":"incidence rates. If appropriate, absolute and relative risk differences will be calculated using","text_display":" incidence rates. If appropriate, absolute and relative risk differences will be calculated using","confidence":1,"confidence_rate":1},{"cnt":[[245,2058],[1850,2058],[1850,2108],[245,2108]],"region":{"top_left_x":244,"top_left_y":2058,"width":1606,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"284ab74fcb3748d881eb8009c70305f2","type":"text","conversion_output":true,"text":"both cumulative incidence and incidence rates. Deaths, withdrawal from study treatment due to","text_display":" both cumulative incidence and incidence rates. Deaths, withdrawal from study treatment due to","confidence":1,"confidence_rate":1},{"cnt":[[245,2110],[1815,2110],[1815,2157],[245,2157]],"region":{"top_left_x":244,"top_left_y":2109,"width":1572,"height":49},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4408e0f439314ff2a130d499b5a77f72","type":"text","conversion_output":true,"text":"AEs, and withdrawal from the study due to AEs will each be summarized by treatment group.","text_display":" AEs, and withdrawal from the study due to AEs will each be summarized by treatment group.","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[245,2179],[1738,2179],[1738,2228],[245,2228]],"region":{"top_left_x":244,"top_left_y":2178,"width":1495,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea715352229b43e8a657f984ce6f5891","type":"text","conversion_output":true,"text":"Clinical safety laboratories, including hematology, blood chemistry, 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& Screen & Run-in & & \\multicolumn{5}{|c|}{Treatment} & & \\\\\n\\hline Visit & \\(S 1 ^{ 1 , 2 }\\) & S2 & S3 & T1 & T2 & T3/phone & T4 & T5 & T6/phone & T7/EOS \\({ }^{ 3 }\\) \\\\\n\\hline Week & Wk -5 & Wk -4 & Wk -1 & Wk 0 & Wk 4 & Wk 8 & Wk 12 & Wk 24 & Wk 36 & Wk 52 \\\\\n\\hline Procedure & Day \\(- 3 5 \\pm 7\\) & Day \\(-28 \\pm 3\\) & Day \\(-7 \\pm 3\\) & Day 1 & Day \\(29 \\pm 3\\) & Day \\(5 7 \\pm 3\\) & Day \\(8 5 \\pm 3\\) & Day \\(1 6 8 \\pm 7\\) & Day \\(2 5 2 \\pm 7\\) & Day 365 \\(\\pm 7\\) \\\\\n\\hline Informed Consent & x & & & & & & & & & \\\\\n\\hline Enrollment Criteria & x & & & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & & & \\\\\n\\hline Medical History & x & & & & & & & & & \\\\\n\\hline HeFH Status Determination & X & & & & & & & & & \\\\\n\\hline Concomitant Medications & X & x & x & X & X & X & X & X & X & X \\\\\n\\hline Adverse Event Recording & & X & X & X & X & X & X & X & X & X \\\\\n\\hline Physical Exam & & & & x & & & & & & X \\\\\n\\hline Weight \\({ }^{4}\\) & X & & & x & x & & X & x & & X \\\\\n\\hline Height/BMI & X & & & & & & & & & \\\\\n\\hline 12-Lead ECG \\({ }^{5}\\) & & & & x & & & & & & x \\\\\n\\hline Vital Signs \\({ }^{6}\\) & x & x & x & x & x & & x & x & & x \\\\\n\\hline Serology \\({ }^{7}\\) & X & & & & & & & & & \\\\\n\\hline Serum Pregnancy and/or \\(FSH ^{8}\\) & X & & & & & & & & & \\\\\n\\hline Urine Pregnancy Test \\({ }^{8}\\) & & & & x & & & & & & \\\\\n\\hline TSH & X & & & & & & & & & \\\\\n\\hline Clinical Safety Labs \\({ }^{9}\\) & X & & & X & X & & X & x & & X \\\\\n\\hline Basic Fasting Lipids \\({ }^{10}\\) & X & & x & X & X & & X & X & & X \\\\\n\\hline \\(HbA _{1 C }\\) & X & & & X & & & X & X & & X \\\\\n\\hline apoB & & & & X & & & x & X & & x \\\\\n\\hline hs-CRP & & & & x & & & x & x & & x \\\\\n\\hline Diet and exercise counseling \\({ }^{11}\\) & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Plasma PK & & & & & & & & X & & X \\\\\n\\hline Establish Patient Eligibility & & & & x & & & & & & \\\\\n\\hline Randomization & & & & X & & & & & & \\\\\n\\hline IWRS Contact & x & x & & x & & & x & X & & \\(x ^{12}\\) \\\\\n\\hline Single-Blind Drug Dispensing & & x & & & & & & & & \\\\\n\\hline Double-blind Drug Dispensing \\({ }^{13}\\) & & & & x & & & X & x & & \\\\\n\\hline Drug Return/Compliance & & & x & X & x & & X & X & & x \\\\\n\\hline Schedule next visit & x & X & X & X & X & X & X & X & x & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{APPENDIX 1. SCHEDULE OF EVENTS (SUBJECT VISIT SCHEDULE)}\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline & Screen & Run-in & & \\multicolumn{5}{|c|}{Treatment} & & \\\\\n\\hline Visit & \\(S 1 ^{ 1 , 2 }\\) & S2 & S3 & T1 & T2 & T3/phone & T4 & T5 & T6/phone & T7/EOS \\({ }^{ 3 }\\) \\\\\n\\hline Week & Wk -5 & Wk -4 & Wk -1 & Wk 0 & Wk 4 & Wk 8 & Wk 12 & Wk 24 & Wk 36 & Wk 52 \\\\\n\\hline Procedure & Day \\(- 3 5 \\pm 7\\) & Day \\(-28 \\pm 3\\) & Day \\(-7 \\pm 3\\) & Day 1 & Day \\(29 \\pm 3\\) & Day \\(5 7 \\pm 3\\) & Day \\(8 5 \\pm 3\\) & Day \\(1 6 8 \\pm 7\\) & Day \\(2 5 2 \\pm 7\\) & Day 365 \\(\\pm 7\\) \\\\\n\\hline Informed Consent & x & & & & & & & & & \\\\\n\\hline Enrollment Criteria & x & & & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & & & \\\\\n\\hline Medical History & x & & & & & & & & & \\\\\n\\hline HeFH Status Determination & X & & & & & & & & & \\\\\n\\hline Concomitant Medications & X & x & x & X & X & X & X & X & X & X \\\\\n\\hline Adverse Event 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Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,221],[245,221]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9af3772f771b4f0ba8d564a43843dda2","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1876,176],[1876,221],[1388,221]],"region":{"top_left_x":1387,"top_left_y":176,"width":489,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9f88997af69412eb59786be9b6138c5","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 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Safety","text_display":"\n\nNOTE: For patients who withdraw from IMP treatment, they will continue to have visits according to the protocol schedule. Safety","confidence":1,"confidence_rate":1},{"cnt":[[271,296],[1936,296],[1936,333],[271,333]],"region":{"top_left_x":270,"top_left_y":296,"width":1666,"height":38},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92db8b8d23c14011a3a0c9d2b765e89d","type":"text","conversion_output":true,"text":"assessments should include clinical safety and basic lipid laboratories (except for apoB and hs-CRP), adverse events, PE, vital signs,","text_display":" assessments should include clinical safety and basic lipid laboratories (except for apoB and hs-CRP), adverse events, PE, vital signs,","confidence":1,"confidence_rate":1},{"cnt":[[271,331],[1904,331],[1904,370],[271,370]],"region":{"top_left_x":270,"top_left_y":330,"width":1634,"height":40},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0dae5661e0d94ae5a7ef762c03d1b0a2","type":"text","conversion_output":true,"text":"and ECGs. For patients who withdraw from IMP treatment, but refuse to come to the clinic for assessments, assessments will take","text_display":" and ECGs. For patients who withdraw from IMP treatment, but refuse to come to the clinic for assessments, assessments will take","confidence":0.99951171875,"confidence_rate":0.9999963000030714},{"cnt":[[271,367],[1927,367],[1927,406],[271,406]],"region":{"top_left_x":270,"top_left_y":367,"width":1658,"height":40},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5747367b5ac44369922a982cf441c37c","type":"text","conversion_output":true,"text":"place by phone. The telephone contacts will occur according the protocol schedule with information regarding current health status","text_display":" place by phone. The telephone contacts will occur according the protocol schedule with information regarding current health status","confidence":1,"confidence_rate":1},{"cnt":[[271,404],[1794,404],[1794,440],[271,440]],"region":{"top_left_x":270,"top_left_y":403,"width":1524,"height":38},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e752c032db624c1dbb1f0eaa022db14f","type":"text","conversion_output":true,"text":"and to collect information on AEs (eg, recent procedures, hospitalizations, and if the patient has died, the cause of death).","text_display":" and to collect information on AEs (eg, recent procedures, hospitalizations, and if the patient has died, the cause of death).","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1936,443],[1936,483],[245,483]],"region":{"top_left_x":244,"top_left_y":442,"width":1692,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c80d61f56aef46fcb55c6cdb9dedafb0","type":"text","conversion_output":true,"text":"\\({ }^{1}\\) An optional visit between Visits S1 and S2 may be completed if patient fails to meet TG entry criterion. If this optional basic fasting","text_display":"\n\\({ }^{1}\\) An optional visit between Visits S1 and S2 may be completed if patient fails to meet TG entry criterion. 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An optional","text_display":" medications for at least 2 weeks, and the repeat blood pressure values (DBP and/or SBP) do not meet exclusionary values. An optional","confidence":1,"confidence_rate":1},{"cnt":[[271,632],[1940,632],[1940,672],[271,672]],"region":{"top_left_x":270,"top_left_y":631,"width":1671,"height":42},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7254ae6c5c334a5cb72bdfc102282c84","type":"text","conversion_output":true,"text":"visit between Visit S1 and S2 may be completed to determine eligibility if the patient's eGFR, ALT, AST, and/or TB meet exclusion","text_display":" visit between Visit S1 and S2 may be completed to determine eligibility if the patient's eGFR, ALT, AST, and/or TB meet exclusion","confidence":0.99951171875,"confidence_rate":0.9999963552268055},{"cnt":[[271,666],[1579,666],[1579,707],[271,707]],"region":{"top_left_x":270,"top_left_y":666,"width":1310,"height":41},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5d63e4a88d9485d95222d29ec8c3d27","type":"text","conversion_output":true,"text":"criteria levels. If this optional visit is completed, the repeated value will be used to determine eligibility.","text_display":" criteria levels. If this optional visit is completed, the repeated value will be used to determine eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[245,705],[1809,705],[1809,750],[245,750]],"region":{"top_left_x":244,"top_left_y":704,"width":1565,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0893fc051eab4466b819c13d64261e08","type":"text","conversion_output":true,"text":"\\({ }^{3}\\) All procedures will be completed for all patients at either End of Study (EOS) if completing the study or early withdrawal.","text_display":"\n\\({ }^{3}\\) All procedures will be completed for all patients at either End of Study (EOS) if completing the study or early withdrawal.","confidence":1,"confidence_rate":1},{"cnt":[[245,748],[1876,748],[1876,793],[245,793]],"region":{"top_left_x":244,"top_left_y":747,"width":1632,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a0f00114d494ceaaa57f81d42c16ba6","type":"text","conversion_output":true,"text":"\\({ }^{4}\\) Body weight will be measured while fasting, using consistent scales, after voiding, and without shoes and outerwear (eg, coats).","text_display":"\n\\({ }^{4}\\) Body weight will be measured while fasting, using consistent scales, after voiding, and without shoes and outerwear (eg, coats).","confidence":1,"confidence_rate":1},{"cnt":[[245,791],[1212,791],[1212,836],[245,836]],"region":{"top_left_x":244,"top_left_y":790,"width":968,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6092bf63a7714338999007ad94e45592","type":"text","conversion_output":true,"text":"\\({ }^{5}\\) Single 12-lead ECG will be collected prior to any blood sample collection.","text_display":"\n\\({ }^{5}\\) Single 12-lead ECG will be collected prior to any blood sample collection.","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[245,834],[1936,834],[1936,879],[245,879]],"region":{"top_left_x":244,"top_left_y":833,"width":1692,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da4356fd26fb4c2b82a823cf2560c468","type":"text","conversion_output":true,"text":"\\({ }^{6}\\) Vital signs will include DBP, SBP, and HR and will be collected prior to any blood sample collection. Patient will rest for 5 minutes","text_display":"\n\\({ }^{6}\\) Vital signs will include DBP, SBP, and HR and will be collected prior to any blood sample collection. Patient will rest for 5 minutes","confidence":1,"confidence_rate":1},{"cnt":[[271,877],[531,877],[531,917],[271,917]],"region":{"top_left_x":270,"top_left_y":876,"width":261,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0900155858fe4618a7a9298b42e3a588","type":"text","conversion_output":true,"text":"prior to assessments","text_display":" prior to assessments","confidence":1,"confidence_rate":1},{"cnt":[[245,913],[621,913],[621,956],[245,956]],"region":{"top_left_x":244,"top_left_y":913,"width":377,"height":44},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"119106e4a2124118a251bf66f876ffc1","type":"text","conversion_output":true,"text":"\\({ }^{7}\\) Serology for HBsAg, HCV","text_display":"\n\\({ }^{7}\\) Serology for HBsAg, HCV","confidence":1,"confidence_rate":1},{"cnt":[[245,954],[1949,954],[1949,1001],[245,1001]],"region":{"top_left_x":244,"top_left_y":953,"width":1705,"height":49},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14b243848325418aabc938fb507cbe2d","type":"text","conversion_output":true,"text":"\\({ }^{8}\\) Serum pregnancy test completed in premenopausal women only. FSH test is completed in women \\(<55\\) years old and \\(>1\\) year without","text_display":"\n\\({ }^{8}\\) Serum pregnancy test completed in premenopausal women only. FSH test is completed in women \\(<55\\) years old and \\(>1\\) year without","confidence":0.9970715045928955,"confidence_rate":0.9999794911764635},{"cnt":[[271,997],[1442,997],[1442,1038],[271,1038]],"region":{"top_left_x":270,"top_left_y":996,"width":1172,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17ec630170cc43a3ba245de5062e1ada","type":"text","conversion_output":true,"text":"menses. Urine pregnancy test in women of childbearing potential just prior to randomization.","text_display":" menses. Urine pregnancy test in women of childbearing potential just prior to randomization.","confidence":1,"confidence_rate":1},{"cnt":[[245,1036],[1931,1036],[1931,1081],[245,1081]],"region":{"top_left_x":244,"top_left_y":1035,"width":1688,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfb1e6071d3244c18b27fd30b996387b","type":"text","conversion_output":true,"text":"\\({ }^{9}\\) Clinical safety labs include hematology, blood chemistry, and urinalysis at all visits. Coagulation is included at Screening (Visit S1)","text_display":"\n\\({ }^{9}\\) Clinical safety labs include hematology, blood chemistry, and urinalysis at all visits. Coagulation is included at Screening (Visit S1)","confidence":1,"confidence_rate":1},{"cnt":[[271,1076],[1871,1076],[1871,1115],[271,1115]],"region":{"top_left_x":270,"top_left_y":1076,"width":1602,"height":40},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ff8373cad2242cb9c432e6e465865f5","type":"text","conversion_output":true,"text":"for all patients, Baseline (Visit T1) and 3-5 days after Visit T1 only if on anticoagulants). Please refer to laboratory manual for","text_display":" for all patients, Baseline (Visit T1) and 3-5 days after Visit T1 only if on anticoagulants). Please refer to laboratory manual for","confidence":1,"confidence_rate":1},{"cnt":[[271,1113],[1528,1113],[1528,1149],[271,1149]],"region":{"top_left_x":270,"top_left_y":1112,"width":1258,"height":38},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"217a9d8556284bb6baff4075d085c6ef","type":"text","conversion_output":true,"text":"detailed schedule of tests. A local laboratory may be used for assessment at \\(3-5\\) days after Visit T1.","text_display":" detailed schedule of tests. A local laboratory may be used for assessment at \\(3-5\\) days after Visit T1.","confidence":1,"confidence_rate":1},{"cnt":[[247,1147],[1880,1147],[1880,1192],[247,1192]],"region":{"top_left_x":247,"top_left_y":1147,"width":1633,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ac3cdce8fd8427a848558aba5404bf9","type":"text","conversion_output":true,"text":"\\({ }^{10}\\) Basic fasting (minimum of 10 hours) lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides.","text_display":"\n\\({ }^{10}\\) Basic fasting (minimum of 10 hours) lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides.","confidence":0.998046875,"confidence_rate":0.9999861346008362},{"cnt":[[247,1190],[1583,1190],[1583,1240],[247,1240]],"region":{"top_left_x":247,"top_left_y":1190,"width":1337,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0a5ea23c11649249f35e404ac6abc93","type":"text","conversion_output":true,"text":"\\({ }^{11}\\) Diet and exercise counseling per local and/or regional guidelines for the management of hyperlipidemia.","text_display":"\n\\({ }^{11}\\) Diet and exercise counseling per local and/or regional guidelines for the management of hyperlipidemia.","confidence":1,"confidence_rate":1},{"cnt":[[249,1233],[1558,1233],[1558,1278],[249,1278]],"region":{"top_left_x":249,"top_left_y":1233,"width":1309,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0377feb9173a41e4803e2e864fb0e8ab","type":"text","conversion_output":true,"text":"\\({ }^{12}\\) IWRS contact at either an early withdrawal or an EOS visit to register study discontinuation visit date.","text_display":"\n\\({ }^{12}\\) IWRS contact at either an early withdrawal or an EOS visit to register study discontinuation visit date.","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[247,1276],[1858,1276],[1858,1323],[247,1323]],"region":{"top_left_x":247,"top_left_y":1276,"width":1612,"height":48},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"68d5957a802a4f3b88ba678baff50998","type":"text","conversion_output":true,"text":"\\({ }^{13}\\) Depending upon the length of time between visits, 1 or 2 bottles of study medication will be dispensed as instructed by IWRS.","text_display":"\n\\({ }^{13}\\) Depending upon the length of time between visits, 1 or 2 bottles of study medication will be dispensed as instructed by IWRS.","confidence":0.99951171875,"confidence_rate":0.9999966317263753},{"cnt":[[249,1319],[1931,1319],[1931,1364],[249,1364]],"region":{"top_left_x":249,"top_left_y":1319,"width":1683,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ee2c0d77c22e4d9fa4fdbf13cceca264","type":"text","conversion_output":true,"text":"\\({ }^{14}\\) If patient is discontinuing treatment and completing the EOS visit, but will be continuing in the study either by returning to clinic or","text_display":"\n\\({ }^{14}\\) If patient is discontinuing treatment and completing the EOS visit, but will be continuing in the study either by returning to clinic or","confidence":1,"confidence_rate":1},{"cnt":[[271,1362],[1571,1362],[1571,1403],[271,1403]],"region":{"top_left_x":270,"top_left_y":1362,"width":1301,"height":41},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c78c1a751d574629abbb70f2a53a084c","type":"text","conversion_output":true,"text":"by phone, continue to schedule study visits for the patient according to the protocol Schedule of Events","text_display":" by phone, continue to schedule study visits for the patient according to the protocol Schedule of 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Inc.","confidence":1,"confidence_rate":1},{"cnt":[[1375,219],[1850,219],[1850,264],[1375,264]],"region":{"top_left_x":1374,"top_left_y":219,"width":476,"height":46},"line":6,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ded6af81e9bf4eb3b8b571c794cba461","type":"text","conversion_output":true,"parent_id":"28e9b5a67dfb4d38979ee8b1ee34df8c","text":"Amendment 3, 09 May 2017","text_display":"\nAmendment 3, 09 May 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Be on maximally tolerated lipid-modifying therapy, including a maximally tolerated","text_display":"\n7. Be on maximally tolerated lipid-modifying therapy, including a maximally tolerated","confidence":1,"confidence_rate":1},{"cnt":[[370,2161],[1833,2161],[1833,2211],[370,2211]],"region":{"top_left_x":369,"top_left_y":2161,"width":1464,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6a6edc67b87467089d609b8b17f2f79","type":"text","conversion_output":true,"text":"statin either alone or in combination with other lipid-lowering therapies, at stable doses","text_display":" statin either alone or in combination with other lipid-lowering therapies, at stable doses","confidence":1,"confidence_rate":1},{"cnt":[[370,2211],[1768,2211],[1768,2260],[370,2260]],"region":{"top_left_x":369,"top_left_y":2210,"width":1400,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87b204fead1b4b31a3229de4e12db92f","type":"text","conversion_output":true,"text":"and regimens for at least 4 weeks prior to screening ( 6 weeks for fibrates; however,","text_display":" and regimens for at least 4 weeks prior to screening ( 6 weeks for fibrates; however,","confidence":0.99755859375,"confidence_rate":0.9999745379143542},{"cnt":[[370,2260],[1777,2260],[1777,2310],[370,2310]],"region":{"top_left_x":369,"top_left_y":2260,"width":1408,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cbbf5b9ff134696a4251087db2c5da3","type":"text","conversion_output":true,"text":"gemfibrozil is not allowed as per co-administration instructions defined in the statin","text_display":" gemfibrozil is not allowed as per co-administration instructions defined in the statin","confidence":1,"confidence_rate":1},{"cnt":[[370,2307],[1762,2307],[1762,2357],[370,2357]],"region":{"top_left_x":369,"top_left_y":2307,"width":1393,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c6f5855a99845808e6f6b2a477bfeaa","type":"text","conversion_output":true,"text":"label). Maximally tolerated statin includes statin regimens other than daily dosing,","text_display":" label). Maximally tolerated statin includes statin regimens other than daily dosing,","confidence":1,"confidence_rate":1},{"cnt":[[370,2357],[1790,2357],[1790,2408],[370,2408]],"region":{"top_left_x":369,"top_left_y":2356,"width":1421,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e52ed7ca38044f49ee4cb10c56b7d36","type":"text","conversion_output":true,"text":"including no to very low doses, but reasons for not using high-intensity statin dosing","text_display":" including no to very low doses, but reasons for not using high-intensity statin dosing","confidence":1,"confidence_rate":1},{"cnt":[[370,2406],[733,2406],[733,2447],[370,2447]],"region":{"top_left_x":369,"top_left_y":2406,"width":364,"height":42},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"833bc957447d463ca6fbdd6b3a131186","type":"text","conversion_output":true,"text":"must be documented.","text_display":" must be 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In the case of PCSK9 inhibitor use,","text_display":" Visit S1 and are taken at a consistent time each day. In the case of PCSK9 inhibitor use,","confidence":1,"confidence_rate":1},{"cnt":[[370,563],[1852,563],[1852,614],[370,614]],"region":{"top_left_x":369,"top_left_y":562,"width":1483,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e7cba6f9f304141bfdcb8177172f8cb","type":"text","conversion_output":true,"text":"the patient must have received 3 stable doses and all lipid values obtained \\(1-2\\) days prior","text_display":" the patient must have received 3 stable doses and all lipid values obtained \\(1-2\\) days prior","confidence":0.6220703125,"confidence_rate":0.9953110065288969},{"cnt":[[370,614],[1807,614],[1807,664],[370,664]],"region":{"top_left_x":369,"top_left_y":614,"width":1438,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8690ab7cc86a4ed983d25621e159c462","type":"text","conversion_output":true,"text":"to their next dose. Patients must have not discontinued investigational or commercial","text_display":" to their next dose. Patients must have not discontinued investigational or commercial","confidence":1,"confidence_rate":1},{"cnt":[[370,662],[1405,662],[1405,711],[370,711]],"region":{"top_left_x":369,"top_left_y":661,"width":1037,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4d775b720714bf1ad4541c7bcad638b","type":"text","conversion_output":true,"text":"PCSK9 inhibitor within 4 months prior to Screening Visit S1.","text_display":" PCSK9 inhibitor within 4 months prior to Screening Visit S1.","confidence":1,"confidence_rate":1},{"cnt":[[241,730],[440,730],[440,778],[241,778]],"region":{"top_left_x":240,"top_left_y":730,"width":201,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d1aae97373d44c5b918aa38ab1b312f","type":"section_header","conversion_output":false,"children_ids":["6bfb6d1110264b18a80883dd536420be"],"text":"","text_display":""},{"cnt":[[245,735],[436,735],[436,776],[245,776]],"region":{"top_left_x":244,"top_left_y":734,"width":193,"height":42},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bfb6d1110264b18a80883dd536420be","type":"text","conversion_output":true,"parent_id":"7d1aae97373d44c5b918aa38ab1b312f","text":"New Text:","text_display":"\n\n\\section*{New Text:}","confidence":1,"confidence_rate":1},{"cnt":[[312,804],[1639,804],[1639,853],[312,853]],"region":{"top_left_x":311,"top_left_y":803,"width":1329,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a8333b4c2ce4d9caba8225b44431298","type":"text","conversion_output":true,"text":"1. Provision of written informed consent prior to any study-specific procedure","text_display":"\n1. Provision of written informed consent prior to any study-specific procedure","confidence":1,"confidence_rate":1},{"cnt":[[305,872],[1798,872],[1798,922],[305,922]],"region":{"top_left_x":305,"top_left_y":872,"width":1494,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25bdd17ea443465f875c09fcf14b4819","type":"text","conversion_output":true,"text":"2. Age \\(\\geq 18\\) years or legal age of majority based on regional law, whichever is greater at","text_display":"\n2. Age \\(\\geq 18\\) years or legal age of majority based on regional law, whichever is greater at","confidence":1,"confidence_rate":1},{"cnt":[[370,920],[694,920],[694,969],[370,969]],"region":{"top_left_x":369,"top_left_y":919,"width":325,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c743096830c4a9d8ada7b51fda889b8","type":"text","conversion_output":true,"text":"Week -5 (Visit S1)","text_display":" Week -5 (Visit S1)","confidence":1,"confidence_rate":1},{"cnt":[[305,988],[1113,988],[1113,1038],[305,1038]],"region":{"top_left_x":305,"top_left_y":988,"width":808,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5403b889f3a84f19b899e9666f5878fe","type":"text","conversion_output":true,"text":"3. Men and nonpregnant, nonlactating women.","text_display":"\n3. Men and nonpregnant, nonlactating women.","confidence":1,"confidence_rate":1},{"cnt":[[305,1057],[767,1057],[767,1102],[305,1102]],"region":{"top_left_x":305,"top_left_y":1057,"width":462,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3057a3cc53040ec8feb229d62cb4eef","type":"text","conversion_output":true,"text":"4. Women must be either:","text_display":"\n4. Women must be either:","confidence":1,"confidence_rate":1},{"cnt":[[370,1130],[1871,1130],[1871,1179],[370,1179]],"region":{"top_left_x":369,"top_left_y":1130,"width":1503,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7838ce8efa9c4947b35e7b0712d7908a","type":"text","conversion_output":true,"text":"- Naturally postmenopausal (as reported by the patient, defined as greater than 55 years","text_display":"\n- Naturally postmenopausal (as reported by the patient, defined as greater than 55 years","confidence":1,"confidence_rate":1},{"cnt":[[434,1179],[1798,1179],[1798,1227],[434,1227]],"region":{"top_left_x":433,"top_left_y":1179,"width":1366,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c81c7ba00514c02ade8e821cb848f79","type":"text","conversion_output":true,"text":"and \\(\\geq 1\\) year without menses, \\(<55\\) years and \\(\\geq 1\\) year without menses with follicle-","text_display":" and \\(\\geq 1\\) year without menses, \\(<55\\) years and \\(\\geq 1\\) year without menses with follicle","confidence":1,"confidence_rate":1},{"cnt":[[434,1229],[1869,1229],[1869,1278],[434,1278]],"region":{"top_left_x":433,"top_left_y":1228,"width":1437,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2367208a8e29482baf670aee3d627884","type":"text","conversion_output":true,"text":"stimulating hormone (FSH) \\(\\geq 40.0 IU / L\\) ), or surgically sterile including hysterectomy,","text_display":"stimulating hormone (FSH) \\(\\geq 40.0 IU / L\\) ), or surgically sterile including hysterectomy,","confidence":0.8369934558868408,"confidence_rate":0.9981859430362171},{"cnt":[[432,1276],[1171,1276],[1171,1326],[432,1326]],"region":{"top_left_x":431,"top_left_y":1276,"width":740,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18d227c0f56e484bbc71a9934868e826","type":"text","conversion_output":true,"text":"bilateral oophorectomy, or tubal ligation or;","text_display":" bilateral oophorectomy, or tubal ligation or;","confidence":1,"confidence_rate":1},{"cnt":[[372,1349],[1833,1349],[1833,1399],[372,1399]],"region":{"top_left_x":371,"top_left_y":1349,"width":1462,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8ea8e94e50a4705b4468a68c5873a39","type":"text","conversion_output":true,"text":"- Women of childbearing potential must be willing to use +2 acceptable methods of","text_display":"\n- Women of childbearing potential must be willing to use +2 acceptable methods of","confidence":0.6488027572631836,"confidence_rate":0.9951508231985278},{"cnt":[[432,1396],[1824,1396],[1824,1446],[432,1446]],"region":{"top_left_x":431,"top_left_y":1396,"width":1394,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2be190e072a44d79c92e3d67ea4da96","type":"text","conversion_output":true,"text":"birth control (unless they have agreed to follow the definition of true abstinence).","text_display":" birth control (unless they have agreed to follow the definition of true abstinence).","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[432,1444],[1846,1444],[1846,1493],[432,1493]],"region":{"top_left_x":431,"top_left_y":1443,"width":1415,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fb3f692cf1f4ee4ae7d9949de74a4be","type":"text","conversion_output":true,"text":"The minimal requirement for adequate contraception it is that it should be started on","text_display":" The minimal requirement for adequate contraception it is that it should be started on","confidence":1,"confidence_rate":1},{"cnt":[[432,1493],[1850,1493],[1850,1543],[432,1543]],"region":{"top_left_x":431,"top_left_y":1493,"width":1419,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b326a670b9b84839aaa0ea90206c5fd7","type":"text","conversion_output":true,"text":"Day 1 , continuing during the study period, and for at least 30 days after the last dose","text_display":" Day 1 , continuing during the study period, and for at least 30 days after the last dose","confidence":0.888671875,"confidence_rate":0.9988085163800413},{"cnt":[[434,1543],[1751,1543],[1751,1592],[434,1592]],"region":{"top_left_x":433,"top_left_y":1542,"width":1318,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"889789d0ad0e45cabb253d29aa1eda31","type":"text","conversion_output":true,"text":"of study drug. Acceptable methods of birth control include: oral, implantable,","text_display":" of study drug. Acceptable methods of birth control include: oral, implantable,","confidence":0.9990236759185791,"confidence_rate":0.9999882313825493},{"cnt":[[432,1590],[1830,1590],[1830,1639],[432,1639]],"region":{"top_left_x":431,"top_left_y":1589,"width":1400,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6f011c190784ba893dbfcd27afdc18a","type":"text","conversion_output":true,"text":"injectable, or topical birth control medications; placement of an intrauterine device","text_display":" injectable, or topical birth control medications; placement of an intrauterine device","confidence":1,"confidence_rate":1},{"cnt":[[434,1637],[1863,1637],[1863,1689],[434,1689]],"region":{"top_left_x":433,"top_left_y":1637,"width":1430,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62ddca65fd004ba0a1775e4fabb8dc74","type":"text","conversion_output":true,"text":"(IUD) with or without hormones; barrier methods including condom or occlusive cap","text_display":" (IUD) with or without hormones; barrier methods including condom or occlusive cap","confidence":1,"confidence_rate":1},{"cnt":[[434,1689],[1880,1689],[1880,1738],[434,1738]],"region":{"top_left_x":433,"top_left_y":1688,"width":1447,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5052943a9ec843a4a474baca2d8dfe46","type":"text","conversion_output":true,"text":"with spermicidal foam or spermicidal jelly; vasectomized male partner who is the sole","text_display":" with spermicidal foam or spermicidal jelly; vasectomized male partner who is the sole","confidence":1,"confidence_rate":1},{"cnt":[[432,1736],[1837,1736],[1837,1785],[432,1785]],"region":{"top_left_x":431,"top_left_y":1735,"width":1406,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"749df81b7d374e53b6faa6bee92e74cd","type":"text","conversion_output":true,"text":"partner for this patient; or true abstinence when this is in line with the preferred and","text_display":" partner for this patient; or true abstinence when this is in line with the preferred and","confidence":1,"confidence_rate":1},{"cnt":[[434,1783],[1669,1783],[1669,1833],[434,1833]],"region":{"top_left_x":433,"top_left_y":1783,"width":1237,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6c3ef4a1710428ebc1f6a5cc2772b3f","type":"text","conversion_output":true,"text":"usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation,","text_display":" usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation,","confidence":0.9990236759185791,"confidence_rate":0.9999880878636791},{"cnt":[[432,1835],[1863,1835],[1863,1884],[432,1884]],"region":{"top_left_x":431,"top_left_y":1834,"width":1432,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2854f8c56ca5406cb682f9dbc5110f2a","type":"text","conversion_output":true,"text":"symptothermal, postovulation methods], declaration of abstinence for the duration of","text_display":" symptothermal, postovulation methods], declaration of abstinence for the duration of","confidence":1,"confidence_rate":1},{"cnt":[[434,1882],[1618,1882],[1618,1931],[434,1931]],"region":{"top_left_x":433,"top_left_y":1882,"width":1185,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1680087d38149f89cd66fcf62214a1c","type":"text","conversion_output":true,"text":"the trial, and withdrawal are not acceptable methods of contraception).","text_display":" the trial, and withdrawal are not acceptable methods of contraception).","confidence":1,"confidence_rate":1},{"cnt":[[370,1951],[1841,1951],[1841,2000],[370,2000]],"region":{"top_left_x":369,"top_left_y":1950,"width":1473,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b8be79d166d4b55a1a2b3b3f8ad05b1","type":"text","conversion_output":true,"text":"There are no protocol-specific birth control requirements for men with partners who are","text_display":"\n\nThere are no protocol-specific birth control requirements for men with partners who are","confidence":1,"confidence_rate":1},{"cnt":[[370,2000],[797,2000],[797,2047],[370,2047]],"region":{"top_left_x":369,"top_left_y":2000,"width":429,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3e9794e97c4496cbc691d89468cb3ab","type":"text","conversion_output":true,"text":"able to become pregnant.","text_display":" able to become pregnant.","confidence":1,"confidence_rate":1},{"cnt":[[305,2069],[1721,2069],[1721,2121],[305,2121]],"region":{"top_left_x":305,"top_left_y":2068,"width":1416,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cccdbd7607d4d93a522a17dbbbc335d","type":"text","conversion_output":true,"text":"5. Fasting LDL-C (minimum of 10 hours) value at Week -5 (Visit S1) \\(\\geq 100 mg / dL\\)","text_display":"\n5. Fasting LDL-C (minimum of 10 hours) value at Week -5 (Visit S1) \\(\\geq 100 mg / dL","confidence":0.9892982799008716,"confidence_rate":0.9998830568888383},{"cnt":[[370,2118],[1841,2118],[1841,2168],[370,2168]],"region":{"top_left_x":369,"top_left_y":2118,"width":1473,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86af3db72e5d4d31a39db308e12283ec","type":"text","conversion_output":true,"text":"\\((2.6 mmol / L )\\) and fasting LDL-C value at Week-1 (Visit S3) \\(\\geq 70\\) mg/dL (1.8 mmol/L)","text_display":" (2.6 mmol / L )\\) and fasting LDL-C value at Week-1 (Visit S3) \\(\\geq 70\\) mg/dL (1.8 mmol/L)","confidence":0.6629767794772125,"confidence_rate":0.9955424069432439},{"cnt":[[370,2187],[1858,2187],[1858,2237],[370,2237]],"region":{"top_left_x":369,"top_left_y":2187,"width":1490,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c01da1667284d1bad62282e5633f966","type":"text","conversion_output":true,"text":"Note: LDL C may be repeated 1 time with the screening period extended up to 4 weeks.","text_display":"\n\nNote: LDL C may be repeated 1 time with the screening period extended up to 4 weeks.","confidence":0.92718510562554,"confidence_rate":0.9992045055114694},{"cnt":[[370,2237],[1824,2237],[1824,2288],[370,2288]],"region":{"top_left_x":369,"top_left_y":2236,"width":1456,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ae5812795944ca7bdfef9ab5359aa0c","type":"text","conversion_output":true,"text":"For those patients who have a repeat \\(L D L C\\), the mean of the first value and the repeat","text_display":" For those patients who have a repeat \\(L D L C\\), the mean of the first value and the repeat","confidence":0.5496812636543531,"confidence_rate":0.9936540859116428},{"cnt":[[370,2282],[1085,2282],[1085,2335],[370,2335]],"region":{"top_left_x":369,"top_left_y":2281,"width":716,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b9bb847f8f14f3ca31f917cc043932a","type":"text","conversion_output":true,"text":"value will be used to determine eligibility.","text_display":" value will be used to determine eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2621],[245,2621]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":44},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ee9009a7eea4a4b9c504741d5d3fec5","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[924,2580],[1201,2580],[1201,2628],[924,2628]],"region":{"top_left_x":923,"top_left_y":2580,"width":278,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0d9b6e9fa874aad92534128d35092c3","type":"page_info","conversion_output":false,"text":"Page 118 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"5bf2b0f7-f4ca-467b-b9ee-e838bf969c31-119","page":119,"lines":[{"cnt":[[245,129],[535,129],[535,174],[245,174]],"region":{"top_left_x":244,"top_left_y":128,"width":291,"height":47},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f78eb64bec7465e9f1156ec014ec5d4","type":"page_info","conversion_output":false,"text":"Bempedoic Acid","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1414,129],[1876,129],[1876,174],[1414,174]],"region":{"top_left_x":1413,"top_left_y":128,"width":463,"height":47},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6845f45a1657418fba392b81d99534fe","type":"page_info","conversion_output":false,"text":"Esperion Therapeutics, Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,221],[245,221]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"880bf1358c0a43f08f51a4553e5940c7","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1876,176],[1876,221],[1388,221]],"region":{"top_left_x":1387,"top_left_y":176,"width":489,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26cc03ac24ca42cbb13b858adb254c96","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,254],[1098,254],[1098,303],[309,303]],"region":{"top_left_x":309,"top_left_y":253,"width":789,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f56de8841bab4ef199537537a602f097","type":"text","conversion_output":true,"text":"6. Have high CV risk that is defined as either:","text_display":"\n6. Have high CV risk that is defined as either:","confidence":1,"confidence_rate":1},{"cnt":[[372,327],[1790,327],[1790,372],[372,372]],"region":{"top_left_x":371,"top_left_y":326,"width":1419,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c481239539d045b19894d175839abb56","type":"text","conversion_output":true,"text":"- Diagnosis of HeFH. Diagnosis must be made by either genotyping or by clinical","text_display":"\n- Diagnosis of HeFH. Diagnosis must be made by either genotyping or by clinical","confidence":0.99658203125,"confidence_rate":0.999959241028889},{"cnt":[[434,374],[1841,374],[1841,421],[434,421]],"region":{"top_left_x":433,"top_left_y":373,"width":1409,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"405e1d6a9f044ec1b441eb37d4c63be2","type":"text","conversion_output":true,"text":"assessment using either the World Health Organization (WHO) criteria/Dutch Lipid","text_display":" assessment using either the World Health Organization (WHO) criteria/Dutch Lipid","confidence":0.99853515625,"confidence_rate":0.9999827540583306},{"cnt":[[434,423],[1760,423],[1760,471],[434,471]],"region":{"top_left_x":433,"top_left_y":423,"width":1327,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb46e5d379524ff1acf47a2521f4b936","type":"text","conversion_output":true,"text":"Clinical Network Criteria with a score that is \\(>8\\) points (see Appendix 4) or the","text_display":" Clinical Network Criteria with a score that is \\(>8\\) points (see Appendix 4) or the","confidence":0.9699666183441877,"confidence_rate":0.9996535415969983},{"cnt":[[434,471],[1833,471],[1833,518],[434,518]],"region":{"top_left_x":433,"top_left_y":470,"width":1400,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37cc931d23be46d5a7a8dfc881cd96ec","type":"text","conversion_output":true,"text":"Simon Broome Register Diagnostic Criteria with an assessment of 'Definite HeFH'","text_display":" Simon Broome Register Diagnostic Criteria with an assessment of 'Definite HeFH'","confidence":1,"confidence_rate":1},{"cnt":[[434,520],[1691,520],[1691,569],[434,569]],"region":{"top_left_x":433,"top_left_y":519,"width":1258,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e086e289860843348bf03cc75c40ff10","type":"text","conversion_output":true,"text":"(see Appendix 5). 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The SAP will be included as an appendix in the clinical study report for this","text_display":" appropriate. 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The","text_display":"\n\nThe primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C. 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Only observed case data will be used (no imputation for missing data). Output from","text_display":" analyses. Only observed case data will be used (no imputation for missing data). 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Baseline LDL-C is defined as the mean of the LDL-C values from Week -1 (Visit S3)","text_display":"\ncovariate. Baseline LDL-C is defined as the mean of the LDL-C values from Week -1 (Visit S3)","confidence":0.7877011299133301,"confidence_rate":0.997542853246213},{"cnt":[[245,301],[1811,301],[1811,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1568,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03874110f09a4bb884381fbf6a738e75","type":"text","conversion_output":true,"text":"and predose Day 1/Week 0 (Visit T1). If a repeat lipid measurement is performed at Week -1","text_display":" and predose Day 1/Week 0 (Visit T1). 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A pattern mixture model (PMM) will be used to","text_display":" that accounts for treatment adherence. A pattern mixture model (PMM) will be used to","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[245,662],[1755,662],[1755,711],[245,711]],"region":{"top_left_x":244,"top_left_y":661,"width":1512,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce0f7d7d2cf24575a303244ce7bb5bd9","type":"text","conversion_output":true,"text":"specify different imputation strategies depending on whether the patient is still on study","text_display":" specify different imputation strategies depending on whether the patient is still on study","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[245,713],[1835,713],[1835,763],[245,763]],"region":{"top_left_x":244,"top_left_y":713,"width":1591,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53cfc65e4ddb4ac0b4eb647fc5235503","type":"text","conversion_output":true,"text":"treatment. Imputed datasets will be analyzed using ANCOVA with treatment group, CV risk","text_display":" treatment. 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The PMM will be used to specify different imputation strategies depending on","text_display":" confirmatory. The PMM will be used to specify different imputation strategies depending on","confidence":1,"confidence_rate":1},{"cnt":[[245,1508],[1749,1508],[1749,1560],[245,1560]],"region":{"top_left_x":244,"top_left_y":1508,"width":1505,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aae3525dd2cc42ec9be6cc49961c1b79","type":"text","conversion_output":true,"text":"whether the patient is still on study treatment. The PMM will be used to specify different","text_display":" whether the patient is still on study treatment. 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In this instance, it is reasonable to impute LDL C values","text_display":" returning toward their baseline value. In this instance, it is reasonable to impute LDL C values","confidence":0.99658203125,"confidence_rate":0.9999661013334881},{"cnt":[[245,1753],[1807,1753],[1807,1803],[245,1803]],"region":{"top_left_x":244,"top_left_y":1753,"width":1563,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b927b68d9cf4a6fbd4d8140e7a9b702","type":"text","conversion_output":true,"text":"based on the patients' baseline value. Patients with missing LDL C data at Week 12 who are","text_display":" based on the patients' baseline value. Patients with missing LDL C data at Week 12 who are","confidence":0.8386787287890911,"confidence_rate":0.9982064311109733},{"cnt":[[245,1800],[1809,1800],[1809,1850],[245,1850]],"region":{"top_left_x":244,"top_left_y":1800,"width":1565,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56ccf7126d034e0b9c98679e3da93918","type":"text","conversion_output":true,"text":"still taking study treatment can be assumed to continue to benefit from study medication, and","text_display":" still taking study treatment can be assumed to continue to benefit from study medication, and","confidence":1,"confidence_rate":1},{"cnt":[[245,1850],[1848,1850],[1848,1899],[245,1899]],"region":{"top_left_x":244,"top_left_y":1849,"width":1604,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"634e9a91d17c4123ac3b99a854ae7c11","type":"text","conversion_output":true,"text":"their missing value(s) can be assumed to be similar to those who remain on study treatment and","text_display":" their missing value(s) can be assumed to be similar to those who remain on study treatment and","confidence":0.9683599066920578,"confidence_rate":0.9996752905439368},{"cnt":[[245,1897],[1768,1897],[1768,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1897,"width":1525,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20a1ad3cf60c4dfb8f362f69e99e7f1d","type":"text","conversion_output":true,"text":"have data. In this instance, it is reasonable to impute LDL C values based on the observed","text_display":" have data. In this instance, it is reasonable to impute LDL C values based on the observed","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[245,1946],[1798,1946],[1798,1996],[245,1996]],"region":{"top_left_x":244,"top_left_y":1946,"width":1555,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71ddb2e955464dcbadc571edf0db4b71","type":"text","conversion_output":true,"text":"values in their randomized treatment group at Week 12. To account for uncertainty, missing","text_display":" values in their randomized treatment group at Week 12. 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Approximately","text_display":" intensity, low intensity) as factors and baseline LDL C as a covariate. 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For each type of ANCOVA (observed case; imputation via","text_display":" combined using Rubin's method. 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Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4abb96f39f2492eb279848c279c1871","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1878,176],[1878,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":491,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa8a23174f7241dfa984bba496985c7d","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,254],[1818,254],[1818,303],[245,303]],"region":{"top_left_x":244,"top_left_y":253,"width":1574,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"934531cd6e564f6481125ace02850641","type":"text","conversion_output":true,"text":"Key secondary efficacy endpoints are also of interest for this study, in terms of controlling the","text_display":"\n\nKey secondary efficacy endpoints are also of interest for this study, in terms of controlling the","confidence":1,"confidence_rate":1},{"cnt":[[245,303],[1833,303],[1833,350],[245,350]],"region":{"top_left_x":244,"top_left_y":302,"width":1589,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac30dad480354cf6ba5d25a8334c84a3","type":"text","conversion_output":true,"text":"overall Type I error rate. A gatekeeping or stepdown approach will be used to test the primary","text_display":" overall Type I error rate. A gatekeeping or stepdown approach will be used to test the primary","confidence":1,"confidence_rate":1},{"cnt":[[245,352],[1729,352],[1729,400],[245,400]],"region":{"top_left_x":244,"top_left_y":352,"width":1486,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"395632bd07174221bc2c3ba8585fbb32","type":"text","conversion_output":true,"text":"efficacy endpoint and then specific secondary efficacy endpoints sequentially in order to","text_display":" efficacy endpoint and then specific secondary efficacy endpoints sequentially in order to","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[245,400],[1876,400],[1876,449],[245,449]],"region":{"top_left_x":244,"top_left_y":399,"width":1632,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f04e570106148159993e841ef6abb10","type":"text","conversion_output":true,"text":"preserve the study-wise Type I error rate. The sequence for the stepdown procedure in this study","text_display":" preserve the study-wise Type I error rate. The sequence for the stepdown procedure in this study","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[473,447],[473,490],[245,490]],"region":{"top_left_x":244,"top_left_y":446,"width":229,"height":44},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da2fc5541bbc445da6028a03a161e443","type":"text","conversion_output":true,"text":"is as follows:","text_display":" is as follows:","confidence":1,"confidence_rate":1},{"cnt":[[309,516],[1846,516],[1846,569],[309,569]],"region":{"top_left_x":309,"top_left_y":515,"width":1537,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f51badad4f934531b65853b9f5d95e2b","type":"text","conversion_output":true,"text":"1. Test the primary efficacy endpoint: percent change from baseline to Week 12 in LDL-C","text_display":"\n1. 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Statistical significance at each step is required in order to test the next hypothesis. If the","text_display":"sided. Statistical significance at each step is required in order to test the next hypothesis. 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change from baseline to Weeks 12, 24, and 52 in LDL C; percent","text_display":" Weeks 24 and 52 in LDL C; change from baseline to Weeks 12, 24, and 52 in LDL C; percent","confidence":0.6847838541933718,"confidence_rate":0.9964341836970643},{"cnt":[[245,1293],[1783,1293],[1783,1343],[245,1343]],"region":{"top_left_x":244,"top_left_y":1293,"width":1540,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9cd68cf2eca4389906f3aca2031855a","type":"text","conversion_output":true,"text":"change from baseline to Weeks 12, 24, and 52, in HDL C, non HDL C, TG, TC, apoB, and","text_display":" change from baseline to Weeks 12, 24, and 52, in HDL C, non HDL C, TG, TC, apoB, and","confidence":0.6604156494140625,"confidence_rate":0.9953492095824789},{"cnt":[[245,1343],[1815,1343],[1815,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1342,"width":1572,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74e662c00cab4fe38fa0d9a19a3c5cc7","type":"text","conversion_output":true,"text":"hs CRP will each be analyzed using ANCOVA-with treatment group, CV risk (ASCVD only;","text_display":" hs CRP will each be analyzed using ANCOVA-with treatment group, CV risk (ASCVD only;","confidence":0.8310546875,"confidence_rate":0.9979228380790838},{"cnt":[[245,1392],[1852,1392],[1852,1442],[245,1442]],"region":{"top_left_x":244,"top_left_y":1392,"width":1608,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25bb526f7a6449b08a67bf089543a92e","type":"text","conversion_output":true,"text":"HeFH with or without ASCVD) and baseline statin intensity (high intensity, moderate intensity,","text_display":" HeFH with or without ASCVD) and baseline statin intensity (high intensity, moderate intensity,","confidence":0.77734375,"confidence_rate":0.9975093185924793},{"cnt":[[245,1439],[1326,1439],[1326,1489],[245,1489]],"region":{"top_left_x":244,"top_left_y":1439,"width":1082,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02e075c9232f4dcfbc8fe3b302f24a7e","type":"text","conversion_output":true,"text":"low intensity) as factors and the relevant baseline as a covariate.","text_display":" low intensity) as factors and the relevant baseline as a covariate.","confidence":0.98828125,"confidence_rate":0.9998362917939837},{"cnt":[[245,1508],[1818,1508],[1818,1560],[245,1560]],"region":{"top_left_x":244,"top_left_y":1508,"width":1574,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ef8fbbfaaac4554aaec4af325b8ae6d","type":"text","conversion_output":true,"text":"Baseline for HDL-C, non-HDL-C, TG, and TC will be defined as the mean of the lipid values","text_display":"\n\nBaseline for HDL-C, non-HDL-C, TG, and TC will be defined as the mean of the lipid values","confidence":1,"confidence_rate":1},{"cnt":[[245,1558],[1858,1558],[1858,1609],[245,1609]],"region":{"top_left_x":244,"top_left_y":1557,"width":1615,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fdfea33c7704edaa29bc3393635a9c1","type":"text","conversion_output":true,"text":"from Week -1 (Visit S3) and predose Day 1/Week 0 (Visit T1). 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If this optional basic","confidence":1,"confidence_rate":1},{"cnt":[[271,2093],[1846,2093],[1846,2133],[271,2133]],"region":{"top_left_x":270,"top_left_y":2092,"width":1576,"height":42},"line":235,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c97d29d2a7214a46b26a9c9133575754","type":"text","conversion_output":true,"text":"fasting (minimum of 10 hours) lipid value visit is completed, the mean of the first value and repeat lipid value will be used to","text_display":" fasting (minimum of 10 hours) lipid value visit is completed, the mean of the first value and repeat lipid value will be used to","confidence":1,"confidence_rate":1},{"cnt":[[271,2131],[539,2131],[539,2168],[271,2168]],"region":{"top_left_x":270,"top_left_y":2131,"width":270,"height":37},"line":236,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a9ecd55eb6249be862faed5b776040a","type":"text","conversion_output":true,"text":"determine eligibility.","text_display":" determine eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[245,2168],[1888,2168],[1888,2213],[245,2213]],"region":{"top_left_x":244,"top_left_y":2167,"width":1645,"height":46},"line":237,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"486cd1192f864bbe93dcad4cc9cc89e3","type":"text","conversion_output":true,"text":"\\({ }^{2}\\) An optional visit between Visits S1 and T1 may be completed if the patient's DBP and/or SBP meet the exclusion criteria levels.","text_display":"\n\\({ }^{2}\\) An optional visit between Visits S1 and T1 may be completed if the patient's DBP and/or SBP meet the exclusion criteria levels.","confidence":1,"confidence_rate":1},{"cnt":[[271,2209],[1955,2209],[1955,2249],[271,2249]],"region":{"top_left_x":270,"top_left_y":2208,"width":1686,"height":42},"line":238,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dac39f4f1363401dbe4dabfca94e1db1","type":"text","conversion_output":true,"text":"Patients may randomize after blood pressure medications have been adjusted, the patients have been on stable doses of blood pressure","text_display":" Patients may randomize after blood pressure medications have been adjusted, the patients have been on stable doses of blood pressure","confidence":1,"confidence_rate":1},{"cnt":[[271,2247],[1962,2247],[1962,2284],[271,2284]],"region":{"top_left_x":270,"top_left_y":2247,"width":1692,"height":37},"line":239,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20aeabe680724428aa4ddf879d4ad28f","type":"text","conversion_output":true,"text":"medications for at least 2 weeks, and the repeat blood pressure values (DBP and/or SBP) do not meet exclusionary values. An optional","text_display":" medications for at least 2 weeks, and the repeat blood pressure values (DBP and/or SBP) do not meet exclusionary values. An optional","confidence":1,"confidence_rate":1},{"cnt":[[271,2282],[1940,2282],[1940,2322],[271,2322]],"region":{"top_left_x":270,"top_left_y":2281,"width":1671,"height":42},"line":240,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3ca065e0d3b4dc5a783df10ce6e2685","type":"text","conversion_output":true,"text":"visit between Visit S1 and T1 may be completed to determine eligibility if the patient's eGFR, ALT, AST, and/or TB meet exclusion","text_display":" visit between Visit S1 and T1 may be completed to determine eligibility if the patient's eGFR, ALT, AST, and/or TB meet exclusion","confidence":0.99853515625,"confidence_rate":0.9999890603756404},{"cnt":[[271,2316],[1579,2316],[1579,2357],[271,2357]],"region":{"top_left_x":270,"top_left_y":2316,"width":1310,"height":41},"line":241,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18a81de819e14fd6af82e830de4bcc7a","type":"text","conversion_output":true,"text":"criteria levels. If this optional visit is completed, the repeated value will be used to determine eligibility.","text_display":" criteria levels. If this optional visit is completed, the repeated value will be used to determine eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[245,2355],[1811,2355],[1811,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2354,"width":1568,"height":46},"line":242,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f37a22557d5f4b94a4bf599019fb571f","type":"text","conversion_output":true,"text":"\\({ }^{3}\\) All procedures will be completed for all patients at either End of Study (EOS) if completing the study or early withdrawal.","text_display":"\n\\({ }^{3}\\) All procedures will be completed for all patients at either End of Study (EOS) if completing the study or early withdrawal.","confidence":1,"confidence_rate":1},{"cnt":[[245,2398],[1876,2398],[1876,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2397,"width":1632,"height":46},"line":243,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a152e71d914040149f5b777e00d96293","type":"text","conversion_output":true,"text":"\\({ }^{4}\\) Body weight will be measured while fasting, using consistent scales, after voiding, and without shoes and outerwear (eg, coats).","text_display":"\n\\({ }^{4}\\) Body weight will be measured while fasting, using consistent scales, after voiding, and without shoes and outerwear (eg, coats).","confidence":1,"confidence_rate":1},{"cnt":[[245,2441],[1212,2441],[1212,2486],[245,2486]],"region":{"top_left_x":244,"top_left_y":2440,"width":968,"height":46},"line":244,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b53a93a4778469ba92c314400734415","type":"text","conversion_output":true,"text":"\\({ }^{5}\\) Single 12-lead ECG will be collected prior to any blood sample collection.","text_display":"\n\\({ }^{5}\\) Single 12-lead ECG will be collected prior to any blood sample collection.","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2623],[245,2623]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":46},"line":245,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d18e155a00aa4913bc82a9dfee3893fc","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[922,2580],[1201,2580],[1201,2628],[922,2628]],"region":{"top_left_x":921,"top_left_y":2580,"width":280,"height":48},"line":246,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa598e77249a43928e40128e0a816ae3","type":"page_info","conversion_output":false,"text":"Page 160 of 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Acid","confidence":1,"confidence_rate":1},{"cnt":[[245,176],[814,176],[814,226],[245,226]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"105432092b5c484a9933ea50f67195aa","type":"text","conversion_output":true,"parent_id":"34cba014b6ea49d082317933c18bb1b5","text":"Clinical Study Protocol 1002-047","text_display":" \\\\ Clinical Study Protocol 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Inc.","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":6,"column":1,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a9cd718ef114c5580c14c8c1bb783a7","type":"text","conversion_output":true,"parent_id":"9bc6fb4996404bba9a272c139d803d3e","text":"Amendment 3, 09 May 2017","text_display":"\nAmendment 3, 09 May 2017","confidence":1,"confidence_rate":1},{"cnt":[[245,245],[1936,245],[1936,290],[245,290]],"region":{"top_left_x":244,"top_left_y":244,"width":1692,"height":47},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dda3691bba8a4db6b8db83c302c32b8e","type":"text","conversion_output":true,"text":"\\({ }^{6}\\) Vital signs will include DBP, SBP, and HR and will be collected prior to any blood sample collection. Patient will rest for 5 minutes","text_display":"\n\\({ }^{6}\\) Vital signs will include DBP, SBP, and HR and will be collected prior to any blood sample collection. Patient will rest for 5 minutes","confidence":1,"confidence_rate":1},{"cnt":[[271,288],[531,288],[531,324],[271,324]],"region":{"top_left_x":270,"top_left_y":287,"width":261,"height":38},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ddde8b57fa1f4f749551fd3dd757075d","type":"text","conversion_output":true,"text":"prior to assessments","text_display":" prior to assessments","confidence":1,"confidence_rate":1},{"cnt":[[245,322],[621,322],[621,367],[245,367]],"region":{"top_left_x":244,"top_left_y":322,"width":377,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f3f17b228654a66a1557ebe2a7e7505","type":"text","conversion_output":true,"text":"\\({ }^{7}\\) Serology for HBsAg, HCV","text_display":"\n\\({ }^{7}\\) Serology for HBsAg, HCV","confidence":1,"confidence_rate":1},{"cnt":[[245,365],[1949,365],[1949,410],[245,410]],"region":{"top_left_x":244,"top_left_y":365,"width":1705,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b1701c9f94a4227bc64000a00b0a19c","type":"text","conversion_output":true,"text":"\\({ }^{8}\\) Serum pregnancy test completed in premenopausal women only. FSH test is completed in women \\(<55\\) years old and \\(>1\\) year without","text_display":"\n\\({ }^{8}\\) Serum pregnancy test completed in premenopausal women only. FSH test is completed in women \\(<55\\) years old and \\(>1\\) year without","confidence":0.99853515625,"confidence_rate":0.9999897488799382},{"cnt":[[271,408],[1442,408],[1442,449],[271,449]],"region":{"top_left_x":270,"top_left_y":408,"width":1172,"height":42},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cbf983abf7a34d039084a0aef256cc48","type":"text","conversion_output":true,"text":"menses. Urine pregnancy test in women of childbearing potential just prior to randomization.","text_display":" menses. Urine pregnancy test in women of childbearing potential just prior to randomization.","confidence":1,"confidence_rate":1},{"cnt":[[245,447],[1938,447],[1938,490],[245,490]],"region":{"top_left_x":244,"top_left_y":446,"width":1694,"height":44},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a298b46dfc5e4812b69bae296987e2e5","type":"text","conversion_output":true,"text":"\\({ }^{9}\\) Clinical safety labs include hematology, blood chemistry, and urinalysis at all visits. Coagulation is included at Screening (Visit S1),","text_display":"\n\\({ }^{9}\\) Clinical safety labs include hematology, blood chemistry, and urinalysis at all visits. Coagulation is included at Screening (Visit S1),","confidence":1,"confidence_rate":1},{"cnt":[[271,486],[1656,486],[1656,526],[271,526]],"region":{"top_left_x":270,"top_left_y":485,"width":1387,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"86fb58eed29f43e5bc69d8d349aff9c8","type":"text","conversion_output":true,"text":"Baseline (Visit T1) only if on anticoagulants). Please refer to laboratory manual for detailed schedule of tests.","text_display":" Baseline (Visit T1) only if on anticoagulants). Please refer to laboratory manual for detailed schedule of tests.","confidence":1,"confidence_rate":1},{"cnt":[[247,524],[1880,524],[1880,569],[247,569]],"region":{"top_left_x":247,"top_left_y":524,"width":1633,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"114bfb8de5d44906a7b8b776e7ca008c","type":"text","conversion_output":true,"text":"\\({ }^{10}\\) Basic fasting (minimum of 10 hours) lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides.","text_display":"\n\\({ }^{10}\\) Basic fasting (minimum of 10 hours) lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides.","confidence":0.99951171875,"confidence_rate":0.9999965361726791},{"cnt":[[271,567],[1010,567],[1010,604],[271,604]],"region":{"top_left_x":270,"top_left_y":567,"width":740,"height":37},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dca1ba9991d64132bca6dc58edec5035","type":"text","conversion_output":true,"text":"Repeat within 1 week if exceed protocol-specified criteria.","text_display":" Repeat within 1 week if exceed protocol-specified criteria.","confidence":1,"confidence_rate":1},{"cnt":[[245,602],[1583,602],[1583,649],[245,649]],"region":{"top_left_x":244,"top_left_y":601,"width":1340,"height":48},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b583e117f330483aa4d0321e8b07e2b3","type":"text","conversion_output":true,"text":"\\({ }^{11}\\) Diet and exercise counseling per local and/or regional guidelines for the management of hyperlipidemia.","text_display":"\n\\({ }^{11}\\) Diet and exercise counseling per local and/or regional guidelines for the management of hyperlipidemia.","confidence":0.99951171875,"confidence_rate":0.999995825645481},{"cnt":[[245,645],[1558,645],[1558,690],[245,690]],"region":{"top_left_x":244,"top_left_y":644,"width":1314,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da2295060c7f4bf3b88a2f4c41a0ea94","type":"text","conversion_output":true,"text":"\\({ }^{12}\\) IWRS contact at either an early withdrawal or an EOS visit to register study discontinuation visit date.","text_display":"\n\\({ }^{12}\\) IWRS contact at either an early withdrawal or an EOS visit to register study discontinuation visit date.","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[247,688],[1858,688],[1858,733],[247,733]],"region":{"top_left_x":247,"top_left_y":687,"width":1612,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"297b437a34ac4984aef9cea90ee0fba3","type":"text","conversion_output":true,"text":"\\({ }^{13}\\) Depending upon the length of time between visits, 1 or 2 bottles of study medication will be dispensed as instructed by IWRS.","text_display":"\n\\({ }^{13}\\) Depending upon the length of time between visits, 1 or 2 bottles of study medication will be dispensed as instructed by IWRS.","confidence":0.99951171875,"confidence_rate":0.9999966317263753},{"cnt":[[247,730],[1931,730],[1931,776],[247,776]],"region":{"top_left_x":247,"top_left_y":730,"width":1685,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f16b5d2980f47f7aad960c1d9e1f23a","type":"text","conversion_output":true,"text":"\\({ }^{14}\\) If patient is discontinuing treatment and completing the EOS visit, but will be continuing in the study either by returning to clinic or","text_display":"\n\\({ }^{14}\\) If patient is discontinuing treatment and completing the EOS visit, but will be continuing in the study either by returning to clinic or","confidence":0.99951171875,"confidence_rate":0.99999674400198},{"cnt":[[271,773],[1571,773],[1571,812],[271,812]],"region":{"top_left_x":270,"top_left_y":773,"width":1301,"height":40},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61f989b92b0b4e68bd6fc8cb246e7989","type":"text","conversion_output":true,"text":"by phone, continue to schedule study visits for the patient according to the protocol Schedule of Events","text_display":" by phone, continue to schedule study visits for the patient according to the protocol Schedule of Events","confidence":0.9990234375,"confidence_rate":0.9999910363736797},{"cnt":[[241,907],[440,907],[440,956],[241,956]],"region":{"top_left_x":240,"top_left_y":906,"width":201,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7befe425bbaf4b46b09073333ac6caa3","type":"section_header","conversion_output":false,"children_ids":["be86d111e59144b98f017c6fd4f86881"],"text":"","text_display":""},{"cnt":[[245,911],[436,911],[436,952],[245,952]],"region":{"top_left_x":244,"top_left_y":910,"width":193,"height":42},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be86d111e59144b98f017c6fd4f86881","type":"text","conversion_output":true,"parent_id":"7befe425bbaf4b46b09073333ac6caa3","text":"New Text:","text_display":"\n\n\\section*{New 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SCHEDULE OF EVENTS (SUBJECT VISIT SCHEDULE)","text_display":"\n\n\\section*{APPENDIX 1. 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& Screen & Run-in & & \\multicolumn{5}{|c|}{Treatment*} & & \\\\\n\\hline Visit & \\(S 1 ^{ 1 , 2 }\\) & S2 & S3 & T1 & T2 & T3/phone & T4 & T5 & T6/phone & T7/EOS \\({ }^{ 3 }\\) \\\\\n\\hline Week & Wk -5 & Wk -4 & Wk -1 & Wk 0 & Wk 4 & Wk 8 & Wk 12 & Wk 24 & Wk 36 & Wk 52 \\\\\n\\hline Procedure & Day \\(- 3 5 \\pm 7\\) & Day \\(-28 \\pm 3\\) & Day \\(-7 \\pm 3\\) & Day 1 & Day \\(2 9 \\pm 3\\) & Day \\(5 7 \\pm 3\\) & Day \\(8 5 \\pm 3\\) & Day \\(1 6 9 \\pm 7\\) & Day \\(2 5 2 \\pm 7\\) & Day 365 \\(\\pm 7\\) \\\\\n\\hline Informed Consent & x & & & & & & & & & \\\\\n\\hline Enrollment Criteria & x & & & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & & & \\\\\n\\hline Medical History & X & & & & & & & & & \\\\\n\\hline HeFH Status Determination & X & & & & & & & & & \\\\\n\\hline Concomitant Medications & X & X & X & X & X & X & X & X & X & X \\\\\n\\hline Adverse Event Recording & & x & X & X & x & X & X & X & X & X \\\\\n\\hline Physical Exam & & & & x & & & & & & x \\\\\n\\hline Weight \\({ }^{4}\\) & x & & & x & x & & x & x & & x \\\\\n\\hline Height/BMI & x & & & & & & & & & \\\\\n\\hline 12-Lead ECG \\({ }^{5}\\) & & & & x & & & & & & x \\\\\n\\hline Vital Signs \\({ }^{6}\\) & x & x & x & x & x & & x & x & & X \\\\\n\\hline Serology \\({ }^{7}\\) & X & & & & & & & & & \\\\\n\\hline Serum Pregnancy and/or \\(FSH ^{8}\\) & X & & & & & & & & & \\\\\n\\hline Urine Pregnancy Test \\({ }^{8}\\) & & & & X & & & & & & \\\\\n\\hline TSH & X & & & & & & & & & \\\\\n\\hline Clinical Safety Labs \\({ }^{9}\\) & X & & & X & x & & x & X & & X \\\\\n\\hline Basic Fasting Lipids \\({ }^{10}\\) & X & & X & X & X & & X & X & & X \\\\\n\\hline \\(HbA _{1 C }\\) & X & & & X & & & X & X & & X \\\\\n\\hline apoB & & & & X & & & X & X & & X \\\\\n\\hline hs-CRP & & & & x & & & X & X & & X \\\\\n\\hline Diet and exercise counseling \\({ }^{11}\\) & x & x & x & X & x & x & X & X & X & X \\\\\n\\hline Plasma PK & & & & & & & & X & & X \\\\\n\\hline Establish Patient Eligibility & & & & X & & & & & & \\\\\n\\hline Randomization & & & & X & & & & & & \\\\\n\\hline IWRS Contact & X & X & & X & & & X & X & & \\(X ^{12}\\) \\\\\n\\hline Single-Blind Drug Dispensing & & X & & & & & & & & \\\\\n\\hline Double-blind Drug Dispensing \\({ }^{13}\\) & & & & X & & & X & X & & \\\\\n\\hline Drug Return/Compliance & & & X & X & x & & X & X & & X \\\\\n\\hline Schedule next visit & X & X & X & X & X & X & X & X & X & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline & Screen & Run-in & & \\multicolumn{5}{|c|}{Treatment*} & & \\\\\n\\hline Visit & \\(S 1 ^{ 1 , 2 }\\) & S2 & S3 & T1 & T2 & T3/phone & T4 & T5 & T6/phone & T7/EOS \\({ }^{ 3 }\\) \\\\\n\\hline Week & Wk -5 & Wk -4 & Wk -1 & Wk 0 & Wk 4 & Wk 8 & Wk 12 & Wk 24 & Wk 36 & Wk 52 \\\\\n\\hline Procedure & Day \\(- 3 5 \\pm 7\\) & Day \\(-28 \\pm 3\\) & Day \\(-7 \\pm 3\\) & Day 1 & Day \\(2 9 \\pm 3\\) & Day \\(5 7 \\pm 3\\) & Day \\(8 5 \\pm 3\\) & Day 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Inc.","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[245,176],[814,176],[814,221],[245,221]],"region":{"top_left_x":244,"top_left_y":176,"width":571,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1d7ad91162a4b77b9314cd1fe6a7fd0","type":"page_info","conversion_output":false,"text":"Clinical Study Protocol 1002-047","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1388,176],[1876,176],[1876,221],[1388,221]],"region":{"top_left_x":1387,"top_left_y":176,"width":489,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20849a6de5894b748566f0bad66fe0cf","type":"page_info","conversion_output":false,"text":"Amendment 3, 09 May 2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,258],[1895,258],[1895,299],[245,299]],"region":{"top_left_x":244,"top_left_y":257,"width":1651,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b7d2f7401904a949e41594c9b452be3","type":"text","conversion_output":true,"text":"NOTE: For patients who withdraw from IMP treatment, they will continue to have visits according to the protocol schedule. Safety","text_display":"\n\nNOTE: For patients who withdraw from IMP treatment, they will continue to have visits according to the protocol schedule. Safety","confidence":1,"confidence_rate":1},{"cnt":[[271,296],[1936,296],[1936,333],[271,333]],"region":{"top_left_x":270,"top_left_y":296,"width":1666,"height":38},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e22eb4cb6dda4a9c804c44082bf62f67","type":"text","conversion_output":true,"text":"assessments should include clinical safety and basic lipid laboratories (except for apoB and hs-CRP), adverse events, PE, vital signs,","text_display":" assessments should include clinical safety and basic lipid laboratories (except for apoB and hs-CRP), adverse events, PE, vital signs,","confidence":1,"confidence_rate":1},{"cnt":[[271,331],[1904,331],[1904,370],[271,370]],"region":{"top_left_x":270,"top_left_y":330,"width":1634,"height":40},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34de9492b48644fd9d0218e679f361f4","type":"text","conversion_output":true,"text":"and ECGs. For patients who withdraw from IMP treatment, but refuse to come to the clinic for assessments, assessments will take","text_display":" and ECGs. For patients who withdraw from IMP treatment, but refuse to come to the clinic for assessments, assessments will take","confidence":0.99951171875,"confidence_rate":0.9999963000030714},{"cnt":[[271,367],[1927,367],[1927,406],[271,406]],"region":{"top_left_x":270,"top_left_y":367,"width":1658,"height":40},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a00e3412e2cc48729164f24a4ba4d55b","type":"text","conversion_output":true,"text":"place by phone. The telephone contacts will occur according the protocol schedule with information regarding current health status","text_display":" place by phone. The telephone contacts will occur according the protocol schedule with information regarding current health status","confidence":1,"confidence_rate":1},{"cnt":[[271,404],[1794,404],[1794,440],[271,440]],"region":{"top_left_x":270,"top_left_y":403,"width":1524,"height":38},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7435723ece6f4af59de262420ce49908","type":"text","conversion_output":true,"text":"and to collect information on AEs (eg, recent procedures, hospitalizations, and if the patient has died, the cause of death).","text_display":" and to collect information on AEs (eg, recent procedures, hospitalizations, and if the patient has died, the cause of death).","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1962,443],[1962,483],[245,483]],"region":{"top_left_x":244,"top_left_y":442,"width":1718,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a309c0ffa2d443bab1a26840caa54ce3","type":"text","conversion_output":true,"text":"* Patients receiving simvastatin 40 mg will have clinic visits performed at weeks 16 and 28 and telephone visits at Weeks 20 and 32. At","text_display":"\n* Patients receiving simvastatin 40 mg will have clinic visits performed at weeks 16 and 28 and telephone visits at Weeks 20 and 32. 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At telephone visits performed at Weeks 20 and 32, assess adverse events and review changes in","text_display":" concomitant medications. At telephone visits performed at Weeks 20 and 32, assess adverse events and review changes in","confidence":1,"confidence_rate":1},{"cnt":[[271,554],[599,554],[599,587],[271,587]],"region":{"top_left_x":270,"top_left_y":554,"width":330,"height":33},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"863164109e2343bb9afe1af56341c2cf","type":"text","conversion_output":true,"text":"concomitant medications.","text_display":" concomitant medications.","confidence":1,"confidence_rate":1},{"cnt":[[245,591],[1884,589],[1884,636],[245,638]],"region":{"top_left_x":244,"top_left_y":588,"width":1641,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad7a7133b8994b449f2fa38a876eb1ea","type":"text","conversion_output":true,"text":"\\({ }^{1}\\) An optional visit between Visits S1 and S2 may be completed if patient fails to meet TGTG entry criterion. If this optional basic","text_display":"\n\\({ }^{1}\\) An optional visit between Visits S1 and S2 may be completed if patient fails to meet TGTG entry criterion. 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An optional","text_display":" medications for at least 2 weeks, and the repeat blood pressure values (DBP and/or SBP) do not meet exclusionary values. An optional","confidence":1,"confidence_rate":1},{"cnt":[[271,782],[1940,782],[1940,821],[271,821]],"region":{"top_left_x":270,"top_left_y":782,"width":1671,"height":39},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d532976ab71945bea6bae5c1930cb05d","type":"text","conversion_output":true,"text":"visit between Visit S1 and S2 may be completed to determine eligibility if the patient's eGFR, ALT, AST, and/or TB meet exclusion","text_display":" visit between Visit S1 and S2 may be completed to determine eligibility if the patient's eGFR, ALT, AST, and/or TB meet exclusion","confidence":0.99951171875,"confidence_rate":0.9999963552268055},{"cnt":[[271,821],[1577,821],[1577,857],[271,857]],"region":{"top_left_x":270,"top_left_y":820,"width":1307,"height":38},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"925251d942474442b1119a8696b20acc","type":"text","conversion_output":true,"text":"criteria levels. If this optional visit is completed, the repeated value will be used to determine eligibility.","text_display":" criteria levels. If this optional visit is completed, the repeated value will be used to determine eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[245,855],[1811,855],[1811,900],[245,900]],"region":{"top_left_x":244,"top_left_y":855,"width":1568,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e2d0936f347641079839d82b0776d7ab","type":"text","conversion_output":true,"text":"\\({ }^{3}\\) All procedures will be completed for all patients at either End of Study (EOS) if completing the study or early withdrawal.","text_display":"\n\\({ }^{3}\\) All procedures will be completed for all patients at either End of Study (EOS) if completing the study or early withdrawal.","confidence":1,"confidence_rate":1},{"cnt":[[245,898],[1876,898],[1876,943],[245,943]],"region":{"top_left_x":244,"top_left_y":898,"width":1632,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ca53ca8d54340628e5d2bf63276084f","type":"text","conversion_output":true,"text":"\\({ }^{4}\\) Body weight will be measured while fasting, using consistent scales, after voiding, and without shoes and outerwear (eg, coats).","text_display":"\n\\({ }^{4}\\) Body weight will be measured while fasting, using consistent scales, after voiding, and without shoes and outerwear (eg, coats).","confidence":1,"confidence_rate":1},{"cnt":[[245,941],[1214,941],[1214,986],[245,986]],"region":{"top_left_x":244,"top_left_y":941,"width":970,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d896fe06b434760b65c42021daa6d44","type":"text","conversion_output":true,"text":"\\({ }^{5}\\) Single 12-lead ECG will be collected prior to any blood sample collection.","text_display":"\n\\({ }^{5}\\) Single 12-lead ECG will be collected prior to any blood sample collection.","confidence":1,"confidence_rate":1},{"cnt":[[245,984],[1936,984],[1936,1029],[245,1029]],"region":{"top_left_x":244,"top_left_y":983,"width":1692,"height":47},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ec65f3b41df48ef92c4479710abe5ae","type":"text","conversion_output":true,"text":"\\({ }^{6}\\) Vital signs will include DBP, SBP, and HR and will be collected prior to any blood sample collection. Patient will rest for 5 minutes","text_display":"\n\\({ }^{6}\\) Vital signs will include DBP, SBP, and HR and will be collected prior to any blood sample collection. Patient will rest for 5 minutes","confidence":1,"confidence_rate":1},{"cnt":[[271,1027],[531,1027],[531,1063],[271,1063]],"region":{"top_left_x":270,"top_left_y":1026,"width":261,"height":38},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9338da8648884f7b860a54c1db1763e9","type":"text","conversion_output":true,"text":"prior to assessments","text_display":" prior to assessments","confidence":1,"confidence_rate":1},{"cnt":[[245,1061],[621,1061],[621,1106],[245,1106]],"region":{"top_left_x":244,"top_left_y":1061,"width":377,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4dcc1f10d809472fb8d8abc35d99708f","type":"text","conversion_output":true,"text":"\\({ }^{7}\\) Serology for HBsAg, HCV","text_display":"\n\\({ }^{7}\\) Serology for HBsAg, HCV","confidence":1,"confidence_rate":1},{"cnt":[[245,1106],[1949,1106],[1949,1154],[245,1154]],"region":{"top_left_x":244,"top_left_y":1106,"width":1705,"height":48},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"372fd68dc23643f5990d6547f30e0bd1","type":"text","conversion_output":true,"text":"\\({ }^{8}\\) Serum pregnancy test completed in premenopausal women only. FSH test is completed in women \\(<55\\) years old and \\(>1\\) year without","text_display":"\n\\({ }^{8}\\) Serum pregnancy test completed in premenopausal women only. FSH test is completed in women \\(<55\\) years old and \\(>1\\) year without","confidence":0.99951171875,"confidence_rate":0.9999965846177338},{"cnt":[[271,1147],[1442,1147],[1442,1188],[271,1188]],"region":{"top_left_x":270,"top_left_y":1147,"width":1172,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58fc3679eef74c23aef560012ded2667","type":"text","conversion_output":true,"text":"menses. Urine pregnancy test in women of childbearing potential just prior to randomization.","text_display":" menses. Urine pregnancy test in women of childbearing potential just prior to randomization.","confidence":1,"confidence_rate":1},{"cnt":[[245,1186],[1931,1186],[1931,1231],[245,1231]],"region":{"top_left_x":244,"top_left_y":1185,"width":1688,"height":47},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"445cb5c33dc24ae1bfdd8c5bd2207285","type":"text","conversion_output":true,"text":"\\({ }^{9}\\) Clinical safety labs include hematology, blood chemistry, and urinalysis at all visits. Coagulation is included at Screening (Visit S1)","text_display":"\n\\({ }^{9}\\) Clinical safety labs include hematology, blood chemistry, and urinalysis at all visits. Coagulation is included at Screening (Visit S1)","confidence":1,"confidence_rate":1},{"cnt":[[271,1229],[1869,1229],[1869,1265],[271,1265]],"region":{"top_left_x":270,"top_left_y":1228,"width":1600,"height":38},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fcfcc1dc84f04772baa5bd6ec3b05ef1","type":"text","conversion_output":true,"text":"for all patients, Baseline (Visit T1) and 3-5 days after Visit T1 only if on anticoagulants). Please refer to laboratory manual for","text_display":" for all patients, Baseline (Visit T1) and 3-5 days after Visit T1 only if on anticoagulants). Please refer to laboratory manual for","confidence":0.9990234375,"confidence_rate":0.9999928159107482},{"cnt":[[271,1263],[1525,1263],[1525,1300],[271,1300]],"region":{"top_left_x":270,"top_left_y":1263,"width":1256,"height":37},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3da7b2cbe1f14851869e5b4a36791026","type":"text","conversion_output":true,"text":"detailed schedule of tests. A local laboratory may be used for assessment at \\(3-5\\) days after Visit T1.","text_display":" detailed schedule of tests. A local laboratory may be used for assessment at \\(3-5\\) days after Visit T1.","confidence":0.8531699180603027,"confidence_rate":0.9985442115996807},{"cnt":[[247,1300],[1880,1300],[1880,1345],[247,1345]],"region":{"top_left_x":247,"top_left_y":1299,"width":1633,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1911b92f06a24878a24488d6cdeafb70","type":"text","conversion_output":true,"text":"\\({ }^{10}\\) Basic fasting (minimum of 10 hours) lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides.","text_display":"\n\\({ }^{10}\\) Basic fasting (minimum of 10 hours) lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides.","confidence":0.99951171875,"confidence_rate":0.9999965361726791},{"cnt":[[247,1343],[1583,1343],[1583,1388],[247,1388]],"region":{"top_left_x":247,"top_left_y":1342,"width":1337,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0323608dc9b14458b8b54758325be2ab","type":"text","conversion_output":true,"text":"\\({ }^{11}\\) Diet and exercise counseling per local and/or regional guidelines for the management of hyperlipidemia.","text_display":"\n\\({ }^{11}\\) Diet and exercise counseling per local and/or regional guidelines for the management of hyperlipidemia.","confidence":1,"confidence_rate":1},{"cnt":[[249,1386],[1558,1386],[1558,1429],[249,1429]],"region":{"top_left_x":249,"top_left_y":1385,"width":1309,"height":44},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"906ed76046bc467785a0cecbccf4a17c","type":"text","conversion_output":true,"text":"\\({ }^{12}\\) IWRS contact at either an early withdrawal or an EOS visit to register study discontinuation visit date.","text_display":"\n\\({ }^{12}\\) IWRS contact at either an early withdrawal or an EOS visit to register study discontinuation visit date.","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[249,1427],[1858,1427],[1858,1472],[249,1472]],"region":{"top_left_x":249,"top_left_y":1426,"width":1610,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a08ca9ad25c4629b7a903f182baece1","type":"text","conversion_output":true,"text":"\\({ }^{13}\\) Depending upon the length of time between visits, 1 or 2 bottles of study medication will be dispensed as instructed by IWRS.","text_display":"\n\\({ }^{13}\\) Depending upon the length of time between visits, 1 or 2 bottles of study medication will be dispensed as instructed by 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Inc.","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[1388,176],[1880,176],[1880,226],[1388,226]],"region":{"top_left_x":1387,"top_left_y":176,"width":493,"height":50},"line":6,"column":2,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88f9076b03e9405a998e271a49f5d467","type":"text","conversion_output":true,"parent_id":"634226a044764a49b1a877305c10a1ea","text":"Amendment 3, 09 May 2017","text_display":"\nAmendment 3, 09 May 2017","confidence":0.9990236759185791,"confidence_rate":0.9999684907868702},{"cnt":[[241,254],[440,254],[440,301],[241,301]],"region":{"top_left_x":240,"top_left_y":253,"width":201,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7f5fe1b0af542258042d5bb5d7d4be8","type":"text","conversion_output":true,"text":"New Text:","text_display":"\n\nNew 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& Screen & Run-in & & \\multicolumn{5}{|c|}{Treatment**} & & \\\\\n\\hline Visit & \\(S 1 ^{ 1 , 2 }\\) & S2 & S3 & T1 & T2 & T3/phone & T4 & T5 & T6/phone & T7/EOS \\({ }^{ 3 }\\) \\\\\n\\hline Week & Wk -5 & Wk -4 & Wk -1 & Wk 0 & Wk 4 & Wk 8 & Wk 12 & Wk 24 & Wk 36 & Wk 52 \\\\\n\\hline Procedure & \\begin{tabular}{l}\nDay \\\\\n\\(-35 \\pm 7\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(-28 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(-7 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n1\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(29 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(5 7 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(8 5 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n168169 \\\\\n\\(\\pm 7\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(2 5 2 \\pm 7\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay 365 \\\\\n\\(\\pm 7\\)\n\\end{tabular} \\\\\n\\hline Informed Consent & X & & & & & & & & & \\\\\n\\hline Enrollment Criteria & X & & & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & & & \\\\\n\\hline Medical History & X & & & & & & & & & \\\\\n\\hline HeFH Status Determination & X & & & & & & & & & \\\\\n\\hline Concomitant Medications & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Adverse Event Recording & & x & x & x & x & x & x & x & x & x \\\\\n\\hline Physical Exam & & & & X & & & & & & x \\\\\n\\hline Weight \\({ }^{4}\\) & x & & & x & x & & x & x & & x \\\\\n\\hline Height/BMI & x & & & & & & & & & \\\\\n\\hline 12-Lead ECG \\({ }^{5}\\) & & & & X & & & & & & X \\\\\n\\hline Vital Signs \\({ }^{6}\\) & X & x & x & X & x & & X & X & & X \\\\\n\\hline Serology \\({ }^{7}\\) & x & & & & & & & & & \\\\\n\\hline Serum Pregnancy and/or \\(FSH ^{8}\\) & X & & & & & & & & & \\\\\n\\hline Urine Pregnancy Test \\({ }^{8}\\) & & & & x & & & & & & \\\\\n\\hline TSH & X & & & & & & & & & \\\\\n\\hline Clinical Safety Labs \\({ }^{9}\\) & X & & & x & X & & x & X & & x \\\\\n\\hline Basic Fasting Lipids \\({ }^{10}\\) & x & & x & x & x & & x & x & & x \\\\\n\\hline \\(HbA _{1 C }\\) & X & & & X & & & X & X & & X \\\\\n\\hline apoB & & & & x & & & x & x & & X \\\\\n\\hline hs-CRP & & & & x & & & x & x & & X \\\\\n\\hline Diet and exercise counseling \\({ }^{11}\\) & x & x & X & X & x & X & x & X & X & X \\\\\n\\hline Plasma PK & & & & & & & & X & & x \\\\\n\\hline Establish Patient Eligibility & & & & x & & & & & & \\\\\n\\hline Randomization & & & & X & & & & & & \\\\\n\\hline IWRS Contact & x & X & & x & & & x & x & & \\(x ^{12}\\) \\\\\n\\hline Single-Blind Drug Dispensing & & X & & & & & & & & \\\\\n\\hline Double-blind Drug Dispensing \\({ }^{13}\\) & & & & X & & & X & X & & \\\\\n\\hline Drug Return/Compliance & & & X & X & X & & X & X & & X \\\\\n\\hline Schedule next visit & X & X & X & X & X & X & X & X & X & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline & Screen & Run-in & & \\multicolumn{5}{|c|}{Treatment**} & & \\\\\n\\hline Visit & \\(S 1 ^{ 1 , 2 }\\) & S2 & S3 & T1 & T2 & T3/phone & T4 & T5 & T6/phone & T7/EOS \\({ }^{ 3 }\\) \\\\\n\\hline Week & Wk -5 & Wk -4 & Wk -1 & Wk 0 & Wk 4 & Wk 8 & Wk 12 & Wk 24 & Wk 36 & Wk 52 \\\\\n\\hline Procedure & \\begin{tabular}{l}\nDay \\\\\n\\(-35 \\pm 7\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(-28 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(-7 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n1\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(29 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(5 7 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(8 5 \\pm 3\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n168169 \\\\\n\\(\\pm 7\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay \\\\\n\\(2 5 2 \\pm 7\\)\n\\end{tabular} & \\begin{tabular}{l}\nDay 365 \\\\\n\\(\\pm 7\\)\n\\end{tabular} \\\\\n\\hline Informed Consent & X & & & & & & & & & \\\\\n\\hline 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2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,258],[1897,258],[1897,299],[245,299]],"region":{"top_left_x":244,"top_left_y":257,"width":1654,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f4de0444d82d440684a1b51d876bcab3","type":"text","conversion_output":true,"text":"NOTE: For patients who withdraw from IMP treatment, they will continue to have visits according to the protocol schedule. Safety","text_display":"\n\nNOTE: For patients who withdraw from IMP treatment, they will continue to have visits according to the protocol schedule. Safety","confidence":1,"confidence_rate":1},{"cnt":[[271,296],[1936,296],[1936,333],[271,333]],"region":{"top_left_x":270,"top_left_y":296,"width":1666,"height":38},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2564340f98e24debb2852bd5501bd29d","type":"text","conversion_output":true,"text":"assessments should include clinical safety and basic lipid laboratories (except for apoB and hs-CRP), adverse events, PE, vital signs,","text_display":" assessments should include clinical safety and basic lipid laboratories (except for apoB and hs-CRP), adverse events, PE, vital signs,","confidence":1,"confidence_rate":1},{"cnt":[[271,331],[1904,331],[1904,370],[271,370]],"region":{"top_left_x":270,"top_left_y":330,"width":1634,"height":40},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"043a7d85496c496aaac93d079ebbd4a9","type":"text","conversion_output":true,"text":"and ECGs. For patients who withdraw from IMP treatment, but refuse to come to the clinic for assessments, assessments will take","text_display":" and ECGs. For patients who withdraw from IMP treatment, but refuse to come to the clinic for assessments, assessments will take","confidence":0.99951171875,"confidence_rate":0.9999963000030714},{"cnt":[[271,367],[1927,367],[1927,406],[271,406]],"region":{"top_left_x":270,"top_left_y":367,"width":1658,"height":40},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b51a590417d43c5a216be2007e534f2","type":"text","conversion_output":true,"text":"place by phone. The telephone contacts will occur according the protocol schedule with information regarding current health status","text_display":" place by phone. The telephone contacts will occur according the protocol schedule with information regarding current health status","confidence":1,"confidence_rate":1},{"cnt":[[271,404],[1794,404],[1794,440],[271,440]],"region":{"top_left_x":270,"top_left_y":403,"width":1524,"height":38},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1451b32337a34e48b17101c215e104e7","type":"text","conversion_output":true,"text":"and to collect information on AEs (eg, recent procedures, hospitalizations, and if the patient has died, the cause of death).","text_display":" and to collect information on AEs (eg, recent procedures, hospitalizations, and if the patient has died, the cause of death).","confidence":1,"confidence_rate":1},{"cnt":[[245,443],[1962,443],[1962,483],[245,483]],"region":{"top_left_x":244,"top_left_y":442,"width":1718,"height":42},"line":10,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"31b3b7ee5ad44d83a228f1b55b4caa5b","type":"text","conversion_output":true,"text":"* Patients receiving simvastatin 40 mg will have clinic visits performed at weeks 16 and 28 and telephone visits at Weeks 20 and 32 . At","text_display":"\n* Patients receiving simvastatin 40 mg will have clinic visits performed at weeks 16 and 28 and telephone visits at Weeks 20 and 32 . At","confidence":0.45169909564617017,"confidence_rate":0.9949826353213757},{"cnt":[[271,481],[1914,481],[1914,522],[271,522]],"region":{"top_left_x":270,"top_left_y":481,"width":1645,"height":42},"line":11,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"34bfd73e7ec24ce29a636e7c001f0501","type":"text","conversion_output":true,"text":"elinic visits at Weeks 16 and 28, perform clinical safety labs as defined in Footnote 9, assess adverse events and review changes in","text_display":" elinic visits at Weeks 16 and 28, perform clinical safety labs as defined in Footnote 9, assess adverse events and review changes in","confidence":0.4002762692936557,"confidence_rate":0.9934813371471627},{"cnt":[[271,520],[1811,520],[1811,556],[271,556]],"region":{"top_left_x":270,"top_left_y":519,"width":1542,"height":38},"line":12,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c100c6376dc74790895c3d135383ad73","type":"text","conversion_output":true,"text":"concomitant medications. At telephone visits performed at Weeks 20 and 32, assess adverse events and review changes in","text_display":" concomitant medications. At telephone visits performed at Weeks 20 and 32, assess adverse events and review changes in","confidence":1,"confidence_rate":1},{"cnt":[[271,554],[604,554],[604,587],[271,587]],"region":{"top_left_x":270,"top_left_y":554,"width":334,"height":33},"line":13,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"0edd7095db834ce3b27a80ac854b3109","type":"text","conversion_output":true,"text":"concomitant medications.","text_display":" concomitant medications.","confidence":0.9985356330871582,"confidence_rate":0.9999494688579158},{"cnt":[[245,591],[1884,591],[1884,638],[245,638]],"region":{"top_left_x":244,"top_left_y":590,"width":1641,"height":49},"line":14,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b04e545fa80a4189a5d916fa21251415","type":"text","conversion_output":true,"text":"\\({ }^{1}\\) An optional visit between Visits S1 and S2 may be completed if patient fails to meet FGTG entry criterion. If this optional basic","text_display":"\n\\({ }^{1}\\) An optional visit between Visits S1 and S2 may be completed if patient fails to meet FGTG entry criterion. If this optional basic","confidence":0.96142578125,"confidence_rate":0.9997230108508313},{"cnt":[[271,632],[1772,632],[1772,672],[271,672]],"region":{"top_left_x":270,"top_left_y":631,"width":1503,"height":42},"line":15,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9f5ecbc95c8c48e79567dca92ece8b3c","type":"text","conversion_output":true,"text":"fasting (minimum of 10 hours) lipid value visit is completed, the repeat lipid value will be used to determine eligibility.","text_display":" fasting (minimum of 10 hours) lipid value visit is completed, the repeat lipid value will be used to determine eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[245,670],[1886,670],[1886,715],[245,715]],"region":{"top_left_x":244,"top_left_y":670,"width":1643,"height":46},"line":16,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"48b02cdafa244e9186e54edaba75e575","type":"text","conversion_output":true,"text":"\\({ }^{2}\\) An optional visit between Visits S1 and S2 may be completed if the patient's DBP and/or SBP meet the exclusion criteria levels.","text_display":"\n\\({ }^{2}\\) An optional visit between Visits S1 and S2 may be completed if the patient's DBP and/or SBP meet the exclusion criteria levels.","confidence":1,"confidence_rate":1},{"cnt":[[271,713],[1955,713],[1955,750],[271,750]],"region":{"top_left_x":270,"top_left_y":713,"width":1686,"height":37},"line":17,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"3067e4d113fc4f0cb1f4d2e3fd50a236","type":"text","conversion_output":true,"text":"Patients may randomize after blood pressure medications have been adjusted, the patients have been on stable doses of blood pressure","text_display":" Patients may randomize after blood pressure medications have been adjusted, the patients have been on stable doses of blood pressure","confidence":1,"confidence_rate":1},{"cnt":[[271,748],[1964,748],[1964,786],[271,786]],"region":{"top_left_x":270,"top_left_y":747,"width":1694,"height":40},"line":18,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"cffb117d42c34df68e91cdc7ed2db59c","type":"text","conversion_output":true,"text":"medications for at least 2 weeks, and the repeat blood pressure values (DBP and/or SBP) do not meet exclusionary values. An optional","text_display":" medications for at least 2 weeks, and the repeat blood pressure values (DBP and/or SBP) do not meet exclusionary values. An optional","confidence":1,"confidence_rate":1},{"cnt":[[271,782],[1940,782],[1940,821],[271,821]],"region":{"top_left_x":270,"top_left_y":782,"width":1671,"height":39},"line":19,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"340ca52089c448f2bb97940752926aaa","type":"text","conversion_output":true,"text":"visit between Visit S1 and S2 may be completed to determine eligibility if the patient's eGFR, ALT, AST, and/or TB meet exclusion","text_display":" visit between Visit S1 and S2 may be completed to determine eligibility if the patient's eGFR, ALT, AST, and/or TB meet exclusion","confidence":1,"confidence_rate":1},{"cnt":[[271,819],[1577,819],[1577,857],[271,857]],"region":{"top_left_x":270,"top_left_y":818,"width":1307,"height":40},"line":20,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"55c77900bc8945a081e2eba8b003b3cc","type":"text","conversion_output":true,"text":"criteria levels. If this optional visit is completed, the repeated value will be used to determine eligibility.","text_display":" criteria levels. If this optional visit is completed, the repeated value will be used to determine eligibility.","confidence":1,"confidence_rate":1},{"cnt":[[245,855],[1811,855],[1811,900],[245,900]],"region":{"top_left_x":244,"top_left_y":855,"width":1568,"height":46},"line":21,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e2c0e5af16454fde85263f363b0ec85d","type":"text","conversion_output":true,"text":"\\({ }^{3}\\) All procedures will be completed for all patients at either End of Study (EOS) if completing the study or early withdrawal.","text_display":"\n\\({ }^{3}\\) All procedures will be completed for all patients at either End of Study (EOS) if completing the study or early withdrawal.","confidence":0.99951171875,"confidence_rate":0.9999964088263151},{"cnt":[[245,898],[1876,898],[1876,943],[245,943]],"region":{"top_left_x":244,"top_left_y":898,"width":1632,"height":46},"line":22,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bf4547f70db342e19a027cac74e15dc5","type":"text","conversion_output":true,"text":"\\({ }^{4}\\) Body weight will be measured while fasting, using consistent scales, after voiding, and without shoes and outerwear (eg, coats).","text_display":"\n\\({ }^{4}\\) Body weight will be measured while fasting, using consistent scales, after voiding, and without shoes and outerwear (eg, coats).","confidence":1,"confidence_rate":1},{"cnt":[[245,941],[1214,941],[1214,986],[245,986]],"region":{"top_left_x":244,"top_left_y":941,"width":970,"height":46},"line":23,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"be22500287214b469fa0456bc4e37994","type":"text","conversion_output":true,"text":"\\({ }^{5}\\) Single 12-lead ECG will be collected prior to any blood sample collection.","text_display":"\n\\({ }^{5}\\) Single 12-lead ECG will be collected prior to any blood sample collection.","confidence":1,"confidence_rate":1},{"cnt":[[245,984],[1936,984],[1936,1029],[245,1029]],"region":{"top_left_x":244,"top_left_y":983,"width":1692,"height":47},"line":24,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"68448f97aae24cfaac44c9c86772a280","type":"text","conversion_output":true,"text":"\\({ }^{6}\\) Vital signs will include DBP, SBP, and HR and will be collected prior to any blood sample collection. Patient will rest for 5 minutes","text_display":"\n\\({ }^{6}\\) Vital signs will include DBP, SBP, and HR and will be collected prior to any blood sample collection. Patient will rest for 5 minutes","confidence":1,"confidence_rate":1},{"cnt":[[271,1027],[531,1027],[531,1063],[271,1063]],"region":{"top_left_x":270,"top_left_y":1026,"width":261,"height":38},"line":25,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"23684eff4a2d404d94405af0b7bc40a7","type":"text","conversion_output":true,"text":"prior to assessments","text_display":" prior to assessments","confidence":1,"confidence_rate":1},{"cnt":[[245,1061],[621,1061],[621,1106],[245,1106]],"region":{"top_left_x":244,"top_left_y":1061,"width":377,"height":46},"line":26,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"52bcce46ad79421d92b7a16c6210d3ee","type":"text","conversion_output":true,"text":"\\({ }^{7}\\) Serology for HBsAg, HCV","text_display":"\n\\({ }^{7}\\) Serology for HBsAg, HCV","confidence":1,"confidence_rate":1},{"cnt":[[245,1106],[1949,1106],[1949,1154],[245,1154]],"region":{"top_left_x":244,"top_left_y":1106,"width":1705,"height":48},"line":27,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"0a025edd9b0a4566a97dc991281fa439","type":"text","conversion_output":true,"text":"\\({ }^{8}\\) Serum pregnancy test completed in premenopausal women only. FSH test is completed in women \\(<55\\) years old and \\(>1\\) year without","text_display":"\n\\({ }^{8}\\) Serum pregnancy test completed in premenopausal women only. FSH test is completed in women \\(<55\\) years old and \\(>1\\) year without","confidence":0.9960954189300537,"confidence_rate":0.9999726421655074},{"cnt":[[271,1147],[1442,1147],[1442,1188],[271,1188]],"region":{"top_left_x":270,"top_left_y":1147,"width":1172,"height":42},"line":28,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2248d0a5648445bb99e1e840cdf36300","type":"text","conversion_output":true,"text":"menses. Urine pregnancy test in women of childbearing potential just prior to randomization.","text_display":" menses. Urine pregnancy test in women of childbearing potential just prior to randomization.","confidence":1,"confidence_rate":1},{"cnt":[[245,1186],[1931,1186],[1931,1231],[245,1231]],"region":{"top_left_x":244,"top_left_y":1185,"width":1688,"height":47},"line":29,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"484487fc136d4a91b6af9c516c50bbfa","type":"text","conversion_output":true,"text":"\\({ }^{9}\\) Clinical safety labs include hematology, blood chemistry, and urinalysis at all visits. Coagulation is included at Screening (Visit S1)","text_display":"\n\\({ }^{9}\\) Clinical safety labs include hematology, blood chemistry, and urinalysis at all visits. Coagulation is included at Screening (Visit S1)","confidence":1,"confidence_rate":1},{"cnt":[[271,1229],[1869,1229],[1869,1265],[271,1265]],"region":{"top_left_x":270,"top_left_y":1228,"width":1600,"height":38},"line":30,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2c5384b669554eeda4e928271a94eb24","type":"text","conversion_output":true,"text":"for all patients, Baseline (Visit T1) and 3-5 days after Visit T1 only if on anticoagulants). Please refer to laboratory manual for","text_display":" for all patients, Baseline (Visit T1) and 3-5 days after Visit T1 only if on anticoagulants). Please refer to laboratory manual for","confidence":0.96044921875,"confidence_rate":0.9997033221957252},{"cnt":[[271,1263],[1525,1263],[1525,1300],[271,1300]],"region":{"top_left_x":270,"top_left_y":1263,"width":1256,"height":37},"line":31,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"07128b72511d4ba6a9895c815721709f","type":"text","conversion_output":true,"text":"detailed schedule of tests. A local laboratory may be used for assessment at \\(3-5\\) days after Visit T1.","text_display":" detailed schedule of tests. A local laboratory may be used for assessment at \\(3-5\\) days after Visit T1.","confidence":0.7697324976325035,"confidence_rate":0.9976018505315217},{"cnt":[[247,1300],[1880,1300],[1880,1345],[247,1345]],"region":{"top_left_x":247,"top_left_y":1299,"width":1633,"height":46},"line":32,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8db00b968f19446aa707c04328f05f70","type":"text","conversion_output":true,"text":"\\({ }^{10}\\) Basic fasting (minimum of 10 hours) lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides.","text_display":"\n\\({ }^{10}\\) Basic fasting (minimum of 10 hours) lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides.","confidence":0.9956097602844238,"confidence_rate":0.9999687954860391},{"cnt":[[247,1343],[1583,1343],[1583,1388],[247,1388]],"region":{"top_left_x":247,"top_left_y":1342,"width":1337,"height":46},"line":33,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ba5aabf98a2a4d028b642df33d707570","type":"text","conversion_output":true,"text":"\\({ }^{11}\\) Diet and exercise counseling per local and/or regional guidelines for the management of hyperlipidemia.","text_display":"\n\\({ }^{11}\\) Diet and exercise counseling per local and/or regional guidelines for the management of hyperlipidemia.","confidence":1,"confidence_rate":1},{"cnt":[[249,1386],[1558,1386],[1558,1429],[249,1429]],"region":{"top_left_x":249,"top_left_y":1385,"width":1309,"height":44},"line":34,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"20c71f25f1a74513909835cb630b64d5","type":"text","conversion_output":true,"text":"\\({ }^{12}\\) IWRS contact at either an early withdrawal or an EOS visit to register study discontinuation visit date.","text_display":"\n\\({ }^{12}\\) IWRS contact at either an early withdrawal or an EOS visit to register study discontinuation visit date.","confidence":1,"confidence_rate":1},{"cnt":[[249,1427],[1858,1427],[1858,1472],[249,1472]],"region":{"top_left_x":249,"top_left_y":1426,"width":1610,"height":46},"line":35,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a47991358a184d7b8c38cf22e92e2e9b","type":"text","conversion_output":true,"text":"\\({ }^{13}\\) Depending upon the length of time between visits, 1 or 2 bottles of study medication will be dispensed as instructed by IWRS.","text_display":"\n\\({ }^{13}\\) Depending upon the length of time between visits, 1 or 2 bottles of study medication will be dispensed as instructed by IWRS.","confidence":1,"confidence_rate":1},{"cnt":[[249,1472],[1931,1472],[1931,1515],[249,1515]],"region":{"top_left_x":249,"top_left_y":1471,"width":1683,"height":44},"line":36,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4cacfa34dd9c401dab21bba66c64156d","type":"text","conversion_output":true,"text":"\\({ }^{14}\\) If patient is discontinuing treatment and completing the EOS visit, but will be continuing in the study either by returning to clinic or","text_display":"\n\\({ }^{14}\\) If patient is discontinuing treatment and completing the EOS visit, but will be continuing in the study either by returning to clinic or","confidence":1,"confidence_rate":1},{"cnt":[[271,1512],[1571,1512],[1571,1551],[271,1551]],"region":{"top_left_x":270,"top_left_y":1512,"width":1301,"height":40},"line":37,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9573995069df433bb2f993731fc53696","type":"text","conversion_output":true,"text":"by phone, continue to schedule study visits for the patient according to the protocol Schedule of Events","text_display":" by phone, continue to schedule study visits for the patient according to the protocol Schedule of Events","confidence":1,"confidence_rate":1},{"cnt":[[245,2578],[462,2578],[462,2619],[245,2619]],"region":{"top_left_x":244,"top_left_y":2578,"width":218,"height":41},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cb0287b652a411e948aa549ee01ece9","type":"page_info","conversion_output":false,"text":"Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[924,2580],[1201,2580],[1201,2628],[924,2628]],"region":{"top_left_x":923,"top_left_y":2580,"width":278,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b94b9576096f4a9a926058ebc44b2d13","type":"page_info","conversion_output":false,"text":"Page 184 of 184","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]}]}