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AE & adverse event \\\\\n\\hline AKIN & Acute Kidney Injury Network \\\\\n\\hline AP & alkaline phosphatase \\\\\n\\hline APACHE & acute physiology and chronic health evaluation \\\\\n\\hline AST & alanine aminotransferase \\\\\n\\hline \\(AUC _{1-7}\\) & area under the time-corrected endogenous creatinine clearance curve from Day 1 to Day 7 \\\\\n\\hline BiAP & bovine intestinal alkaline phosphatase \\\\\n\\hline BMI & body mass index \\\\\n\\hline BUN & blood urea nitrogen \\\\\n\\hline CI & confidence interval \\\\\n\\hline CKD & chronic kidney disease \\\\\n\\hline CKD-EPI & chronic kidney disease epidemiology collaboration \\\\\n\\hline CMH & Cochran-Mantel-Haenzel \\\\\n\\hline CRP & C-reactive protein \\\\\n\\hline DMC & data monitoring committee \\\\\n\\hline ECG & electrocardiogram \\\\\n\\hline eCRF & electronic case report form \\\\\n\\hline eGFR & estimated glomerular filtration rate \\\\\n\\hline EQ-5D & EuroQol-5D \\\\\n\\hline FeNa & fractional excretion of sodium 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Of the 290 planned patients, at least 120 patients will enroll in","text_display":" during this interim analysis. Of the 290 planned patients, at least 120 patients will enroll in","confidence":1,"confidence_rate":1},{"cnt":[[348,816],[1880,816],[1880,866],[348,866]],"region":{"top_left_x":348,"top_left_y":816,"width":1532,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff3cf1148ba24384a05f20bacd2b9ea2","type":"text","conversion_output":true,"text":"Part 1 and 170 patients will enroll in Part 2. Patients enrolled during Part 1 will be","text_display":" Part 1 and 170 patients will enroll in Part 2. Patients enrolled during Part 1 will be","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[346,866],[1878,866],[1878,915],[346,915]],"region":{"top_left_x":345,"top_left_y":865,"width":1533,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7124497b41d444698683a1d70d0ea6b7","type":"text","conversion_output":true,"text":"randomly assigned to receive, by 1 -hour intravenous (IV) infusion, either placebo","text_display":" randomly assigned to receive, by 1 -hour intravenous (IV) infusion, either placebo","confidence":0.9931640625,"confidence_rate":0.9999237872426632},{"cnt":[[348,913],[1880,913],[1880,965],[348,965]],"region":{"top_left_x":348,"top_left_y":913,"width":1532,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8639f4e894e43b689b5aca0b324e306","type":"text","conversion_output":true,"text":"( \\(n 1=30\\) ) or 1 of 3 different doses of recAP ( \\(n 1=30\\) in each dosing arm; i.e., \\(0.4 mg / kg\\)","text_display":" ( \\(n 1=30\\) ) or 1 of 3 different doses of recAP ( \\(n 1=30\\) in each dosing arm; i.e., \\(0.4 mg / kg\\)","confidence":0.8529192138503817,"confidence_rate":0.9986175612826893},{"cnt":[[348,958],[1880,958],[1880,1010],[348,1010]],"region":{"top_left_x":348,"top_left_y":958,"width":1532,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1808b9544404c5b8b964f64f5c49cd6","type":"text","conversion_output":true,"text":"[250 U/kg], or \\(0.8 mg / kg\\) [ \\(500 U / kg\\) ], or \\(1.6 mg / kg\\) [ \\(1000 U / kg\\) ]) using a \\(1: 1: 1: 1\\) allocation","text_display":" [250 U/kg], or \\(0.8 mg / kg\\) [ \\(500 U / kg\\) ], or \\(1.6 mg / kg\\) [ \\(1000 U / kg\\) ]) using a \\(1: 1: 1: 1\\) allocation","confidence":0.4266610075333017,"confidence_rate":0.9936162118246836},{"cnt":[[346,1010],[1880,1010],[1880,1059],[346,1059]],"region":{"top_left_x":345,"top_left_y":1009,"width":1535,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40fe908826334445a5c5d33860a7ec09","type":"text","conversion_output":true,"text":"ratio. Patients will receive study drug once daily for 3 days (Days 1,2 , and 3 ). The interim","text_display":" ratio. Patients will receive study drug once daily for 3 days (Days 1,2 , and 3 ). The interim","confidence":0.9922001289683067,"confidence_rate":0.9999274984697238},{"cnt":[[348,1057],[1880,1057],[1880,1106],[348,1106]],"region":{"top_left_x":348,"top_left_y":1057,"width":1532,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ef8b146af8845b88f49b1bf242d0448","type":"text","conversion_output":true,"text":"analysis on the primary endpoint will be performed after 120 patients have completed the","text_display":" analysis on the primary endpoint will be performed after 120 patients have completed the","confidence":1,"confidence_rate":1},{"cnt":[[348,1104],[1880,1104],[1880,1154],[348,1154]],"region":{"top_left_x":348,"top_left_y":1104,"width":1532,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d420279cb7243829be4f4961e83d170","type":"text","conversion_output":true,"text":"first 7 days in Part 1 (allowing for patients that were randomized but discontinued/died","text_display":" first 7 days in Part 1 (allowing for patients that were randomized but discontinued/died","confidence":1,"confidence_rate":1},{"cnt":[[346,1154],[1880,1154],[1880,1205],[346,1205]],"region":{"top_left_x":345,"top_left_y":1153,"width":1535,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1118962bbca4f1b9aa87a99cf62455e","type":"text","conversion_output":true,"text":"prior to 7 days) and all relevant data have been monitored to select the dose to be","text_display":" prior to 7 days) and all relevant data have been monitored to select the dose to be","confidence":1,"confidence_rate":1},{"cnt":[[346,1199],[1880,1199],[1880,1250],[346,1250]],"region":{"top_left_x":345,"top_left_y":1198,"width":1535,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94204e2440a24ee59f05c5267c16505a","type":"text","conversion_output":true,"text":"administered in Part 2. The dose chosen will be the most optimal dose of recAP on the","text_display":" administered in Part 2. The dose chosen will be the most optimal dose of recAP on the","confidence":1,"confidence_rate":1},{"cnt":[[346,1248],[1880,1248],[1880,1300],[346,1300]],"region":{"top_left_x":345,"top_left_y":1248,"width":1535,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5fc17995f384e16907ab4f0b03a55ab","type":"text","conversion_output":true,"text":"primary endpoint in Part 1, provided there are no safety issues with that dose as judged by","text_display":" primary endpoint in Part 1, provided there are no safety issues with that dose as judged by","confidence":1,"confidence_rate":1},{"cnt":[[346,1298],[1880,1298],[1880,1347],[346,1347]],"region":{"top_left_x":345,"top_left_y":1297,"width":1535,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68839b28768b4f08b755b45dc8b4a305","type":"text","conversion_output":true,"text":"the DMC. While the intention is to choose the optimal recAP dose based on the primary","text_display":" the DMC. While the intention is to choose the optimal recAP dose based on the primary","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[346,1345],[1880,1345],[1880,1394],[346,1394]],"region":{"top_left_x":345,"top_left_y":1344,"width":1535,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fc84e85eaad4286bda96bb5fa88f316","type":"text","conversion_output":true,"text":"efficacy endpoint results for Part 1, it is possible that this dosing group will have adverse","text_display":" efficacy endpoint results for Part 1, it is possible that this dosing group will have adverse","confidence":0.9990236759185791,"confidence_rate":0.9999900326925697},{"cnt":[[346,1392],[1880,1392],[1880,1442],[346,1442]],"region":{"top_left_x":345,"top_left_y":1392,"width":1535,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be10aa54bfc04c6285114cc2def2f8e6","type":"text","conversion_output":true,"text":"safety issues. In this case, the next \"best\" dose with supportive safety data would be chosen","text_display":" safety issues. In this case, the next \"best\" dose with supportive safety data would be chosen","confidence":1,"confidence_rate":1},{"cnt":[[348,1439],[520,1439],[520,1480],[348,1480]],"region":{"top_left_x":348,"top_left_y":1439,"width":172,"height":42},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f3817a13eab4f569385f83bb2d165c7","type":"text","conversion_output":true,"text":"for Part 2.","text_display":" for Part 2.","confidence":0.99951171875,"confidence_rate":0.9999674404968648},{"cnt":[[348,1536],[1880,1536],[1880,1586],[348,1586]],"region":{"top_left_x":348,"top_left_y":1536,"width":1532,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03da92bb0c3246759942b415e0923c93","type":"text","conversion_output":true,"text":"In Part 2, patients will be randomly assigned to receive either placebo ( \\(n _{2}=85\\) ) or the dose","text_display":"\n\nIn Part 2, patients will be randomly assigned to receive either placebo ( \\(n _{2}=85\\) ) or the dose","confidence":0.99560546875,"confidence_rate":0.9999603231692639},{"cnt":[[348,1586],[1270,1586],[1270,1635],[348,1635]],"region":{"top_left_x":348,"top_left_y":1585,"width":922,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b538eb467b24583a77de63b81431ded","type":"text","conversion_output":true,"text":"of recAP ( \\(n _{2}=85\\) ) selected during the interim analysis.","text_display":" of recAP ( \\(n _{2}=85\\) ) selected during the interim analysis.","confidence":0.967160714134131,"confidence_rate":0.9995488774803314},{"cnt":[[348,1680],[1878,1680],[1878,1729],[348,1729]],"region":{"top_left_x":348,"top_left_y":1680,"width":1530,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8bda4ff53ce440ca0e1f1f4d3a9433c","type":"text","conversion_output":true,"text":"Each part involves the following schedule of events: potential patients who have been","text_display":"\n\nEach part involves the following schedule of events: potential patients who have been","confidence":1,"confidence_rate":1},{"cnt":[[348,1727],[1878,1727],[1878,1777],[348,1777]],"region":{"top_left_x":348,"top_left_y":1727,"width":1530,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a79b952d009d441b841758ee0dc9930e","type":"text","conversion_output":true,"text":"admitted to the intensive care unit (ICU)/Intermediate care will undergo a pre-screening,","text_display":" admitted to the intensive care unit (ICU)/Intermediate care will undergo a pre-screening,","confidence":1,"confidence_rate":1},{"cnt":[[348,1775],[1880,1775],[1880,1824],[348,1824]],"region":{"top_left_x":348,"top_left_y":1774,"width":1532,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2eec55ffb7664471be645880e646f0d8","type":"text","conversion_output":true,"text":"will provide informed consent, and will undergo screening assessments to determine","text_display":" will provide informed consent, and will undergo screening assessments to determine","confidence":1,"confidence_rate":1},{"cnt":[[348,1822],[1880,1822],[1880,1871],[348,1871]],"region":{"top_left_x":348,"top_left_y":1821,"width":1532,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76a7165bba6e4b51ad06432d3ec45a77","type":"text","conversion_output":true,"text":"eligibility. As soon as possible when inclusion and exclusion criteria are met, and after","text_display":" eligibility. As soon as possible when inclusion and exclusion criteria are met, and after","confidence":1,"confidence_rate":1},{"cnt":[[348,1869],[1880,1869],[1880,1921],[348,1921]],"region":{"top_left_x":348,"top_left_y":1869,"width":1532,"height":52},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a58db95a8d6b463db7966e2a9406bed9","type":"text","conversion_output":true,"text":"confirmation of continuing (i.e., not resolving) AKI by a fluid-corrected serum creatinine","text_display":" confirmation of continuing (i.e., not resolving) AKI by a fluid-corrected serum creatinine","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[348,1921],[1880,1921],[1880,1968],[348,1968]],"region":{"top_left_x":348,"top_left_y":1920,"width":1532,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c32a1030fdfb48389c236c838d9d4a98","type":"text","conversion_output":true,"text":"assessment or urine output, eligible patients will be randomly assigned to a treatment","text_display":" assessment or urine output, eligible patients will be randomly assigned to a treatment","confidence":1,"confidence_rate":1},{"cnt":[[348,1968],[1880,1968],[1880,2017],[348,2017]],"region":{"top_left_x":348,"top_left_y":1967,"width":1532,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f4023f53120446f9e9fddcfa191601b","type":"text","conversion_output":true,"text":"group (Baseline), undergo baseline determinations, and start treatment with study drug","text_display":" group (Baseline), undergo baseline determinations, and start treatment with study drug","confidence":1,"confidence_rate":1},{"cnt":[[348,2015],[1880,2015],[1880,2065],[348,2065]],"region":{"top_left_x":348,"top_left_y":2015,"width":1532,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d765d8978504ed7bc25aa3400a519ef","type":"text","conversion_output":true,"text":"(Day 1). Treatment must be administered within 24 hours, at the latest, after SA-AKI is","text_display":" (Day 1). Treatment must be administered within 24 hours, at the latest, after SA-AKI is","confidence":1,"confidence_rate":1},{"cnt":[[346,2062],[1884,2062],[1884,2112],[346,2112]],"region":{"top_left_x":345,"top_left_y":2062,"width":1540,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc3552d880564d75a0577bb4cf33bb8b","type":"text","conversion_output":true,"text":"first diagnosed and within 96 hours from sepsis first diagnosis. Table 15-1 Schedule of","text_display":" first diagnosed and within 96 hours from sepsis first diagnosis. Table 15-1 Schedule of","confidence":1,"confidence_rate":1},{"cnt":[[348,2114],[565,2114],[565,2155],[348,2155]],"region":{"top_left_x":348,"top_left_y":2114,"width":218,"height":41},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fb0090e72a14b4097a555f6065088f3","type":"text","conversion_output":true,"text":"Assessments","text_display":" Assessments","confidence":1,"confidence_rate":1},{"cnt":[[1100,2582],[1126,2582],[1126,2628],[1100,2628]],"region":{"top_left_x":1100,"top_left_y":2582,"width":26,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0245279edc7a4530852c467e41ab4b6c","type":"page_info","conversion_output":false,"text":"3","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-11","page":11,"lines":[{"cnt":[[344,125],[492,125],[492,157],[344,157]],"region":{"top_left_x":343,"top_left_y":124,"width":149,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"cfe58d0afc944c0eba8b4ac0183487bf","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1854,125],[1854,161],[1366,161]],"region":{"top_left_x":1366,"top_left_y":124,"width":489,"height":38},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"62c49aa25f944656bdc493bf681778e2","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[344,155],[599,155],[599,191],[344,191]],"region":{"top_left_x":343,"top_left_y":154,"width":257,"height":38},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"dc3a0a9906fb47638b57d2d6aef84478","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999575209175736},{"cnt":[[1568,155],[1854,155],[1854,191],[1568,191]],"region":{"top_left_x":1568,"top_left_y":154,"width":287,"height":38},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bea8665097e44cf289dd3ba325728d67","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,318],[2086,318],[2086,2348],[322,2348]],"region":{"top_left_x":322,"top_left_y":317,"width":1765,"height":2032},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd594194e1ce4927a130ebf6710b2e93","type":"table","conversion_output":true,"children_ids":["45a83fe22371446597276aa021c41ca5","5c0197228c284235a3e664133ce5241f","36d4d3b90a7b49b9accefa8d967c5925","ad4d036be2024b43a869ae999c38354c","ccb64836fb0847e598135299b67ad48b","18ba430bd31d40428a76ac3d1513d041","8ae25761600c49baafaa4c52f4e0f5e1","49e5a5425be941d0a6cb5afc274a054c","9e71283fc86e425da5528f806cd8566d","11a2e2b676b440d2ba0d72c688b0f14d","b53d82fc16ed4911a37b9dfcf68312fc","67606932b6544d4fb45d882c5ee15d94","69e410d22fd94231988826ed18669953","b0ab6430f75d4d458f6244e99a6a2de5","6582eef1de9a48e1a49a0c396f0f35cc","eba6d6ff858644a5840cdf724f982c0c","f94f9c35a5454e82a715083d3218174b","05bd3760296b43c28e9f4ff011047ef1","fe786772371949ba89bea1804cc16046","fe6611f0584b4c499f60e1674d98da9a","2f8a2a97be024da5ab00bbcf2589e611","6247f2f81ba34214b20284b6763cd87c","e10af87bf62641aa8424fbfa0f4acefb","544f62e24a314bd0bec1c72b57cdb97e","07adfd02f83d4e299eff8fe1448da25a","a144332034db420abaabc09c7becb152","1e84fdedb2734422bfeb9f2d76b2f1ad","ad24837a5e9f487f96dc7bbfe5f94c37","32ed467e8edf43408fd25cd71edc26ee","a7eeb81462ca49d8a6e704ff8ca32dbf","d664fe84030f4357b05990b6e72542d0","9b17800e812a44268dd009e0b92956b6","67a6314a964c4f2b8657a5150562bb2a","5cdde13fa61146968a5eea195fabcf83","e27a7087ae3040b49e95b46da3b6367d","3b9a3bc7e0e6458ead65f3923bb93bf9","ae4345ab2ad94369b722dff852a1b949","45b1d4166005405eb9293aee9917c597","bc8c7bb05bd94568a0e8ccb2ddf79d2d","c923db908ec9490dae3d5e43199ee60d","7b7dd6ede4a44a0e823423d8bfbcdfd7","2e7aafa3adab442fa987f0360ed009bf","050137061531477e9720a33e5925d05c","078475cfd4df4f989eaaba5e8871b860","62cef742a6fd40a997f467ad7721dbde","061a072634574044ae8abbbffc410991","bdc360b9a6c44f198b2df444909aa01e","09a3598a6781420faae993dc53c6f907","93750f019b2f4e3fb6fac379904c9e6c","0c41593d28d14ebf94452927acc32c8a","6a6a577d1af94a56a53c76070a90a746","faa3b58fe31e4c42b76b9f368d9949cb","6614775da6274a419cc4e7c88d5aede4","523314423f0042108232a07ff11bdf7e","8f5d660652914f21a8989b29374d3d7a","333067305dcc466395cbf1c96e6cc307","0e6657b229cf4d9cbb05e5dfcbf850e0","3b3a6d39854149a5983e05e7d35098bd","64d2b6e56cba4b4b9e45753082d3dfb3","3abb1da3bf2444239b1ecd949ebd70cc","3da865021c7f428cbf84b92db6d2a7fe","23fb320c5e4f4b5888d93c80c835ad6f"],"text":"\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline Assessment & Screeni ng ( \\(\\leq 2 4 ~ h )\\) & Basel ine ( \\(\\leq 2 4 ~ h )\\) & Da y 1 & Da y 2 & Day 3 & Da y 4 & Da y 5 & Da y 6 & Day 7 \\(( \\pm 1\\) day ) & Day 14 \\(( \\pm 2\\) days ) & Day 21 \\(( \\pm 3\\) days ) & Day 28 \\(( \\pm 3\\) days ) & Day 60 \\(( \\pm 5\\) days ) & Day 90 \\(( \\pm 1 0\\) days ) \\\\\n\\hline AKI diagnosis \\({ }^{\\text {a }}\\) (prescreening) Record site of infection and pathogen & X & & & & & & & & & & & & & \\\\\n\\hline Inclusion and exclusion criteria & X & X \\({ }^{\\text {b }}\\) & & & & & & & & & & & & \\\\\n\\hline Informed consent & X & & & & & & & & & & & & & \\\\\n\\hline Medical history & X & & & & & & & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & & & & & & & \\\\\n\\hline Child-Pugh score \\({ }^{\\text {c }}\\) & X & & & & & & & & & & & & & \\\\\n\\hline Recent hematology and clinical chemistry results, if available & X & & & & & & & & & & & & & \\\\\n\\hline Recent microbial test results, if available & X & & & & 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2=\\) fraction of inspired oxygen; \\(GGT =\\) gamma-glutamyl transpeptidase; GST-","text_display":" \\(ECG =\\) electrocardiogram; \\(FiO 2=\\) fraction of inspired oxygen; \\(GGT =\\) gamma-glutamyl transpeptidase; GST","confidence":0.28060553287647355,"confidence_rate":0.989288246612036},{"cnt":[[344,1714],[1871,1714],[1871,1755],[344,1755]],"region":{"top_left_x":343,"top_left_y":1714,"width":1529,"height":42},"line":143,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"028951081502400d8a4bd45380486447","type":"text","conversion_output":true,"text":"alpha = alpha-glutathione s-transferase; h = hour; Hct = hematocrit; Hgb = hemoglobin; HR = heart rate; ICU = intensive","text_display":"alpha = alpha-glutathione s-transferase; h = hour; Hct = hematocrit; Hgb = hemoglobin; HR = heart rate; ICU = intensive","confidence":0.4069965185064204,"confidence_rate":0.9927766129800303},{"cnt":[[344,1749],[1785,1749],[1785,1790],[344,1790]],"region":{"top_left_x":343,"top_left_y":1748,"width":1443,"height":42},"line":144,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"677c024050be4bfb9dd6185d247173f7","type":"text","conversion_output":true,"text":"care unit; IgE = immunoglobulin E; IgG = immunoglobulin G; IL-6 = interleukin-6; IL-18 = interleukin-18; KIM-","text_display":" care unit; IgE = immunoglobulin E; IgG = immunoglobulin G; IL-6 = interleukin-6; IL-18 = interleukin-18; KIM","confidence":0.9631229783408344,"confidence_rate":0.9996704563116988},{"cnt":[[346,1783],[1835,1783],[1835,1824],[346,1824]],"region":{"top_left_x":345,"top_left_y":1783,"width":1490,"height":42},"line":145,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"927e1a8dca8349eb965d0e3a3b16504e","type":"text","conversion_output":true,"text":"\\(1=\\) kidney injury molecule-1; LBP = lipopolysaccharide binding protein; LDH = lactate dehydrogenase; OS = oxygen","text_display":"\\(1=\\) kidney injury molecule-1; LBP = lipopolysaccharide binding protein; LDH = lactate dehydrogenase; OS = oxygen","confidence":0.5554794883673578,"confidence_rate":0.9949006668796971},{"cnt":[[346,1822],[1850,1822],[1850,1863],[346,1863]],"region":{"top_left_x":345,"top_left_y":1821,"width":1505,"height":42},"line":146,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0824efc14394791bedbf0949ddf0166","type":"text","conversion_output":true,"text":"saturation; PEEP = positive end expiratory pressure; \\(P / F\\) ratio = fraction \\(PaO _{2} / FiO _{2}\\); RR \\(=\\) respiratory rate; RRT \\(=\\) renal","text_display":" saturation; PEEP = positive end expiratory pressure; \\(P / F\\) ratio = fraction \\(PaO _{2} / FiO _{2}\\); RR \\(=\\) respiratory rate; RRT \\(=\\) renal","confidence":0.40802304783347293,"confidence_rate":0.9945155145392949},{"cnt":[[344,1856],[1783,1856],[1783,1897],[344,1897]],"region":{"top_left_x":343,"top_left_y":1856,"width":1441,"height":42},"line":147,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1def2b10f0a454b9859126d010d55b1","type":"text","conversion_output":true,"text":"replacement therapy; SAPS-2 \\(=\\) simplified acute physiology score 2; SOFA \\(=\\) sequential organ failure assessment;","text_display":" replacement therapy; SAPS-2 \\(=\\) simplified acute physiology score 2; SOFA \\(=\\) sequential organ failure assessment;","confidence":0.7175489285702952,"confidence_rate":0.9972606667687087},{"cnt":[[344,1895],[563,1895],[563,1931],[344,1931]],"region":{"top_left_x":343,"top_left_y":1894,"width":220,"height":38},"line":148,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"54d4291726f84778877d838004dbf10d","type":"text","conversion_output":true,"text":"\\(T =\\) temperature.","text_display":" \\(T =\\) temperature.","confidence":1,"confidence_rate":1},{"cnt":[[344,1934],[1876,1934],[1876,1979],[344,1979]],"region":{"top_left_x":343,"top_left_y":1933,"width":1533,"height":46},"line":149,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89371622991f48689936df8960e57cd6","type":"text","conversion_output":true,"text":"a. The AKI diagnosis can be made according to one of the AKIN serum creatinine criteria (absolute or relative increase,","text_display":"\na. The AKI diagnosis can be made according to one of the AKIN serum creatinine criteria (absolute or relative increase,","confidence":0.87744140625,"confidence_rate":0.9989461597173953},{"cnt":[[395,1972],[1854,1972],[1854,2013],[395,2013]],"region":{"top_left_x":395,"top_left_y":1972,"width":1460,"height":42},"line":150,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9990b3e6fb6495d8eb0270a2517f03f","type":"text","conversion_output":true,"text":"see inclusion criteria Error! Reference source not found. and Error! Reference source not found.), or according","text_display":" see inclusion criteria Error! Reference source not found. and Error! Reference source not found.), or according","confidence":1,"confidence_rate":1},{"cnt":[[395,2007],[1760,2007],[1760,2047],[395,2047]],"region":{"top_left_x":395,"top_left_y":2006,"width":1365,"height":42},"line":151,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16ad48bf878548a0a6933f3fdeee3516","type":"text","conversion_output":true,"text":"to the AKIN urine output criteria (urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\) hours, see inclusion criterion Error!","text_display":" to the AKIN urine output criteria (urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\) hours, see inclusion criterion Error!","confidence":1,"confidence_rate":1},{"cnt":[[395,2045],[1768,2045],[1768,2086],[395,2086]],"region":{"top_left_x":395,"top_left_y":2045,"width":1374,"height":42},"line":152,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02cb255e81fe4038b41f87014963cca7","type":"text","conversion_output":true,"text":"Reference source not found.), the oliguria or anuria should still meet the AKIN urine output criteria prior to","text_display":" Reference source not found.), the oliguria or anuria should still meet the AKIN urine output criteria prior to","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[395,2080],[973,2080],[973,2121],[395,2121]],"region":{"top_left_x":395,"top_left_y":2079,"width":579,"height":42},"line":153,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0942ecf65e844bc380f092f14aaea576","type":"text","conversion_output":true,"text":"randomization and study drug administration.","text_display":" randomization and study drug administration.","confidence":1,"confidence_rate":1},{"cnt":[[344,2118],[578,2118],[578,2163],[344,2163]],"region":{"top_left_x":343,"top_left_y":2118,"width":235,"height":46},"line":154,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9475df4037c74266affb46df71460eea","type":"text","conversion_output":true,"text":"b. Confirmatory.","text_display":"\nb. Confirmatory.","confidence":1,"confidence_rate":1},{"cnt":[[346,2161],[849,2161],[849,2206],[346,2206]],"region":{"top_left_x":345,"top_left_y":2161,"width":504,"height":46},"line":155,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"473467f7e0ae4bd0b1617d96c7c96fec","type":"text","conversion_output":true,"text":"c. Only for patients with liver disease.","text_display":"\nc. Only for patients with liver disease.","confidence":0.99951171875,"confidence_rate":0.9999891467144949},{"cnt":[[344,2200],[617,2200],[617,2247],[344,2247]],"region":{"top_left_x":343,"top_left_y":2200,"width":274,"height":48},"line":156,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f4e31f63befe4ed6bb4aeea8d974a036","type":"text","conversion_output":true,"text":"d. Local laboratory.","text_display":"\nd. Local laboratory.","confidence":1,"confidence_rate":1},{"cnt":[[346,2247],[1858,2247],[1858,2292],[346,2292]],"region":{"top_left_x":345,"top_left_y":2247,"width":1514,"height":46},"line":157,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f00cb876035144d19c8b76ec0acf2d30","type":"text","conversion_output":true,"text":"\\({ }^{\\text {e. }}\\) See flowchart (Section Error! Reference source not found., Error! Reference source not found.) for options and","text_display":"\n\\({ }^{\\text {e. }}\\) See flowchart (Section Error! Reference source not found., Error! Reference source not found.) for options and","confidence":0.995125050657407,"confidence_rate":0.9999621179991859},{"cnt":[[395,2288],[1755,2288],[1755,2327],[395,2327]],"region":{"top_left_x":395,"top_left_y":2288,"width":1361,"height":39},"line":158,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3665ef84cb846688f4451df4c58b8c7","type":"text","conversion_output":true,"text":"preference for reference serum creatinine value. The reference creatinine value is the serum creatinine value","text_display":" preference for reference serum creatinine value. The reference creatinine value is the serum creatinine value","confidence":1,"confidence_rate":1},{"cnt":[[395,2325],[1807,2325],[1807,2365],[395,2365]],"region":{"top_left_x":395,"top_left_y":2324,"width":1412,"height":42},"line":159,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a7ca903de3842a59a5192a622de6507","type":"text","conversion_output":true,"text":"according to the following order of preference: 1) lowest value within 3 months of the hospital admission. If not","text_display":" according to the following order of preference: 1) lowest value within 3 months of the hospital admission. If not","confidence":0.9990236759185791,"confidence_rate":0.9999919272970785},{"cnt":[[1091,2582],[1130,2582],[1130,2628],[1091,2628]],"region":{"top_left_x":1091,"top_left_y":2582,"width":40,"height":46},"line":160,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9da82ff4be8243d9b3e6cc0db340c1a1","type":"page_info","conversion_output":false,"text":"8","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-16","page":16,"lines":[{"cnt":[[348,129],[492,129],[492,157],[348,157]],"region":{"top_left_x":348,"top_left_y":128,"width":144,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f98e282622e14179bade4e1fcf57af01","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1371,127],[1850,127],[1850,157],[1371,157]],"region":{"top_left_x":1370,"top_left_y":126,"width":480,"height":31},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"02c3d592f8a1405982e8998109635401","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[348,159],[597,159],[597,187],[348,187]],"region":{"top_left_x":348,"top_left_y":158,"width":250,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a8d55623a7e54091a319ca6680150fe0","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.998046875,"confidence_rate":0.9999150020979262},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ef349d24c90d41daa3df29347f0190d0","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[395,327],[1863,327],[1863,363],[395,363]],"region":{"top_left_x":395,"top_left_y":326,"width":1468,"height":38},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8127185b3fc840a4831c5f05fe689130","type":"text","conversion_output":true,"text":"available, 2) at hospital admission. If not available, 3) at ICU or intermediate care unit admission. If not available, 4)","text_display":"\navailable, 2) at hospital admission. If not available, 3) at ICU or intermediate care unit admission. If not available, 4)","confidence":0.994636058807373,"confidence_rate":0.9999576514575393},{"cnt":[[395,363],[1235,363],[1235,400],[395,400]],"region":{"top_left_x":395,"top_left_y":363,"width":841,"height":37},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a0c310debc44b6e89a2209d4f2bc9eb","type":"text","conversion_output":true,"text":"lowest value between 3 and 12 months prior to hospital admission.","text_display":" lowest value between 3 and 12 months prior to hospital admission.","confidence":1,"confidence_rate":1},{"cnt":[[348,400],[1800,400],[1800,440],[348,440]],"region":{"top_left_x":348,"top_left_y":399,"width":1453,"height":42},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0eb724f807d34213a475c5fc0ee89189","type":"text","conversion_output":true,"text":"f. When the diagnosis of AKI is made according to one of the AKIN serum creatinine criteria (absolute or relative","text_display":"\nf. When the diagnosis of AKI is made according to one of the AKIN serum creatinine criteria (absolute or relative","confidence":0.689453125,"confidence_rate":0.9968536333703034},{"cnt":[[395,443],[1807,443],[1807,477],[395,477]],"region":{"top_left_x":395,"top_left_y":442,"width":1412,"height":35},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3689e68236d42b2b32e626a665090a8","type":"text","conversion_output":true,"text":"increase, see inclusion criteria Error! Reference source not found. and Error! Reference source not found.),","text_display":" increase, see inclusion criteria Error! Reference source not found. and Error! Reference source not found.),","confidence":0.974609375,"confidence_rate":0.9997724282940514},{"cnt":[[395,477],[1811,477],[1811,513],[395,513]],"region":{"top_left_x":395,"top_left_y":476,"width":1417,"height":38},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6897b69e3d4a4aeeafe23acfe1c0c72d","type":"text","conversion_output":true,"text":"patients will be eligible for the study and can be randomly assigned when the volume-corrected serum creatinine","text_display":" patients will be eligible for the study and can be randomly assigned when the volume-corrected serum creatinine","confidence":1,"confidence_rate":1},{"cnt":[[395,516],[1815,516],[1815,550],[395,550]],"region":{"top_left_x":395,"top_left_y":515,"width":1421,"height":35},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"187f7eed11d648c3a73891e0e123799d","type":"text","conversion_output":true,"text":"sample, taken at screening confirms the continuation of AKI according to the AKIN criteria for serum creatinine.","text_display":" sample, taken at screening confirms the continuation of AKI according to the AKIN criteria for serum creatinine.","confidence":1,"confidence_rate":1},{"cnt":[[395,550],[1871,550],[1871,587],[395,587]],"region":{"top_left_x":395,"top_left_y":550,"width":1477,"height":37},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05301de583044c4e87f1a4a6796cde97","type":"text","conversion_output":true,"text":"When the AKI diagnosis was made according to the AKIN urine output criteria (urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\)","text_display":" When the AKI diagnosis was made according to the AKIN urine output criteria (urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\)","confidence":1,"confidence_rate":1},{"cnt":[[395,584],[1876,584],[1876,621],[395,621]],"region":{"top_left_x":395,"top_left_y":584,"width":1481,"height":37},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3626dbace22845efbdf72ec83ea3b2dd","type":"text","conversion_output":true,"text":"hours, see inclusion criterion Error! Reference source not found.), the oliguria or anuria should still meet the AKIN","text_display":" hours, see inclusion criterion Error! Reference source not found.), the oliguria or anuria should still meet the AKIN","confidence":0.99951171875,"confidence_rate":0.9999959967252418},{"cnt":[[395,621],[1326,621],[1326,657],[395,657]],"region":{"top_left_x":395,"top_left_y":620,"width":931,"height":38},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"67a5b0aae83d4911a00c3f634c802176","type":"text","conversion_output":true,"text":"urine output criteria prior to randomization and study drug administration.","text_display":" urine output criteria prior to randomization and study drug administration.","confidence":1,"confidence_rate":1},{"cnt":[[348,662],[1850,662],[1850,700],[348,700]],"region":{"top_left_x":348,"top_left_y":661,"width":1502,"height":40},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eff6c7c3a8d8445c9fa398c5f6ce8e98","type":"text","conversion_output":true,"text":"g. Vital signs in ambulant patients will be obtained with the patient in a sitting position and after 5 minutes rest. Blood","text_display":"\ng. Vital signs in ambulant patients will be obtained with the patient in a sitting position and after 5 minutes rest. Blood","confidence":0.99951171875,"confidence_rate":0.9999962717588727},{"cnt":[[393,700],[1854,700],[1854,737],[393,737]],"region":{"top_left_x":393,"top_left_y":700,"width":1462,"height":37},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f58cf0ce4b44027afabac31638ac94e","type":"text","conversion_output":true,"text":"pressure will be monitored non-invasively. In patients who already have an arterial line placed as part of standard or","text_display":" pressure will be monitored non-invasively. 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Additionally, vital signs (excluding temperature) will also be monitored during study drug infusion on all treatment","text_display":"\nh. Additionally, vital signs (excluding temperature) will also be monitored during study drug infusion on all treatment","confidence":1,"confidence_rate":1},{"cnt":[[395,816],[1826,816],[1826,853],[395,853]],"region":{"top_left_x":395,"top_left_y":816,"width":1432,"height":37},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a80a5cf3d314924bba008e4643ce6ff","type":"text","conversion_output":true,"text":"days at the following times: a) immediately before the administration of the study drug, b) within 5 minutes of the","text_display":" days at the following times: a) immediately before the administration of the study drug, b) within 5 minutes of the","confidence":0.9951171875,"confidence_rate":0.9999602058944347},{"cnt":[[395,851],[1794,851],[1794,887],[395,887]],"region":{"top_left_x":395,"top_left_y":850,"width":1399,"height":38},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b46f206098746539d7e6ea2fd0fee0c","type":"text","conversion_output":true,"text":"start of the study drug infusion, c) 30 minutes after the start of the study drug infusion, d) immediately after the","text_display":" start of the study drug infusion, c) 30 minutes after the start of the study drug infusion, d) immediately after the","confidence":1,"confidence_rate":1},{"cnt":[[395,887],[1833,887],[1833,922],[395,922]],"region":{"top_left_x":395,"top_left_y":887,"width":1438,"height":35},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e2b12032b374830a4339369295a7045","type":"text","conversion_output":true,"text":"completion of the administration of the study drug, which includes post-dose saline flushing, e) 30 and 60 minutes","text_display":" completion of the administration of the study drug, which includes post-dose saline flushing, e) 30 and 60 minutes","confidence":1,"confidence_rate":1},{"cnt":[[395,924],[1876,924],[1876,960],[395,960]],"region":{"top_left_x":395,"top_left_y":923,"width":1481,"height":38},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"94414504328f465593d28c5d2c59c848","type":"text","conversion_output":true,"text":"after completion of study drug administration, f) 2 hours, 3 hours, 4 hours, and 5 hours after completion of study drug","text_display":" after completion of study drug administration, f) 2 hours, 3 hours, 4 hours, and 5 hours after completion of study drug","confidence":1,"confidence_rate":1},{"cnt":[[395,958],[758,958],[758,995],[395,995]],"region":{"top_left_x":395,"top_left_y":958,"width":364,"height":37},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"732dea2ae5ae41afab62a05634e69791","type":"text","conversion_output":true,"text":"administration (Day 1 only).","text_display":" administration (Day 1 only).","confidence":1,"confidence_rate":1},{"cnt":[[346,997],[1807,997],[1807,1038],[346,1038]],"region":{"top_left_x":345,"top_left_y":996,"width":1462,"height":42},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a53a4cdfc42c4ddaa26de79f5d84cbe5","type":"text","conversion_output":true,"text":"i. SOFA score to be obtained on each visit day as long as the patient is in the ICU or intermediate care unit, and at","text_display":"\ni. SOFA score to be obtained on each visit day as long as the patient is in the ICU or intermediate care unit, and at","confidence":0.92919921875,"confidence_rate":0.9993982784934069},{"cnt":[[395,1038],[982,1038],[982,1072],[395,1072]],"region":{"top_left_x":395,"top_left_y":1037,"width":587,"height":36},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"577e0f4383934edfb1dda9b0d1519f53","type":"text","conversion_output":true,"text":"discharge from ICU or intermediate care unit .","text_display":" discharge from ICU or intermediate care unit .","confidence":1,"confidence_rate":1},{"cnt":[[344,1074],[1863,1074],[1863,1117],[344,1117]],"region":{"top_left_x":343,"top_left_y":1074,"width":1520,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3fa47442acc4175bb25297852d22d93","type":"text","conversion_output":true,"text":"j. EQ-5D will be performed at baseline, at discharge from the ICU or intermediate care unit, and at the Day 90 visit. In","text_display":"\nj. EQ-5D will be performed at baseline, at discharge from the ICU or intermediate care unit, and at the Day 90 visit. In","confidence":0.89794921875,"confidence_rate":0.9991594022382645},{"cnt":[[395,1117],[1508,1117],[1508,1154],[395,1154]],"region":{"top_left_x":395,"top_left_y":1117,"width":1114,"height":37},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59ee93ec948243649ab4f900454c7a03","type":"text","conversion_output":true,"text":"case the patient is unconscious, EQ-5D questionnaire will be completed by a next of kin.","text_display":" case the patient is unconscious, EQ-5D questionnaire will be completed by a next of kin.","confidence":1,"confidence_rate":1},{"cnt":[[348,1154],[1072,1154],[1072,1197],[348,1197]],"region":{"top_left_x":348,"top_left_y":1153,"width":725,"height":44},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c185244de394eca9e1ed9ece73b5881","type":"text","conversion_output":true,"text":"k. At \\(24 \\pm 1\\) hour after the previous drug administration.","text_display":"\nk. At \\(24 \\pm 1\\) hour after the previous drug administration.","confidence":1,"confidence_rate":1},{"cnt":[[346,1195],[1800,1195],[1800,1240],[346,1240]],"region":{"top_left_x":345,"top_left_y":1194,"width":1456,"height":46},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6c4c063d38b4a77a0ef317b3dffdf2b","type":"text","conversion_output":true,"text":"\\({ }^{1}\\). Creatinine and BUN will be measured by a central laboratory. At Days 60 and 90 , only serum creatinine will be","text_display":"\n\\({ }^{1}\\). Creatinine and BUN will be measured by a central laboratory. At Days 60 and 90 , only serum creatinine will be","confidence":0.6539332866668701,"confidence_rate":0.9967628848310458},{"cnt":[[395,1238],[1725,1238],[1725,1274],[395,1274]],"region":{"top_left_x":395,"top_left_y":1237,"width":1331,"height":38},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d8128ab1a3714e38801a22521486e884","type":"text","conversion_output":true,"text":"measured. When patients have a Foley catheter, serum creatinine samples should be collected prior to and","text_display":" measured. When patients have a Foley catheter, serum creatinine samples should be collected prior to and","confidence":1,"confidence_rate":1},{"cnt":[[395,1274],[1747,1274],[1747,1311],[395,1311]],"region":{"top_left_x":395,"top_left_y":1274,"width":1352,"height":37},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9976c0ad04444bc9b0c61b377708ae15","type":"text","conversion_output":true,"text":"immediately after each urine collection for at least up to Day 7. If the patient is discharged from the ICU or","text_display":" immediately after each urine collection for at least up to Day 7. If the patient is discharged from the ICU or","confidence":0.64794921875,"confidence_rate":0.9962336934191112},{"cnt":[[395,1311],[1850,1311],[1850,1347],[395,1347]],"region":{"top_left_x":395,"top_left_y":1310,"width":1455,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f206b0035c04bdc8f79ba32c6e18e6c","type":"text","conversion_output":true,"text":"intermediate care unit , the Foley catheter might be removed. In this case, a patient might urinate spontaneously and","text_display":" intermediate care unit , the Foley catheter might be removed. In this case, a patient might urinate spontaneously and","confidence":0.93896484375,"confidence_rate":0.9994839263219308},{"cnt":[[395,1347],[1803,1347],[1803,1381],[395,1381]],"region":{"top_left_x":395,"top_left_y":1347,"width":1408,"height":35},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3d99321b4da481a873608f6e1d1a720","type":"text","conversion_output":true,"text":"all efforts should be undertaken to start collecting urine produced from this time point onward. Approximately 6","text_display":" all efforts should be undertaken to start collecting urine produced from this time point onward. Approximately 6","confidence":1,"confidence_rate":1},{"cnt":[[395,1384],[1777,1384],[1777,1418],[395,1418]],"region":{"top_left_x":395,"top_left_y":1383,"width":1382,"height":35},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b611f3cdc1fb4388befd42d1a941b6f5","type":"text","conversion_output":true,"text":"hours later (exact duration needs to be recorded) the patient might urinate again and this urine will be used for","text_display":" hours later (exact duration needs to be recorded) the patient might urinate again and this urine will be used for","confidence":1,"confidence_rate":1},{"cnt":[[395,1418],[1850,1418],[1850,1454],[395,1454]],"region":{"top_left_x":395,"top_left_y":1417,"width":1455,"height":38},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"620173bef4c04f0cb5349bbf5a4cddb9","type":"text","conversion_output":true,"text":"analysis, and a blood sample will be drawn at this time too. The urine volume produced over approximately 6 hours","text_display":" analysis, and a blood sample will be drawn at this time too. The urine volume produced over approximately 6 hours","confidence":1,"confidence_rate":1},{"cnt":[[395,1454],[754,1454],[754,1485],[395,1485]],"region":{"top_left_x":395,"top_left_y":1454,"width":360,"height":31},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0997ffa27a8a4477b461a0300684ba8a","type":"text","conversion_output":true,"text":"will be entered in the eCRF.","text_display":" will be entered in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[408,1491],[1852,1491],[1852,1532],[408,1532]],"region":{"top_left_x":408,"top_left_y":1491,"width":1444,"height":41},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d83eb639af140de98163de1070fbea8","type":"text","conversion_output":true,"text":"m. Urine creatinine and urea will be measured by a central laboratory. The central laboratory will calculate blood","text_display":"\nm. Urine creatinine and urea will be measured by a central laboratory. The central laboratory will calculate blood","confidence":0.9985356330871582,"confidence_rate":0.9999876854527495},{"cnt":[[473,1534],[1807,1534],[1807,1566],[473,1566]],"region":{"top_left_x":472,"top_left_y":1533,"width":1335,"height":34},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"215a39270b5f49eeabb53a80307a1517","type":"text","conversion_output":true,"text":"urea nitrogen (BUN) clearance at all visits from Day 1 to Day 7, inclusive, and on subsequent visit days if","text_display":" urea nitrogen (BUN) clearance at all visits from Day 1 to Day 7, inclusive, and on subsequent visit days if","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[473,1568],[1876,1568],[1876,1605],[473,1605]],"region":{"top_left_x":472,"top_left_y":1568,"width":1404,"height":37},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b9ea0ffdd1a4e7ea7179145ae326624","type":"text","conversion_output":true,"text":"reliable urine collection is possible. Urine will be collected within a \\(6 \\pm 1\\) hour period at all visits from Day 1 to","text_display":" reliable urine collection is possible. Urine will be collected within a \\(6 \\pm 1\\) hour period at all visits from Day 1 to","confidence":0.9970724578015506,"confidence_rate":0.9999767317323609},{"cnt":[[473,1607],[1865,1607],[1865,1641],[473,1641]],"region":{"top_left_x":472,"top_left_y":1607,"width":1393,"height":35},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3d67d52b4ea4d26a7465aa00d2a24bb","type":"text","conversion_output":true,"text":"Day 28, only if reliable urine collection is possible (i.e., patient remains in the ICU or intermediate care unit or","text_display":" Day 28, only if reliable urine collection is possible (i.e., patient remains in the ICU or intermediate care unit or","confidence":1,"confidence_rate":1},{"cnt":[[473,1641],[595,1641],[595,1678],[473,1678]],"region":{"top_left_x":472,"top_left_y":1641,"width":124,"height":37},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4b87351eb7a4cc7850ec57a8f8e1d6e","type":"text","conversion_output":true,"text":"hospital).","text_display":" hospital).","confidence":1,"confidence_rate":1},{"cnt":[[346,1680],[1854,1680],[1854,1721],[346,1721]],"region":{"top_left_x":345,"top_left_y":1680,"width":1510,"height":41},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9cd60ad80bac4944bfb985b3658a21c5","type":"text","conversion_output":true,"text":"\\({ }^{\\text {n }}\\) These assessments will be performed before treatment if possible. Treatment should not be delayed because of these","text_display":"\n\\({ }^{\\text {n }}\\) These assessments will be performed before treatment if possible. Treatment should not be delayed because of these","confidence":0.6715864404191052,"confidence_rate":0.996988539450651},{"cnt":[[395,1723],[561,1723],[561,1751],[395,1751]],"region":{"top_left_x":395,"top_left_y":1723,"width":166,"height":28},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3268a9479143455499be4856a65364eb","type":"text","conversion_output":true,"text":"assessments.","text_display":" assessments.","confidence":1,"confidence_rate":1},{"cnt":[[348,1762],[1815,1762],[1815,1798],[348,1798]],"region":{"top_left_x":348,"top_left_y":1761,"width":1468,"height":38},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6c09b03d0e04351b614bdf7a99b4529","type":"text","conversion_output":true,"text":"\\({ }^{\\text {o }}\\) Urine volume collection in a \\(6 \\pm 1\\) hour collection period, only if reliable urine collection is possible (i.e., patient","text_display":"\n\\({ }^{\\text {o }}\\) Urine volume collection in a \\(6 \\pm 1\\) hour collection period, only if reliable urine collection is possible (i.e., patient","confidence":0.5330655671423301,"confidence_rate":0.9954516011845468},{"cnt":[[395,1798],[1854,1798],[1854,1833],[395,1833]],"region":{"top_left_x":395,"top_left_y":1798,"width":1460,"height":35},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"752347ec30f24c30b644369fa6385173","type":"text","conversion_output":true,"text":"remains in the ICU or intermediate care unit or hospital). The volume should be corrected to account for the volume","text_display":" remains in the ICU or intermediate care unit or hospital). The volume should be corrected to account for the volume","confidence":1,"confidence_rate":1},{"cnt":[[395,1835],[1233,1835],[1233,1871],[395,1871]],"region":{"top_left_x":395,"top_left_y":1834,"width":839,"height":38},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"172b67f62bfa4bf6ad99d0d042865794","type":"text","conversion_output":true,"text":"of samples previously taken from the total urine initially collected.","text_display":" of samples previously taken from the total urine initially collected.","confidence":1,"confidence_rate":1},{"cnt":[[346,1876],[1543,1876],[1543,1914],[346,1914]],"region":{"top_left_x":345,"top_left_y":1875,"width":1198,"height":40},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c532935c6dcf4b70983bb93bb16dd8d0","type":"text","conversion_output":true,"text":"p. Only when possible within the 24 -hour time window from first AKI diagnosis to treatment.","text_display":"\np. Only when possible within the 24 -hour time window from first AKI diagnosis to treatment.","confidence":0.9794921875,"confidence_rate":0.9997928112901707},{"cnt":[[348,1957],[348,1916],[1822,1919],[1822,1959]],"region":{"top_left_x":347,"top_left_y":1916,"width":1475,"height":44},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42d12b9b82cc40b4970d59dc9a58bb26","type":"text","conversion_output":true,"text":"q. Assays will be performed by a central reference laboratory. See Section Error! Reference source not found. for","text_display":"\nq. Assays will be performed by a central reference laboratory. See Section Error! 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Verification that no concomitant medications that should be avoided are taken.","text_display":"\nu. Verification that no concomitant medications that should be avoided are taken.","confidence":0.98291015625,"confidence_rate":0.9997995833358754},{"cnt":[[348,2204],[1841,2204],[1841,2241],[348,2241]],"region":{"top_left_x":348,"top_left_y":2204,"width":1494,"height":37},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f94cbddf05f42b486751cdab179a305","type":"text","conversion_output":true,"text":"v. The actual stop date is collected for calculation of shock-free days. Only required when the patient is in the ICU or","text_display":"\nv. The actual stop date is collected for calculation of shock-free days. 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All safety data will be summarized for all four treatment","confidence":1,"confidence_rate":1},{"cnt":[[1091,2582],[1141,2582],[1141,2628],[1091,2628]],"region":{"top_left_x":1091,"top_left_y":2582,"width":50,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"879ed793c2134494ace3f385a69c91c7","type":"page_info","conversion_output":false,"text":"14","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-22","page":22,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"88d429382a984614adb9c8db1c3615d4","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1369,125],[1850,125],[1850,159],[1369,159]],"region":{"top_left_x":1368,"top_left_y":124,"width":482,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"21d4594203924daeadc5cb459cdc5f00","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[348,159],[599,159],[599,187],[348,187]],"region":{"top_left_x":348,"top_left_y":158,"width":252,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"dd8d7eca7ef442aebd5a7c0f2e11e1a2","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e1366da467f34ef0836e70996e879057","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[348,329],[1876,329],[1876,376],[348,376]],"region":{"top_left_x":348,"top_left_y":328,"width":1528,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6dcc88023fc4cdea964734ccae68718","type":"text","conversion_output":true,"text":"groups including patients recruited at any point in the study. 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Similarly, all data listings will","confidence":1,"confidence_rate":1},{"cnt":[[348,374],[1195,374],[1195,423],[348,423]],"region":{"top_left_x":348,"top_left_y":373,"width":847,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5cb19e98ede4409af4015058a2af78e","type":"text","conversion_output":true,"text":"include patients recruited at any point in the study.","text_display":" include patients recruited at any point in the study.","confidence":1,"confidence_rate":1},{"cnt":[[348,473],[1878,473],[1878,520],[348,520]],"region":{"top_left_x":348,"top_left_y":472,"width":1530,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15338062c4fb4342b09a1da0f00fc0eb","type":"text","conversion_output":true,"text":"See also Section 4.3 for definitions of the analysis sets used in the study, which also state","text_display":"\n\nSee also Section 4.3 for definitions of the analysis sets used in the study, which also state","confidence":0.99853515625,"confidence_rate":0.9999854860688677},{"cnt":[[348,520],[1878,520],[1878,569],[348,569]],"region":{"top_left_x":348,"top_left_y":519,"width":1530,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"324e4c21ec544d9d8b5e4d443a22bcc9","type":"text","conversion_output":true,"text":"which patients (i.e. recruited during Part 1, or recruited during Part 2) are included in each","text_display":" which patients (i.e. recruited during Part 1, or recruited during Part 2) are included in each","confidence":1,"confidence_rate":1},{"cnt":[[348,567],[552,567],[552,617],[348,617]],"region":{"top_left_x":348,"top_left_y":567,"width":205,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d0edcf06e8b4aacadcc911145194f35","type":"text","conversion_output":true,"text":"analysis set.","text_display":" analysis set.","confidence":1,"confidence_rate":1},{"cnt":[[344,614],[625,614],[625,666],[344,666]],"region":{"top_left_x":343,"top_left_y":614,"width":283,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5efd8dea25df428dae963aef88fa32e7","type":"section_header","conversion_output":false,"children_ids":["0475c8c7a04141d1bb6b695de9d3972b"],"text":"","text_display":""},{"cnt":[[348,614],[621,614],[621,664],[348,664]],"region":{"top_left_x":348,"top_left_y":614,"width":273,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0475c8c7a04141d1bb6b695de9d3972b","type":"text","conversion_output":true,"parent_id":"5efd8dea25df428dae963aef88fa32e7","text":"Display of data","text_display":"\n\n\\section*{Display of data}","confidence":1,"confidence_rate":1},{"cnt":[[348,711],[1880,711],[1880,758],[348,758]],"region":{"top_left_x":348,"top_left_y":711,"width":1532,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f6983422f124d0eb46a15404b327286","type":"text","conversion_output":true,"text":"Continuous variables will be summarized using descriptive statistics, including but not","text_display":"\n\nContinuous variables will be summarized using descriptive statistics, including but not","confidence":1,"confidence_rate":1},{"cnt":[[348,758],[1878,758],[1878,806],[348,806]],"region":{"top_left_x":348,"top_left_y":758,"width":1530,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bab6cf824f53496190ee826e0e876e35","type":"text","conversion_output":true,"text":"limited to the mean, standard deviation, median, lower quartile, upper quartile, minimum","text_display":" limited to the mean, standard deviation, median, lower quartile, upper quartile, minimum","confidence":1,"confidence_rate":1},{"cnt":[[348,808],[1878,808],[1878,853],[348,853]],"region":{"top_left_x":348,"top_left_y":807,"width":1530,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"236463afbe4b49728ba0056d5231b5a4","type":"text","conversion_output":true,"text":"value, and maximum value. 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If a p -value is less than 0.001 it will be reported as","text_display":" rounded to three decimal places. 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The denominator for all percentages will be the","text_display":" draw attention to the non-zero counts. 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Categorical summaries","text_display":" specified. All percentages will be presented to one decimal place. Categorical summaries","confidence":1,"confidence_rate":1},{"cnt":[[346,1429],[1878,1429],[1878,1480],[346,1480]],"region":{"top_left_x":345,"top_left_y":1428,"width":1533,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f242814d908b4a41993f5af3d08986a8","type":"text","conversion_output":true,"text":"will display all categories available on the electronic case report form (eCRF). A row","text_display":" will display all categories available on the electronic case report form (eCRF). 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For the efficacy analyses which are based on","text_display":" prior to the first infusion of study treatment. For the efficacy analyses which are based on","confidence":1,"confidence_rate":1},{"cnt":[[1091,2582],[1141,2582],[1141,2628],[1091,2628]],"region":{"top_left_x":1091,"top_left_y":2582,"width":50,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9be367cf6dd54766accfc6463b4563f4","type":"page_info","conversion_output":false,"text":"15","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-23","page":23,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8b033476056447b3aaa34674abf11f6e","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1369,125],[1850,125],[1850,157],[1369,157]],"region":{"top_left_x":1368,"top_left_y":124,"width":482,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c18a431ab57a4be5b3a3afa2471c4ac3","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6b243b01eb314cbe9462ada06b748c86","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.99755859375,"confidence_rate":0.9998937277628692},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ce44c10fcdad4838846b5f9daddaf097","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[346,329],[1878,329],[1878,376],[346,376]],"region":{"top_left_x":345,"top_left_y":328,"width":1533,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"106407cb2f774d30b2a4bba839c2ca6c","type":"text","conversion_output":true,"text":"the ITT analysis set, any subjects who were not dosed will have their baseline defined as","text_display":"\nthe ITT analysis set, any subjects who were not dosed will have their baseline defined as","confidence":1,"confidence_rate":1},{"cnt":[[346,374],[883,374],[883,423],[346,423]],"region":{"top_left_x":345,"top_left_y":373,"width":539,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5349d32e52e4c9c865648717d5e96eb","type":"text","conversion_output":true,"text":"the last non-missing evaluation.","text_display":" the last non-missing evaluation.","confidence":0.99853515625,"confidence_rate":0.9999603813880137},{"cnt":[[339,614],[565,614],[565,668],[339,668]],"region":{"top_left_x":339,"top_left_y":614,"width":227,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac9cff1207064f069e710038cb8293a3","type":"section_header","conversion_output":false,"children_ids":["649601e098b743578a3a395efe48a79a"],"text":"","text_display":""},{"cnt":[[348,614],[561,614],[561,664],[348,664]],"region":{"top_left_x":348,"top_left_y":614,"width":213,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"649601e098b743578a3a395efe48a79a","type":"text","conversion_output":true,"parent_id":"ac9cff1207064f069e710038cb8293a3","text":"Study Time","text_display":"\n\n\\section*{Study Time}","confidence":1,"confidence_rate":1},{"cnt":[[348,709],[750,709],[750,758],[348,758]],"region":{"top_left_x":348,"top_left_y":708,"width":402,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0b3a7797d694a2e9b600e0acf80ea23","type":"text","conversion_output":true,"text":"Study day is defined as:","text_display":"\n\nStudy day is defined as:","confidence":1,"confidence_rate":1},{"cnt":[[610,804],[1611,804],[1611,853],[610,853]],"region":{"top_left_x":610,"top_left_y":803,"width":1002,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e14b2187b684265b7e1d5a5e0ee963f","type":"text","conversion_output":true,"text":"Assessment date - first infusion date of study treatment +1 .","text_display":"\nAssessment date - first infusion date of study treatment +1 .","confidence":0.998046875,"confidence_rate":0.9999716665631994},{"cnt":[[346,902],[1880,902],[1880,952],[346,952]],"region":{"top_left_x":345,"top_left_y":902,"width":1535,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"705778db46ba47d4a5edfa6ce8cc7b1c","type":"text","conversion_output":true,"text":"Assessments will be performed during a total of 12 visits, at the following intervals: daily","text_display":"\nAssessments will be performed during a total of 12 visits, at the following intervals: daily","confidence":1,"confidence_rate":1},{"cnt":[[346,950],[1880,950],[1880,999],[346,999]],"region":{"top_left_x":345,"top_left_y":949,"width":1535,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fcea842dc604e68893adde6ecc845a6","type":"text","conversion_output":true,"text":"from Day 1 to Day 6; Day 7+1 day; weekly on Day \\(14 \\pm 2\\) days, Day \\(21 \\pm 3\\) days, and","text_display":" from Day 1 to Day 6; Day 7+1 day; weekly on Day \\(14 \\pm 2\\) days, Day \\(21 \\pm 3\\) days, and","confidence":0.9060311738128348,"confidence_rate":0.9989161749570536},{"cnt":[[346,997],[1880,997],[1880,1046],[346,1046]],"region":{"top_left_x":345,"top_left_y":996,"width":1535,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba3feba4a56f481e87835a48ff1a99eb","type":"text","conversion_output":true,"text":"Day \\(28 \\pm 3\\) days; and follow-up assessments will be completed on Day \\(60 \\pm 5\\) days and","text_display":" Day \\(28 \\pm 3\\) days; and follow-up assessments will be completed on Day \\(60 \\pm 5\\) days and","confidence":0.9970729344058782,"confidence_rate":0.9999674298878795},{"cnt":[[346,1044],[655,1044],[655,1094],[346,1094]],"region":{"top_left_x":345,"top_left_y":1044,"width":311,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1850f95ef8ab4071aefefe120f115663","type":"text","conversion_output":true,"text":"Day \\(90 \\pm 10\\) days.","text_display":" Day \\(90 \\pm 10\\) days.","confidence":1,"confidence_rate":1},{"cnt":[[344,1143],[1373,1143],[1373,1197],[344,1197]],"region":{"top_left_x":343,"top_left_y":1142,"width":1030,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05038b734ba3472db33884995f35675f","type":"section_header","conversion_output":false,"children_ids":["fe08fdbbf39040cc8b3133721661ba9c"],"text":"","text_display":""},{"cnt":[[348,1145],[1369,1145],[1369,1192],[348,1192]],"region":{"top_left_x":348,"top_left_y":1145,"width":1021,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe08fdbbf39040cc8b3133721661ba9c","type":"text","conversion_output":true,"parent_id":"05038b734ba3472db33884995f35675f","text":"Method of assigning patients to received treatment group","text_display":"\n\n\\section*{Method of assigning patients to received treatment group}","confidence":1,"confidence_rate":1},{"cnt":[[346,1240],[1880,1240],[1880,1287],[346,1287]],"region":{"top_left_x":345,"top_left_y":1239,"width":1535,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be83fd22294d4550aa1b2cf79d0be576","type":"text","conversion_output":true,"text":"Actual treatment received for a patient will be calculated as the average dose received over","text_display":"\n\nActual treatment received for a patient will be calculated as the average dose received over","confidence":1,"confidence_rate":1},{"cnt":[[346,1285],[1880,1285],[1880,1334],[346,1334]],"region":{"top_left_x":345,"top_left_y":1284,"width":1535,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"580b0daa751f4a4397c010e2ecca25c0","type":"text","conversion_output":true,"text":"the three treatment days. The average dose received will be determined according to the","text_display":" the three treatment days. The average dose received will be determined according to the","confidence":1,"confidence_rate":1},{"cnt":[[348,1332],[1882,1332],[1882,1381],[348,1381]],"region":{"top_left_x":348,"top_left_y":1332,"width":1535,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9aaf3c8516864b5db7a796c593437e50","type":"text","conversion_output":true,"text":"treatment kit dispensed to the patient (per the materials/kit schedule) and the volume of","text_display":" treatment kit dispensed to the patient (per the materials/kit schedule) and the volume of","confidence":1,"confidence_rate":1},{"cnt":[[348,1381],[1687,1381],[1687,1429],[348,1429]],"region":{"top_left_x":348,"top_left_y":1381,"width":1339,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e99eeee2c5a64c7895018ba1edcde787","type":"text","conversion_output":true,"text":"infusion received as recorded on the treatment administration page of the eCRF.","text_display":" infusion received as recorded on the treatment administration page of the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[346,1478],[1880,1478],[1880,1525],[346,1525]],"region":{"top_left_x":345,"top_left_y":1478,"width":1535,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e0993a21b094a2a942c64fc18a0171f","type":"text","conversion_output":true,"text":"For the safety and per protocol (PP) analyses, patients are analyzed according to their","text_display":"\n\nFor the safety and per protocol (PP) analyses, patients are analyzed according to their","confidence":1,"confidence_rate":1},{"cnt":[[346,1525],[1878,1525],[1878,1575],[346,1575]],"region":{"top_left_x":345,"top_left_y":1525,"width":1533,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b54727a844364872a25db3751578f373","type":"text","conversion_output":true,"text":"received treatment group. Using the average dose received over the three treatment days,","text_display":" received treatment group. Using the average dose received over the three treatment days,","confidence":1,"confidence_rate":1},{"cnt":[[348,1573],[1880,1573],[1880,1622],[348,1622]],"region":{"top_left_x":348,"top_left_y":1572,"width":1532,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a9fd816ae1a4757b8a7cb4088e7a401","type":"text","conversion_output":true,"text":"each patient will be assigned to a received treatment group based on the dose windows","text_display":" each patient will be assigned to a received treatment group based on the dose windows","confidence":1,"confidence_rate":1},{"cnt":[[348,1620],[700,1620],[700,1665],[348,1665]],"region":{"top_left_x":348,"top_left_y":1619,"width":353,"height":47},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b716b8100d084c02b0e5f03684d8a83a","type":"text","conversion_output":true,"text":"defined in Table 4-1.","text_display":" defined in Table 4-1.","confidence":1,"confidence_rate":1},{"cnt":[[346,1725],[1231,1725],[1231,1775],[346,1775]],"region":{"top_left_x":345,"top_left_y":1725,"width":887,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f22ff2bc61647c3bbd3075c77428b00","type":"figure_label","conversion_output":false,"text":"Table 4-1 Actual Treatment Dose Assignment","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[327,1826],[1899,1826],[1899,2037],[327,2037]],"region":{"top_left_x":326,"top_left_y":1826,"width":1574,"height":211},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f2681e3d4cf44f7a2fc5697185342f2","type":"table","conversion_output":true,"selected_labels":["5f22ff2bc61647c3bbd3075c77428b00"],"text":"\\begin{tabular}{|c|c|}\n\\hline Average dose received & Received treatment group assignment \\\\\n\\hline\\(>0.0-0.62 mg / kg\\) & recAP \\(0.4 mg / kg [250 U / kg ]\\) \\\\\n\\hline\\(>0.62-1.23 mg / kg\\) & recAP \\(0.8 mg / kg [500 U / kg ]\\) \\\\\n\\hline\\(>1.23 mg / kg\\) & recAP \\(1.6 mg / kg [1000 U / kg ]\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4-1 Actual Treatment Dose Assignment}\n\\begin{tabular}{|c|c|}\n\\hline Average dose received & Received treatment group assignment \\\\\n\\hline\\(>0.0-0.62 mg / kg\\) & recAP \\(0.4 mg / kg [250 U / kg ]\\) \\\\\n\\hline\\(>0.62-1.23 mg / kg\\) & recAP \\(0.8 mg / kg [500 U / kg ]\\) \\\\\n\\hline\\(>1.23 mg / kg\\) & recAP \\(1.6 mg / kg [1000 U / kg ]\\) \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":1,"confidence_rate":1},{"cnt":[[348,2082],[1878,2082],[1878,2133],[348,2133]],"region":{"top_left_x":348,"top_left_y":2081,"width":1530,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c4c2194f1a84f36915992c34c3c4f7b","type":"text","conversion_output":true,"text":"Please note that any patients who do not receive any dose of study drug will be excluded","text_display":"\n\nPlease note that any patients who do not receive any dose of study drug will be excluded","confidence":1,"confidence_rate":1},{"cnt":[[346,2129],[1880,2129],[1880,2176],[346,2176]],"region":{"top_left_x":345,"top_left_y":2129,"width":1535,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e193b7c30dc34ba8b9ed0fbd33087e5b","type":"text","conversion_output":true,"text":"from the safety and PP analyses, and therefore do not need to be considered in the Table","text_display":" from the safety and PP analyses, and therefore do not need to be considered in the Table","confidence":1,"confidence_rate":1},{"cnt":[[346,2176],[1880,2176],[1880,2226],[346,2226]],"region":{"top_left_x":345,"top_left_y":2176,"width":1535,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d12075a83b3b44a29735dd8cec83721e","type":"text","conversion_output":true,"text":"4-1. Dose windows were constructed in line with the weight ranges and corresponding pre-","text_display":" 4-1. Dose windows were constructed in line with the weight ranges and corresponding pre","confidence":0.98974609375,"confidence_rate":0.9998891799075873},{"cnt":[[348,2226],[1880,2226],[1880,2275],[348,2275]],"region":{"top_left_x":348,"top_left_y":2225,"width":1532,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad7c6f1fcc114975b3bedbb69024419a","type":"text","conversion_output":true,"text":"calculating volumes displayed in Table 15-3. See Section 15.3 for full justification of these","text_display":"calculating volumes displayed in Table 15-3. See Section 15.3 for full justification of these","confidence":1,"confidence_rate":1},{"cnt":[[348,2273],[513,2273],[513,2314],[348,2314]],"region":{"top_left_x":348,"top_left_y":2273,"width":166,"height":41},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98965e7cbdf6407fb5f934992cac61ae","type":"text","conversion_output":true,"text":"windows.","text_display":" 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displaying 95\\% two-sided confidence intervals (CIs), unless specifically stated otherwise.","confidence":0.56982421875,"confidence_rate":0.994097202436082},{"cnt":[[348,520],[1876,520],[1876,569],[348,569]],"region":{"top_left_x":348,"top_left_y":519,"width":1528,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"672c12dafd7c42ec83afdb6e46323c27","type":"text","conversion_output":true,"text":"As the primary efficacy endpoint is analyzed at the interim analysis and at the end of the","text_display":" As the primary efficacy endpoint is analyzed at the interim analysis and at the end of the","confidence":1,"confidence_rate":1},{"cnt":[[348,567],[1876,567],[1876,617],[348,617]],"region":{"top_left_x":348,"top_left_y":567,"width":1528,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b67b5f220634201afc12bedabd8ea75","type":"text","conversion_output":true,"text":"study, multiplicity will be 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This does not apply to the","text_display":"\nreduce the number of missing baseline values in the analyses. This does not apply to the","confidence":1,"confidence_rate":1},{"cnt":[[348,378],[1798,378],[1798,423],[348,423]],"region":{"top_left_x":348,"top_left_y":378,"width":1451,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef03b340313749099ee14f34cedd99bc","type":"text","conversion_output":true,"text":"calculation of endogenous creatinine clearance. The following conversion rates will be","text_display":" calculation of endogenous creatinine clearance. The following conversion rates will be","confidence":1,"confidence_rate":1},{"cnt":[[348,425],[1717,425],[1717,471],[348,471]],"region":{"top_left_x":348,"top_left_y":425,"width":1369,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bab8806f1e6d40d18183a3bae4fb9e91","type":"text","conversion_output":true,"text":"used to convert the local lab measured value to \\(mg / dL\\) (if source unit is different):","text_display":" used to convert the local lab measured value to \\(mg / dL\\) (if source unit is different):","confidence":1,"confidence_rate":1},{"cnt":[[346,529],[1540,529],[1540,576],[346,576]],"region":{"top_left_x":345,"top_left_y":528,"width":1196,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b585723aad6477b8ed378e1de41388a","type":"figure_label","conversion_output":false,"text":"Table 4-2 Serum Creatinine and CRP Laboratory Conversions","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[391,623],[1652,623],[1652,879],[391,879]],"region":{"top_left_x":391,"top_left_y":623,"width":1262,"height":256},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b0f931089684fa983722abcb63bb5bb","type":"table","conversion_output":true,"selected_labels":["5b585723aad6477b8ed378e1de41388a"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline Parameter & Source Unit & Standard unit & Conversion rate \\\\\n\\hline Serum creatinine & \\(mg / L\\) & \\(mg / dL\\) & 0.1 \\\\\n\\hline & \\(umol / L\\) & \\(mg / dL\\) & 0.0113122 \\\\\n\\hline CRP & \\(mg / L\\) & \\(mg / dL\\) & 0.1 \\\\\n\\hline & \\(nmol / L\\) & \\(mg / dL\\) & 0.0105 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4-2 Serum Creatinine and CRP Laboratory Conversions}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Parameter & Source Unit & Standard unit & Conversion rate \\\\\n\\hline Serum creatinine & \\(mg / L\\) & \\(mg / dL\\) & 0.1 \\\\\n\\hline & \\(umol / L\\) & \\(mg / dL\\) & 0.0113122 \\\\\n\\hline CRP & \\(mg / L\\) & \\(mg / dL\\) & 0.1 \\\\\n\\hline & \\(nmol / L\\) & \\(mg / dL\\) & 0.0105 \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":1,"confidence_rate":1},{"cnt":[[406,1016],[707,1016],[707,1068],[406,1068]],"region":{"top_left_x":406,"top_left_y":1016,"width":301,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a10426ec61645509b56b9420cb0b727","type":"section_header","conversion_output":false,"children_ids":["ec64196f0dd84eaba6c0c6de6406a5b6"],"text":"","text_display":""},{"cnt":[[408,1018],[703,1018],[703,1066],[408,1066]],"region":{"top_left_x":408,"top_left_y":1018,"width":295,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec64196f0dd84eaba6c0c6de6406a5b6","type":"text","conversion_output":true,"parent_id":"1a10426ec61645509b56b9420cb0b727","text":"4.1. Sample Size","text_display":"\n\n\\subsection*{4.1. Sample Size}","confidence":0.99951171875,"confidence_rate":0.9999767431038692},{"cnt":[[348,1117],[1878,1117],[1878,1162],[348,1162]],"region":{"top_left_x":348,"top_left_y":1117,"width":1530,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"386d7c0d94604ce2b6132de26a63f648","type":"text","conversion_output":true,"text":"A sample size of \\(n _{1}=30\\) patients per treatment group in Part 1 with an additional \\(n _{2}=85\\)","text_display":"\n\nA sample size of \\(n _{1}=30\\) patients per treatment group in Part 1 with an additional \\(n _{2}=85\\)","confidence":0.9669570922851562,"confidence_rate":0.9997103768066223},{"cnt":[[348,1164],[1878,1164],[1878,1210],[348,1210]],"region":{"top_left_x":348,"top_left_y":1164,"width":1530,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0eb379c768a441179e78eccfc0b60113","type":"text","conversion_output":true,"text":"patients recruited to each of the optimal recAP dose and placebo treatment groups in Part 2","text_display":" patients recruited to each of the optimal recAP dose and placebo treatment groups in Part 2","confidence":1,"confidence_rate":1},{"cnt":[[348,1212],[1880,1212],[1880,1257],[348,1257]],"region":{"top_left_x":348,"top_left_y":1211,"width":1532,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33129387e69f4501b1890504533fa4d3","type":"text","conversion_output":true,"text":"(for a total sample size of \\(n =290\\) patients) is planned. Recruitment will continue during","text_display":" (for a total sample size of \\(n =290\\) patients) is planned. Recruitment will continue during","confidence":1,"confidence_rate":1},{"cnt":[[348,1259],[1876,1259],[1876,1304],[348,1304]],"region":{"top_left_x":348,"top_left_y":1258,"width":1528,"height":47},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1d11a0d46b8466c9dfad9f4398d3e97","type":"text","conversion_output":true,"text":"the interim analysis, so the total number of patients will exceed 290 . Custom programmed","text_display":" the interim analysis, so the total number of patients will exceed 290 . Custom programmed","confidence":0.994631290435791,"confidence_rate":0.9999445049123337},{"cnt":[[348,1302],[1876,1302],[1876,1354],[348,1354]],"region":{"top_left_x":348,"top_left_y":1301,"width":1528,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef9307202ef14ee99ed8befb578c2508","type":"text","conversion_output":true,"text":"simulations were performed using SAS \\({ }^{\\text {® }}\\) Version 9.2 (SAS Institute, Inc, Cary, North","text_display":" simulations were performed using SAS \\({ }^{\\text {® }}\\) Version 9.2 (SAS Institute, Inc, Cary, North","confidence":0.8388671875,"confidence_rate":0.9983437986439428},{"cnt":[[348,1354],[1876,1354],[1876,1403],[348,1403]],"region":{"top_left_x":348,"top_left_y":1353,"width":1528,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e532300f6e48469293764722f65e5e58","type":"text","conversion_output":true,"text":"Carolina) to determine power and type I error rate of the chosen sample size and design","text_display":" Carolina) to determine power and type I error rate of the chosen sample size and design","confidence":1,"confidence_rate":1},{"cnt":[[348,1405],[1878,1405],[1878,1450],[348,1450]],"region":{"top_left_x":348,"top_left_y":1405,"width":1530,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47f16e3fea374251b44266015939c633","type":"text","conversion_output":true,"text":"under a number of different dose response scenarios. Each scenario assumed a standard","text_display":" under a number of different dose response scenarios. Each scenario assumed a standard","confidence":1,"confidence_rate":1},{"cnt":[[348,1452],[1878,1452],[1878,1497],[348,1497]],"region":{"top_left_x":348,"top_left_y":1452,"width":1530,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bd7c92b065a40f18f1069b5272400b8","type":"text","conversion_output":true,"text":"deviation of \\(49 mL / min\\) for the primary endpoint (area under the time-corrected","text_display":" deviation of \\(49 mL / min\\) for the primary endpoint (area under the time-corrected","confidence":1,"confidence_rate":1},{"cnt":[[348,1500],[1878,1500],[1878,1547],[348,1547]],"region":{"top_left_x":348,"top_left_y":1499,"width":1530,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee4de37e972e4044869349a880b5a24a","type":"text","conversion_output":true,"text":"endogenous creatinine clearance curve from Day 1 to Day 7 [ \\(AUC _{1-7}\\) ]) with an assumed","text_display":" endogenous creatinine clearance curve from Day 1 to Day 7 [ \\(AUC _{1-7}\\) ]) with an assumed","confidence":0.5805034440974965,"confidence_rate":0.9950228899542928},{"cnt":[[348,1547],[1880,1547],[1880,1594],[348,1594]],"region":{"top_left_x":348,"top_left_y":1546,"width":1532,"height":49},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b5a43bddfb1439ea18ef0382d2a85fe","type":"text","conversion_output":true,"text":"response of \\(60 mL / min\\) for the placebo group, and between \\(60 mL / min\\) (no treatment","text_display":" response of \\(60 mL / min\\) for the placebo group, and between \\(60 mL / min\\) (no treatment","confidence":1,"confidence_rate":1},{"cnt":[[348,1594],[1594,1594],[1594,1641],[348,1641]],"region":{"top_left_x":348,"top_left_y":1594,"width":1247,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34b455342dea4265b5b27cc503632ac0","type":"text","conversion_output":true,"text":"effect) and \\(79 mL / min\\) (strong treatment effect) for the recAP dose groups.","text_display":" effect) and \\(79 mL / min\\) (strong treatment effect) for the recAP dose groups.","confidence":1,"confidence_rate":1},{"cnt":[[348,1691],[1878,1691],[1878,1738],[348,1738]],"region":{"top_left_x":348,"top_left_y":1690,"width":1530,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7f508945ebb425b978b6ac5d23345d8","type":"text","conversion_output":true,"text":"Fifty-thousand simulations were performed to show that the 1 -sided type I error rate is","text_display":"\n\nFifty-thousand simulations were performed to show that the 1 -sided type I error rate is","confidence":0.99853515625,"confidence_rate":0.9999847301407262},{"cnt":[[348,1740],[1878,1740],[1878,1785],[348,1785]],"region":{"top_left_x":348,"top_left_y":1740,"width":1530,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da9f7da90434402591f1655fe34c9c96","type":"text","conversion_output":true,"text":"\\(2.4 \\%\\) (and hence is well controlled at the 1 -sided \\(2.5 \\%\\) significance level). The power was","text_display":" \\(2.4 \\%\\) (and hence is well controlled at the 1 -sided \\(2.5 \\%\\) significance level). The power was","confidence":0.975597620010376,"confidence_rate":0.9997529799928961},{"cnt":[[348,1788],[1876,1788],[1876,1833],[348,1833]],"region":{"top_left_x":348,"top_left_y":1787,"width":1528,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65abc5ce743343bfa69f51bca09a9cd4","type":"text","conversion_output":true,"text":"defined as the probability of rejecting the null hypothesis (of no difference between","text_display":" defined as the probability of rejecting the null hypothesis (of no difference between","confidence":1,"confidence_rate":1},{"cnt":[[348,1835],[1876,1835],[1876,1880],[348,1880]],"region":{"top_left_x":348,"top_left_y":1834,"width":1528,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cc10fc14b2143c4bcd7a10b5e4b40d4","type":"text","conversion_output":true,"text":"treatment groups) when 1 or more recAP dose groups have an effective treatment effect,","text_display":" treatment groups) when 1 or more recAP dose groups have an effective treatment effect,","confidence":1,"confidence_rate":1},{"cnt":[[348,1882],[1876,1882],[1876,1927],[348,1927]],"region":{"top_left_x":348,"top_left_y":1882,"width":1528,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c02e97dc0f5458f85cd4a776e6d9639","type":"text","conversion_output":true,"text":"defined as a response of \\(69.5 mL / min\\). This was investigated across 7 scenarios with","text_display":" defined as a response of \\(69.5 mL / min\\). This was investigated across 7 scenarios with","confidence":0.9912109375,"confidence_rate":0.999911724755253},{"cnt":[[348,1929],[1878,1929],[1878,1979],[348,1979]],"region":{"top_left_x":348,"top_left_y":1929,"width":1530,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7717b16608514971869297d0ab22260b","type":"text","conversion_output":true,"text":"10000 simulations performed for each. In the most realistic scenarios (with strong","text_display":" 10000 simulations performed for each. In the most realistic scenarios (with strong","confidence":1,"confidence_rate":1},{"cnt":[[348,1979],[1876,1979],[1876,2026],[348,2026]],"region":{"top_left_x":348,"top_left_y":1978,"width":1528,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a02caa5de544bc6bc1c0274dcce2bde","type":"text","conversion_output":true,"text":"treatment effects, i.e., responses of \\(79 mL / min\\) for the medium and high recAP dose groups","text_display":" treatment effects, i.e., responses of \\(79 mL / min\\) for the medium and high recAP dose groups","confidence":0.9951240979141858,"confidence_rate":0.9999520812650134},{"cnt":[[348,2028],[1878,2028],[1878,2073],[348,2073]],"region":{"top_left_x":348,"top_left_y":2028,"width":1530,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"827228c3fc574a7582555bcc7dd335d7","type":"text","conversion_output":true,"text":"and a varying response of between \\(60 mL / min\\) and \\(79 mL / min\\) for the low-dose group) the","text_display":" and a varying response of between \\(60 mL / min\\) and \\(79 mL / min\\) for the low-dose group) the","confidence":0.9912149906158447,"confidence_rate":0.999916759831852},{"cnt":[[348,2075],[1880,2075],[1880,2121],[348,2121]],"region":{"top_left_x":348,"top_left_y":2075,"width":1532,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9539746fb60243bd864257593b3f950b","type":"text","conversion_output":true,"text":"chosen design achieved power of between \\(79 \\%\\) and \\(86 \\%\\). This dropped to \\(66 \\%\\) to \\(67 \\%\\) for","text_display":" chosen design achieved power of between \\(79 \\%\\) and \\(86 \\%\\). This dropped to \\(66 \\%\\) to \\(67 \\%\\) for","confidence":1,"confidence_rate":1},{"cnt":[[348,2123],[1751,2123],[1751,2168],[348,2168]],"region":{"top_left_x":348,"top_left_y":2122,"width":1403,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4c101330c2a47158018ba1fe3dbd117","type":"text","conversion_output":true,"text":"other scenarios where only the high recAP dose group had a strong treatment effect.","text_display":" other scenarios where only the high recAP dose group had a strong treatment effect.","confidence":1,"confidence_rate":1},{"cnt":[[408,2213],[1274,2213],[1274,2262],[408,2262]],"region":{"top_left_x":408,"top_left_y":2212,"width":867,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a249c71677146f19b6601d57b4bfccc","type":"section_header","conversion_output":false,"children_ids":["d59857315a2145fca1f71cd37f521c60"],"text":"","text_display":""},{"cnt":[[408,2213],[1272,2213],[1272,2258],[408,2258]],"region":{"top_left_x":408,"top_left_y":2212,"width":864,"height":47},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d59857315a2145fca1f71cd37f521c60","type":"text","conversion_output":true,"parent_id":"2a249c71677146f19b6601d57b4bfccc","text":"4.2. Randomization, Stratification, and Blinding","text_display":"\n\n\\subsection*{4.2. 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Disposition}","confidence":1,"confidence_rate":1},{"cnt":[[348,1046],[1880,1046],[1880,1094],[348,1094]],"region":{"top_left_x":348,"top_left_y":1046,"width":1532,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72198644795e4ae8ae7cebecc0f847b0","type":"text","conversion_output":true,"text":"Patient disposition will be summarized for the all Enrolled Set. A disposition of patients","text_display":"\n\nPatient disposition will be summarized for the all Enrolled Set. A disposition of patients","confidence":1,"confidence_rate":1},{"cnt":[[348,1096],[1880,1096],[1880,1143],[348,1143]],"region":{"top_left_x":348,"top_left_y":1095,"width":1532,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"660adb73eb394c87a775405187112948","type":"text","conversion_output":true,"text":"includes the number and percentage of patients for the following categories: patients who","text_display":" includes the number and percentage of patients for the following categories: patients who","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[348,1143],[1880,1143],[1880,1192],[348,1192]],"region":{"top_left_x":348,"top_left_y":1142,"width":1532,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f3e1ff496864aa084807fc2ce340e97","type":"text","conversion_output":true,"text":"were not randomly assigned to treatment, patients in the ITT Combined Set, patients","text_display":" were not randomly assigned to treatment, patients in the ITT Combined Set, patients","confidence":1,"confidence_rate":1},{"cnt":[[348,1190],[1880,1190],[1880,1240],[348,1240]],"region":{"top_left_x":348,"top_left_y":1190,"width":1532,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"582b98c8db38435288f35010146a0955","type":"text","conversion_output":true,"text":"treated (Safety Set), patients in the PP Day 1-7 Combined Set, patients in the PP Day 1-7","text_display":" treated (Safety Set), patients in the PP Day 1-7 Combined Set, patients in the PP Day 1-7","confidence":1,"confidence_rate":1},{"cnt":[[348,1238],[1878,1238],[1878,1287],[348,1287]],"region":{"top_left_x":348,"top_left_y":1237,"width":1530,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c65184f70ddf446cbca28592173d80c5","type":"text","conversion_output":true,"text":"Part 1 Analysis Set, patients in the ITT Part 1 Set, patients in the ITT Part 1 Interim Set,","text_display":" Part 1 Analysis Set, patients in the ITT Part 1 Set, patients in the ITT Part 1 Interim Set,","confidence":1,"confidence_rate":1},{"cnt":[[346,1285],[1880,1285],[1880,1336],[346,1336]],"region":{"top_left_x":345,"top_left_y":1284,"width":1535,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be82be2b94164173aa15428de3ffa38c","type":"text","conversion_output":true,"text":"patients in the ITT Part 2 Set, patients in the PP Day 1-7 Part 2 Set, patients in the PK Set","text_display":" patients in the ITT Part 2 Set, patients in the PP Day 1-7 Part 2 Set, patients in the PK Set","confidence":1,"confidence_rate":1},{"cnt":[[346,1334],[1880,1334],[1880,1384],[346,1384]],"region":{"top_left_x":345,"top_left_y":1334,"width":1535,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fedd6f698c844189ceffc03b72c178a","type":"text","conversion_output":true,"text":"and patients in the Iohexol Set. The number and percentage of patients who completed the","text_display":" and patients in the Iohexol Set. The number and percentage of patients who completed the","confidence":1,"confidence_rate":1},{"cnt":[[348,1384],[1880,1384],[1880,1431],[348,1431]],"region":{"top_left_x":348,"top_left_y":1383,"width":1532,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b7550eb50a64fcca47dc94320e91efb","type":"text","conversion_output":true,"text":"study and patients who discontinued from the study will be summarized for the ITT","text_display":" study and patients who discontinued from the study will be summarized for the ITT","confidence":1,"confidence_rate":1},{"cnt":[[348,1431],[1880,1431],[1880,1476],[348,1476]],"region":{"top_left_x":348,"top_left_y":1430,"width":1532,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0258653f77dd458489fdcda3b00f5f5e","type":"text","conversion_output":true,"text":"Combined Set, the ITT Part 1 Set, ITT Part 1 Interim Set and the ITT Part 2 Set. The","text_display":" Combined Set, the ITT Part 1 Set, ITT Part 1 Interim Set and the ITT Part 2 Set. The","confidence":1,"confidence_rate":1},{"cnt":[[346,1478],[1558,1478],[1558,1528],[346,1528]],"region":{"top_left_x":345,"top_left_y":1478,"width":1213,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4a7dcbd1c254f27a1418062fa0a35e1","type":"text","conversion_output":true,"text":"percentages will be based on the number of patients in each analysis set.","text_display":" percentages will be based on the number of patients in each analysis set.","confidence":1,"confidence_rate":1},{"cnt":[[346,1573],[1880,1573],[1880,1622],[346,1622]],"region":{"top_left_x":345,"top_left_y":1572,"width":1535,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c0de6815f254242bdbe3fb9ec0cece8","type":"text","conversion_output":true,"text":"The reasons for study discontinuation will also be summarized in this table. The reason for","text_display":"\n\nThe reasons for study discontinuation will also be summarized in this table. The reason for","confidence":1,"confidence_rate":1},{"cnt":[[348,1620],[1880,1620],[1880,1669],[348,1669]],"region":{"top_left_x":348,"top_left_y":1619,"width":1532,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8110dc7549ce459d8eb039f1fae4bd83","type":"text","conversion_output":true,"text":"study discontinuation includes the following: Adverse Event, Lab abnormality, Patient","text_display":" study discontinuation includes the following: Adverse Event, Lab abnormality, Patient","confidence":0.9985356330871582,"confidence_rate":0.9999837174642737},{"cnt":[[348,1669],[1880,1669],[1880,1717],[348,1717]],"region":{"top_left_x":348,"top_left_y":1669,"width":1532,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"114552b9e8814dd2ae9397b2254038d4","type":"text","conversion_output":true,"text":"Withdrew consent, Investigator Decision, Sponsor termination of study, Protocol Non-","text_display":" Withdrew consent, Investigator Decision, Sponsor termination of study, Protocol Non","confidence":1,"confidence_rate":1},{"cnt":[[348,1714],[1882,1714],[1882,1764],[348,1764]],"region":{"top_left_x":348,"top_left_y":1714,"width":1535,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cca0233fa080463ba2a45d0ab7bfb36d","type":"text","conversion_output":true,"text":"Compliance or violation, Death and Other. The percentages will be based on the number of","text_display":"Compliance or violation, Death and Other. The percentages will be based on the number of","confidence":1,"confidence_rate":1},{"cnt":[[348,1766],[1051,1766],[1051,1815],[348,1815]],"region":{"top_left_x":348,"top_left_y":1766,"width":703,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43e534ec173c48dfbaf7a17301787e30","type":"text","conversion_output":true,"text":"patients who discontinued from the study.","text_display":" patients who discontinued from the study.","confidence":1,"confidence_rate":1},{"cnt":[[348,1861],[1497,1861],[1497,1910],[348,1910]],"region":{"top_left_x":348,"top_left_y":1860,"width":1150,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53e01abe9bab4c588164041c89948295","type":"text","conversion_output":true,"text":"The disposition table will be repeated by site for the all Enrolled Set.","text_display":"\n\nThe disposition table will be repeated by site for the all Enrolled Set.","confidence":1,"confidence_rate":1},{"cnt":[[348,1955],[1231,1955],[1231,2007],[348,2007]],"region":{"top_left_x":348,"top_left_y":1955,"width":884,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7b10a46b91643d3855ec44a7137d5b8","type":"text","conversion_output":true,"text":"Patient disposition data will be presented in a listing.","text_display":"\nPatient disposition data will be presented in a listing.","confidence":1,"confidence_rate":1},{"cnt":[[406,2045],[769,2045],[769,2090],[406,2090]],"region":{"top_left_x":406,"top_left_y":2045,"width":364,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aca2c4fbff294cbfa133c0fd2dfdfe6e","type":"section_header","conversion_output":false,"children_ids":["8a9790e201e94f0d92aad1e712877bc7"],"text":"","text_display":""},{"cnt":[[408,2050],[767,2050],[767,2086],[408,2086]],"region":{"top_left_x":408,"top_left_y":2049,"width":359,"height":38},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a9790e201e94f0d92aad1e712877bc7","type":"text","conversion_output":true,"parent_id":"aca2c4fbff294cbfa133c0fd2dfdfe6e","text":"5.2. 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Significant PDs will be identified according to","text_display":" system), and reviewed on an ongoing basis. Significant PDs will be identified according to","confidence":1,"confidence_rate":1},{"cnt":[[348,522],[1824,522],[1824,569],[348,569]],"region":{"top_left_x":348,"top_left_y":522,"width":1477,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"734db31db4a141d892dade4b4901bcb6","type":"text","conversion_output":true,"text":"the Significant PD Rules for the study, and presented in a listing for the all Enrolled Set.","text_display":" the Significant PD Rules for the study, and presented in a listing for the all Enrolled Set.","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[374,649],[1222,649],[1222,703],[374,703]],"region":{"top_left_x":373,"top_left_y":648,"width":850,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6db241e3f7224b16b670587ffe908e14","type":"section_header","conversion_output":false,"children_ids":["0112d9e80c9d457ebee23e5c9e2fbccb"],"text":"","text_display":""},{"cnt":[[378,653],[1220,653],[1220,698],[378,698]],"region":{"top_left_x":378,"top_left_y":653,"width":843,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0112d9e80c9d457ebee23e5c9e2fbccb","type":"text","conversion_output":true,"parent_id":"6db241e3f7224b16b670587ffe908e14","text":"6. 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Baseline weight can be recorded on the eCRF at screening in","confidence":1,"confidence_rate":1},{"cnt":[[348,984],[1878,984],[1878,1029],[348,1029]],"region":{"top_left_x":348,"top_left_y":983,"width":1530,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9126e5ff07b64deb997b351ea3ed380b","type":"text","conversion_output":true,"text":"either kg or lb , weight in lb will be converted to kg using the calculation in Section 4.","text_display":" either kg or lb , weight in lb will be converted to kg using the calculation in Section 4.","confidence":0.9970703125,"confidence_rate":0.9999751360088194},{"cnt":[[348,1023],[1880,1023],[1880,1079],[348,1079]],"region":{"top_left_x":348,"top_left_y":1022,"width":1532,"height":57},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df6027db6f014906aea375de3b2a569a","type":"text","conversion_output":true,"text":"Baseline weight ( kg ), baseline height ( cm ), and body mass index (BMI) ( \\(kg / m ^{2}\\) ) will be","text_display":" Baseline weight ( kg ), baseline height ( cm ), and body mass index (BMI) ( \\(kg / m ^{2}\\) ) will be","confidence":0.9159492304828154,"confidence_rate":0.9992922317065369},{"cnt":[[348,1079],[776,1079],[776,1126],[348,1126]],"region":{"top_left_x":348,"top_left_y":1078,"width":428,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d0848a745d14403b313dcd1eac3676c","type":"text","conversion_output":true,"text":"included in the summary.","text_display":" included in the summary.","confidence":1,"confidence_rate":1},{"cnt":[[348,1175],[1876,1175],[1876,1222],[348,1222]],"region":{"top_left_x":348,"top_left_y":1175,"width":1528,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ac4bf08409d402f80fce743b00238f8","type":"text","conversion_output":true,"text":"A patient's age in years will be calculated using the date of the informed consent and date","text_display":"\n\nA patient's age in years will be calculated using the date of the informed consent and date","confidence":0.99853515625,"confidence_rate":0.9999847301407262},{"cnt":[[348,1225],[1878,1225],[1878,1270],[348,1270]],"region":{"top_left_x":348,"top_left_y":1224,"width":1530,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31387e060a654fe1b4b46ba450be9fe8","type":"text","conversion_output":true,"text":"of birth. Age (years) and baseline weight (kg) will be summarized using descriptive","text_display":" of birth. Age (years) and baseline weight (kg) will be summarized using descriptive","confidence":0.9990234375,"confidence_rate":0.9999888973383643},{"cnt":[[348,1272],[1878,1272],[1878,1317],[348,1317]],"region":{"top_left_x":348,"top_left_y":1271,"width":1530,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dabd8a55790e4409854a297817e6470b","type":"text","conversion_output":true,"text":"statistics. The number and percentage of patients by age category ( \\(<55, \\geq 55-<70, \\geq 70\\) ),","text_display":" statistics. The number and percentage of patients by age category ( \\(<55, \\geq 55-<70, \\geq 70\\) ),","confidence":0.9800083503381529,"confidence_rate":0.9997851913023459},{"cnt":[[348,1319],[1878,1319],[1878,1364],[348,1364]],"region":{"top_left_x":348,"top_left_y":1319,"width":1530,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bae33cd6fd7447cf80fbe36154cfe192","type":"text","conversion_output":true,"text":"sex (Male, Female) and race (Caucasian, Black, Asian, Other and Not Collectable), will","text_display":" sex (Male, Female) and race (Caucasian, Black, Asian, Other and Not Collectable), will","confidence":1,"confidence_rate":1},{"cnt":[[348,1366],[1878,1366],[1878,1414],[348,1414]],"region":{"top_left_x":348,"top_left_y":1366,"width":1530,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9460242b74a2406ebe1deec3448c8120","type":"text","conversion_output":true,"text":"also be reported. Not Collectable category is available as race is not allowed to be collected","text_display":" also be reported. Not Collectable category is available as race is not allowed to be collected","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[348,1414],[681,1414],[681,1454],[348,1454]],"region":{"top_left_x":348,"top_left_y":1413,"width":334,"height":42},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"945adb4ed7544dbbb96d5f4cef5fa7b1","type":"text","conversion_output":true,"text":"in certain countries.","text_display":" in certain countries.","confidence":1,"confidence_rate":1},{"cnt":[[348,1508],[1878,1508],[1878,1558],[348,1558]],"region":{"top_left_x":348,"top_left_y":1508,"width":1530,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a9f8b81c562443298e01f46f4ca4266","type":"text","conversion_output":true,"text":"Patient demographic and baseline characteristics will be presented in a listing based on the","text_display":"\n\nPatient demographic and baseline characteristics will be presented in a listing based on the","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[348,1560],[672,1560],[672,1601],[348,1601]],"region":{"top_left_x":348,"top_left_y":1559,"width":325,"height":42},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a5a296c3c5a46c897005069bdce3549","type":"text","conversion_output":true,"text":"ITT Combined Set.","text_display":" ITT Combined Set.","confidence":1,"confidence_rate":1},{"cnt":[[406,1693],[1063,1693],[1063,1738],[406,1738]],"region":{"top_left_x":406,"top_left_y":1692,"width":658,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e34d5d8ce7574fef959690390a7e2a63","type":"section_header","conversion_output":false,"children_ids":["2bb7da3b55c446b2a0a7da50598ab9ca"],"text":"","text_display":""},{"cnt":[[408,1697],[1059,1697],[1059,1738],[408,1738]],"region":{"top_left_x":408,"top_left_y":1697,"width":652,"height":42},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bb7da3b55c446b2a0a7da50598ab9ca","type":"text","conversion_output":true,"parent_id":"e34d5d8ce7574fef959690390a7e2a63","text":"6.2. Baseline Disease Characteristics","text_display":"\n\n\\subsection*{6.2. Baseline Disease Characteristics}","confidence":0.880859375,"confidence_rate":0.9969841452935837},{"cnt":[[348,1800],[1880,1800],[1880,1850],[348,1850]],"region":{"top_left_x":348,"top_left_y":1800,"width":1532,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4dfe18e849d43a4b2e543a6e0abd047","type":"text","conversion_output":true,"text":"The distribution of patients across treatment groups will be presented for the following","text_display":"\n\nThe distribution of patients across treatment groups will be presented for the following","confidence":1,"confidence_rate":1},{"cnt":[[348,1852],[1880,1852],[1880,1897],[348,1897]],"region":{"top_left_x":348,"top_left_y":1851,"width":1532,"height":47},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37a25fe923c54cf2b4c1396aad3ffd2d","type":"text","conversion_output":true,"text":"characteristics. This will be in the form of descriptive statistics for continuous data, or as","text_display":" characteristics. This will be in the form of descriptive statistics for continuous data, or as","confidence":1,"confidence_rate":1},{"cnt":[[348,1899],[1880,1899],[1880,1944],[348,1944]],"region":{"top_left_x":348,"top_left_y":1899,"width":1532,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a62185898324a4bada3ff4b8b839209","type":"text","conversion_output":true,"text":"the number and percentage of patients included in each category for categorical data. This","text_display":" the number and percentage of patients included in each category for categorical data. This","confidence":1,"confidence_rate":1},{"cnt":[[348,1946],[1880,1946],[1880,1996],[348,1996]],"region":{"top_left_x":348,"top_left_y":1946,"width":1532,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e93e99c4cbc24e8185c455ba94c841e9","type":"text","conversion_output":true,"text":"summary will be presented for the ITT Combined Set, and also for the ITT Part 1 Set and","text_display":" summary will be presented for the ITT Combined Set, and also for the ITT Part 1 Set and","confidence":1,"confidence_rate":1},{"cnt":[[348,1994],[1880,1994],[1880,2041],[348,2041]],"region":{"top_left_x":348,"top_left_y":1993,"width":1532,"height":49},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc116e0103854cbab10ab947a6ca69cd","type":"text","conversion_output":true,"text":"ITT Part 2 Set to check the assumption that patients recruited in each part of the study will","text_display":" ITT Part 2 Set to check the assumption that patients recruited in each part of the study will","confidence":1,"confidence_rate":1},{"cnt":[[348,2041],[1418,2041],[1418,2090],[348,2090]],"region":{"top_left_x":348,"top_left_y":2041,"width":1070,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab16c598c27449308217d91efdf64c5a","type":"text","conversion_output":true,"text":"belong to the same overall patient population. This will include:","text_display":" belong to the same overall patient population. This will include:","confidence":1,"confidence_rate":1},{"cnt":[[408,2140],[1880,2140],[1880,2189],[408,2189]],"region":{"top_left_x":408,"top_left_y":2139,"width":1472,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be07cbb2626a43a2bbb336e2a408ac27","type":"text","conversion_output":true,"text":"- Fractional excretion of sodium and fractional excretion of urea summarized by","text_display":"\n- Fractional excretion of sodium and fractional excretion of urea summarized by","confidence":1,"confidence_rate":1},{"cnt":[[473,2187],[827,2187],[827,2237],[473,2237]],"region":{"top_left_x":472,"top_left_y":2187,"width":356,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d90edd769ca04406b459d16ca6dc3346","type":"text","conversion_output":true,"text":"descriptive statistics;","text_display":" descriptive 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statistics;","confidence":1,"confidence_rate":1},{"cnt":[[408,2342],[1094,2342],[1094,2391],[408,2391]],"region":{"top_left_x":408,"top_left_y":2341,"width":686,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b056b9edd33a459794378ab402b60861","type":"text","conversion_output":true,"text":"- SOFA score by descriptive statistics;","text_display":"\n- SOFA score by descriptive 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Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7884e4ad13c84ba6ae3996043c0e367e","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.99755859375,"confidence_rate":0.9998937277628692},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f6bc07321f8c438997824324a54f300f","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[408,331],[1384,331],[1384,380],[408,380]],"region":{"top_left_x":408,"top_left_y":330,"width":976,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"769b3357e796499988647944ec57850e","type":"text","conversion_output":true,"text":"- Alkaline Phosphatase activity by descriptive statistics;","text_display":"\n- Alkaline Phosphatase activity by descriptive statistics;","confidence":1,"confidence_rate":1},{"cnt":[[408,382],[1880,382],[1880,432],[408,432]],"region":{"top_left_x":408,"top_left_y":382,"width":1472,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"606919af5eaf448085e8b031864d17f7","type":"text","conversion_output":true,"text":"- The number and percentages of patients by mechanical ventilation at baseline","text_display":"\n- The number and percentages of patients by mechanical ventilation at baseline","confidence":1,"confidence_rate":1},{"cnt":[[468,430],[814,430],[814,479],[468,479]],"region":{"top_left_x":468,"top_left_y":429,"width":347,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f12b92c848554bdb9f8af450d03e7c69","type":"text","conversion_output":true,"text":"categories (yes, no);","text_display":" categories (yes, no);","confidence":1,"confidence_rate":1},{"cnt":[[408,481],[1818,481],[1818,531],[408,531]],"region":{"top_left_x":408,"top_left_y":481,"width":1410,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7d9604fffd1418da478ffbaa0c28577","type":"text","conversion_output":true,"text":"- The number and percentages of patients by infectious agent categories (yes, no);","text_display":"\n- The number and percentages of patients by infectious agent categories (yes, no);","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[408,529],[1878,529],[1878,580],[408,580]],"region":{"top_left_x":408,"top_left_y":528,"width":1470,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b6af4b0ed314680824a6261f836a15e","type":"text","conversion_output":true,"text":"- The number and percentages of patients by AKI stage (stage 1, stage 2, stage 3)","text_display":"\n- The number and percentages of patients by AKI stage (stage 1, stage 2, stage 3)","confidence":0.99560546875,"confidence_rate":0.999948789502175},{"cnt":[[468,580],[1003,580],[1003,627],[468,627]],"region":{"top_left_x":468,"top_left_y":580,"width":536,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"567d6a4352694a69b693cbc10df237c3","type":"text","conversion_output":true,"text":"according to the AKIN criteria;","text_display":" according to the AKIN criteria;","confidence":1,"confidence_rate":1},{"cnt":[[408,632],[1055,632],[1055,681],[408,681]],"region":{"top_left_x":408,"top_left_y":631,"width":647,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a86a0423b5a24c9d9d0f983cf4d76c93","type":"text","conversion_output":true,"text":"- Heart rate by descriptive statistics;","text_display":"\n- Heart rate by descriptive statistics;","confidence":1,"confidence_rate":1},{"cnt":[[408,681],[1278,681],[1278,733],[408,733]],"region":{"top_left_x":408,"top_left_y":681,"width":871,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c96b6584665409690067b1a785adeea","type":"text","conversion_output":true,"text":"- Systolic blood pressure by descriptive statistics;","text_display":"\n- Systolic blood pressure by descriptive statistics;","confidence":1,"confidence_rate":1},{"cnt":[[408,730],[1296,730],[1296,780],[408,780]],"region":{"top_left_x":408,"top_left_y":730,"width":888,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2be6c37c4964410b8daad8088e3dbbd8","type":"text","conversion_output":true,"text":"- Diastolic blood pressure by descriptive statistics;","text_display":"\n- Diastolic blood pressure by descriptive statistics;","confidence":1,"confidence_rate":1},{"cnt":[[408,782],[1880,782],[1880,831],[408,831]],"region":{"top_left_x":408,"top_left_y":782,"width":1472,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03564ec3d440477ca6c01552fd66917a","type":"text","conversion_output":true,"text":"- The number and percentages of patients by body temperature categories ( \\(<36^{\\circ} C\\),","text_display":"\n- The number and percentages of patients by body temperature categories ( \\(<36^{\\circ} C\\),","confidence":0.9365541934967041,"confidence_rate":0.999338119234222},{"cnt":[[468,829],[1027,829],[1027,879],[468,879]],"region":{"top_left_x":468,"top_left_y":829,"width":559,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cae9283422d4d96ab8b769365466f50","type":"text","conversion_output":true,"text":"\\(>=36^{\\circ} C\\) to \\(<=38^{\\circ} C\\) and \\(>38^{\\circ} C\\) );","text_display":" \\(>=36^{\\circ} C\\) to \\(<=38^{\\circ} C\\) and \\(>38^{\\circ} C\\) );","confidence":0.9902389049530029,"confidence_rate":0.999857850005258},{"cnt":[[408,881],[1102,881],[1102,930],[408,930]],"region":{"top_left_x":408,"top_left_y":880,"width":695,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1155dee5c4c4dfc9a2c5f37b5fda55f","type":"text","conversion_output":true,"text":"- Urine output by descriptive statistics;","text_display":"\n- Urine output by descriptive statistics;","confidence":1,"confidence_rate":1},{"cnt":[[408,932],[1880,932],[1880,982],[408,982]],"region":{"top_left_x":408,"top_left_y":932,"width":1472,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b37b90dfb23e4d05b8a4ae44a33b072e","type":"text","conversion_output":true,"text":"- Serum creatinine at baseline from the central laboratory data by descriptive","text_display":"\n- Serum creatinine at baseline from the central laboratory data by descriptive","confidence":1,"confidence_rate":1},{"cnt":[[468,980],[1880,980],[1880,1029],[468,1029]],"region":{"top_left_x":468,"top_left_y":979,"width":1412,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ce8b9bd6508429fa60d5456e7fd90d5","type":"text","conversion_output":true,"text":"statistics; values will be converted to \\(mg / dL\\); if baseline central laboratory data is","text_display":" statistics; values will be converted to \\(mg / 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The number and percentages of patients will also","text_display":" will be summarized by treatment group. The number and percentages of patients will also","confidence":1,"confidence_rate":1},{"cnt":[[348,2084],[1880,2084],[1880,2129],[348,2129]],"region":{"top_left_x":348,"top_left_y":2083,"width":1532,"height":47},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d58c373b9e147d28de417165f5ad337","type":"text","conversion_output":true,"text":"be presented by total number of doses received ( 1 dose, 2 doses, 3 doses) by treatment","text_display":" be presented by total number of doses received ( 1 dose, 2 doses, 3 doses) by treatment","confidence":0.96435546875,"confidence_rate":0.9996407050685802},{"cnt":[[348,2131],[1878,2131],[1878,2176],[348,2176]],"region":{"top_left_x":348,"top_left_y":2131,"width":1530,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25c70901fc964a748a67f7d642fa890b","type":"text","conversion_output":true,"text":"group. All summaries will be performed using the Safety Set. The number and percentage","text_display":" group. All summaries will be performed using the Safety Set. The number and percentage","confidence":1,"confidence_rate":1},{"cnt":[[348,2179],[1878,2179],[1878,2226],[348,2226]],"region":{"top_left_x":348,"top_left_y":2178,"width":1530,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db93f581a2464da7ada03747a309b3e7","type":"text","conversion_output":true,"text":"of patients who discontinued the study prior to receiving treatment on Day 1, Day 2 and","text_display":" of patients who discontinued the study prior to receiving treatment on Day 1, Day 2 and","confidence":1,"confidence_rate":1},{"cnt":[[348,2226],[819,2226],[819,2275],[348,2275]],"region":{"top_left_x":348,"top_left_y":2225,"width":471,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64efa270b50f42809733f38ebdc24b42","type":"text","conversion_output":true,"text":"Day 3 will also be included.","text_display":" Day 3 will also be included.","confidence":1,"confidence_rate":1},{"cnt":[[348,2325],[1880,2325],[1880,2370],[348,2370]],"region":{"top_left_x":348,"top_left_y":2324,"width":1532,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af4de9047d5746078dcb32342cadd8f1","type":"text","conversion_output":true,"text":"Study Drug Infusion information will be presented in the form of a listing for the Safety","text_display":"\n\nStudy Drug Infusion information will be presented in the form of a listing for the Safety","confidence":0.9794921875,"confidence_rate":0.9997795879364628},{"cnt":[[348,2372],[1884,2372],[1884,2417],[348,2417]],"region":{"top_left_x":348,"top_left_y":2371,"width":1537,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"779a39bc97824b9a939cd2fc628a5ecb","type":"text","conversion_output":true,"text":"Set, including: was patient dosed (Yes, No); infusion start time; infusion end time; route of","text_display":" Set, including: was patient dosed (Yes, No); infusion start time; infusion end time; route of","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ca9e87e905e4884ab86b0cdf2944795","type":"page_info","conversion_output":false,"text":"25","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-33","page":33,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"503d3ec216434d6ca91626f81285e14e","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1850,125],[1850,159],[1366,159]],"region":{"top_left_x":1366,"top_left_y":124,"width":484,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bcfc9af6611b4e3a85004490dec0a072","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"91a68fac6ca243f39725e32568601777","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.998046875,"confidence_rate":0.9999150020979262},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ba924c7ab19e41d58ee865c363e9f2ce","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[346,329],[1880,329],[1880,376],[346,376]],"region":{"top_left_x":345,"top_left_y":328,"width":1535,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01c49287f4fd41f19581575db943ac34","type":"text","conversion_output":true,"text":"administration (central line, peripheral line); volume of all 4 vials drawn into the 50 mL","text_display":"\nadministration (central line, peripheral line); volume of all 4 vials drawn into the 50 mL","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[346,374],[1878,374],[1878,423],[346,423]],"region":{"top_left_x":345,"top_left_y":373,"width":1533,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84e230a8813b4355b85ea2a9b675952f","type":"text","conversion_output":true,"text":"syringe (yes, no); volume from the 4 vials discarded from the syringe based on patients","text_display":" syringe (yes, no); volume from the 4 vials discarded from the syringe based on patients","confidence":1,"confidence_rate":1},{"cnt":[[348,423],[1880,423],[1880,471],[348,471]],"region":{"top_left_x":348,"top_left_y":423,"width":1532,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f0901da59d749a59cf4ff2f6da673be","type":"text","conversion_output":true,"text":"weight (mL); 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All analyses performed on the other secondary","text_display":" test analysis of the primary endpoint. 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The results of this hierarchical method will be presented indicating where","text_display":" required. 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This table will be based on the ITT","text_display":" placebo treatment groups for certain key endpoints. This table will be based on the ITT","confidence":1,"confidence_rate":1},{"cnt":[[348,1283],[599,1283],[599,1326],[348,1326]],"region":{"top_left_x":348,"top_left_y":1282,"width":252,"height":44},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dd7af911c0948528ab463719c10a9d3","type":"text","conversion_output":true,"text":"Combined Set.","text_display":" Combined Set.","confidence":1,"confidence_rate":1},{"cnt":[[348,1379],[1880,1379],[1880,1429],[348,1429]],"region":{"top_left_x":348,"top_left_y":1379,"width":1532,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aad8b799bed49ac952c33aa0b272f6e","type":"text","conversion_output":true,"text":"Supportive analysis will be undertaken on a selection of endpoints ( \\(AUC _{1-7}\\) and RRT","text_display":"\n\nSupportive analysis will be undertaken on a selection of endpoints ( \\(AUC _{1-7}\\) and RRT","confidence":0.9897665865719318,"confidence_rate":0.9998981622670877},{"cnt":[[348,1427],[1878,1427],[1878,1476],[348,1476]],"region":{"top_left_x":348,"top_left_y":1426,"width":1530,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5085691e0754a6eb8705d7ad27b57c7","type":"text","conversion_output":true,"text":"incidence from Day 1 to Day 28, inclusive) including specific group categories as factors","text_display":" incidence from Day 1 to Day 28, inclusive) including specific group categories as factors","confidence":1,"confidence_rate":1},{"cnt":[[348,1474],[1106,1474],[1106,1521],[348,1521]],"region":{"top_left_x":348,"top_left_y":1473,"width":759,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62dda30eff0e4ac6aeb835765f6cd3f2","type":"text","conversion_output":true,"text":"to assess the consistency of treatment effects.","text_display":" to assess the consistency of treatment effects.","confidence":1,"confidence_rate":1},{"cnt":[[404,1659],[978,1659],[978,1712],[404,1712]],"region":{"top_left_x":403,"top_left_y":1658,"width":575,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b57593c7cdf04e20b8d91555c5b4a2ad","type":"section_header","conversion_output":false,"children_ids":["29483e1d888c42cf898eba36c38ed56c"],"text":"","text_display":""},{"cnt":[[408,1663],[973,1663],[973,1708],[408,1708]],"region":{"top_left_x":408,"top_left_y":1662,"width":566,"height":47},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29483e1d888c42cf898eba36c38ed56c","type":"text","conversion_output":true,"parent_id":"b57593c7cdf04e20b8d91555c5b4a2ad","text":"8.1. Primary Efficacy Endpoint","text_display":"\n\n\\subsection*{8.1. Primary Efficacy Endpoint}","confidence":0.9970703125,"confidence_rate":0.9999161753010639},{"cnt":[[346,1757],[1880,1757],[1880,1807],[346,1807]],"region":{"top_left_x":345,"top_left_y":1757,"width":1535,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"777edc75f58649cbaf0a55f04728d7b5","type":"text","conversion_output":true,"text":"The primary endpoint will be calculated from standardized endogenous creatinine","text_display":"\n\nThe primary endpoint will be calculated from standardized endogenous creatinine","confidence":1,"confidence_rate":1},{"cnt":[[346,1807],[1876,1807],[1876,1854],[346,1854]],"region":{"top_left_x":345,"top_left_y":1806,"width":1531,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47b28e71bfe8467084f4d6020230ebbc","type":"text","conversion_output":true,"text":"clearance measurements on Day 1 (first measurement after treatment) to Day 7, inclusive.","text_display":" clearance measurements on Day 1 (first measurement after treatment) to Day 7, inclusive.","confidence":1,"confidence_rate":1},{"cnt":[[348,1852],[1880,1852],[1880,1901],[348,1901]],"region":{"top_left_x":348,"top_left_y":1851,"width":1532,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f2039a91b6c4e95a18e6264cbb70949","type":"text","conversion_output":true,"text":"Standardized endogenous creatinine clearance is assessed on each day during a \\(6 \\pm 1\\) hour","text_display":" Standardized endogenous creatinine clearance is assessed on each day during a \\(6 \\pm 1\\) hour","confidence":1,"confidence_rate":1},{"cnt":[[348,1901],[1878,1901],[1878,1951],[348,1951]],"region":{"top_left_x":348,"top_left_y":1901,"width":1530,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d7ac2e20e584adc916de89a91b33480","type":"text","conversion_output":true,"text":"period and calculated in \\(mL / min\\) as the mean creatinine clearance over the period, which is","text_display":" period and calculated in \\(mL / min\\) as the mean creatinine clearance over the period, which is","confidence":0.9019031524658203,"confidence_rate":0.9990077221100045},{"cnt":[[348,1951],[1377,1951],[1377,1996],[348,1996]],"region":{"top_left_x":348,"top_left_y":1950,"width":1030,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3dd994c712d1410ab0810797317e5202","type":"text","conversion_output":true,"text":"expected to be representative of the full 24 hours for that day.","text_display":" expected to be representative of the full 24 hours for that day.","confidence":1,"confidence_rate":1},{"cnt":[[346,2045],[1880,2045],[1880,2093],[346,2093]],"region":{"top_left_x":345,"top_left_y":2045,"width":1535,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edcf606f8d174e2f8170e16012e8114a","type":"text","conversion_output":true,"text":"An adjudication committee will review the standardized endogenous creatinine clearance","text_display":"\n\nAn adjudication committee will review the standardized endogenous creatinine clearance","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[348,2093],[1880,2093],[1880,2142],[348,2142]],"region":{"top_left_x":348,"top_left_y":2092,"width":1532,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4762ef5a03084bd08777fa22e7989228","type":"text","conversion_output":true,"text":"data on a case-by-case basis to determine the values to be used in the analysis and for the","text_display":" data on a case-by-case basis to determine the values to be used in the analysis and for the","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[348,2140],[1880,2140],[1880,2189],[348,2189]],"region":{"top_left_x":348,"top_left_y":2139,"width":1532,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8260878343e46a59ebf1750f0f54280","type":"text","conversion_output":true,"text":"derivation of \\(AUC _{1-7}\\) (see Section 8.1.2). The standardized endogenous creatinine","text_display":" derivation of \\(AUC _{1-7}\\) (see Section 8.1.2). The standardized endogenous creatinine","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[348,2187],[1824,2187],[1824,2237],[348,2237]],"region":{"top_left_x":348,"top_left_y":2187,"width":1477,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b840f8fced9248f49a321c2ad8965933","type":"text","conversion_output":true,"text":"clearance ( \\(mL / min\\) ) will be calculated by PPD Biostatistics using the following formula.","text_display":" clearance ( \\(mL / min\\) ) will be calculated by PPD Biostatistics using the following formula.","confidence":0.9941470623016357,"confidence_rate":0.9999430100388688},{"cnt":[[337,2282],[1886,2282],[1886,2385],[337,2385]],"region":{"top_left_x":337,"top_left_y":2281,"width":1550,"height":104},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fbbc2ed76f541728fa041ec1464c4c9","type":"text","conversion_output":true,"text":"\\(\\frac{\\text { Urine Creatinine }( mg / dL )}{\\text { Serum Creatinine }( mg / dL )} \\times \\frac{\\text { Total urine volume collected }( mL )}{\\text { Stop date/time }- \\text { Start date/time of urine collection (min) }}\\)","text_display":"\n\\(\\frac{\\text { Urine Creatinine }( mg / dL )}{\\text { Serum Creatinine }( mg / dL )} \\times \\frac{\\text { Total urine volume collected }( mL )}{\\text { Stop date/time }- \\text { Start date/time of urine collection (min) }}\\)","confidence":0.685813990835762,"confidence_rate":0.9979634342501742},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9244e520be1140cfa3fee46767eb2c55","type":"page_info","conversion_output":false,"text":"26","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-34","page":34,"lines":[{"cnt":[[344,125],[492,125],[492,157],[344,157]],"region":{"top_left_x":343,"top_left_y":124,"width":149,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"853029e0835f415990788880f99603fd","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1850,125],[1850,161],[1366,161]],"region":{"top_left_x":1366,"top_left_y":124,"width":484,"height":38},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ae45b513e64d417fa29f8ddf119cd0e5","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[344,157],[599,157],[599,191],[344,191]],"region":{"top_left_x":343,"top_left_y":156,"width":257,"height":36},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a49136be910b459d976e4544ba673867","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.998046875,"confidence_rate":0.9999150020979262},{"cnt":[[1568,159],[1854,159],[1854,191],[1568,191]],"region":{"top_left_x":1568,"top_left_y":158,"width":287,"height":34},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"67c5523ce0664b6f8726109d3019bb3b","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[408,374],[1880,374],[1880,428],[408,428]],"region":{"top_left_x":408,"top_left_y":373,"width":1472,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2cad5fb78da480d9d3fc25f71bb8b97","type":"text","conversion_output":true,"text":"- The urine creatinine ( \\(mg / dL\\) ) and serum creatinine ( \\(mg / dL\\) ) assessed by the central","text_display":"\n- The urine creatinine ( \\(mg / dL\\) ) and serum creatinine ( \\(mg / dL\\) ) assessed by the central","confidence":0.9566798210144043,"confidence_rate":0.9995974764088956},{"cnt":[[468,425],[1880,425],[1880,475],[468,475]],"region":{"top_left_x":468,"top_left_y":425,"width":1412,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fef90c09f2d4f3dabcee73c6ccd7ab4","type":"text","conversion_output":true,"text":"laboratory will be used to determine the standardized endogenous creatinine","text_display":" laboratory will be used to determine the standardized endogenous creatinine","confidence":1,"confidence_rate":1},{"cnt":[[468,473],[647,473],[647,518],[468,518]],"region":{"top_left_x":468,"top_left_y":472,"width":179,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffc8badcbae840b8856c2a05dc497c29","type":"text","conversion_output":true,"text":"clearance.","text_display":" clearance.","confidence":1,"confidence_rate":1},{"cnt":[[408,524],[1880,524],[1880,574],[408,574]],"region":{"top_left_x":408,"top_left_y":524,"width":1472,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"264bf985196f40bc8c9eff7ac653b923","type":"text","conversion_output":true,"text":"- Per protocol, two blood samples are collected to evaluate the serum creatinine, one","text_display":"\n- Per protocol, two blood samples are collected to evaluate the serum creatinine, one","confidence":1,"confidence_rate":1},{"cnt":[[468,571],[1880,571],[1880,621],[468,621]],"region":{"top_left_x":468,"top_left_y":571,"width":1412,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf0aa941b74e4d1980676fa34c8ed7ec","type":"text","conversion_output":true,"text":"at the beginning of the urine sample collection and the other at the end of the urine","text_display":" at the beginning of the urine sample collection and the other at the end of the urine","confidence":1,"confidence_rate":1},{"cnt":[[468,619],[1880,619],[1880,668],[468,668]],"region":{"top_left_x":468,"top_left_y":618,"width":1412,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"215fe180dec043d79d3e22e044f43a0e","type":"text","conversion_output":true,"text":"sample collection. The average of these two serum creatinine measurements will be","text_display":" sample collection. The average of these two serum creatinine measurements will be","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[468,666],[1880,666],[1880,718],[468,718]],"region":{"top_left_x":468,"top_left_y":666,"width":1412,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3b05dc1550740818936a850e7574e77","type":"text","conversion_output":true,"text":"used in the formula above to assess the standardized endogenous creatinine","text_display":" used in the formula above to assess the standardized endogenous creatinine","confidence":1,"confidence_rate":1},{"cnt":[[468,715],[1880,715],[1880,767],[468,767]],"region":{"top_left_x":468,"top_left_y":715,"width":1412,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e730599db79d41d8ab8a4487216511c7","type":"text","conversion_output":true,"text":"clearance. In case there is only one serum creatinine sample available, then the","text_display":" clearance. In case there is only one serum creatinine sample available, then the","confidence":1,"confidence_rate":1},{"cnt":[[468,765],[1824,765],[1824,814],[468,814]],"region":{"top_left_x":468,"top_left_y":764,"width":1357,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e03fab3964cb4d46b2e7a2b6169ca391","type":"text","conversion_output":true,"text":"serum creatinine concentration from that one sample will be used in the formula.","text_display":" serum creatinine concentration from that one sample will be used in the formula.","confidence":1,"confidence_rate":1},{"cnt":[[408,814],[1880,814],[1880,866],[408,866]],"region":{"top_left_x":408,"top_left_y":814,"width":1472,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ab3994b1e8849ee89e46c66f6f0e80c","type":"text","conversion_output":true,"text":"- The number of minutes from the start date/time to the stop date/time of urine","text_display":"\n- The number of minutes from the start date/time to the stop date/time of urine","confidence":1,"confidence_rate":1},{"cnt":[[468,864],[1880,864],[1880,913],[468,913]],"region":{"top_left_x":468,"top_left_y":863,"width":1412,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f1475184af44e37bbb806979964022e","type":"text","conversion_output":true,"text":"sample collection and the total urine volume ( mL ) will be derived from the Urine","text_display":" sample collection and the total urine volume ( mL ) will be derived from the Urine","confidence":0.9794921875,"confidence_rate":0.9997772181782927},{"cnt":[[468,911],[1880,911],[1880,960],[468,960]],"region":{"top_left_x":468,"top_left_y":910,"width":1412,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2655167c54c445fea09e311c9395ebdb","type":"text","conversion_output":true,"text":"Volume eCRF page. If the urine volume is recorded as 0 mL , then the standardized","text_display":" Volume eCRF page. If the urine volume is recorded as 0 mL , then the standardized","confidence":1,"confidence_rate":1},{"cnt":[[468,958],[1880,958],[1880,1008],[468,1008]],"region":{"top_left_x":468,"top_left_y":958,"width":1412,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0b8be018469477b8adec7ff9f9f52b8","type":"text","conversion_output":true,"text":"creatinine clearance will be \\(0 mL / min\\) and will not be set to missing. If the urine","text_display":" creatinine clearance will be \\(0 mL / min\\) and will not be set to missing. If the urine","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[468,1005],[1880,1005],[1880,1055],[468,1055]],"region":{"top_left_x":468,"top_left_y":1005,"width":1412,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48cb3577263a46daa0c3f87119a9467b","type":"text","conversion_output":true,"text":"volume is not recorded as missing but the volume is less than \\(30 mL / 24 hrs\\), then","text_display":" volume is not recorded as missing but the volume is less than \\(30 mL / 24 hrs\\), then","confidence":0.998535871389322,"confidence_rate":0.9999842452693294},{"cnt":[[468,1053],[1502,1053],[1502,1102],[468,1102]],"region":{"top_left_x":468,"top_left_y":1052,"width":1034,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"540b78c0fe6741408c71b7345c44d967","type":"text","conversion_output":true,"text":"the standardized creatinine clearance will be set to \\(1 mL / min\\).","text_display":" the standardized creatinine clearance will be set to \\(1 mL / min\\).","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[344,1147],[1880,1147],[1880,1201],[344,1201]],"region":{"top_left_x":343,"top_left_y":1147,"width":1537,"height":54},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df112ef240594badaee385a4eb673f88","type":"text","conversion_output":true,"text":"The adjudicated Part 2 data will be used to determine the \\(AUC _{1-7}\\) (primary endpoint), while","text_display":"\n\nThe adjudicated Part 2 data will be used to determine the \\(AUC _{1-7}\\) (primary endpoint), while","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[344,1199],[1880,1199],[1880,1248],[344,1248]],"region":{"top_left_x":343,"top_left_y":1198,"width":1537,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88fd60c65954462e9b169528e7412a19","type":"text","conversion_output":true,"text":"the adjudicated Part 1 data will be used in a sensitivity analysis of the primary endpoint (as","text_display":" the adjudicated Part 1 data will be used in a sensitivity analysis of the primary endpoint (as","confidence":0.9912109375,"confidence_rate":0.9999134555675034},{"cnt":[[344,1246],[1182,1246],[1182,1296],[344,1296]],"region":{"top_left_x":343,"top_left_y":1246,"width":839,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b59416302b144979a13a937d0aed311","type":"text","conversion_output":true,"text":"described in section 8.1.4). All data will be listed.","text_display":" described in section 8.1.4). All data will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[344,1341],[1880,1341],[1880,1394],[344,1394]],"region":{"top_left_x":343,"top_left_y":1340,"width":1537,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9dbc9c52b0964a989a4ad7c84d26ba3a","type":"text","conversion_output":true,"text":"The primary endpoint is the area under the time-corrected endogenous creatinine clearance","text_display":"\n\nThe primary endpoint is the area under the time-corrected endogenous creatinine clearance","confidence":1,"confidence_rate":1},{"cnt":[[344,1388],[975,1388],[975,1442],[344,1442]],"region":{"top_left_x":343,"top_left_y":1387,"width":633,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e36f8f7cc7f54d18995bbc606b31dead","type":"text","conversion_output":true,"text":"curve from Day 1 to Day \\(7\\left( AUC _{1-7}\\right)\\).","text_display":" curve from Day 1 to Day \\(7\\left( AUC _{1-7}\\right)\\).","confidence":0.9658203125,"confidence_rate":0.9993791664759197},{"cnt":[[344,1487],[1880,1487],[1880,1536],[344,1536]],"region":{"top_left_x":343,"top_left_y":1486,"width":1537,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ea451b63d5d48899ed74f08dcd4babb","type":"text","conversion_output":true,"text":"\\(AUC _{1-7}\\) is calculated as the average of the standardized endogenous creatinine clearance","text_display":"\n\\(AUC _{1-7}\\) is calculated as the average of the standardized endogenous creatinine clearance","confidence":0.99609375,"confidence_rate":0.9999612492724017},{"cnt":[[344,1534],[1880,1534],[1880,1588],[344,1588]],"region":{"top_left_x":343,"top_left_y":1533,"width":1537,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cfb45ef8cc843b4af01dd4cccb4935b","type":"text","conversion_output":true,"text":"values over the 7 days. Specifically, denoting \\(C_{\\bar{i}}\\) as the standardized endogenous creatinine","text_display":" values over the 7 days. Specifically, denoting \\(C_{\\bar{i}}\\) as the standardized endogenous creatinine","confidence":0.53125,"confidence_rate":0.9943683944327284},{"cnt":[[344,1586],[1044,1586],[1044,1635],[344,1635]],"region":{"top_left_x":343,"top_left_y":1585,"width":702,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35b1e0d410374712a742996b0b35f20d","type":"text","conversion_output":true,"text":"clearance on Day \\(i\\), AUC \\(_{1-7}\\) is defined as:","text_display":" clearance on Day \\(i\\), AUC \\(_{1-7}\\) is defined as:","confidence":0.901603753257632,"confidence_rate":0.9982751533710296},{"cnt":[[945,1620],[1280,1620],[1280,1772],[945,1772]],"region":{"top_left_x":945,"top_left_y":1619,"width":336,"height":154},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e3b6ec376674a52b2c3f226f77fa901","type":"math","conversion_output":true,"text":"\\[\nAUC_{1-7}=\\frac{1}{7} \\sum_{i=1}^{7} C_{i}\n\\]","text_display":"\n\\[\nAUC_{1-7}=\\frac{1}{7} \\sum_{i=1}^{7} C_{i}\n\\]","confidence":0.9970729344058782,"confidence_rate":0.9999348608365711},{"cnt":[[344,1764],[1880,1764],[1880,1815],[344,1815]],"region":{"top_left_x":343,"top_left_y":1763,"width":1537,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48e211acf12d4d858be03ae24f37dbb7","type":"text","conversion_output":true,"text":"Any missing \\(C_{\\bar{i}}\\) values will be handled by linear interpolation where possible, otherwise","text_display":"\n\nAny missing \\(C_{\\bar{i}}\\) values will be handled by linear interpolation where possible, otherwise","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[344,1826],[1880,1826],[1880,1876],[344,1876]],"region":{"top_left_x":343,"top_left_y":1826,"width":1537,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"865132de60a744cbac62b3f12bcb3567","type":"text","conversion_output":true,"text":"they will be imputed by last observation carried forward (LOCF). When there are no","text_display":" they will be imputed by last observation carried forward (LOCF). When there are no","confidence":1,"confidence_rate":1},{"cnt":[[344,1873],[1880,1873],[1880,1925],[344,1925]],"region":{"top_left_x":343,"top_left_y":1873,"width":1537,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ddf98b56143410f84b6e8a33b2559ce","type":"text","conversion_output":true,"text":"preceding post-baseline measurements to use, the baseline measurement from Day 0 (i.e.,","text_display":" preceding post-baseline measurements to use, the baseline measurement from Day 0 (i.e.,","confidence":0.995610237121582,"confidence_rate":0.9999536913230422},{"cnt":[[344,1921],[1880,1921],[1880,1972],[344,1972]],"region":{"top_left_x":343,"top_left_y":1920,"width":1537,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55ed51c34ddd43ca9a04bd2eaa03a33b","type":"text","conversion_output":true,"text":"prior to treatment) will be carried forward. If it is not possible to impute the missing values","text_display":" prior to treatment) will be carried forward. If it is not possible to impute the missing values","confidence":1,"confidence_rate":1},{"cnt":[[344,1970],[1880,1970],[1880,2020],[344,2020]],"region":{"top_left_x":343,"top_left_y":1970,"width":1537,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b67d379d46904043916241b0edfdf97c","type":"text","conversion_output":true,"text":"(as there is no baseline result), the standardized endogenous creatinine clearance values","text_display":" (as there is no baseline result), the standardized endogenous creatinine clearance values","confidence":1,"confidence_rate":1},{"cnt":[[344,2017],[1878,2017],[1878,2069],[344,2069]],"region":{"top_left_x":343,"top_left_y":2017,"width":1535,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f0065a54e264be68fc5ac6679be3c0e","type":"text","conversion_output":true,"text":"will be averaged based on the days available (i.e. if baseline, Day 1 and Day 2 are missing,","text_display":" will be averaged based on the days available (i.e. if baseline, Day 1 and Day 2 are missing,","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[344,2067],[1880,2067],[1880,2116],[344,2116]],"region":{"top_left_x":343,"top_left_y":2066,"width":1537,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8eaf91aeb0d541fcb2c850ede32ec664","type":"text","conversion_output":true,"text":"the sum of the values from Day 3 to Day 7 will be divided by 5 - as there is 5 available","text_display":" the sum of the values from Day 3 to Day 7 will be divided by 5 - as there is 5 available","confidence":0.68603515625,"confidence_rate":0.9964176092290429},{"cnt":[[344,2114],[1098,2114],[1098,2163],[344,2163]],"region":{"top_left_x":343,"top_left_y":2114,"width":755,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06c921fcdeef4039ad3814b1754be610","type":"text","conversion_output":true,"text":"days with non-missing data after imputation.","text_display":" days with non-missing data after imputation.","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e8fe6731d43493daeac8e75390a6391","type":"page_info","conversion_output":false,"text":"27","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-35","page":35,"lines":[{"cnt":[[346,127],[492,127],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":126,"width":147,"height":31},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"86e6466a518a42b592eb891680e4176c","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1369,125],[1850,125],[1850,159],[1369,159]],"region":{"top_left_x":1368,"top_left_y":124,"width":482,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"0571cd77f0a34c50b9abebf481a12bdf","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[348,159],[599,159],[599,187],[348,187]],"region":{"top_left_x":348,"top_left_y":158,"width":252,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"02d33a43a07941669e89b4f6c93ea754","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d01d0b71ee2142a892de4292e6d9fc80","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[468,327],[917,327],[917,380],[468,380]],"region":{"top_left_x":468,"top_left_y":326,"width":450,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c745f54529c14e1ca916409dd2e8fddd","type":"section_header","conversion_output":false,"children_ids":["8f171a5e711e4551a78bb3bda62819bc"],"text":"","text_display":""},{"cnt":[[473,331],[913,331],[913,376],[473,376]],"region":{"top_left_x":472,"top_left_y":330,"width":442,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f171a5e711e4551a78bb3bda62819bc","type":"text","conversion_output":true,"parent_id":"c745f54529c14e1ca916409dd2e8fddd","text":"8.1.1. Primary Analysis","text_display":"\n\n\\subsection*{8.1.1. Primary Analysis}","confidence":0.99951171875,"confidence_rate":0.9999825572771935},{"cnt":[[346,425],[1880,425],[1880,475],[346,475]],"region":{"top_left_x":345,"top_left_y":425,"width":1535,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ec6666d1dca44709340fcd5732e5eb8","type":"text","conversion_output":true,"text":"The primary efficacy analysis will be an analysis of variance (ANOVA) of the area under","text_display":"\n\nThe primary efficacy analysis will be an analysis of variance (ANOVA) of the area under","confidence":1,"confidence_rate":1},{"cnt":[[348,475],[1880,475],[1880,522],[348,522]],"region":{"top_left_x":348,"top_left_y":474,"width":1532,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b667b70a6dbe4e85923a0be715bd1d36","type":"text","conversion_output":true,"text":"the time-corrected endogenous creatinine clearance curve from Day 1 to Day 7 with","text_display":" the time-corrected endogenous creatinine clearance curve from Day 1 to Day 7 with","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[348,524],[1072,524],[1072,569],[348,569]],"region":{"top_left_x":348,"top_left_y":524,"width":725,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9b482480f1f494caea76c114b0a7c1f","type":"text","conversion_output":true,"text":"treatment and site as explanatory variables.","text_display":" treatment and site as explanatory variables.","confidence":1,"confidence_rate":1},{"cnt":[[346,619],[1878,619],[1878,666],[346,666]],"region":{"top_left_x":345,"top_left_y":618,"width":1533,"height":49},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e3ec47e1519457784fbd9f00ca8838e","type":"text","conversion_output":true,"text":"For all patients recruited up to the interim analysis, the primary efficacy analysis will be","text_display":"\n\nFor all patients recruited up to the interim analysis, the primary efficacy analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[348,666],[1880,666],[1880,713],[348,713]],"region":{"top_left_x":348,"top_left_y":666,"width":1532,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c88d5d897094df1b336b41062655507","type":"text","conversion_output":true,"text":"conducted for the ITT Combined Set at the interim analysis (which is identical to the ITT","text_display":" conducted for the ITT Combined Set at the interim analysis (which is identical to the ITT","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[348,713],[1880,713],[1880,763],[348,763]],"region":{"top_left_x":348,"top_left_y":713,"width":1532,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42a8c3ca9db34cd4a625ca8acce4dea2","type":"text","conversion_output":true,"text":"Part 1 Interim set at the time of the interim analysis) where \\(AUC _{1-7}\\) will be compared","text_display":" Part 1 Interim set at the time of the interim analysis) where \\(AUC _{1-7}\\) will be compared","confidence":0.9809749083360657,"confidence_rate":0.9998188051217095},{"cnt":[[348,761],[1880,761],[1880,810],[348,810]],"region":{"top_left_x":348,"top_left_y":760,"width":1532,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0ebdcc96d584e55ad3d9a08e92b4e4b","type":"text","conversion_output":true,"text":"between the 3 active treatment groups and placebo. This analysis will be considered in","text_display":" between the 3 active treatment groups and placebo. This analysis will be considered in","confidence":1,"confidence_rate":1},{"cnt":[[348,810],[1794,810],[1794,857],[348,857]],"region":{"top_left_x":348,"top_left_y":809,"width":1446,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa4cf05d95d54022a96d4b66b09a5b19","type":"text","conversion_output":true,"text":"conjunction with the safety data to determine the optimal recAP dose for use in Part 2.","text_display":" conjunction with the safety data to determine the optimal recAP dose for use in Part 2.","confidence":1,"confidence_rate":1},{"cnt":[[348,907],[1876,907],[1876,952],[348,952]],"region":{"top_left_x":348,"top_left_y":906,"width":1528,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40c75b7a38b94256b2f384a4c59436c0","type":"text","conversion_output":true,"text":"The primary efficacy analysis will be conducted for the ITT Part 2 Set, PP Day 1-7 Part 1","text_display":"\n\nThe primary efficacy analysis will be conducted for the ITT Part 2 Set, PP Day 1-7 Part 1","confidence":0.51171875,"confidence_rate":0.9930453367878574},{"cnt":[[348,954],[1878,954],[1878,1003],[348,1003]],"region":{"top_left_x":348,"top_left_y":953,"width":1530,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90f2113960554b13922c5d8c32dab839","type":"text","conversion_output":true,"text":"and PP Day 1-7 Part 2 Set where \\(AUC _{1-7}\\) will be compared between the optimal recAP","text_display":" and PP Day 1-7 Part 2 Set where \\(AUC _{1-7}\\) will be compared between the optimal recAP","confidence":0.9477791786193848,"confidence_rate":0.9994743172607284},{"cnt":[[348,1001],[1880,1001],[1880,1051],[348,1051]],"region":{"top_left_x":348,"top_left_y":1001,"width":1532,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b4d45943d274f839140ab4b22f325ae","type":"text","conversion_output":true,"text":"dose and placebo (for the PP Day 1-7 Combined Set, each dose of recAP will be","text_display":" dose and placebo (for the PP Day 1-7 Combined Set, each dose of recAP will be","confidence":1,"confidence_rate":1},{"cnt":[[348,1048],[1661,1048],[1661,1098],[348,1098]],"region":{"top_left_x":348,"top_left_y":1048,"width":1313,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3ba46fa321742c5a6020f740186172d","type":"text","conversion_output":true,"text":"compared to Placebo). Also, all doses combined will be compared to Placebo.","text_display":" compared to Placebo). Also, all doses combined will be compared to Placebo.","confidence":0.9990234375,"confidence_rate":0.9999877870789805},{"cnt":[[348,1143],[1880,1143],[1880,1192],[348,1192]],"region":{"top_left_x":348,"top_left_y":1142,"width":1532,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a11666db9982409a855f498535d44133","type":"text","conversion_output":true,"text":"Confirmatory testing of the single hypothesis comparing optimal dose with placebo will be","text_display":"\n\nConfirmatory testing of the single hypothesis comparing optimal dose with placebo will be","confidence":1,"confidence_rate":1},{"cnt":[[348,1192],[1880,1192],[1880,1240],[348,1240]],"region":{"top_left_x":348,"top_left_y":1192,"width":1532,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"514dc47a1a544a1fbc71671ed33843f9","type":"text","conversion_output":true,"text":"based on a closed-testing procedure. This hypothesis will be rejected at the \\(5 \\%\\) significant","text_display":" based on a closed-testing procedure. This hypothesis will be rejected at the \\(5 \\%\\) significant","confidence":0.9990236759185791,"confidence_rate":0.999990133371946},{"cnt":[[348,1240],[1880,1240],[1880,1291],[348,1291]],"region":{"top_left_x":348,"top_left_y":1239,"width":1532,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"538e35e651184d90a77286192f04607e","type":"text","conversion_output":true,"text":"level if it and all intersection hypotheses involving it are all rejected at the \\(5 \\%\\) significance","text_display":" level if it and all intersection hypotheses involving it are all rejected at the \\(5 \\%\\) significance","confidence":0.9980478286743164,"confidence_rate":0.9999812109525197},{"cnt":[[348,1289],[1880,1289],[1880,1336],[348,1336]],"region":{"top_left_x":348,"top_left_y":1289,"width":1532,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4df16ac9aa84d94b84a86ef19b2b292","type":"text","conversion_output":true,"text":"level. The testing strategy used to combine results from Parts 1 and 2 will be a combination","text_display":" level. 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For the","text_display":" the one-sided p -values from interim analysis at Part 1 and from Part 2, respectively. 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Adjudication Committee}","confidence":0.51953125,"confidence_rate":0.980924625853978},{"cnt":[[344,1770],[1880,1770],[1880,1818],[344,1818]],"region":{"top_left_x":343,"top_left_y":1770,"width":1537,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35107a0bcb61497690e762175e935a22","type":"text","conversion_output":true,"text":"An adjudication committee will review the standardized endogenous creatinine clearance","text_display":"\n\nAn adjudication committee will review the standardized endogenous creatinine clearance","confidence":1,"confidence_rate":1},{"cnt":[[344,1818],[1880,1818],[1880,1867],[344,1867]],"region":{"top_left_x":343,"top_left_y":1817,"width":1537,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3ef69bb6e2845f2bf96e792a1c9920e","type":"text","conversion_output":true,"text":"data on a case-by-case basis for part 1 patients in the same way as for the part 2 data","text_display":" data on a case-by-case basis for part 1 patients in the same way as for the part 2 data","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[344,1865],[1880,1865],[1880,1914],[344,1914]],"region":{"top_left_x":343,"top_left_y":1864,"width":1537,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"972d60a43fc34d3ebfc964b514a48f04","type":"text","conversion_output":true,"text":"review to determine the values to be used in the analysis. The adjudication committee will","text_display":" review to determine the values to be used in the analysis. The adjudication committee will","confidence":1,"confidence_rate":1},{"cnt":[[344,1912],[1878,1912],[1878,1962],[344,1962]],"region":{"top_left_x":343,"top_left_y":1912,"width":1535,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18ca82b9ae854fd4a091cf87761212d3","type":"text","conversion_output":true,"text":"be provided with a data listing of collection time of urine and blood creatinine, their results","text_display":" be provided with a data listing of collection time of urine and blood creatinine, their results","confidence":1,"confidence_rate":1},{"cnt":[[344,1962],[1880,1962],[1880,2009],[344,2009]],"region":{"top_left_x":343,"top_left_y":1961,"width":1537,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f47e0a96de641a99fa8f50adac777a9","type":"text","conversion_output":true,"text":"as well as the calculated standardized endogenous creatinine clearance (more details are","text_display":" as well as the calculated standardized endogenous creatinine clearance (more details are","confidence":1,"confidence_rate":1},{"cnt":[[344,2007],[1880,2007],[1880,2058],[344,2058]],"region":{"top_left_x":343,"top_left_y":2006,"width":1537,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70a9da5d9b904656b094cd170950a122","type":"text","conversion_output":true,"text":"included in the adjudication committee charter). Additionally the adjudication committee","text_display":" included in the adjudication committee charter). Additionally the adjudication committee","confidence":1,"confidence_rate":1},{"cnt":[[344,2056],[1882,2056],[1882,2105],[344,2105]],"region":{"top_left_x":343,"top_left_y":2056,"width":1540,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"307eff1f0424483e94b69d84e2a5189e","type":"text","conversion_output":true,"text":"will be provided with a data listing of collection time or urine urea nitrogen, volume of","text_display":" will be provided with a data listing of collection time or urine urea nitrogen, volume of","confidence":1,"confidence_rate":1},{"cnt":[[346,2105],[1880,2105],[1880,2155],[346,2155]],"region":{"top_left_x":345,"top_left_y":2105,"width":1535,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"199a630d386d46c4a6724e441ca477c4","type":"text","conversion_output":true,"text":"urine and BUN as well as the calculated value for urea clearance. The adjudication","text_display":" urine and BUN as well as the calculated value for urea clearance. The adjudication","confidence":1,"confidence_rate":1},{"cnt":[[344,2153],[1880,2153],[1880,2202],[344,2202]],"region":{"top_left_x":343,"top_left_y":2152,"width":1537,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3d56b6506e4421b884fb8ec6dcc3f40","type":"text","conversion_output":true,"text":"committee will also be provided with patients figures for standardized creatinine clearance","text_display":" committee will also be provided with patients figures for standardized creatinine clearance","confidence":1,"confidence_rate":1},{"cnt":[[344,2200],[672,2200],[672,2245],[344,2245]],"region":{"top_left_x":343,"top_left_y":2200,"width":330,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9fa2c10a2df1470d82edba3dc7815aeb","type":"text","conversion_output":true,"text":"and urea clearance.","text_display":" and urea clearance.","confidence":1,"confidence_rate":1},{"cnt":[[346,2295],[1880,2295],[1880,2344],[346,2344]],"region":{"top_left_x":345,"top_left_y":2294,"width":1535,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c98287ed9e39442a9144fcebf8ea2726","type":"text","conversion_output":true,"text":"The adjudication committee will then indicate for each record if the standardized","text_display":"\n\nThe adjudication committee will then indicate for each record if the standardized","confidence":1,"confidence_rate":1},{"cnt":[[346,2344],[1880,2344],[1880,2396],[346,2396]],"region":{"top_left_x":345,"top_left_y":2343,"width":1535,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"104dfe67623f4305b6c4bf66e8494e33","type":"text","conversion_output":true,"text":"endogenous creatinine clearance is acceptable (i.e. can be used in the analysis) and provide","text_display":" endogenous creatinine clearance is acceptable (i.e. can be used in the analysis) and provide","confidence":0.99072265625,"confidence_rate":0.9999039154789536},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e10af5d62bb84edd8449946f6d37d7ca","type":"page_info","conversion_output":false,"text":"29","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-37","page":37,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"db97a978349a44c197b8945d37e592cd","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1850,125],[1850,159],[1366,159]],"region":{"top_left_x":1366,"top_left_y":124,"width":484,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"571d2ff16aee430b96ee2e6b6b1547e9","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4019ad45b34340a2a13b94c022b4a33e","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.998046875,"confidence_rate":0.9999150020979262},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5b9d765307c049689ebf96263adfd697","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[346,329],[1878,327],[1878,376],[346,378]],"region":{"top_left_x":345,"top_left_y":326,"width":1533,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed5242de4fc34be2bdd394a3053e7269","type":"text","conversion_output":true,"text":"comments (if applicable). PPD Biostatistics will use the standardized endogenous","text_display":"\ncomments (if applicable). PPD Biostatistics will use the standardized endogenous","confidence":1,"confidence_rate":1},{"cnt":[[346,374],[1878,374],[1878,423],[346,423]],"region":{"top_left_x":345,"top_left_y":373,"width":1533,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bbb153ec4854914975ab47c3c8785d9","type":"text","conversion_output":true,"text":"creatinine clearance deemed acceptable by the adjudication committee to re-derive the","text_display":" creatinine clearance deemed acceptable by the adjudication committee to re-derive the","confidence":1,"confidence_rate":1},{"cnt":[[348,425],[505,425],[505,466],[348,466]],"region":{"top_left_x":348,"top_left_y":425,"width":157,"height":42},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8adb95bf40974ef4975dd7ee8d281770","type":"text","conversion_output":true,"text":"AUC1-7.","text_display":" AUC1-7.","confidence":1,"confidence_rate":1},{"cnt":[[468,559],[965,559],[965,612],[468,612]],"region":{"top_left_x":468,"top_left_y":558,"width":497,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac6433c05a1c478dbdf966d5e601a21d","type":"section_header","conversion_output":false,"children_ids":["e51fcf9217bd47b7b2acb008fa929e93"],"text":"","text_display":""},{"cnt":[[473,563],[960,563],[960,608],[473,608]],"region":{"top_left_x":472,"top_left_y":562,"width":489,"height":47},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e51fcf9217bd47b7b2acb008fa929e93","type":"text","conversion_output":true,"parent_id":"ac6433c05a1c478dbdf966d5e601a21d","text":"8.1.3. Assumption Testing","text_display":"\n\n\\subsection*{8.1.3. Assumption Testing}","confidence":0.99560546875,"confidence_rate":0.9998532035894828},{"cnt":[[348,660],[1878,660],[1878,707],[348,707]],"region":{"top_left_x":348,"top_left_y":659,"width":1530,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f404b3dc60f944b2aa2ea48c1be1a294","type":"text","conversion_output":true,"text":"The underlying assumptions for ANOVA (normality and homogeneity of variance of the","text_display":"\n\nThe underlying assumptions for ANOVA (normality and homogeneity of variance of the","confidence":1,"confidence_rate":1},{"cnt":[[348,709],[1880,709],[1880,754],[348,754]],"region":{"top_left_x":348,"top_left_y":708,"width":1532,"height":47},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cded0ebbfc26436fa2571ff534e202e7","type":"text","conversion_output":true,"text":"studentized residuals) will be investigated at the Part 1 interim analysis and at the Part 2","text_display":" studentized residuals) will be investigated at the Part 1 interim analysis and at the Part 2","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[348,756],[1878,756],[1878,801],[348,801]],"region":{"top_left_x":348,"top_left_y":756,"width":1530,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b98186fb70954da18b1eb4f4ef69d17f","type":"text","conversion_output":true,"text":"analysis by examining a normal probability plot of the residuals and a plot of the fitted","text_display":" analysis by examining a normal probability plot of the residuals and a plot of the fitted","confidence":1,"confidence_rate":1},{"cnt":[[348,795],[1652,795],[1652,851],[348,851]],"region":{"top_left_x":348,"top_left_y":794,"width":1305,"height":57},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b571456ad924be782d0e0aebfc09d0b","type":"text","conversion_output":true,"text":"values against the residuals. These results will be presented as a SAS \\({ }^{\\circledR}\\) output.","text_display":" values against the residuals. These results will be presented as a SAS \\({ }^{\\circledR}\\) output.","confidence":0.99267578125,"confidence_rate":0.9999226222303292},{"cnt":[[348,898],[1880,898],[1880,947],[348,947]],"region":{"top_left_x":348,"top_left_y":898,"width":1532,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"deeeedc131934f1d98b73198313573b2","type":"text","conversion_output":true,"text":"Should there be a strong indication that these assumptions are not satisfied, a","text_display":"\n\nShould there be a strong indication that these assumptions are not satisfied, a","confidence":1,"confidence_rate":1},{"cnt":[[348,947],[1880,947],[1880,995],[348,995]],"region":{"top_left_x":348,"top_left_y":947,"width":1532,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad08426034dc437893c1730af8a5d9cc","type":"text","conversion_output":true,"text":"corresponding non-parametric analysis will be conducted to calculate the p -values for","text_display":" corresponding non-parametric analysis will be conducted to calculate the p -values for","confidence":0.99853515625,"confidence_rate":0.9999848875607663},{"cnt":[[348,993],[1880,993],[1880,1042],[348,1042]],"region":{"top_left_x":348,"top_left_y":992,"width":1532,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c7783169b574ac1ae653612c241d358","type":"text","conversion_output":true,"text":"interim analysis at Part 1 and at Part 2 (i.e., using ANOVA with the rank-transformed","text_display":" interim analysis at Part 1 and at Part 2 (i.e., using ANOVA with the rank-transformed","confidence":0.9873297214508057,"confidence_rate":0.9998671834974638},{"cnt":[[348,1042],[1858,1042],[1858,1091],[348,1091]],"region":{"top_left_x":348,"top_left_y":1041,"width":1511,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"984c2ae877fa4c1f9671f402d9d55d8e","type":"text","conversion_output":true,"text":"values of \\(AUC _{1-7}\\) as the outcome variable and treatment and site as explanatory variables).","text_display":" values of \\(AUC _{1-7}\\) as the outcome variable and treatment and site as explanatory variables).","confidence":1,"confidence_rate":1},{"cnt":[[468,1179],[958,1179],[958,1231],[468,1231]],"region":{"top_left_x":468,"top_left_y":1179,"width":491,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61f87cfa70c94bd78c1ff6fe5699aac4","type":"section_header","conversion_output":false,"children_ids":["e5f3cc0a193b4fd2b45e31fb1b4f3dd3"],"text":"","text_display":""},{"cnt":[[473,1182],[956,1182],[956,1229],[473,1229]],"region":{"top_left_x":472,"top_left_y":1181,"width":485,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5f3cc0a193b4fd2b45e31fb1b4f3dd3","type":"text","conversion_output":true,"parent_id":"61f87cfa70c94bd78c1ff6fe5699aac4","text":"8.1.4. Sensitivity Analyses","text_display":"\n\n\\subsection*{8.1.4. 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The ANOVA analysis will be","text_display":" analysis will be conducted on the primary efficacy endpoint. The ANOVA analysis will be","confidence":1,"confidence_rate":1},{"cnt":[[348,1566],[1878,1566],[1878,1613],[348,1613]],"region":{"top_left_x":348,"top_left_y":1566,"width":1530,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a417ffde1d8245718f30bac07859f138","type":"text","conversion_output":true,"text":"performed as described in Section 8.1.1 but excluding any patients that died prior to Day 8","text_display":" performed as described in Section 8.1.1 but excluding any patients that died prior to Day 8","confidence":1,"confidence_rate":1},{"cnt":[[348,1611],[1878,1611],[1878,1661],[348,1661]],"region":{"top_left_x":348,"top_left_y":1611,"width":1530,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3adbf5430f6c466cb19a72ac106e1ce9","type":"text","conversion_output":true,"text":"of the study. The descriptive statistics for the primary endpoint will also be repeated for","text_display":" of the study. 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If the analysis","text_display":" score for the ITT Combined Set for the optimal recAP dose and Placebo. If the analysis","confidence":1,"confidence_rate":1},{"cnt":[[348,1901],[1807,1901],[1807,1949],[348,1949]],"region":{"top_left_x":348,"top_left_y":1901,"width":1459,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba5cc2e706414a5194862d2b73f1b72a","type":"text","conversion_output":true,"text":"does not converge, APACHE score will be categorized into two categories ( \\(<25, \\geq 25\\) ).","text_display":" does not converge, APACHE score will be categorized into two categories ( \\(<25, \\geq 25\\) ).","confidence":0.9346334780566394,"confidence_rate":0.9992654782777629},{"cnt":[[348,1998],[1880,1998],[1880,2047],[348,2047]],"region":{"top_left_x":348,"top_left_y":1998,"width":1532,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9f56a2bd8034cd69f5d020dabb3910e","type":"text","conversion_output":true,"text":"Finally, the area under the time-corrected endogenous creatinine clearance curve from Day","text_display":"\n\nFinally, the area under the time-corrected endogenous creatinine clearance curve from Day","confidence":1,"confidence_rate":1},{"cnt":[[348,2045],[1880,2045],[1880,2090],[348,2090]],"region":{"top_left_x":348,"top_left_y":2045,"width":1532,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d60ce2737be4dde915f1f9400a88132","type":"text","conversion_output":true,"text":"5 to Day 7 ( \\(AUC _{5-7}\\) ) will be derived and analyzed with an ANOVA as described in Section","text_display":" 5 to Day 7 ( \\(AUC _{5-7}\\) ) will be derived and analyzed with an ANOVA as described in Section","confidence":0.7541458022315055,"confidence_rate":0.9973907289881127},{"cnt":[[348,2093],[1439,2093],[1439,2140],[348,2140]],"region":{"top_left_x":348,"top_left_y":2092,"width":1092,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2781b908046480fbdb7255ab9dd8c27","type":"text","conversion_output":true,"text":"8.1.1 to determine if the \\(AUC _{5-7}\\) is a predictor of treatment effect.","text_display":" 8.1.1 to determine if the \\(AUC _{5-7}\\) is a predictor of treatment effect.","confidence":1,"confidence_rate":1},{"cnt":[[348,2187],[1880,2187],[1880,2237],[348,2237]],"region":{"top_left_x":348,"top_left_y":2187,"width":1532,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f849c99ad647430ebac3e7785d383488","type":"text","conversion_output":true,"text":"\\(AUC _{5-7}\\) is calculated as the average of the standardized endogenous creatinine clearance","text_display":"\n\\(AUC _{5-7}\\) is calculated as the average of the standardized endogenous creatinine clearance","confidence":0.9980475902557373,"confidence_rate":0.9999806505022475},{"cnt":[[348,2239],[1880,2239],[1880,2288],[348,2288]],"region":{"top_left_x":348,"top_left_y":2238,"width":1532,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d218769b02b4705b95fd16258b1322e","type":"text","conversion_output":true,"text":"values over the 3 days. Specifically, denoting \\(C_{\\bar{i}}\\) as the standardized endogenous creatinine","text_display":" values over the 3 days. Specifically, denoting \\(C_{\\bar{i}}\\) as the standardized endogenous creatinine","confidence":0.9892578125,"confidence_rate":0.9999035733872843},{"cnt":[[348,2286],[1042,2286],[1042,2335],[348,2335]],"region":{"top_left_x":348,"top_left_y":2285,"width":694,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e4cc6d6062046f8abaf73f214d60664","type":"text","conversion_output":true,"text":"clearance on Day \\(i, AUC _{5-7}\\) is defined as:","text_display":" clearance on Day \\(i, AUC _{5-7}\\) is defined as:","confidence":0.6914201598774525,"confidence_rate":0.9936579960465816},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cf5294cf2d6435da9f9c9969eb56c49","type":"page_info","conversion_output":false,"text":"30","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-38","page":38,"lines":[{"cnt":[[344,125],[492,125],[492,157],[344,157]],"region":{"top_left_x":343,"top_left_y":124,"width":149,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9047eafd2ce64c4799c72733e0d317cc","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1852,125],[1852,161],[1366,161]],"region":{"top_left_x":1366,"top_left_y":124,"width":486,"height":38},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"545193a16193471f93f0113b1186ba3d","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[344,155],[599,155],[599,191],[344,191]],"region":{"top_left_x":343,"top_left_y":154,"width":257,"height":38},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2b8315d201fa4f26805b8fdab7f273c1","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999575209175736},{"cnt":[[1568,159],[1854,159],[1854,191],[1568,191]],"region":{"top_left_x":1568,"top_left_y":158,"width":287,"height":34},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"bcbd84660fe4476b8186bf3719f58837","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[928,314],[1296,314],[1296,397],[928,397]],"region":{"top_left_x":928,"top_left_y":313,"width":368,"height":85},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f5950d975464f4291f0c204d371f973","type":"math","conversion_output":true,"text":"\\[\nA U C_{5-7}=\\frac{1}{3} \\sum_{k=5}^{7} C_{i}\n\\]","text_display":"\n\\[\nA U C_{5-7}=\\frac{1}{3} \\sum_{k=5}^{7} C_{i}\n\\]","confidence":0.8464886056026444,"confidence_rate":0.9960398019180025},{"cnt":[[344,438],[1880,438],[1880,492],[344,492]],"region":{"top_left_x":343,"top_left_y":438,"width":1537,"height":54},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b7fa9b3b7f4401593274751ec989fd4","type":"text","conversion_output":true,"text":"Any missing \\(C_{i}\\) values will be handled by linear interpolation where possible, otherwise","text_display":"\n\nAny missing \\(C_{i}\\) values will be handled by linear interpolation where possible, otherwise","confidence":0.9985356330871582,"confidence_rate":0.9999856330429514},{"cnt":[[344,503],[1880,503],[1880,552],[344,552]],"region":{"top_left_x":343,"top_left_y":502,"width":1537,"height":51},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a101749db8f14809a94c1cbf75cd5aba","type":"text","conversion_output":true,"text":"they will be imputed by last observation carried forward (LOCF). When there are no","text_display":" they will be imputed by last observation carried forward (LOCF). When there are no","confidence":1,"confidence_rate":1},{"cnt":[[344,552],[1878,552],[1878,602],[344,602]],"region":{"top_left_x":343,"top_left_y":552,"width":1535,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c875a5b6203d4f0296a83c6f7f95585b","type":"text","conversion_output":true,"text":"preceding post-baseline measurements to use, the baseline measurement from Day 0 (i.e.,","text_display":" preceding post-baseline measurements to use, the baseline measurement from Day 0 (i.e.,","confidence":1,"confidence_rate":1},{"cnt":[[344,597],[1880,597],[1880,649],[344,649]],"region":{"top_left_x":343,"top_left_y":597,"width":1537,"height":52},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c53183b927e24749a3435bd5aa76b877","type":"text","conversion_output":true,"text":"prior to treatment) will be carried forward. If there are missing values the values imputed","text_display":" prior to treatment) will be carried forward. If there are missing values the values imputed","confidence":1,"confidence_rate":1},{"cnt":[[344,647],[1197,647],[1197,698],[344,698]],"region":{"top_left_x":343,"top_left_y":646,"width":854,"height":53},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f01091831fc4ae985db4ab84369db5b","type":"text","conversion_output":true,"text":"for deriving \\(AUC _{1-7}\\) will be used to derive \\(AUC _{5-7}\\).","text_display":" for deriving \\(AUC _{1-7}\\) will be used to derive \\(AUC _{5-7}\\).","confidence":0.9830020274966955,"confidence_rate":0.9997909475096778},{"cnt":[[466,782],[1592,782],[1592,838],[466,838]],"region":{"top_left_x":466,"top_left_y":782,"width":1126,"height":56},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da67b5e78628438ea83932b3def84bac","type":"section_header","conversion_output":false,"children_ids":["a7fc598552784c9cb3186f0a06bb0e2e"],"text":"","text_display":""},{"cnt":[[471,786],[1588,786],[1588,836],[471,836]],"region":{"top_left_x":470,"top_left_y":786,"width":1118,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7fc598552784c9cb3186f0a06bb0e2e","type":"text","conversion_output":true,"parent_id":"da67b5e78628438ea83932b3def84bac","text":"8.1.5. Supportive Analysis for the Primary Efficacy Endpoint","text_display":"\n\n\\subsection*{8.1.5. Supportive Analysis for the Primary Efficacy Endpoint}","confidence":0.998046875,"confidence_rate":0.9999699229933099},{"cnt":[[346,889],[1880,889],[1880,939],[346,939]],"region":{"top_left_x":345,"top_left_y":889,"width":1535,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51c7057c3d43447cb84d61f982e566b4","type":"text","conversion_output":true,"text":"Due to the high variability of the creatinine clearance, the change from baseline in serum","text_display":"\n\nDue to the high variability of the creatinine clearance, the change from baseline in serum","confidence":1,"confidence_rate":1},{"cnt":[[344,939],[1880,939],[1880,990],[344,990]],"region":{"top_left_x":343,"top_left_y":938,"width":1537,"height":53},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a15acf168a864ffe81210d3725e5566e","type":"text","conversion_output":true,"text":"creatinine at Day 7 will be analyzed using an ANOVA with baseline serum creatinine,","text_display":" creatinine at Day 7 will be analyzed using an ANOVA with baseline serum creatinine,","confidence":1,"confidence_rate":1},{"cnt":[[346,988],[1880,988],[1880,1038],[346,1038]],"region":{"top_left_x":345,"top_left_y":988,"width":1535,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb79f538250a463fab592b1b6e40dfea","type":"text","conversion_output":true,"text":"treatment (optimal recAP dose and placebo) and site as explanatory variables. The analysis","text_display":" treatment (optimal recAP dose and placebo) and site as explanatory variables. The analysis","confidence":1,"confidence_rate":1},{"cnt":[[346,1036],[1880,1036],[1880,1085],[346,1085]],"region":{"top_left_x":345,"top_left_y":1035,"width":1535,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d243a64e22e843629c18ef7beeb04ca8","type":"text","conversion_output":true,"text":"will be run on the ITT Combined Set. If there is more than one serum creatinine result","text_display":" will be run on the ITT Combined Set. If there is more than one serum creatinine result","confidence":1,"confidence_rate":1},{"cnt":[[346,1083],[1824,1083],[1824,1132],[346,1132]],"region":{"top_left_x":345,"top_left_y":1082,"width":1480,"height":51},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a2eba2665e4490f96ba8b37ed14f596","type":"text","conversion_output":true,"text":"collected at Day 7 , the average at Day 7 will be used to derive the change from baseline.","text_display":" collected at Day 7 , the average at Day 7 will be used to derive the change from baseline.","confidence":0.97265625,"confidence_rate":0.9997255371964139},{"cnt":[[346,1177],[1878,1177],[1878,1227],[346,1227]],"region":{"top_left_x":345,"top_left_y":1177,"width":1533,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84d32fba2ea54e6ca26c397151932eb7","type":"text","conversion_output":true,"text":"Additionally the primary endpoint analysis will be repeated with the following variables as","text_display":"\n\nAdditionally the primary endpoint analysis will be repeated with the following variables as","confidence":1,"confidence_rate":1},{"cnt":[[344,1225],[1880,1225],[1880,1276],[344,1276]],"region":{"top_left_x":343,"top_left_y":1224,"width":1537,"height":53},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"976b201fc4884b419a2a6fc59b014cfd","type":"text","conversion_output":true,"text":"additional factors within the ANOVA model for the ITT Combined Set (for the optimal","text_display":" additional factors within the ANOVA model for the ITT Combined Set (for the optimal","confidence":1,"confidence_rate":1},{"cnt":[[344,1274],[780,1274],[780,1326],[344,1326]],"region":{"top_left_x":343,"top_left_y":1274,"width":437,"height":52},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00e6e0ba567b45b78a4fdc5de85ad0fd","type":"text","conversion_output":true,"text":"recAP dose and placebo):","text_display":" recAP dose and placebo):","confidence":1,"confidence_rate":1},{"cnt":[[408,1371],[1162,1371],[1162,1420],[408,1420]],"region":{"top_left_x":408,"top_left_y":1370,"width":755,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab5848654365465c8c43cb68f9b136f8","type":"text","conversion_output":true,"text":"- Baseline biomarkers for kidney function:","text_display":"\n- Baseline biomarkers for kidney function:","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[533,1420],[1566,1420],[1566,1472],[533,1472]],"region":{"top_left_x":532,"top_left_y":1420,"width":1035,"height":52},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d396ed20846b48dda310e54e4e99fbfe","type":"text","conversion_output":true,"text":"- Fractional excretion of sodium ( \\(<1 \\%, \\geq 1 \\%-\\leq 2 \\%,>2 \\%\\) ).","text_display":"\n- Fractional excretion of sodium ( \\(<1 \\%, \\geq 1 \\%-\\leq 2 \\%,>2 \\%\\) ).","confidence":0.7813064509283283,"confidence_rate":0.995962470804912},{"cnt":[[533,1470],[1334,1470],[1334,1519],[533,1519]],"region":{"top_left_x":532,"top_left_y":1469,"width":803,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81bd2a5eac114c34a515cdca4562fc28","type":"text","conversion_output":true,"text":"- Fractional excretion of urea ( \\(<35 \\%, \\geq 35 \\%\\) ).","text_display":"\n- Fractional excretion of urea ( \\(<35 \\%, \\geq 35 \\%\\) ).","confidence":0.5672058570198715,"confidence_rate":0.989358292486384},{"cnt":[[408,1568],[1334,1568],[1334,1618],[408,1618]],"region":{"top_left_x":408,"top_left_y":1568,"width":927,"height":50},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f219736e5b284805b1c6e7e193d10ee9","type":"text","conversion_output":true,"text":"- Baseline AKIN stage (stage 1, stage 2 and stage 3).","text_display":"\n- Baseline AKIN stage (stage 1, stage 2 and stage 3).","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[408,1663],[1586,1663],[1586,1717],[408,1717]],"region":{"top_left_x":408,"top_left_y":1662,"width":1178,"height":55},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3c3986084784723a52988ad4eef2b3b","type":"text","conversion_output":true,"text":"- Microbial infection. The following are the five possible outcomes:","text_display":"\n- Microbial infection. The following are the five possible outcomes:","confidence":1,"confidence_rate":1},{"cnt":[[535,1762],[844,1762],[844,1811],[535,1811]],"region":{"top_left_x":534,"top_left_y":1761,"width":311,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b7b3d0e424e4d8bacd5bbbab750cee4","type":"text","conversion_output":true,"text":"1. Gram positive","text_display":"\n1. Gram positive","confidence":1,"confidence_rate":1},{"cnt":[[533,1809],[851,1809],[851,1858],[533,1858]],"region":{"top_left_x":532,"top_left_y":1808,"width":319,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4975bb1915054d28a598f64f9c4a8762","type":"text","conversion_output":true,"text":"2. Gram negative","text_display":"\n2. 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Other (e.g. fungal)","confidence":1,"confidence_rate":1},{"cnt":[[533,1955],[778,1955],[778,2000],[533,2000]],"region":{"top_left_x":532,"top_left_y":1955,"width":246,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7247ed1f4a44538965812fc26ad3b05","type":"text","conversion_output":true,"text":"5. Unknown.","text_display":"\n5. Unknown.","confidence":1,"confidence_rate":1},{"cnt":[[468,2050],[1880,2050],[1880,2099],[468,2099]],"region":{"top_left_x":468,"top_left_y":2049,"width":1412,"height":51},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"072cc94ed8004115a31f519caf0e39c6","type":"text","conversion_output":true,"text":"If a blood culture is available this is leading. (Note that if a staphylococcus","text_display":"\n\nIf a blood culture is available this is leading. (Note that if a staphylococcus","confidence":1,"confidence_rate":1},{"cnt":[[468,2097],[1880,2097],[1880,2146],[468,2146]],"region":{"top_left_x":468,"top_left_y":2096,"width":1412,"height":51},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df5b463128644bbd8d01bda6360fcdf4","type":"text","conversion_output":true,"text":"epidermis is the outcome this is a contamination and should be ignored). If no","text_display":" epidermis is the outcome this is a contamination and should be ignored). If no","confidence":1,"confidence_rate":1},{"cnt":[[468,2144],[1880,2144],[1880,2196],[468,2196]],"region":{"top_left_x":468,"top_left_y":2144,"width":1412,"height":52},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f508a7eccce84a14b6da21295f421c02","type":"text","conversion_output":true,"text":"blood culture is available, the culture from the site for which the patient was","text_display":" blood culture is available, the culture from the site for which the patient was","confidence":1,"confidence_rate":1},{"cnt":[[468,2191],[1880,2191],[1880,2245],[468,2245]],"region":{"top_left_x":468,"top_left_y":2191,"width":1412,"height":55},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"abe451a1d03a420abc789cfa118a80fd","type":"text","conversion_output":true,"text":"hospitalized (index indication) is leading e.g. patient hospitalized for lung infection,","text_display":" hospitalized (index indication) is leading e.g. patient 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proximal tubular cell 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Set.","confidence":0.9975600242614746,"confidence_rate":0.9999157636401392},{"cnt":[[346,471],[1880,471],[1880,520],[346,520]],"region":{"top_left_x":345,"top_left_y":470,"width":1535,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c05d10edf2b74aa6b75ac6babab8a717","type":"text","conversion_output":true,"text":"The optimal recAP dose will be formally compared with placebo using a logistic","text_display":"\n\nThe optimal recAP dose will be formally compared with placebo using a logistic","confidence":1,"confidence_rate":1},{"cnt":[[344,520],[1880,520],[1880,569],[344,569]],"region":{"top_left_x":343,"top_left_y":519,"width":1537,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f8cf7b8e0d14a7bb158d0b4b5c684ea","type":"text","conversion_output":true,"text":"regression model with treatment group and site as explanatory variables, if a statistically","text_display":" regression model with treatment group and site as explanatory variables, if a statistically","confidence":0.9990234375,"confidence_rate":0.999989822555459},{"cnt":[[346,567],[1880,567],[1880,617],[346,617]],"region":{"top_left_x":345,"top_left_y":567,"width":1535,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01a9e33394ac4170b3beff199b859a1f","type":"text","conversion_output":true,"text":"significant result is obtained from the combination test analysis of the primary endpoint.","text_display":" significant result is obtained from the combination test analysis of the primary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[346,614],[1880,614],[1880,664],[346,664]],"region":{"top_left_x":345,"top_left_y":614,"width":1535,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3edc1d2006294f49b9f770fb2175e9c6","type":"text","conversion_output":true,"text":"Otherwise the results will be reported as exploratory analyses only. In the event that there","text_display":" Otherwise the results will be reported as exploratory analyses only. In the event that there","confidence":0.984375,"confidence_rate":0.9998376589831813},{"cnt":[[346,662],[1880,662],[1880,711],[346,711]],"region":{"top_left_x":345,"top_left_y":661,"width":1535,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60c13f3b365a427f8eb97cc4ee6a2808","type":"text","conversion_output":true,"text":"are issues with the model (e.g. quasi-complete separation of data points) the reason will be","text_display":" are issues with the model (e.g. quasi-complete separation of data points) the reason will be","confidence":1,"confidence_rate":1},{"cnt":[[344,709],[1880,709],[1880,758],[344,758]],"region":{"top_left_x":343,"top_left_y":708,"width":1537,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f02b0a5ee6d5469abe9b4c342a980a81","type":"text","conversion_output":true,"text":"investigated and if needed, site will be removed from the model. In this case, it will be","text_display":" investigated and if needed, site will be removed from the model. In this case, it will be","confidence":1,"confidence_rate":1},{"cnt":[[344,756],[1882,756],[1882,810],[344,810]],"region":{"top_left_x":343,"top_left_y":756,"width":1540,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76a169f37bdf49ff97314e22d9eb1379","type":"text","conversion_output":true,"text":"documented as a deviation from the protocol in order to avoid a questionable validity of","text_display":" documented as a deviation from the protocol in order to avoid a questionable validity of","confidence":1,"confidence_rate":1},{"cnt":[[344,804],[576,804],[576,849],[344,849]],"region":{"top_left_x":343,"top_left_y":803,"width":233,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4200cb4a163045a09ba66a3b98088bcc","type":"text","conversion_output":true,"text":"the model fit.","text_display":" the model fit.","confidence":1,"confidence_rate":1},{"cnt":[[344,853],[1880,853],[1880,904],[344,904]],"region":{"top_left_x":343,"top_left_y":852,"width":1537,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfd989160c9e4492885f94822676a550","type":"text","conversion_output":true,"text":"This endpoint will additionally be summarized for all four treatment groups using counts","text_display":"\nThis endpoint will additionally be summarized for all four treatment groups using counts","confidence":1,"confidence_rate":1},{"cnt":[[344,902],[1880,902],[1880,952],[344,952]],"region":{"top_left_x":343,"top_left_y":902,"width":1537,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efdbd7f463604fc69b03d976cd86693d","type":"text","conversion_output":true,"text":"and percentages. The odds ratio and associated \\(95 \\%\\) confidence interval from the","text_display":" and percentages. The odds ratio and associated \\(95 \\%\\) confidence interval from the","confidence":1,"confidence_rate":1},{"cnt":[[344,950],[1880,950],[1880,999],[344,999]],"region":{"top_left_x":343,"top_left_y":949,"width":1537,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ee6ce90b6504bf5ada41839616e63c7","type":"text","conversion_output":true,"text":"comparisons of the optimal recAP dose versus Placebo will also be presented. The counts","text_display":" comparisons of the optimal recAP dose versus Placebo will also be presented. The counts","confidence":1,"confidence_rate":1},{"cnt":[[344,997],[1880,997],[1880,1046],[344,1046]],"region":{"top_left_x":343,"top_left_y":996,"width":1537,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28df5677295d4bbe953ad554ee3144c9","type":"text","conversion_output":true,"text":"and percentages will also be presented for ITT Part 1 Interim Set and ITT Part 2 Set","text_display":" and percentages will also be presented for ITT Part 1 Interim Set and ITT Part 2 Set","confidence":1,"confidence_rate":1},{"cnt":[[344,1044],[531,1044],[531,1096],[344,1096]],"region":{"top_left_x":343,"top_left_y":1044,"width":188,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6bb1d97cfdc44cca55678ec3742919a","type":"text","conversion_output":true,"text":"separately.","text_display":" separately.","confidence":1,"confidence_rate":1},{"cnt":[[344,1143],[1880,1143],[1880,1192],[344,1192]],"region":{"top_left_x":343,"top_left_y":1142,"width":1537,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95c9df5dd66a4543bfd111745b4110e5","type":"text","conversion_output":true,"text":"The analysis of this key secondary endpoint will be repeated excluding patients who died","text_display":"\n\nThe analysis of this key secondary endpoint will be repeated excluding patients who died","confidence":1,"confidence_rate":1},{"cnt":[[344,1190],[1880,1190],[1880,1240],[344,1240]],"region":{"top_left_x":343,"top_left_y":1190,"width":1537,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33ac5bfb5c094ea6b3663256cddb9594","type":"text","conversion_output":true,"text":"or withdrew from the study prior to completion of this 28 Day period. If a statistically","text_display":" or withdrew from the study prior to completion of this 28 Day period. If a statistically","confidence":1,"confidence_rate":1},{"cnt":[[344,1238],[1880,1238],[1880,1287],[344,1287]],"region":{"top_left_x":343,"top_left_y":1237,"width":1537,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f679d6e7abb9472994b8945347a2cab1","type":"text","conversion_output":true,"text":"significant result is obtained from the combination test analysis of the primary endpoint","text_display":" significant result is obtained from the combination test analysis of the primary endpoint","confidence":1,"confidence_rate":1},{"cnt":[[344,1285],[1880,1285],[1880,1334],[344,1334]],"region":{"top_left_x":343,"top_left_y":1284,"width":1537,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f09f7036a3b84a01b68823fd9eb80745","type":"text","conversion_output":true,"text":"and the key secondary endpoint, the optimal recAP dose will be formally compared with","text_display":" and the key secondary endpoint, the optimal recAP dose will be formally compared with","confidence":1,"confidence_rate":1},{"cnt":[[344,1332],[1880,1332],[1880,1381],[344,1381]],"region":{"top_left_x":343,"top_left_y":1332,"width":1537,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e69e8fdff676404e82dcf4b9beb999f7","type":"text","conversion_output":true,"text":"placebo using a logistic regression model with treatment group and site as explanatory","text_display":" placebo using a logistic regression model with treatment group and site as explanatory","confidence":1,"confidence_rate":1},{"cnt":[[344,1379],[513,1379],[513,1424],[344,1424]],"region":{"top_left_x":343,"top_left_y":1379,"width":171,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ed13b80d30d411d87cb59e0a90146fd","type":"text","conversion_output":true,"text":"variables.","text_display":" variables.","confidence":1,"confidence_rate":1},{"cnt":[[346,1474],[1880,1474],[1880,1525],[346,1525]],"region":{"top_left_x":345,"top_left_y":1473,"width":1535,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5014e46545a44a77af816d54525e8dd5","type":"text","conversion_output":true,"text":"The analysis of RRT incidence for the ITT Combined Set will also be presented for the","text_display":"\n\nThe analysis of RRT incidence for the ITT Combined Set will also be presented for the","confidence":0.99658203125,"confidence_rate":0.9999619582419443},{"cnt":[[344,1525],[1691,1525],[1691,1575],[344,1575]],"region":{"top_left_x":343,"top_left_y":1525,"width":1348,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abc6dcabec234e19a5046a5d614d5476","type":"text","conversion_output":true,"text":"supportive factor analysis as described in section 8.1.5 for the primary endpoint.","text_display":" supportive factor analysis as described in section 8.1.5 for the primary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[344,1620],[1003,1620],[1003,1669],[344,1669]],"region":{"top_left_x":343,"top_left_y":1619,"width":661,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"780b05b7084446c2893395289ea56177","type":"text","conversion_output":true,"text":"RRT data will be presented in a listing.","text_display":"\n\nRRT data will be presented in a listing.","confidence":1,"confidence_rate":1},{"cnt":[[468,1757],[1261,1757],[1261,1811],[468,1811]],"region":{"top_left_x":468,"top_left_y":1757,"width":794,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0672904878214c9e8fe0e95ac186b871","type":"section_header","conversion_output":false,"children_ids":["37fb94ea3b834cdaad8bae32687b8396"],"text":"","text_display":""},{"cnt":[[473,1762],[1257,1762],[1257,1807],[473,1807]],"region":{"top_left_x":472,"top_left_y":1761,"width":785,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37fb94ea3b834cdaad8bae32687b8396","type":"text","conversion_output":true,"parent_id":"0672904878214c9e8fe0e95ac186b871","text":"8.2.2. Other Secondary Efficacy Endpoints","text_display":"\n\n\\subsection*{8.2.2. Other Secondary Efficacy Endpoints}","confidence":0.99560546875,"confidence_rate":0.999904260766229},{"cnt":[[346,1865],[1880,1865],[1880,1914],[346,1914]],"region":{"top_left_x":345,"top_left_y":1864,"width":1535,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7fba3b811e4a41eea8bce803ef680ec7","type":"text","conversion_output":true,"text":"Unless stated otherwise all analysis on the other secondary endpoints will compare the","text_display":"\n\nUnless stated otherwise all analysis on the other secondary endpoints will compare the","confidence":1,"confidence_rate":1},{"cnt":[[346,1912],[1880,1912],[1880,1962],[346,1962]],"region":{"top_left_x":345,"top_left_y":1912,"width":1535,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df132fac3e6c4cdd84030d69e547e335","type":"text","conversion_output":true,"text":"optimal recAP with placebo and be based on the ITT Combined Set, i.e. include all","text_display":" optimal recAP with placebo and be based on the ITT Combined Set, i.e. include all","confidence":1,"confidence_rate":1},{"cnt":[[346,1962],[1880,1962],[1880,2013],[346,2013]],"region":{"top_left_x":345,"top_left_y":1961,"width":1535,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3340babad9c74c2490d63ffc9adc48c1","type":"text","conversion_output":true,"text":"patients randomized to those treatment groups during Part 1 and Part 2 of the study. All","text_display":" patients randomized to those treatment groups during Part 1 and Part 2 of the study. All","confidence":1,"confidence_rate":1},{"cnt":[[346,2007],[1880,2007],[1880,2058],[346,2058]],"region":{"top_left_x":345,"top_left_y":2006,"width":1535,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0db0ad46ac69488db082d6e827e9d4d2","type":"text","conversion_output":true,"text":"summary statistics, counts and percentages, and data listings will be based on the ITT","text_display":" summary statistics, counts and percentages, and data listings will be based on the ITT","confidence":1,"confidence_rate":1},{"cnt":[[346,2056],[1880,2056],[1880,2108],[346,2108]],"region":{"top_left_x":345,"top_left_y":2056,"width":1535,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88105b9e423a4fe6bc02e111b65108d3","type":"text","conversion_output":true,"text":"Combined Set, displaying results for all four treatment groups and including all patients","text_display":" Combined Set, displaying results for all four treatment groups and including all patients","confidence":1,"confidence_rate":1},{"cnt":[[346,2105],[1147,2105],[1147,2155],[346,2155]],"region":{"top_left_x":345,"top_left_y":2105,"width":803,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a4027f0c83046be9500552f26348913","type":"text","conversion_output":true,"text":"randomized during Part 1 or Part 2 of the study.","text_display":" randomized during Part 1 or Part 2 of the study.","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfac09ce907141cd916f8b4830a8ee32","type":"page_info","conversion_output":false,"text":"33","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-41","page":41,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7f8548445da54e5a826315cf39073913","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1850,125],[1850,159],[1366,159]],"region":{"top_left_x":1366,"top_left_y":124,"width":484,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4009bf7a7a0342f787e079f12a05724c","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"555e234cfa2047aea70a81f832233485","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.998046875,"confidence_rate":0.9999150020979262},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2e9515e0beb646e699c346b056ac8441","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[529,327],[836,327],[836,372],[529,372]],"region":{"top_left_x":528,"top_left_y":326,"width":308,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ed8dea35cb74fcf94f77caaadd25dfc","type":"section_header","conversion_output":false,"children_ids":["d61eb1ebd35e48d8b78b89a0e136c04b"],"text":"","text_display":""},{"cnt":[[533,331],[831,331],[831,367],[533,367]],"region":{"top_left_x":532,"top_left_y":330,"width":300,"height":38},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d61eb1ebd35e48d8b78b89a0e136c04b","type":"text","conversion_output":true,"parent_id":"2ed8dea35cb74fcf94f77caaadd25dfc","text":"8.2.2.1 Renal","text_display":"\n\n\\subsection*{8.2.2.1 Renal}","confidence":0.83740234375,"confidence_rate":0.9901900662769121},{"cnt":[[339,432],[1618,432],[1618,483],[339,483]],"region":{"top_left_x":339,"top_left_y":431,"width":1279,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59d6a4eba2a74cdc8c4eed3d58007e16","type":"section_header","conversion_output":false,"children_ids":["8e1267b9bb5c41a0844c8c62020018a4"],"text":"","text_display":""},{"cnt":[[344,434],[1613,434],[1613,481],[344,481]],"region":{"top_left_x":343,"top_left_y":433,"width":1271,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e1267b9bb5c41a0844c8c62020018a4","type":"text","conversion_output":true,"parent_id":"59d6a4eba2a74cdc8c4eed3d58007e16","text":"Volume of Urine, Serum Creatinine, BUN/Urea Clearance, Proteinuria","text_display":"\n\n\\section*{Volume of Urine, Serum Creatinine, BUN/Urea Clearance, Proteinuria}","confidence":1,"confidence_rate":1},{"cnt":[[346,529],[1878,529],[1878,578],[346,578]],"region":{"top_left_x":345,"top_left_y":528,"width":1533,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46f75af37c3a46648f5c013ec6167870","type":"text","conversion_output":true,"text":"A summary table will present descriptive statistics for the following renal endpoints:","text_display":"\n\nA summary table will present descriptive statistics for the following renal endpoints:","confidence":1,"confidence_rate":1},{"cnt":[[346,576],[1880,576],[1880,625],[346,625]],"region":{"top_left_x":345,"top_left_y":575,"width":1535,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46e8a5a538ff4019b31e0855da737951","type":"text","conversion_output":true,"text":"volume of urine (daily from Day 1 to Day 7, inclusive, and on Day 14, 21 and 28 if reliable","text_display":" volume of urine (daily from Day 1 to Day 7, inclusive, and on Day 14, 21 and 28 if reliable","confidence":1,"confidence_rate":1},{"cnt":[[344,623],[1880,623],[1880,675],[344,675]],"region":{"top_left_x":343,"top_left_y":623,"width":1537,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15bc96233d0d40c492e60ac0eac78b66","type":"text","conversion_output":true,"text":"6 hour urine collection is possible); Serum creatinine, proteinuria, blood urea nitrogen","text_display":" 6 hour urine collection is possible); Serum creatinine, proteinuria, blood urea nitrogen","confidence":1,"confidence_rate":1},{"cnt":[[346,672],[1880,672],[1880,724],[346,724]],"region":{"top_left_x":345,"top_left_y":672,"width":1535,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b2f2070840e43e4b37249eff8ed07a0","type":"text","conversion_output":true,"text":"(BUN) and urea clearance (daily from Day 1 to Day 7, inclusive, and on Day 14, 21 and 28","text_display":" (BUN) and urea clearance (daily from Day 1 to Day 7, inclusive, and on Day 14, 21 and 28","confidence":1,"confidence_rate":1},{"cnt":[[344,722],[1351,722],[1351,771],[344,771]],"region":{"top_left_x":343,"top_left_y":721,"width":1009,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50cb819191e449ae9e855032249747c8","type":"text","conversion_output":true,"text":"and on Day 60 and 90 for serum creatinine and proteinuria).","text_display":" and on Day 60 and 90 for serum creatinine and proteinuria).","confidence":1,"confidence_rate":1},{"cnt":[[346,816],[1880,816],[1880,866],[346,866]],"region":{"top_left_x":345,"top_left_y":816,"width":1535,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b138acd390d4656b857309aabf02879","type":"text","conversion_output":true,"text":"Urine volume will be collected over a 6 hour period +/- 1 hour period, and converted to","text_display":"\n\nUrine volume will be collected over a 6 hour period +/- 1 hour period, and converted to","confidence":0.9607444844441488,"confidence_rate":0.9995914427634787},{"cnt":[[344,864],[1880,864],[1880,913],[344,913]],"region":{"top_left_x":343,"top_left_y":863,"width":1537,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"425c9fa0e0ac4923907c2f6406de1e90","type":"text","conversion_output":true,"text":"\\(mL /\\) hour by PPD Biostatistics. Urine output ( \\(mL /\\) hour ) will be calculated using the","text_display":" \\(mL /\\) hour by PPD Biostatistics. Urine output ( \\(mL /\\) hour ) will be calculated using the","confidence":0.8156468723772152,"confidence_rate":0.9980042121587432},{"cnt":[[344,911],[668,911],[668,965],[344,965]],"region":{"top_left_x":343,"top_left_y":910,"width":326,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36e892b5de7c4ec0aa749a1e4ecc6386","type":"text","conversion_output":true,"text":"following formula:","text_display":" following formula:","confidence":1,"confidence_rate":1},{"cnt":[[473,1001],[1745,1001],[1745,1188],[473,1188]],"region":{"top_left_x":472,"top_left_y":1001,"width":1273,"height":188},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a73142d597944c48990f378689c38b05","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n\\text { Urine output }(mL / \\text { hour })= & \\frac{\\text { Urine output collected }(mL)}{(\\text { Stop date } / \\text { time of Urine Collection }-} \\\\\n& \\text { Start date } / \\text { time of Urine Collection }, \\text { in hours })\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n\\text { Urine output }(mL / \\text { hour })= & \\frac{\\text { Urine output collected }(mL)}{(\\text { Stop date } / \\text { time of Urine Collection }-} \\\\\n& \\text { Start date } / \\text { time of Urine Collection }, \\text { in hours })\n\\end{aligned}\n\\]","confidence":0.2619267574552757,"confidence_rate":0.9932226120817288},{"cnt":[[346,1238],[1493,1238],[1493,1287],[346,1287]],"region":{"top_left_x":345,"top_left_y":1237,"width":1149,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7c1fd48df7044679a470fb811b16038","type":"text","conversion_output":true,"text":"The calculated values per hour will be used in the tables and figures.","text_display":"\n\nThe calculated values per hour will be used in the tables and figures.","confidence":1,"confidence_rate":1},{"cnt":[[346,1332],[1880,1332],[1880,1381],[346,1381]],"region":{"top_left_x":345,"top_left_y":1332,"width":1535,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e98bd428e64347f69a2ce4be5ea2756b","type":"text","conversion_output":true,"text":"Urea clearance ( \\(mL / min\\) ) will be calculated by PPD Biostatistics using the following","text_display":"\nUrea clearance ( \\(mL / min\\) ) will be calculated by PPD Biostatistics using the following","confidence":0.9512781846494818,"confidence_rate":0.9994955945160613},{"cnt":[[344,1379],[494,1379],[494,1424],[344,1424]],"region":{"top_left_x":343,"top_left_y":1379,"width":152,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"138c8b52d38742cfae6aa414d60a300a","type":"text","conversion_output":true,"text":"formula.","text_display":" formula.","confidence":1,"confidence_rate":1},{"cnt":[[312,1472],[1914,1472],[1914,1577],[312,1577]],"region":{"top_left_x":311,"top_left_y":1471,"width":1604,"height":106},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf3cd26a4bdf468899a8844a98870bd8","type":"text","conversion_output":true,"text":"\\(\\frac{\\text { Urine Urea Nitrogen }( mg / dL )}{\\text { BUN }( mg / dL )} \\times \\frac{\\text { Total urine volume collected }( mL )}{\\text { Stop date/time }- \\text { Start date/time of urine collection (min) }}\\)","text_display":"\n\\(\\frac{\\text { Urine Urea Nitrogen }( mg / dL )}{\\text { BUN }( mg / dL )} \\times \\frac{\\text { Total urine volume collected }( mL )}{\\text { Stop date/time }- \\text { Start date/time of urine collection (min) }}\\)","confidence":0.6788444881517384,"confidence_rate":0.9977889439457694},{"cnt":[[408,1624],[1878,1624],[1878,1674],[408,1674]],"region":{"top_left_x":408,"top_left_y":1624,"width":1470,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca871021f38e4be78143c2a087c8749c","type":"text","conversion_output":true,"text":"- The urine urea nitrogen ( \\(mg / dL\\) ) and BUN ( \\(mg / dL\\) ) assessed by the central","text_display":"\n- The urine urea nitrogen ( \\(mg / dL\\) ) and BUN ( \\(mg / dL\\) ) assessed by the central","confidence":0.9985356330871582,"confidence_rate":0.9999853457059158},{"cnt":[[468,1671],[1401,1671],[1401,1721],[468,1721]],"region":{"top_left_x":468,"top_left_y":1671,"width":933,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"227121f4f6544dc29c2a98aff5e3b659","type":"text","conversion_output":true,"text":"laboratory will be used to determine the urea clearance.","text_display":" laboratory will be used to determine the urea clearance.","confidence":1,"confidence_rate":1},{"cnt":[[408,1723],[1880,1723],[1880,1772],[408,1772]],"region":{"top_left_x":408,"top_left_y":1723,"width":1472,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d19b5fdf79364afab4d1509a4f2ad2da","type":"text","conversion_output":true,"text":"- Per protocol, two blood samples are collected to evaluate the BUN, one at the","text_display":"\n- Per protocol, two blood samples are collected to evaluate the BUN, one at the","confidence":1,"confidence_rate":1},{"cnt":[[468,1770],[1880,1770],[1880,1820],[468,1820]],"region":{"top_left_x":468,"top_left_y":1770,"width":1412,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8f334bc633c445aa6a5c23744cb70ec","type":"text","conversion_output":true,"text":"beginning of the urine sample collection and the other at the end of the urine","text_display":" beginning of the urine sample collection and the other at the end of the urine","confidence":1,"confidence_rate":1},{"cnt":[[468,1818],[1880,1818],[1880,1867],[468,1867]],"region":{"top_left_x":468,"top_left_y":1817,"width":1412,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f79bfadc6f3445fa86a7a081893b392","type":"text","conversion_output":true,"text":"sample collection. The average of these two BUN measurements will be used in the","text_display":" sample collection. The average of these two BUN measurements will be used in the","confidence":1,"confidence_rate":1},{"cnt":[[468,1867],[1880,1867],[1880,1916],[468,1916]],"region":{"top_left_x":468,"top_left_y":1866,"width":1412,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"001b4a9d142c478ca893992b6d811fae","type":"text","conversion_output":true,"text":"formula above to assess the urea clearance. In case there is only one BUN sample","text_display":" formula above to assess the urea clearance. In case there is only one BUN sample","confidence":1,"confidence_rate":1},{"cnt":[[468,1916],[1880,1916],[1880,1966],[468,1966]],"region":{"top_left_x":468,"top_left_y":1916,"width":1412,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e29c1c9364ea44b7af03ca4083146f47","type":"text","conversion_output":true,"text":"available, then the BUN concentration from that one sample will be used in the","text_display":" available, then the BUN concentration from that one sample will be used in the","confidence":1,"confidence_rate":1},{"cnt":[[468,1964],[621,1964],[621,2007],[468,2007]],"region":{"top_left_x":468,"top_left_y":1963,"width":153,"height":44},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d0fd470a41b494e82dd24cedabd4ede","type":"text","conversion_output":true,"text":"formula.","text_display":" formula.","confidence":1,"confidence_rate":1},{"cnt":[[408,2015],[1880,2015],[1880,2065],[408,2065]],"region":{"top_left_x":408,"top_left_y":2015,"width":1472,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cf802239d3948039614fd0a20856e5b","type":"text","conversion_output":true,"text":"- The number of minutes from the start date/time to the stop date/time of urine","text_display":"\n- The number of minutes from the start date/time to the stop date/time of urine","confidence":1,"confidence_rate":1},{"cnt":[[468,2062],[1880,2062],[1880,2112],[468,2112]],"region":{"top_left_x":468,"top_left_y":2062,"width":1412,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"645ffbf71b944560bb6ebf4d79342897","type":"text","conversion_output":true,"text":"sample collection and the total urine volume ( mL ) will be derived from the Urine","text_display":" sample collection and the total urine volume ( mL ) will be derived from the Urine","confidence":0.96337890625,"confidence_rate":0.9995989140034187},{"cnt":[[468,2110],[1880,2110],[1880,2159],[468,2159]],"region":{"top_left_x":468,"top_left_y":2109,"width":1412,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a22476be25f41368d6b2b274849c1f4","type":"text","conversion_output":true,"text":"Volume eCRF page. If the urine volume is recorded as 0 mL , then the urea","text_display":" Volume eCRF page. If the urine volume is recorded as 0 mL , then the urea","confidence":1,"confidence_rate":1},{"cnt":[[468,2157],[1446,2157],[1446,2206],[468,2206]],"region":{"top_left_x":468,"top_left_y":2157,"width":978,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88ee07d9b553442f93488ec4403b7f78","type":"text","conversion_output":true,"text":"clearance will be \\(0 mL / min\\) and will not be set to missing.","text_display":" clearance will be \\(0 mL / min\\) and will not be set to missing.","confidence":0.98193359375,"confidence_rate":0.9997432499182444},{"cnt":[[344,2254],[1880,2254],[1880,2305],[344,2305]],"region":{"top_left_x":343,"top_left_y":2253,"width":1537,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7485df6bc2104056a74e53e1e8d15c7d","type":"text","conversion_output":true,"text":"A time-course plot of serum creatinine, urine output and BUN/urea clearance by day will","text_display":"\n\nA time-course plot of serum creatinine, urine output and BUN/urea clearance by day will","confidence":1,"confidence_rate":1},{"cnt":[[344,2303],[750,2303],[750,2353],[344,2353]],"region":{"top_left_x":343,"top_left_y":2303,"width":407,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ddfe11ce26842a6936621f93d24da61","type":"text","conversion_output":true,"text":"be presented separately.","text_display":" be presented separately.","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cd9e820e2484e7b96aa01c9f67224fe","type":"page_info","conversion_output":false,"text":"34","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-42","page":42,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"44d43926a1894d23b1d3aad87df67c86","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1369,125],[1850,125],[1850,159],[1369,159]],"region":{"top_left_x":1368,"top_left_y":124,"width":482,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"648e6fb841d84bc2aec868d998592e81","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[348,159],[599,159],[599,187],[348,187]],"region":{"top_left_x":348,"top_left_y":158,"width":252,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a4dca9c7993d4ac8a907ba562b9164fa","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"21e6d5e8ba4940cd8d2fb7b5c840b279","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[348,329],[1128,329],[1128,376],[348,376]],"region":{"top_left_x":348,"top_left_y":328,"width":780,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a7205bbc9634bc788e96db6f8a83104","type":"text","conversion_output":true,"text":"All data for these endpoints will also be listed.","text_display":"\n\nAll data for these endpoints will also be listed.","confidence":0.99951171875,"confidence_rate":0.9999909555872323},{"cnt":[[346,425],[1880,425],[1880,471],[346,471]],"region":{"top_left_x":345,"top_left_y":425,"width":1535,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6268e756872c493898008c9d0b399a24","type":"text","conversion_output":true,"text":"A summary table will present the descriptive statistics for the peak value of serum","text_display":"\nA summary table will present the descriptive statistics for the peak value of serum","confidence":1,"confidence_rate":1},{"cnt":[[348,473],[1878,473],[1878,518],[348,518]],"region":{"top_left_x":348,"top_left_y":472,"width":1530,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a236d643b6054d9f92e4b7f1ee4dbede","type":"text","conversion_output":true,"text":"creatinine and the peak value of blood urea nitrogen (during the period Day 1 to Day 7 ,","text_display":" creatinine and the peak value of blood urea nitrogen (during the period Day 1 to Day 7 ,","confidence":0.9453389644622803,"confidence_rate":0.9994323659808327},{"cnt":[[348,520],[526,520],[526,565],[348,565]],"region":{"top_left_x":348,"top_left_y":519,"width":179,"height":47},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ed3730e28074ebfa6587188f94bb140","type":"text","conversion_output":true,"text":"inclusive).","text_display":" inclusive).","confidence":1,"confidence_rate":1},{"cnt":[[344,614],[445,614],[445,655],[344,655]],"region":{"top_left_x":343,"top_left_y":614,"width":102,"height":42},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"416252703c56471f873e3afc690fc31b","type":"section_header","conversion_output":false,"children_ids":["78a00740a95c438ca7acc8ddea08f127"],"text":"","text_display":""},{"cnt":[[348,619],[440,619],[440,655],[348,655]],"region":{"top_left_x":348,"top_left_y":618,"width":93,"height":38},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78a00740a95c438ca7acc8ddea08f127","type":"text","conversion_output":true,"parent_id":"416252703c56471f873e3afc690fc31b","text":"RRT","text_display":"\n\n\\section*{RRT}","confidence":1,"confidence_rate":1},{"cnt":[[348,713],[1878,713],[1878,758],[348,758]],"region":{"top_left_x":348,"top_left_y":713,"width":1530,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"697ecdf5d8df4540ae721eec33993643","type":"text","conversion_output":true,"text":"A summary table for RRT during the period Day 1 to Day 28 will be presented including","text_display":"\n\nA summary table for RRT during the period Day 1 to Day 28 will be presented including","confidence":1,"confidence_rate":1},{"cnt":[[348,761],[1878,761],[1878,806],[348,806]],"region":{"top_left_x":348,"top_left_y":760,"width":1530,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e5e5b7a60a34390ac648916f99c1a9c","type":"text","conversion_output":true,"text":"the following endpoints: RRT-free days, total number of days on RRT, reasons for","text_display":" the following endpoints: RRT-free days, total number of days on RRT, reasons for","confidence":1,"confidence_rate":1},{"cnt":[[348,808],[1171,808],[1171,853],[348,853]],"region":{"top_left_x":348,"top_left_y":807,"width":823,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b588bef781d4398bce97a041ef641c5","type":"text","conversion_output":true,"text":"initiation of RRT, and reasons for stopping RRT.","text_display":" initiation of RRT, and reasons for stopping RRT.","confidence":1,"confidence_rate":1},{"cnt":[[348,902],[1876,902],[1876,950],[348,950]],"region":{"top_left_x":348,"top_left_y":902,"width":1528,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89aa3999cd6a4c20b182f21e0b632dad","type":"text","conversion_output":true,"text":"An RRT-free day is a day on which a patient did not receive any form of RRT. Conversely,","text_display":"\n\nAn RRT-free day is a day on which a patient did not receive any form of RRT. Conversely,","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[348,954],[1876,954],[1876,999],[348,999]],"region":{"top_left_x":348,"top_left_y":953,"width":1528,"height":47},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eca4f4e0c43843e9917e0a284d471fb6","type":"text","conversion_output":true,"text":"a day on RRT is defined as a day on which a patient received any form of RRT for any","text_display":" a day on RRT is defined as a day on which a patient received any form of RRT for any","confidence":1,"confidence_rate":1},{"cnt":[[348,1001],[1783,1001],[1783,1046],[348,1046]],"region":{"top_left_x":348,"top_left_y":1001,"width":1436,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f10a38070b54ae682a514f82c219508","type":"text","conversion_output":true,"text":"period of time on that day. For intermittent RRT, the following additional rules apply:","text_display":" period of time on that day. For intermittent RRT, the following additional rules apply:","confidence":1,"confidence_rate":1},{"cnt":[[408,1051],[1878,1051],[1878,1098],[408,1098]],"region":{"top_left_x":408,"top_left_y":1050,"width":1470,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6970fffa98814b76991ec6b3314b832c","type":"text","conversion_output":true,"text":"- Following conclusion of intermittent RRT, if the patient then has a period of six or","text_display":"\n- Following conclusion of intermittent RRT, if the patient then has a period of six or","confidence":1,"confidence_rate":1},{"cnt":[[473,1100],[1876,1100],[1876,1145],[473,1145]],"region":{"top_left_x":472,"top_left_y":1100,"width":1404,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0956cf14bcb4ae3b7304c4cd9d34f3a","type":"text","conversion_output":true,"text":"more days before next initiation of any form of RRT, all (six or more) days in this","text_display":" more days before next initiation of any form of RRT, all (six or more) days in this","confidence":0.99072265625,"confidence_rate":0.9998940891733388},{"cnt":[[473,1147],[1212,1147],[1212,1192],[473,1192]],"region":{"top_left_x":472,"top_left_y":1147,"width":740,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afaec92edf7d4b44b928ef15803dfac9","type":"text","conversion_output":true,"text":"intervening period are counted as RRT-free.","text_display":" intervening period are counted as RRT-free.","confidence":1,"confidence_rate":1},{"cnt":[[408,1199],[1880,1199],[1880,1244],[408,1244]],"region":{"top_left_x":408,"top_left_y":1198,"width":1472,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb2454d9f22944a193fe991773455e16","type":"text","conversion_output":true,"text":"- Following conclusion of intermittent RRT, if the patient then has a period of five or","text_display":"\n- Following conclusion of intermittent RRT, if the patient then has a period of five or","confidence":1,"confidence_rate":1},{"cnt":[[473,1246],[1876,1246],[1876,1291],[473,1291]],"region":{"top_left_x":472,"top_left_y":1246,"width":1404,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bdb6df08cc347f9a073185fc2c2ab04","type":"text","conversion_output":true,"text":"less days before next initiation of any form of RRT, all (five or less) days in this","text_display":" less days before next initiation of any form of RRT, all (five or less) days in this","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[473,1293],[1132,1293],[1132,1338],[473,1338]],"region":{"top_left_x":472,"top_left_y":1293,"width":661,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"338351b327714f42a7cdebe575688e7c","type":"text","conversion_output":true,"text":"intervening period are counted as RRT.","text_display":" intervening period are counted as RRT.","confidence":1,"confidence_rate":1},{"cnt":[[348,1396],[1661,1396],[1661,1442],[348,1442]],"region":{"top_left_x":348,"top_left_y":1396,"width":1313,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6eb315f382704c3b81b949d7ad4071b8","type":"figure_label","conversion_output":false,"text":"Table 8-1 Example of Derivation of RRT-Free Days and Days on RTT","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999929217569623},{"cnt":[[327,1491],[1871,1491],[1871,1835],[327,1835]],"region":{"top_left_x":326,"top_left_y":1491,"width":1546,"height":344},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6a2d4e212b24bd0880bd40c57693701","type":"table","conversion_output":true,"selected_labels":["6eb315f382704c3b81b949d7ad4071b8"],"text":"\\begin{tabular}{|l|l|l|c|c|}\n\\hline \\begin{tabular}{l} \nOn intermittent \\\\\nRRT\n\\end{tabular} & Off RRT & On RRT & \\begin{tabular}{l} \nRRT-free \\\\\ndays\n\\end{tabular} & \\begin{tabular}{l} \nDays on \\\\\nRRT\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l} \nDay 2 to Day 4 \\\\\ninclusive\n\\end{tabular} & \\begin{tabular}{l} \nDay 5 to Day 9 \\\\\ninclusive\n\\end{tabular} & \\begin{tabular}{l} \nDay 10 to Day 15 \\\\\ninclusive\n\\end{tabular} & 0 & 14 \\\\\n\\hline \\begin{tabular}{l} \nDay 2 to Day 4 \\\\\ninclusive\n\\end{tabular} & \\begin{tabular}{l} \nDay 5 to Day 10 \\\\\ninclusive\n\\end{tabular} & \\begin{tabular}{l} \nDay 11 to Day 15 \\\\\ninclusive\n\\end{tabular} & 6 & 8 \\\\\n\\hline Note: all instances of Day refer to study day & \\multicolumn{3}{|l|}{} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 8-1 Example of Derivation of RRT-Free Days and Days on RTT}\n\\begin{tabular}{|l|l|l|c|c|}\n\\hline \\begin{tabular}{l} \nOn intermittent \\\\\nRRT\n\\end{tabular} & Off RRT & On RRT & \\begin{tabular}{l} \nRRT-free \\\\\ndays\n\\end{tabular} & \\begin{tabular}{l} \nDays on \\\\\nRRT\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l} \nDay 2 to Day 4 \\\\\ninclusive\n\\end{tabular} & \\begin{tabular}{l} \nDay 5 to Day 9 \\\\\ninclusive\n\\end{tabular} & \\begin{tabular}{l} \nDay 10 to Day 15 \\\\\ninclusive\n\\end{tabular} & 0 & 14 \\\\\n\\hline \\begin{tabular}{l} \nDay 2 to Day 4 \\\\\ninclusive\n\\end{tabular} & \\begin{tabular}{l} \nDay 5 to Day 10 \\\\\ninclusive\n\\end{tabular} & \\begin{tabular}{l} \nDay 11 to Day 15 \\\\\ninclusive\n\\end{tabular} & 6 & 8 \\\\\n\\hline Note: all instances of Day refer to study day & \\multicolumn{3}{|l|}{} \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.2988287953030592,"confidence_rate":0.9977019123501696},{"cnt":[[348,1882],[1876,1882],[1876,1927],[348,1927]],"region":{"top_left_x":348,"top_left_y":1882,"width":1528,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dd0ceab432b4b15afa4aeb1ca3f22b1","type":"text","conversion_output":true,"text":"RRT-free days from Day 1 to Day 28 will be summarized by descriptive statistics. The","text_display":"\n\nRRT-free days from Day 1 to Day 28 will be summarized by descriptive statistics. The","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[348,1929],[1878,1929],[1878,1979],[348,1979]],"region":{"top_left_x":348,"top_left_y":1929,"width":1530,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"868c4fa3f79042ed9f8925a79f355b0a","type":"text","conversion_output":true,"text":"total number of days on RRT from Day 1 to Day 28 will also be summarized by","text_display":" total number of days on RRT from Day 1 to Day 28 will also be summarized by","confidence":1,"confidence_rate":1},{"cnt":[[348,1981],[698,1981],[698,2026],[348,2026]],"region":{"top_left_x":348,"top_left_y":1980,"width":351,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ce76ad2751f41c4a88cbafbd2843518","type":"text","conversion_output":true,"text":"descriptive statistics.","text_display":" descriptive statistics.","confidence":1,"confidence_rate":1},{"cnt":[[348,2075],[1876,2075],[1876,2121],[348,2121]],"region":{"top_left_x":348,"top_left_y":2075,"width":1528,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75f967823705487f90c39b15737cc5be","type":"text","conversion_output":true,"text":"Reasons for initiation of RRT and reasons for stopping RRT will be summarized by counts","text_display":"\n\nReasons for initiation of RRT and reasons for stopping RRT will be summarized by counts","confidence":1,"confidence_rate":1},{"cnt":[[348,2123],[1876,2123],[1876,2168],[348,2168]],"region":{"top_left_x":348,"top_left_y":2122,"width":1528,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6ee14d20e0245f09d14515dc16a1c62","type":"text","conversion_output":true,"text":"and percentages. A patient can have more than one reason for initiation, but will only be","text_display":" and percentages. A patient can have more than one reason for initiation, but will only be","confidence":1,"confidence_rate":1},{"cnt":[[348,2170],[1876,2170],[1876,2219],[348,2219]],"region":{"top_left_x":348,"top_left_y":2169,"width":1528,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63e43a092c3441a0983b5f5b4cbf9d12","type":"text","conversion_output":true,"text":"counted once under each reason in the table if the patient reported that reason multiple","text_display":" counted once under each reason in the table if the patient reported that reason multiple","confidence":1,"confidence_rate":1},{"cnt":[[348,2217],[1880,2217],[1880,2267],[348,2267]],"region":{"top_left_x":348,"top_left_y":2217,"width":1532,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca79f10b5e0a4f95b9dfe4df39f46f70","type":"text","conversion_output":true,"text":"times. The same approach will be applied for patients who report more than one reason for","text_display":" times. The same approach will be applied for patients who report more than one reason for","confidence":0.99853515625,"confidence_rate":0.9999844052526365},{"cnt":[[348,2264],[505,2264],[505,2314],[348,2314]],"region":{"top_left_x":348,"top_left_y":2264,"width":157,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8987441c1cd4c5ba502d17a4dfa3df1","type":"text","conversion_output":true,"text":"stopping.","text_display":" stopping.","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d37116b8a8e14510b233dceaaa75e6bf","type":"page_info","conversion_output":false,"text":"35","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-43","page":43,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c957fc6118dc48a8bade1ef7eb16a46c","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1369,125],[1850,125],[1850,161],[1369,161]],"region":{"top_left_x":1368,"top_left_y":124,"width":482,"height":38},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ef85936e6a3c401db6b029083b607619","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[348,159],[599,159],[599,187],[348,187]],"region":{"top_left_x":348,"top_left_y":158,"width":252,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a3b07f2d48cd41188df87c770bd61c98","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"aadb6bb6d7a247428739213f0d8a7d70","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[348,329],[1880,329],[1880,376],[348,376]],"region":{"top_left_x":348,"top_left_y":328,"width":1532,"height":48},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d321f03111b47e8ae26dd9408c16b70","type":"text","conversion_output":true,"text":"Exploratory analysis of the total number of days on RRT will be undertaken for the","text_display":"\n\nExploratory analysis of the total number of days on RRT will be undertaken for the","confidence":1,"confidence_rate":1},{"cnt":[[346,374],[1880,374],[1880,423],[346,423]],"region":{"top_left_x":345,"top_left_y":373,"width":1535,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa671bd39c084e71bec19de52d9f89f6","type":"text","conversion_output":true,"text":"comparison of the optimal recAP dose and placebo using an ANOVA with treatment and","text_display":" comparison of the optimal recAP dose and placebo using an ANOVA with treatment and","confidence":1,"confidence_rate":1},{"cnt":[[348,423],[1880,423],[1880,471],[348,471]],"region":{"top_left_x":348,"top_left_y":423,"width":1532,"height":48},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5eccac2cab7943bea069c9ce3461012a","type":"text","conversion_output":true,"text":"site as explanatory variables. The least square means for each treatment and the difference","text_display":" site as explanatory variables. The least square means for each treatment and the difference","confidence":1,"confidence_rate":1},{"cnt":[[348,473],[1878,473],[1878,518],[348,518]],"region":{"top_left_x":348,"top_left_y":472,"width":1530,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24978770ea004f5295adf1e828a6e44e","type":"text","conversion_output":true,"text":"in least squares means between the treatment groups will also be presented along with the","text_display":" in least squares means between the treatment groups will also be presented along with the","confidence":1,"confidence_rate":1},{"cnt":[[346,520],[1878,520],[1878,569],[346,569]],"region":{"top_left_x":345,"top_left_y":519,"width":1533,"height":51},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d05cfaa4af6748a9bdd4ec0214321c09","type":"text","conversion_output":true,"text":"associated \\(95 \\%\\) CI and p-value. If a subject withdrew from study or died while still on","text_display":" associated \\(95 \\%\\) CI and p-value. If a subject withdrew from study or died while still on","confidence":0.8414301872253418,"confidence_rate":0.9981649598860235},{"cnt":[[346,567],[1878,567],[1878,614],[346,614]],"region":{"top_left_x":345,"top_left_y":567,"width":1533,"height":48},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c703fbba67c948f3a8ebda8095b10b15","type":"text","conversion_output":true,"text":"RRT treatment before Day 28, then duration of RRT (ie, number of days on RRT) will be","text_display":" RRT treatment before Day 28, then duration of RRT (ie, number of days on RRT) will be","confidence":1,"confidence_rate":1},{"cnt":[[348,614],[1878,614],[1878,664],[348,664]],"region":{"top_left_x":348,"top_left_y":614,"width":1530,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8f9f61ed4ab4007b96a171ce0cf993a","type":"text","conversion_output":true,"text":"calculated as from RRT start date up to Day 28 (ie calculating with the \"remaining days up","text_display":" calculated as from RRT start date up to Day 28 (ie calculating with the \"remaining days up","confidence":1,"confidence_rate":1},{"cnt":[[346,662],[1878,662],[1878,711],[346,711]],"region":{"top_left_x":345,"top_left_y":661,"width":1533,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdd6110ac1414164b56cc014b217d212","type":"text","conversion_output":true,"text":"to Day 28). For the calculation of total number of days on RRT, any missing RRT stop","text_display":" to Day 28). For the calculation of total number of days on RRT, any missing RRT stop","confidence":1,"confidence_rate":1},{"cnt":[[346,709],[1880,709],[1880,758],[346,758]],"region":{"top_left_x":345,"top_left_y":708,"width":1535,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8d2a11a773f401e993da5f857cb1f18","type":"text","conversion_output":true,"text":"days will be set to either the day before the next RRT start date if more than one RRT","text_display":" days will be set to either the day before the next RRT start date if more than one RRT","confidence":1,"confidence_rate":1},{"cnt":[[346,758],[1377,758],[1377,806],[346,806]],"region":{"top_left_x":345,"top_left_y":758,"width":1033,"height":48},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2389ba8c0a62451a996a996ac473469f","type":"text","conversion_output":true,"text":"record or to Day 28 if the patient has no further RRT records.","text_display":" record or to Day 28 if the patient has no further RRT records.","confidence":1,"confidence_rate":1},{"cnt":[[348,855],[810,855],[810,896],[348,896]],"region":{"top_left_x":348,"top_left_y":855,"width":462,"height":41},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"08520262b7d8427c8715fa2060acf1a2","type":"text","conversion_output":true,"text":"All RRT data will be listed.","text_display":"\n\nAll RRT data will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[344,950],[647,950],[647,1003],[344,1003]],"region":{"top_left_x":343,"top_left_y":949,"width":304,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e66e9b02ec4f4c9a8d3cb672e6109437","type":"section_header","conversion_output":false,"children_ids":["c57930cf451747e089a67042c1786143"],"text":"","text_display":""},{"cnt":[[348,954],[642,954],[642,999],[348,999]],"region":{"top_left_x":348,"top_left_y":953,"width":295,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c57930cf451747e089a67042c1786143","type":"text","conversion_output":true,"parent_id":"e66e9b02ec4f4c9a8d3cb672e6109437","text":"Kidney function","text_display":"\n\n\\section*{Kidney function}","confidence":1,"confidence_rate":1},{"cnt":[[348,1044],[1880,1044],[1880,1094],[348,1094]],"region":{"top_left_x":348,"top_left_y":1044,"width":1532,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e16dbb2eae94d518030acca80327319","type":"text","conversion_output":true,"text":"The reference eGFR will be estimated by the CKD-EPI formula based on the reference","text_display":"\n\nThe reference eGFR will be estimated by the CKD-EPI formula based on the reference","confidence":0.99609375,"confidence_rate":0.9999550136633968},{"cnt":[[348,1096],[1876,1096],[1876,1143],[348,1143]],"region":{"top_left_x":348,"top_left_y":1095,"width":1528,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c684a248e1eb4e5585a3979ebb59d794","type":"text","conversion_output":true,"text":"serum creatinine value recorded on the AKI Diagnosis page of the eCRF for each patient.","text_display":" serum creatinine value recorded on the AKI Diagnosis page of the eCRF for each patient.","confidence":1,"confidence_rate":1},{"cnt":[[348,1143],[1882,1143],[1882,1190],[348,1190]],"region":{"top_left_x":348,"top_left_y":1142,"width":1535,"height":49},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8147de9211f945e8bff158ecd325b16b","type":"text","conversion_output":true,"text":"The reference serum creatinine value is recorded on the eCRF using the following order of","text_display":" The reference serum creatinine value is recorded on the eCRF using the following order of","confidence":1,"confidence_rate":1},{"cnt":[[348,1190],[539,1190],[539,1240],[348,1240]],"region":{"top_left_x":348,"top_left_y":1190,"width":192,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72cdacd7091944a494c463e3dc90f0ce","type":"text","conversion_output":true,"text":"preference:","text_display":" preference:","confidence":0.99853515625,"confidence_rate":0.9999083843418147},{"cnt":[[412,1285],[1777,1285],[1777,1334],[412,1334]],"region":{"top_left_x":412,"top_left_y":1284,"width":1365,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d83b5f9a113405a872278ff748ccd08","type":"text","conversion_output":true,"text":"1. Lowest value within 3 months of the hospital admission; if not available then:","text_display":"\n1. Lowest value within 3 months of the hospital admission; if not available then:","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[408,1334],[1304,1334],[1304,1381],[408,1381]],"region":{"top_left_x":408,"top_left_y":1334,"width":897,"height":48},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1b32b548e6a470ca76353ec5e6a63eb","type":"text","conversion_output":true,"text":"2. Value at hospital admission; if not available then:","text_display":"\n2. Value at hospital admission; if not available then:","confidence":1,"confidence_rate":1},{"cnt":[[408,1381],[1506,1381],[1506,1429],[408,1429]],"region":{"top_left_x":408,"top_left_y":1381,"width":1099,"height":48},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"689f009d93ca4f74a65d9db073e40e0c","type":"text","conversion_output":true,"text":"3. Value ICU/Intermediate care admission; if not available then:","text_display":"\n3. Value ICU/Intermediate care admission; if not available then:","confidence":1,"confidence_rate":1},{"cnt":[[408,1429],[1594,1429],[1594,1480],[408,1480]],"region":{"top_left_x":408,"top_left_y":1428,"width":1187,"height":53},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8a0028b558f49ca9174c21a8d0f6717","type":"text","conversion_output":true,"text":"4. Lowest value between 3 and 12 months prior to hospital admission","text_display":"\n4. Lowest value between 3 and 12 months prior to hospital admission","confidence":1,"confidence_rate":1},{"cnt":[[348,1525],[1880,1525],[1880,1575],[348,1575]],"region":{"top_left_x":348,"top_left_y":1525,"width":1532,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d8bfbde8a2dc4ba2b3beab9089941cd9","type":"text","conversion_output":true,"text":"Baseline serum creatinine from the laboratory data will not be included in the calculation","text_display":"\n\nBaseline serum creatinine from the laboratory data will not be included in the calculation","confidence":1,"confidence_rate":1},{"cnt":[[348,1573],[672,1573],[672,1618],[348,1618]],"region":{"top_left_x":348,"top_left_y":1572,"width":325,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"12ed50649c384a668f4e436cf2d104b5","type":"text","conversion_output":true,"text":"of reference eGFR .","text_display":" of reference eGFR .","confidence":0.605748176574707,"confidence_rate":0.9834291349889047},{"cnt":[[348,1669],[1880,1669],[1880,1717],[348,1717]],"region":{"top_left_x":348,"top_left_y":1669,"width":1532,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75e6ab8c9c7f420abf31bb6e3a8ab01e","type":"text","conversion_output":true,"text":"Kidney function will be assessed at Baseline, Day 14, 21 and 28 by measured creatinine","text_display":"\n\nKidney function will be assessed at Baseline, Day 14, 21 and 28 by measured creatinine","confidence":1,"confidence_rate":1},{"cnt":[[346,1717],[1880,1717],[1880,1764],[346,1764]],"region":{"top_left_x":345,"top_left_y":1716,"width":1535,"height":48},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"645ea33071354bd9b0b85ba8a0c0ac06","type":"text","conversion_output":true,"text":"clearance. Baseline kidney function will only be measured by standardized creatinine","text_display":" clearance. Baseline kidney function will only be measured by standardized creatinine","confidence":1,"confidence_rate":1},{"cnt":[[348,1766],[1880,1766],[1880,1813],[348,1813]],"region":{"top_left_x":348,"top_left_y":1766,"width":1532,"height":48},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7410ebeae54e42b1ad848ea127d2ace2","type":"text","conversion_output":true,"text":"clearance, however for Day 14, 21 and 28 summaries if creatinine clearance is not","text_display":" clearance, however for Day 14, 21 and 28 summaries if creatinine clearance is not","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[348,1813],[1880,1813],[1880,1863],[348,1863]],"region":{"top_left_x":348,"top_left_y":1813,"width":1532,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3dac9359a179448ca8fc7a365919fd6d","type":"text","conversion_output":true,"text":"available then kidney function as assessed by eGFR (estimated by the CKD-EPI formula","text_display":" available then kidney function as assessed by eGFR (estimated by the CKD-EPI formula","confidence":1,"confidence_rate":1},{"cnt":[[348,1861],[1880,1861],[1880,1910],[348,1910]],"region":{"top_left_x":348,"top_left_y":1860,"width":1532,"height":50},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb0e6d5544ac48429c6069a1aed79e15","type":"text","conversion_output":true,"text":"based on serum creatinine) will be used.. Kidney function will also be assessed at Day 60","text_display":" based on serum creatinine) will be used.. Kidney function will also be assessed at Day 60","confidence":1,"confidence_rate":1},{"cnt":[[348,1908],[1878,1908],[1878,1957],[348,1957]],"region":{"top_left_x":348,"top_left_y":1907,"width":1530,"height":51},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b218da0e55f74b6893f4a678115a2a0a","type":"text","conversion_output":true,"text":"and Day 90 by eGFR. Sustained loss of Kidney function, defined by eGFR \\(<60 mL / min\\),","text_display":" and Day 90 by eGFR. Sustained loss of Kidney function, defined by eGFR \\(<60 mL / min\\),","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[348,1955],[1878,1955],[1878,2004],[348,2004]],"region":{"top_left_x":348,"top_left_y":1955,"width":1530,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f4501cc0b8f49e996d94417e839b7a2","type":"text","conversion_output":true,"text":"will be assessed at Day 60 and Day 90. The analyses of kidney function and sustained loss","text_display":" will be assessed at Day 60 and Day 90. The analyses of kidney function and sustained loss","confidence":1,"confidence_rate":1},{"cnt":[[348,2004],[1880,2004],[1880,2052],[348,2052]],"region":{"top_left_x":348,"top_left_y":2004,"width":1532,"height":48},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04d8ac9d97c2452993981869abfc935c","type":"text","conversion_output":true,"text":"of kidney function at each timepoint will exclude any patients who die prior to the","text_display":" of kidney function at each timepoint will exclude any patients who die prior to the","confidence":1,"confidence_rate":1},{"cnt":[[348,2052],[1880,2052],[1880,2101],[348,2101]],"region":{"top_left_x":348,"top_left_y":2051,"width":1532,"height":51},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5433096102974477a964312da6deb929","type":"text","conversion_output":true,"text":"timepoint. Any other missing assessments (including early withdrawals) at Day 60 or Day","text_display":" timepoint. Any other missing assessments (including early withdrawals) at Day 60 or Day","confidence":1,"confidence_rate":1},{"cnt":[[348,2101],[1880,2101],[1880,2151],[348,2151]],"region":{"top_left_x":348,"top_left_y":2101,"width":1532,"height":50},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d6e9eca4289f493897f129d65f96800a","type":"text","conversion_output":true,"text":"90 will be imputed by LOCF where possible, missing Day 14, 21 and 28 values will not be","text_display":" 90 will be imputed by LOCF where possible, missing Day 14, 21 and 28 values will not be","confidence":1,"confidence_rate":1},{"cnt":[[348,2148],[1880,2148],[1880,2198],[348,2198]],"region":{"top_left_x":348,"top_left_y":2148,"width":1532,"height":50},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2e04c905f3c6458ebc5a4b1141cf0177","type":"text","conversion_output":true,"text":"imputed and will be treated as missing. A summary table will present descriptive statistics","text_display":" imputed and will be treated as missing. A summary table will present descriptive statistics","confidence":1,"confidence_rate":1},{"cnt":[[348,2196],[1880,2196],[1880,2245],[348,2245]],"region":{"top_left_x":348,"top_left_y":2195,"width":1532,"height":51},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49cd53a1ea7749cdbdc47cff2293bd0b","type":"text","conversion_output":true,"text":"for the reference kidney function and the kidney function at Baseline and at Days 14, 21,","text_display":" for the reference kidney function and the kidney function at Baseline and at Days 14, 21,","confidence":1,"confidence_rate":1},{"cnt":[[348,2243],[1880,2243],[1880,2292],[348,2292]],"region":{"top_left_x":348,"top_left_y":2242,"width":1532,"height":51},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8256689e23e34d3fb7456497679f0705","type":"text","conversion_output":true,"text":"28, 60 and 90 along with counts and percentages of patients with loss of sustained kidney","text_display":" 28, 60 and 90 along with counts and percentages of patients with loss of sustained kidney","confidence":1,"confidence_rate":1},{"cnt":[[348,2292],[1880,2292],[1880,2340],[348,2340]],"region":{"top_left_x":348,"top_left_y":2292,"width":1532,"height":48},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"032451b2d453428aad63dd5c69b33100","type":"text","conversion_output":true,"text":"function at Day 60 and Day 90. Descriptive statistics will also be presented for the change","text_display":" function at Day 60 and Day 90. Descriptive statistics will also be presented for the change","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[348,2340],[1878,2340],[1878,2391],[348,2391]],"region":{"top_left_x":348,"top_left_y":2339,"width":1530,"height":53},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d95176c8bb34bf1bcafd702212a59dd","type":"text","conversion_output":true,"text":"from baseline creatinine clearance value at Day 14, Day 21, Day 28, Day 60, and Day 90.","text_display":" from baseline creatinine clearance value at Day 14, Day 21, Day 28, Day 60, and Day 90.","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca32e113e3404a129ac5240bf5c04c40","type":"page_info","conversion_output":false,"text":"36","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-44","page":44,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"88ebf02d7de74c35b3be1b34f9ed5e86","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1850,125],[1850,159],[1366,159]],"region":{"top_left_x":1366,"top_left_y":124,"width":484,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"18a00e6bb25943b397bec481c2705ca7","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"65c0af5f74b74d4e9622ef8293abd32a","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.998046875,"confidence_rate":0.9999150020979262},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"83f107e27a7a4f149920e956d85221af","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[346,329],[1878,329],[1878,374],[346,374]],"region":{"top_left_x":345,"top_left_y":328,"width":1533,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"901d99628e6942aa8fc677896ab2900c","type":"text","conversion_output":true,"text":"The absolute difference between placebo and each of the treatment groups will also be","text_display":"\n\nThe absolute difference between placebo and each of the treatment groups will also be","confidence":0.99853515625,"confidence_rate":0.9999837121583983},{"cnt":[[346,374],[1880,374],[1880,423],[346,423]],"region":{"top_left_x":345,"top_left_y":373,"width":1535,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92758f12138747cd94a2652d593eb0dc","type":"text","conversion_output":true,"text":"presented at each time point. Summaries for Day 60 and 90 will be repeated with and","text_display":" presented at each time point. Summaries for Day 60 and 90 will be repeated with and","confidence":1,"confidence_rate":1},{"cnt":[[348,423],[1293,423],[1293,471],[348,471]],"region":{"top_left_x":348,"top_left_y":423,"width":946,"height":48},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"749580cb414344f2977060fffba6f26a","type":"text","conversion_output":true,"text":"without the LOCF imputation of missing values applied.","text_display":" without the LOCF imputation of missing values applied.","confidence":1,"confidence_rate":1},{"cnt":[[346,520],[993,520],[993,569],[346,569]],"region":{"top_left_x":345,"top_left_y":519,"width":648,"height":51},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dd873976b0494db688d306e0b8d2ac86","type":"text","conversion_output":true,"text":"All kidney function data will be listed.","text_display":"\n\nAll kidney function data will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[339,614],[724,614],[724,668],[339,668]],"region":{"top_left_x":339,"top_left_y":614,"width":386,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d617c5a40b894b7a8c4aa61845dc01ea","type":"section_header","conversion_output":false,"children_ids":["06ca85426bcf492880a49689fcdb781c"],"text":"","text_display":""},{"cnt":[[346,614],[720,614],[720,664],[346,664]],"region":{"top_left_x":345,"top_left_y":614,"width":375,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06ca85426bcf492880a49689fcdb781c","type":"text","conversion_output":true,"parent_id":"d617c5a40b894b7a8c4aa61845dc01ea","text":"Dialysis Dependency","text_display":"\n\n\\section*{Dialysis Dependency}","confidence":1,"confidence_rate":1},{"cnt":[[346,709],[1880,709],[1880,758],[346,758]],"region":{"top_left_x":345,"top_left_y":708,"width":1535,"height":51},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ce0cde7bf414e92811733d8ee45c9bb","type":"text","conversion_output":true,"text":"Incidence of dialysis dependency will be assessed at Day 60 and Day 90. Patients who die","text_display":"\n\nIncidence of dialysis dependency will be assessed at Day 60 and Day 90. Patients who die","confidence":1,"confidence_rate":1},{"cnt":[[348,758],[1878,758],[1878,806],[348,806]],"region":{"top_left_x":348,"top_left_y":758,"width":1530,"height":48},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eae43785b22541a48234bff812cf8bb2","type":"text","conversion_output":true,"text":"or withdraw from the study prior to Day 60 or Day 90, respectively, without recording","text_display":" or withdraw from the study prior to Day 60 or Day 90, respectively, without recording","confidence":1,"confidence_rate":1},{"cnt":[[348,808],[1878,808],[1878,855],[348,855]],"region":{"top_left_x":348,"top_left_y":807,"width":1530,"height":49},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b46b7968ef504e398dd3d36590aaa23d","type":"text","conversion_output":true,"text":"incidence of chronic dialysis will be counted as not being dialysis dependent. A summary","text_display":" incidence of chronic dialysis will be counted as not being dialysis dependent. A summary","confidence":1,"confidence_rate":1},{"cnt":[[348,855],[1880,855],[1880,902],[348,902]],"region":{"top_left_x":348,"top_left_y":855,"width":1532,"height":48},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9af782ffd6184ba9a5f3133d8b2d28c6","type":"text","conversion_output":true,"text":"table will present the counts and percentages of patients who are dialysis dependent at","text_display":" table will present the counts and percentages of patients who are dialysis dependent at","confidence":1,"confidence_rate":1},{"cnt":[[348,902],[1880,902],[1880,952],[348,952]],"region":{"top_left_x":348,"top_left_y":902,"width":1532,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"daac79c8aae74c29866fe51e36db1f5a","type":"text","conversion_output":true,"text":"Day 60 and Day 90. Percentages for each timepoint are calculated based on the number of","text_display":" Day 60 and Day 90. Percentages for each timepoint are calculated based on the number of","confidence":1,"confidence_rate":1},{"cnt":[[346,952],[1755,952],[1755,999],[346,999]],"region":{"top_left_x":345,"top_left_y":951,"width":1411,"height":49},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73257c70a599414fabc2ba2d612274af","type":"text","conversion_output":true,"text":"patients that were assessed including those who died or withdrew prior to timepoint.","text_display":" patients that were assessed including those who died or withdrew prior to timepoint.","confidence":0.9970703125,"confidence_rate":0.9999670343924248},{"cnt":[[348,1044],[1119,1044],[1119,1094],[348,1094]],"region":{"top_left_x":348,"top_left_y":1044,"width":772,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3acaee330160436c87913f2b04d22db9","type":"text","conversion_output":true,"text":"All data on dialysis dependency will be listed.","text_display":"\n\nAll data on dialysis dependency will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[529,1134],[982,1134],[982,1188],[529,1188]],"region":{"top_left_x":528,"top_left_y":1134,"width":454,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b76f340f1d29417f870cfd59e394806e","type":"section_header","conversion_output":false,"children_ids":["70788574006f4e4e895efa61f525844d"],"text":"","text_display":""},{"cnt":[[533,1139],[978,1139],[978,1184],[533,1184]],"region":{"top_left_x":532,"top_left_y":1138,"width":446,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70788574006f4e4e895efa61f525844d","type":"text","conversion_output":true,"parent_id":"b76f340f1d29417f870cfd59e394806e","text":"8.2.2.2 Other Organs","text_display":"\n\n\\subsection*{8.2.2.2 Other 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Enzymes}","confidence":1,"confidence_rate":1},{"cnt":[[346,1336],[1880,1336],[1880,1386],[346,1386]],"region":{"top_left_x":345,"top_left_y":1336,"width":1535,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e783977c2fd0418b8f9f928083aa66e9","type":"text","conversion_output":true,"text":"Liver enzymes is assessed by AST ( \\(U / L\\) ), ALT ( \\(U / L\\) ), GGT ( \\(U / L\\) ), LDH ( \\(U / L\\) ) and","text_display":"\n\nLiver enzymes is assessed by AST ( \\(U / L\\) ), ALT ( \\(U / L\\) ), GGT ( \\(U / L\\) ), LDH ( \\(U / L\\) ) and","confidence":0.9468208579875443,"confidence_rate":0.9995594086082419},{"cnt":[[348,1386],[1846,1386],[1846,1435],[348,1435]],"region":{"top_left_x":348,"top_left_y":1385,"width":1498,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb9a53b5a9724c5ea85ae11676f47408","type":"text","conversion_output":true,"text":"bilirubin ( \\(\\mu mol / L\\) ) at Baseline, Day 1, Day 3, Day 5, Day 7, Day 14, Day 21 and Day 28.","text_display":" bilirubin ( \\(\\mu mol / L\\) ) at Baseline, Day 1, Day 3, Day 5, Day 7, Day 14, Day 21 and Day 28.","confidence":0.7867791630442298,"confidence_rate":0.9976968133755924},{"cnt":[[346,1482],[1880,1482],[1880,1532],[346,1532]],"region":{"top_left_x":345,"top_left_y":1482,"width":1535,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b74341994f947f4b0e64bbb9f81f833","type":"text","conversion_output":true,"text":"The observed values and change from baseline for liver enzymes will be calculated by visit","text_display":"\n\nThe observed values and change from baseline for liver enzymes will be calculated by visit","confidence":1,"confidence_rate":1},{"cnt":[[348,1530],[1033,1530],[1033,1579],[348,1579]],"region":{"top_left_x":348,"top_left_y":1529,"width":686,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39e8dca79e35410893988dbc06a977e5","type":"text","conversion_output":true,"text":"and summarized by descriptive statistics.","text_display":" and summarized by descriptive statistics.","confidence":1,"confidence_rate":1},{"cnt":[[348,1624],[1876,1624],[1876,1674],[348,1674]],"region":{"top_left_x":348,"top_left_y":1624,"width":1528,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75cc270ee9e0464ea4eb0e5bd7f936fc","type":"text","conversion_output":true,"text":"Time-course plots similar to the plot being produced for the primary endpoint will be","text_display":"\n\nTime-course plots similar to the plot being produced for the primary endpoint will 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only.","confidence":1,"confidence_rate":1},{"cnt":[[348,1818],[965,1818],[965,1865],[348,1865]],"region":{"top_left_x":348,"top_left_y":1817,"width":617,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe083bbbcc1d44adb3a96c92e30207e4","type":"text","conversion_output":true,"text":"All liver enzymes data will be listed.","text_display":"\n\nAll liver enzymes data will be listed.","confidence":0.9990234375,"confidence_rate":0.9999772784058643},{"cnt":[[344,1912],[621,1912],[621,1962],[344,1962]],"region":{"top_left_x":343,"top_left_y":1912,"width":278,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"618fe50baa084ca1b2e8886375d99511","type":"section_header","conversion_output":false,"children_ids":["c817db33a6b54b16998c9b5d36e62e79"],"text":"","text_display":""},{"cnt":[[348,1916],[617,1916],[617,1962],[348,1962]],"region":{"top_left_x":348,"top_left_y":1916,"width":269,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c817db33a6b54b16998c9b5d36e62e79","type":"text","conversion_output":true,"parent_id":"618fe50baa084ca1b2e8886375d99511","text":"Lung Function","text_display":"\n\n\\section*{Lung Function}","confidence":1,"confidence_rate":1},{"cnt":[[348,2011],[1876,2011],[1876,2056],[348,2056]],"region":{"top_left_x":348,"top_left_y":2010,"width":1528,"height":47},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a9ca64a50fa4cbf95fc65d8497b930b","type":"text","conversion_output":true,"text":"Lung function is assessed, for patients on mechanical ventilation, by \\(PaO 2, P / F\\) ratio,","text_display":"\n\nLung function is assessed, for patients on mechanical ventilation, by \\(PaO 2, P / F\\) ratio,","confidence":0.9931640625,"confidence_rate":0.9999327531479268},{"cnt":[[348,2058],[1880,2058],[1880,2103],[348,2103]],"region":{"top_left_x":348,"top_left_y":2058,"width":1532,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f5ccec977f4466c8c5b0d69da78de9e","type":"text","conversion_output":true,"text":"PEEP \\(\\left( cmH _{2} O \\right)\\) and tidal volume ( \\(mL / kg\\) ) daily from Day 1 to Day 28. The observed","text_display":" PEEP \\(\\left( cmH _{2} O \\right)\\) and tidal volume ( \\(mL / kg\\) ) daily from Day 1 to Day 28. The observed","confidence":0.29801893599142204,"confidence_rate":0.9893439237140762},{"cnt":[[348,2105],[1880,2105],[1880,2151],[348,2151]],"region":{"top_left_x":348,"top_left_y":2105,"width":1532,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7e9bb068f0c4a569c49ae0e35081254","type":"text","conversion_output":true,"text":"values and change from baseline for \\(PaO 2, P / F\\) ratio, PEEP and tidal volume will be","text_display":" values and change from baseline for \\(PaO 2, P / F\\) ratio, PEEP and tidal volume will be","confidence":0.9970703125,"confidence_rate":0.999970061800863},{"cnt":[[348,2153],[1878,2153],[1878,2202],[348,2202]],"region":{"top_left_x":348,"top_left_y":2152,"width":1530,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36dba06dae134de2a00c2f63e7b3fdde","type":"text","conversion_output":true,"text":"calculated by visit and summarized with descriptive statistics. For non-mechanical","text_display":" calculated by visit and summarized with descriptive statistics. For non-mechanical","confidence":1,"confidence_rate":1},{"cnt":[[348,2200],[1313,2200],[1313,2249],[348,2249]],"region":{"top_left_x":348,"top_left_y":2200,"width":965,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a51a50208024074b5559dcf2ce45145","type":"text","conversion_output":true,"text":"ventilation liters of administered oxygen will be assessed.","text_display":" ventilation liters of administered oxygen will be assessed.","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5075f50fc76645b6bc20c732a70eeed4","type":"page_info","conversion_output":false,"text":"37","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-45","page":45,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"c25c95ef8f644c94a673f659aff49faf","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1369,125],[1850,125],[1850,157],[1369,157]],"region":{"top_left_x":1368,"top_left_y":124,"width":482,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1116a947f7fc4eb6a07c23b0bc7de827","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[348,159],[599,159],[599,187],[348,187]],"region":{"top_left_x":348,"top_left_y":158,"width":252,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"47817fd8ab1a4ef6a91251682fb97c4b","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"2c9d533c31014aa5a252a19c57cf3489","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[348,331],[1433,331],[1433,376],[348,376]],"region":{"top_left_x":348,"top_left_y":330,"width":1086,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa95b9a9d5ee400b87850b3cf0ec6fa3","type":"figure_label","conversion_output":false,"text":"Table 8-2 Normal Ranges for Lung Function Parameters","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[329,432],[1897,432],[1897,638],[329,638]],"region":{"top_left_x":328,"top_left_y":431,"width":1570,"height":208},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b46ad13708c54168abc46a0a87c9d12f","type":"table","conversion_output":true,"selected_labels":["fa95b9a9d5ee400b87850b3cf0ec6fa3"],"text":"\\begin{tabular}{|c|l|}\n\\hline Parameter & \\multicolumn{1}{|c|}{ Normal Range } \\\\\n\\hline PCO2 & \\(4.7-6.4 kPa\\) or \\(35-48 mmHg\\) \\\\\n\\hline PO2 & \\(10.0-13.3 kPa\\) or \\(75-100 mmHg\\) \\\\\n\\hline Oxygen saturation & \\(95-100 \\%\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 8-2 Normal Ranges for Lung Function Parameters}\n\\begin{tabular}{|c|l|}\n\\hline Parameter & \\multicolumn{1}{|c|}{ Normal Range } \\\\\n\\hline PCO2 & \\(4.7-6.4 kPa\\) or \\(35-48 mmHg\\) \\\\\n\\hline PO2 & \\(10.0-13.3 kPa\\) or \\(75-100 mmHg\\) \\\\\n\\hline Oxygen saturation & \\(95-100 \\%\\) \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.8907310704234987,"confidence_rate":0.9994006318897584},{"cnt":[[348,687],[1732,687],[1732,733],[348,733]],"region":{"top_left_x":348,"top_left_y":687,"width":1384,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad3856e494274748860dc6add079d4fe","type":"text","conversion_output":true,"text":"The following conversion rate will be performed for PO 2 and PCO 2 where needed","text_display":"\n\nThe following conversion rate will be performed for PO 2 and PCO 2 where needed","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[846,735],[1377,735],[1377,780],[846,780]],"region":{"top_left_x":846,"top_left_y":734,"width":532,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c65ef388940e44d0805127c8125a2240","type":"text","conversion_output":true,"text":"kilopascal (kPa) x \\(7.5= mmHg\\)","text_display":" kilopascal (kPa) x \\(7.5= mmHg\\)","confidence":0.30509895957152366,"confidence_rate":0.9656872378170962},{"cnt":[[348,829],[954,829],[954,879],[348,879]],"region":{"top_left_x":348,"top_left_y":829,"width":606,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c73363e86d8143f3b69f2868e3d10254","type":"text","conversion_output":true,"text":"All lung function data will be listed.","text_display":"\n\nAll lung function data will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[344,971],[1162,971],[1162,1025],[344,1025]],"region":{"top_left_x":343,"top_left_y":971,"width":820,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a00d1b1bab84f8bb15de030305b162b","type":"section_header","conversion_output":false,"children_ids":["698265ddd7d140739ef62b9c1d6d3f84"],"text":"","text_display":""},{"cnt":[[348,975],[1158,975],[1158,1021],[348,1021]],"region":{"top_left_x":348,"top_left_y":975,"width":811,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"698265ddd7d140739ef62b9c1d6d3f84","type":"text","conversion_output":true,"parent_id":"7a00d1b1bab84f8bb15de030305b162b","text":"Mechanical Ventilation from Day 1 to Day 28","text_display":"\n\n\\section*{Mechanical Ventilation from Day 1 to Day 28}","confidence":1,"confidence_rate":1},{"cnt":[[348,1070],[1878,1070],[1878,1115],[348,1115]],"region":{"top_left_x":348,"top_left_y":1069,"width":1530,"height":47},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02785e02602a4396a191e04f0a9f71d7","type":"text","conversion_output":true,"text":"A ventilator-free day is defined as a day on which a patient was not on ventilator (invasive","text_display":"\n\nA ventilator-free day is defined as a day on which a patient was not on ventilator (invasive","confidence":1,"confidence_rate":1},{"cnt":[[348,1117],[1880,1117],[1880,1162],[348,1162]],"region":{"top_left_x":348,"top_left_y":1117,"width":1532,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79534c13348240aba790bd316f66c19a","type":"text","conversion_output":true,"text":"or non-invasive mechanical ventilation). The start and stop dates of the patient been under","text_display":" or non-invasive mechanical ventilation). The start and stop dates of the patient been under","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[348,1164],[1880,1164],[1880,1212],[348,1212]],"region":{"top_left_x":348,"top_left_y":1164,"width":1532,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44e561c337844f44a7d5a7186d9b9d91","type":"text","conversion_output":true,"text":"mechanical ventilation is collected in the eCRF, therefore days not on ventilator","text_display":" mechanical ventilation is collected in the eCRF, therefore days not on ventilator","confidence":1,"confidence_rate":1},{"cnt":[[348,1214],[1878,1214],[1878,1261],[348,1261]],"region":{"top_left_x":348,"top_left_y":1213,"width":1530,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0abeec5637084109871ca91df5b1b956","type":"text","conversion_output":true,"text":"correspond to days that are outside of the start and stop dates of when the patient is on","text_display":" correspond to days that are outside of the start and stop dates of when the patient is on","confidence":1,"confidence_rate":1},{"cnt":[[348,1261],[1878,1261],[1878,1308],[348,1308]],"region":{"top_left_x":348,"top_left_y":1261,"width":1530,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f3e6eb115764e3c921780b210baf28a","type":"text","conversion_output":true,"text":"mechanical ventilation. If the method of mechanical ventilation is changed with no","text_display":" mechanical ventilation. If the method of mechanical ventilation is changed with no","confidence":1,"confidence_rate":1},{"cnt":[[348,1311],[1588,1311],[1588,1356],[348,1356]],"region":{"top_left_x":348,"top_left_y":1310,"width":1240,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc32194faee346aa98789a8985305061","type":"text","conversion_output":true,"text":"interruption, it corresponds to the same episode of mechanical ventilation.","text_display":" interruption, it corresponds to the same episode of mechanical ventilation.","confidence":0.99853515625,"confidence_rate":0.9999816761968517},{"cnt":[[348,1405],[1878,1405],[1878,1452],[348,1452]],"region":{"top_left_x":348,"top_left_y":1405,"width":1530,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a862924cf73946f4a7ac543061d95da3","type":"text","conversion_output":true,"text":"Should a patient die or withdraw prior to Day 28, the days remaining in this period will be","text_display":"\n\nShould a patient die or withdraw prior to Day 28, the days remaining in this period will be","confidence":1,"confidence_rate":1},{"cnt":[[348,1452],[1515,1452],[1515,1502],[348,1502]],"region":{"top_left_x":348,"top_left_y":1452,"width":1167,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86d304e4e8ff4128a6dbbf7acf0fd881","type":"text","conversion_output":true,"text":"counted as per the status of the patient at time of death or withdrawal.","text_display":" counted as per the status of the patient at time of death or withdrawal.","confidence":1,"confidence_rate":1},{"cnt":[[348,1549],[1880,1549],[1880,1596],[348,1596]],"region":{"top_left_x":348,"top_left_y":1549,"width":1532,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4929ae351fa4d06951e133d8c878ef1","type":"text","conversion_output":true,"text":"Ventilator-free days are calculated as 28 days minus the number of days a patient is on","text_display":"\n\nVentilator-free days are calculated as 28 days minus the number of days a patient is on","confidence":1,"confidence_rate":1},{"cnt":[[348,1598],[1882,1598],[1882,1644],[348,1644]],"region":{"top_left_x":348,"top_left_y":1598,"width":1535,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9619cd85bfa4eb2b64700113b1e76fc","type":"text","conversion_output":true,"text":"ventilator during this period. Descriptive statistics will be presented for the number of","text_display":" ventilator during this period. Descriptive statistics will be presented for the number of","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[348,1646],[685,1646],[685,1691],[348,1691]],"region":{"top_left_x":348,"top_left_y":1645,"width":338,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef22075881914a11a4b2ea6fe71fb78a","type":"text","conversion_output":true,"text":"ventilator-free days.","text_display":" ventilator-free days.","confidence":0.99951171875,"confidence_rate":0.9999812155418875},{"cnt":[[348,1740],[1878,1740],[1878,1790],[348,1790]],"region":{"top_left_x":348,"top_left_y":1740,"width":1530,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"437dce3e9c5a4cbcb42f7fdb0245fb44","type":"text","conversion_output":true,"text":"Time to being off ventilator from Day 1 to Day 28, for those patients that are on ventilator","text_display":"\n\nTime to being off ventilator from Day 1 to Day 28, for those patients that are on ventilator","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[348,1788],[1876,1788],[1876,1837],[348,1837]],"region":{"top_left_x":348,"top_left_y":1787,"width":1528,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a202e6c10ff24107a2b7b96caaf732bb","type":"text","conversion_output":true,"text":"at Day 1, will be compared between treatment groups by displaying Kaplan-Meier plots.","text_display":" at Day 1, will be compared between treatment groups by displaying Kaplan-Meier plots.","confidence":1,"confidence_rate":1},{"cnt":[[348,1835],[1089,1835],[1089,1884],[348,1884]],"region":{"top_left_x":348,"top_left_y":1834,"width":742,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61be488ea6ef40f191f9db7ee4566632","type":"text","conversion_output":true,"text":"Time to being off ventilator is calculated as:","text_display":" Time to being off ventilator is calculated as:","confidence":1,"confidence_rate":1},{"cnt":[[552,1931],[1669,1931],[1669,1979],[552,1979]],"region":{"top_left_x":552,"top_left_y":1931,"width":1118,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90999e19936c4782822de00502e039e9","type":"math","conversion_output":true,"text":"\\[\n\\text { Date of being off ventilator }- \\text { Start date of study drug infusion }+1 \\text {. }\n\\]","text_display":"\n\\[\n\\text { Date of being off ventilator }- \\text { Start date of study drug infusion }+1 \\text {. }\n\\]","confidence":0.60009765625,"confidence_rate":0.9936370439322232},{"cnt":[[348,2028],[1880,2028],[1880,2073],[348,2073]],"region":{"top_left_x":348,"top_left_y":2028,"width":1532,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bcada13bf3c4d73920edefb23b90e6b","type":"text","conversion_output":true,"text":"For patients that have been off ventilator and had to be put back on ventilator the latest","text_display":"\n\nFor patients that have been off ventilator and had to be put back on ventilator the latest","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[348,2075],[1880,2075],[1880,2123],[348,2123]],"region":{"top_left_x":348,"top_left_y":2075,"width":1532,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f44a22343b64830bc38c0a3042745ca","type":"text","conversion_output":true,"text":"case of ventilation will be used to calculate time to being off ventilator. Patients that do","text_display":" case of ventilation will be used to calculate time to being off ventilator. Patients that do","confidence":1,"confidence_rate":1},{"cnt":[[348,2123],[1880,2123],[1880,2172],[348,2172]],"region":{"top_left_x":348,"top_left_y":2122,"width":1532,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4c12988c3d74780b783630991e63c6f","type":"text","conversion_output":true,"text":"not have an off ventilator date will be censored at the earliest of Day 28 or date of study","text_display":" not have an off ventilator date will be censored at the earliest of Day 28 or date of study","confidence":1,"confidence_rate":1},{"cnt":[[348,2172],[1880,2172],[1880,2219],[348,2219]],"region":{"top_left_x":348,"top_left_y":2172,"width":1532,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d559679e4da04cb1928956815610baa5","type":"text","conversion_output":true,"text":"withdrawal. Patients not on ventilator at the start of study drug infusion will be excluded","text_display":" withdrawal. Patients not on ventilator at the start of study drug infusion will be excluded","confidence":1,"confidence_rate":1},{"cnt":[[348,2221],[657,2221],[657,2267],[348,2267]],"region":{"top_left_x":348,"top_left_y":2221,"width":310,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed1f8037b8c242d88a35cdcef9a5e988","type":"text","conversion_output":true,"text":"from this analysis.","text_display":" from this analysis.","confidence":1,"confidence_rate":1},{"cnt":[[348,2316],[1876,2316],[1876,2361],[348,2361]],"region":{"top_left_x":348,"top_left_y":2316,"width":1528,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a95c23f285a4da0ace13754bd4bd897","type":"text","conversion_output":true,"text":"A table of the corresponding Kaplan-Meier estimates will be presented displaying the","text_display":"\n\nA table of the corresponding Kaplan-Meier estimates will be presented displaying the","confidence":1,"confidence_rate":1},{"cnt":[[348,2363],[1878,2363],[1878,2411],[348,2411]],"region":{"top_left_x":348,"top_left_y":2363,"width":1530,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1154adc33d84a45ac303e5b64cb1bf2","type":"text","conversion_output":true,"text":"number of patients at risk, number of patients censored, number of patients off-ventilator,","text_display":" number of patients at risk, number of patients censored, number of patients off-ventilator,","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b602411f971446eb7444e253e56ade9","type":"page_info","conversion_output":false,"text":"38","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-46","page":46,"lines":[{"cnt":[[346,127],[492,127],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":126,"width":147,"height":31},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"29669ab87b99462a8d1ca75e14869bf7","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1850,125],[1850,159],[1366,159]],"region":{"top_left_x":1366,"top_left_y":124,"width":484,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fdf2ff5c5bb64e7aa62a0ad9ce4e5220","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"99af2faff8c749839bb37800947c4a3a","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.99755859375,"confidence_rate":0.9998937277628692},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"be48ecdc44d54b06be31c0af8d6b2dfe","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[346,329],[1878,329],[1878,376],[346,376]],"region":{"top_left_x":345,"top_left_y":328,"width":1533,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05d343c722de42ddb269000edd8fa8a9","type":"text","conversion_output":true,"text":"cumulative number of patients off-ventilator, Kaplan-Meier estimate, and standard errors","text_display":"\ncumulative number of patients off-ventilator, Kaplan-Meier estimate, and standard errors","confidence":1,"confidence_rate":1},{"cnt":[[346,374],[1878,374],[1878,423],[346,423]],"region":{"top_left_x":345,"top_left_y":373,"width":1533,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8c3c199ac7540e084a28fdd1241ff95","type":"text","conversion_output":true,"text":"of the Kaplan-Meier estimates. Summary statistics (based on the Kaplan-Meier analysis)","text_display":" of the Kaplan-Meier estimates. Summary statistics (based on the Kaplan-Meier analysis)","confidence":1,"confidence_rate":1},{"cnt":[[348,423],[1596,423],[1596,471],[348,471]],"region":{"top_left_x":348,"top_left_y":423,"width":1249,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d88082362af44e1bbc11e03f7ec8b12","type":"text","conversion_output":true,"text":"for the time to being off ventilator will also be included in a separate table.","text_display":" for the time to being off ventilator will also be included in a separate table.","confidence":0.996584415435791,"confidence_rate":0.9999592695082042},{"cnt":[[346,520],[1878,520],[1878,569],[346,569]],"region":{"top_left_x":345,"top_left_y":519,"width":1533,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6915ee56cab742f5b84d023bae0ecf85","type":"text","conversion_output":true,"text":"Exploratory analysis of time to being off-ventilator will be undertaken for the comparison","text_display":"\n\nExploratory analysis of time to being off-ventilator will be undertaken for the comparison","confidence":1,"confidence_rate":1},{"cnt":[[346,567],[1880,567],[1880,617],[346,617]],"region":{"top_left_x":345,"top_left_y":567,"width":1535,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26902c3067014414822e472f8464aa10","type":"text","conversion_output":true,"text":"of the optimal recAP dose and placebo using a log rank test stratified by site. The hazard","text_display":" of the optimal recAP dose and placebo using a log rank test stratified by site. The hazard","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[346,614],[1880,614],[1880,664],[346,664]],"region":{"top_left_x":345,"top_left_y":614,"width":1535,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ccbe4658cae4a079dc7f69b821d83b6","type":"text","conversion_output":true,"text":"ratio, associated \\(95 \\%\\) confidence interval and p -value from the comparisons of the optimal","text_display":" ratio, associated \\(95 \\%\\) confidence interval and p -value from the comparisons of the optimal","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[348,662],[1106,662],[1106,711],[348,711]],"region":{"top_left_x":348,"top_left_y":661,"width":759,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02f865bb8c6b4a9faf9c1cbad6c0124e","type":"text","conversion_output":true,"text":"recAP dose versus Placebo will be presented.","text_display":" recAP dose versus Placebo will be presented.","confidence":0.99951171875,"confidence_rate":0.9999900326925697},{"cnt":[[346,758],[1867,758],[1867,806],[346,806]],"region":{"top_left_x":345,"top_left_y":758,"width":1522,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04f5a4b6247a4b5e8c961b33eb6ea004","type":"text","conversion_output":true,"text":"The number and percentage of patients not on mechanical ventilation at baseline, requiring","text_display":"\n\nThe number and percentage of patients not on mechanical ventilation at baseline, requiring","confidence":1,"confidence_rate":1},{"cnt":[[348,808],[1807,808],[1807,853],[348,853]],"region":{"top_left_x":348,"top_left_y":807,"width":1459,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76441ff7b56241bfa503db20ec59a988","type":"text","conversion_output":true,"text":"and not requiring mechanical ventilation during the first 28 days will also be presented.","text_display":" and not requiring mechanical ventilation during the first 28 days will also be presented.","confidence":1,"confidence_rate":1},{"cnt":[[348,902],[1396,902],[1396,943],[348,943]],"region":{"top_left_x":348,"top_left_y":902,"width":1049,"height":42},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcc11d75324c4ca2bad5e85a130cfcae","type":"text","conversion_output":true,"text":"Mechanical and non-mechanical ventilation data will be listed.","text_display":"\n\nMechanical and non-mechanical ventilation data will be listed.","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[344,997],[939,997],[939,1051],[344,1051]],"region":{"top_left_x":343,"top_left_y":996,"width":596,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"104d23a0b8bc4482a80de7cbd90560d9","type":"section_header","conversion_output":false,"children_ids":["fb028dd74fce45378ea308783069defd"],"text":"","text_display":""},{"cnt":[[348,1001],[935,1001],[935,1046],[348,1046]],"region":{"top_left_x":348,"top_left_y":1001,"width":587,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb028dd74fce45378ea308783069defd","type":"text","conversion_output":true,"parent_id":"104d23a0b8bc4482a80de7cbd90560d9","text":"Shock-free from Day 1 to Day 28","text_display":"\n\n\\section*{Shock-free from Day 1 to Day 28}","confidence":1,"confidence_rate":1},{"cnt":[[348,1096],[1878,1096],[1878,1141],[348,1141]],"region":{"top_left_x":348,"top_left_y":1095,"width":1530,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9e97660508f477bbbd9561275e36fa4","type":"text","conversion_output":true,"text":"Shock-free is defined as a patient that is not on vasopressors or inotropic agents. Shock-","text_display":"\n\nShock-free is defined as a patient that is not on vasopressors or inotropic agents. 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mean SOFA score displaying the optimal recAP and placebo groups only.","text_display":" presented for the mean SOFA score displaying the optimal recAP and placebo groups only.","confidence":1,"confidence_rate":1},{"cnt":[[348,2101],[1880,2101],[1880,2148],[348,2148]],"region":{"top_left_x":348,"top_left_y":2101,"width":1532,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"871401f4e0dc4877b5f4fa1a225fc3c2","type":"text","conversion_output":true,"text":"The number of dysfunctional organs for each patient will be summarized with counts and","text_display":"\n\nThe number of dysfunctional organs for each patient will be summarized with counts 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period}","confidence":1,"confidence_rate":1},{"cnt":[[348,425],[1884,425],[1884,471],[348,471]],"region":{"top_left_x":348,"top_left_y":425,"width":1537,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ba6d4f9a4304d3f80f4b100868adb46","type":"text","conversion_output":true,"text":"Mortality at Day 28 and Day 90 will be summarized by the counts and percentages of","text_display":"\n\nMortality at Day 28 and Day 90 will be summarized by the counts and percentages of","confidence":1,"confidence_rate":1},{"cnt":[[348,473],[1880,473],[1880,520],[348,520]],"region":{"top_left_x":348,"top_left_y":472,"width":1532,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccb5d7e9c8794f439e2d0beb8de77cd5","type":"text","conversion_output":true,"text":"patients who died prior to or at these timepoints. Exploratory analysis will also be","text_display":" patients who died prior to or at these timepoints. Exploratory analysis will also be","confidence":1,"confidence_rate":1},{"cnt":[[348,520],[1878,520],[1878,569],[348,569]],"region":{"top_left_x":348,"top_left_y":519,"width":1530,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c268b33ce0241c4821eaa3d86cfe64c","type":"text","conversion_output":true,"text":"undertaken to compare the number of deaths between the optimal recAP dose and placebo","text_display":" undertaken to compare the number of deaths between the optimal recAP dose and placebo","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[348,567],[1880,567],[1880,617],[348,617]],"region":{"top_left_x":348,"top_left_y":567,"width":1532,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa8570cd53d94a91a6303b3ca9beabfb","type":"text","conversion_output":true,"text":"at Day 28 and Day 90 using a Cochran-Mantel-Haenzel (CMH) test. The CMH test","text_display":" at Day 28 and Day 90 using a Cochran-Mantel-Haenzel (CMH) test. The CMH test","confidence":1,"confidence_rate":1},{"cnt":[[348,614],[1300,614],[1300,664],[348,664]],"region":{"top_left_x":348,"top_left_y":614,"width":952,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c459b37636d4d7fb63245b3cf7d1d1d","type":"text","conversion_output":true,"text":"statistic and the corresponding p -value will be presented.","text_display":" statistic and the corresponding p -value will be presented.","confidence":0.99609375,"confidence_rate":0.9999440887156493},{"cnt":[[348,709],[1880,709],[1880,758],[348,758]],"region":{"top_left_x":348,"top_left_y":708,"width":1532,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e02b43b38fb64cc4a44bdcda27b61552","type":"text","conversion_output":true,"text":"Should either of the CMH tests at Day 28 and Day 90 produce a significant result, time to","text_display":"\n\nShould either of the CMH tests at Day 28 and Day 90 produce a significant result, time to","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[346,758],[1880,758],[1880,810],[346,810]],"region":{"top_left_x":345,"top_left_y":758,"width":1535,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f35c3a1bb0a4b50bc5a5783119ae047","type":"text","conversion_output":true,"text":"death from Day 1 to Day 90 will be compared between treatment groups by displaying","text_display":" death from Day 1 to Day 90 will be compared between treatment groups by displaying","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[346,808],[1205,808],[1205,855],[346,855]],"region":{"top_left_x":345,"top_left_y":807,"width":861,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12e3656f07984bb7b4f7424c23148b0d","type":"text","conversion_output":true,"text":"Kaplan-Meier plots. Time to death is calculated as:","text_display":" Kaplan-Meier plots. Time to death is calculated as:","confidence":1,"confidence_rate":1},{"cnt":[[664,898],[1558,898],[1558,956],[664,956]],"region":{"top_left_x":663,"top_left_y":898,"width":895,"height":59},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee551a16ae7741559545330cce37a58b","type":"quote","conversion_output":false,"children_ids":["6320ca91e84447e894fdb7900516d8bf"],"text":"","text_display":""},{"cnt":[[666,902],[1553,902],[1553,952],[666,952]],"region":{"top_left_x":666,"top_left_y":902,"width":888,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6320ca91e84447e894fdb7900516d8bf","type":"text","conversion_output":true,"parent_id":"ee551a16ae7741559545330cce37a58b","text":"Date of death - Start date of study drug infusion +1 .","text_display":"\n\n> Date of death - Start date of study drug infusion +1 .","confidence":0.6003684997558594,"confidence_rate":0.9918045472446787},{"cnt":[[346,999],[1880,999],[1880,1046],[346,1046]],"region":{"top_left_x":345,"top_left_y":999,"width":1535,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d36aea673ae439bb401ba755939bc8b","type":"text","conversion_output":true,"text":"Patients that do not die will be censored at the earliest of Day 90 or date of study","text_display":"\n\nPatients that do not die will be censored at the earliest of Day 90 or date of study","confidence":1,"confidence_rate":1},{"cnt":[[346,1044],[1880,1044],[1880,1094],[346,1094]],"region":{"top_left_x":345,"top_left_y":1044,"width":1535,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8cafa8b71554ea08aa7b9bfa926925a","type":"text","conversion_output":true,"text":"withdrawal. A table of the corresponding Kaplan-Meier estimates will be presented","text_display":" withdrawal. A table of the corresponding Kaplan-Meier estimates will be presented","confidence":1,"confidence_rate":1},{"cnt":[[348,1096],[1880,1096],[1880,1143],[348,1143]],"region":{"top_left_x":348,"top_left_y":1095,"width":1532,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5d65038c2b44387ad8d525394547a60","type":"text","conversion_output":true,"text":"displaying the number of patients at risk, number of patients censored, number of deaths,","text_display":" displaying the number of patients at risk, number of patients censored, number of deaths,","confidence":1,"confidence_rate":1},{"cnt":[[348,1143],[1880,1143],[1880,1190],[348,1190]],"region":{"top_left_x":348,"top_left_y":1142,"width":1532,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7b86a5f6da84c4abaafd383a0eac60e","type":"text","conversion_output":true,"text":"cumulative number of deaths, Kaplan-Meier estimate, and standard errors of the Kaplan-","text_display":" cumulative number of deaths, Kaplan-Meier estimate, and standard errors of the Kaplan","confidence":1,"confidence_rate":1},{"cnt":[[348,1190],[1878,1190],[1878,1240],[348,1240]],"region":{"top_left_x":348,"top_left_y":1190,"width":1530,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96d761eb467647a0b62d4d09f643ff24","type":"text","conversion_output":true,"text":"Meier estimates. Summary statistics (based on the Kaplan-Meier analysis) for the time to","text_display":"Meier estimates. Summary statistics (based on the Kaplan-Meier analysis) for the time to","confidence":1,"confidence_rate":1},{"cnt":[[346,1238],[1119,1238],[1119,1287],[346,1287]],"region":{"top_left_x":345,"top_left_y":1237,"width":775,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cf63fbb18374003b8093551a9e16a64","type":"text","conversion_output":true,"text":"death will also be included in a separate table.","text_display":" death will also be included in a separate table.","confidence":0.998046875,"confidence_rate":0.9999631132306015},{"cnt":[[344,1332],[574,1332],[574,1377],[344,1377]],"region":{"top_left_x":343,"top_left_y":1332,"width":231,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"167ea7e2d7e64d13ba039ff591801e6a","type":"section_header","conversion_output":false,"children_ids":["010ebbf40a5949e4b9b05617795dd701"],"text":"","text_display":""},{"cnt":[[348,1336],[569,1336],[569,1377],[348,1377]],"region":{"top_left_x":348,"top_left_y":1336,"width":222,"height":42},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"010ebbf40a5949e4b9b05617795dd701","type":"text","conversion_output":true,"parent_id":"167ea7e2d7e64d13ba039ff591801e6a","text":"Purine Data","text_display":"\n\n\\section*{Purine Data}","confidence":1,"confidence_rate":1},{"cnt":[[346,1431],[1878,1431],[1878,1480],[346,1480]],"region":{"top_left_x":345,"top_left_y":1430,"width":1533,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"059656d78fb149d0b139fd6a8be6b84b","type":"text","conversion_output":true,"text":"Purine data will be listed along with urine volume and urine sample collection start date","text_display":"\n\nPurine data will be listed along with urine volume and urine sample collection start date","confidence":1,"confidence_rate":1},{"cnt":[[348,1478],[1012,1478],[1012,1519],[348,1519]],"region":{"top_left_x":348,"top_left_y":1478,"width":664,"height":41},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32d030acd60d45e39cd71f18c3e11f75","type":"text","conversion_output":true,"text":"and collection times for the Iohexol set.","text_display":" and collection times for the Iohexol set.","confidence":1,"confidence_rate":1},{"cnt":[[529,1616],[958,1616],[958,1665],[529,1665]],"region":{"top_left_x":528,"top_left_y":1615,"width":431,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aae53a6342134e4b8e3734b02ce6513a","type":"section_header","conversion_output":false,"children_ids":["dc3a99749bd44300a35134a652ffd042"],"text":"","text_display":""},{"cnt":[[533,1620],[956,1620],[956,1661],[533,1661]],"region":{"top_left_x":532,"top_left_y":1619,"width":425,"height":42},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc3a99749bd44300a35134a652ffd042","type":"text","conversion_output":true,"parent_id":"aae53a6342134e4b8e3734b02ce6513a","text":"8.2.2.3. 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proteinuria at Baseline and Day 1 to Day 90.","confidence":0.64404296875,"confidence_rate":0.9926936581520979},{"cnt":[[348,2058],[1880,2058],[1880,2108],[348,2108]],"region":{"top_left_x":348,"top_left_y":2058,"width":1532,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33e4b64704b44302aa7d65308ce9e5b3","type":"text","conversion_output":true,"text":"The observed values and change from baseline for kidney function markers will be","text_display":"\n\nThe observed values and change from baseline for kidney function markers will be","confidence":1,"confidence_rate":1},{"cnt":[[348,2108],[1381,2108],[1381,2157],[348,2157]],"region":{"top_left_x":348,"top_left_y":2107,"width":1034,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02a6e3a91f374fcca7a27778f4603a40","type":"text","conversion_output":true,"text":"calculated by visit and summarized with descriptive statistics.","text_display":" calculated by visit and summarized with descriptive statistics.","confidence":1,"confidence_rate":1},{"cnt":[[348,2204],[1059,2204],[1059,2254],[348,2254]],"region":{"top_left_x":348,"top_left_y":2204,"width":712,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb4d491a4c074d179e16b77eee63b5f5","type":"text","conversion_output":true,"text":"All kidney function markers will be listed.","text_display":"\n\nAll kidney function markers will be 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Each dimension has 5 response options (no","confidence":1,"confidence_rate":1},{"cnt":[[346,2148],[1880,2148],[1880,2198],[346,2198]],"region":{"top_left_x":345,"top_left_y":2148,"width":1535,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e8f6b757c704ebf950b8d911d17e23c","type":"text","conversion_output":true,"text":"problems, slight problems, moderate problems, severe problems, and extreme problems)","text_display":" problems, slight problems, moderate problems, severe problems, and extreme problems)","confidence":1,"confidence_rate":1},{"cnt":[[348,2196],[1880,2196],[1880,2245],[348,2245]],"region":{"top_left_x":348,"top_left_y":2195,"width":1532,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94a7f502c7d648fb98a274b003fd5e1d","type":"text","conversion_output":true,"text":"that reflect increasing levels of difficulty. The patient will be asked to indicate his/her","text_display":" that reflect increasing levels of difficulty. 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For the calculation of Total time in","text_display":" summarized by the descriptive statistics. For the calculation of Total time in","confidence":1,"confidence_rate":1},{"cnt":[[348,1143],[1878,1143],[1878,1192],[348,1192]],"region":{"top_left_x":348,"top_left_y":1142,"width":1530,"height":51},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fa062f608ff04d5386772993583f50e2","type":"text","conversion_output":true,"text":"ICU/Immediate care for Day 1 to 28 if a subject discontinued or died prior to Day 28","text_display":" ICU/Immediate care for Day 1 to 28 if a subject discontinued or died prior to Day 28","confidence":1,"confidence_rate":1},{"cnt":[[348,1190],[1882,1190],[1882,1240],[348,1240]],"region":{"top_left_x":348,"top_left_y":1190,"width":1535,"height":50},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"033aea5da645408fa41c77eda410dfc2","type":"text","conversion_output":true,"text":"whilst still in ICU, the ICU discharge date is assumed as Day 28. For the calculation of","text_display":" whilst still in ICU, the ICU discharge date is assumed as Day 28. For the calculation of","confidence":1,"confidence_rate":1},{"cnt":[[346,1237],[1880,1237],[1880,1287],[346,1287]],"region":{"top_left_x":345,"top_left_y":1237,"width":1535,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab57913a43c9498e8a40191d45f27d53","type":"text","conversion_output":true,"text":"Total time in ICU/Immediate care for Day 1 to 90, if a subject discontinued or died whilst","text_display":" Total time in ICU/Immediate care for Day 1 to 90, if a subject discontinued or died whilst","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[348,1285],[1880,1285],[1880,1334],[348,1334]],"region":{"top_left_x":348,"top_left_y":1284,"width":1532,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"933559869d4f46d98411d4df7463610a","type":"text","conversion_output":true,"text":"still in ICU, then the discharge date will be assumed as taking the maximum of Day 28 or","text_display":" still in ICU, then the discharge date will be assumed as taking the maximum of Day 28 or","confidence":1,"confidence_rate":1},{"cnt":[[348,1332],[801,1332],[801,1381],[348,1381]],"region":{"top_left_x":348,"top_left_y":1332,"width":454,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9369e1d8e6f4457a9596462554bfdec","type":"text","conversion_output":true,"text":"study discontinuation date.","text_display":" study discontinuation date.","confidence":1,"confidence_rate":1},{"cnt":[[346,1429],[1880,1429],[1880,1480],[346,1480]],"region":{"top_left_x":345,"top_left_y":1428,"width":1535,"height":53},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d2598b46861849768ada9b7cb5665c99","type":"text","conversion_output":true,"text":"Time to being discharged from ICU/Intermediate care will be compared between treatment","text_display":"\n\nTime to being discharged from ICU/Intermediate care will be compared between treatment","confidence":1,"confidence_rate":1},{"cnt":[[348,1478],[1880,1478],[1880,1528],[348,1528]],"region":{"top_left_x":348,"top_left_y":1478,"width":1532,"height":50},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29d6dce9e6c74990ad26c5ff2094ce6d","type":"text","conversion_output":true,"text":"groups by displaying Kaplan-Meier plots, where discharge is defined as the time when the","text_display":" groups by displaying Kaplan-Meier plots, where discharge is defined as the time when the","confidence":1,"confidence_rate":1},{"cnt":[[348,1525],[1880,1525],[1880,1575],[348,1575]],"region":{"top_left_x":348,"top_left_y":1525,"width":1532,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d0a00eb2d5e46d68993556cd6c10bcc","type":"text","conversion_output":true,"text":"decision was made to transfer the patient (as opposed to the time of actual transfer). Time","text_display":" decision was made to transfer the patient (as opposed to the time of actual transfer). Time","confidence":1,"confidence_rate":1},{"cnt":[[348,1573],[1429,1573],[1429,1622],[348,1622]],"region":{"top_left_x":348,"top_left_y":1572,"width":1081,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d5eb3a2e7e34b989037dfe56c5cd1cd","type":"text","conversion_output":true,"text":"to being discharged from ICU/Intermediate care is calculated as:","text_display":" to being discharged from ICU/Intermediate care is calculated as:","confidence":1,"confidence_rate":1},{"cnt":[[350,1669],[1871,1669],[1871,1717],[350,1717]],"region":{"top_left_x":350,"top_left_y":1669,"width":1522,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"056db3e078b046c2ac7ad074f4d01c7f","type":"text","conversion_output":true,"text":"Planned discharge date from ICU/Intermediate care - Start date of study drug infusion +1 .","text_display":"\n\nPlanned discharge date from ICU/Intermediate care - Start date of study drug infusion +1 .","confidence":0.9848773445701227,"confidence_rate":0.9998445205693758},{"cnt":[[346,1766],[1880,1766],[1880,1813],[346,1813]],"region":{"top_left_x":345,"top_left_y":1766,"width":1535,"height":48},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c40335eba174873b177e36885abbfc6","type":"text","conversion_output":true,"text":"For patients that have been discharged from the ICU/Intermediate care and had to be","text_display":"\n\nFor patients that have been discharged from the ICU/Intermediate care and had to be","confidence":1,"confidence_rate":1},{"cnt":[[346,1813],[1880,1813],[1880,1863],[346,1863]],"region":{"top_left_x":345,"top_left_y":1813,"width":1535,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"066fec13b1484647990f656c0e900d7c","type":"text","conversion_output":true,"text":"readmitted, only their first case of admission will be used to calculate time to being","text_display":" readmitted, only their first case of admission will be used to calculate time to being","confidence":1,"confidence_rate":1},{"cnt":[[346,1861],[1880,1861],[1880,1910],[346,1910]],"region":{"top_left_x":345,"top_left_y":1860,"width":1535,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a76f328f6bf4bb8ade7797baa2049a8","type":"text","conversion_output":true,"text":"discharged from the ICU/Intermediate care. Patients that have transferred to another","text_display":" discharged from the ICU/Intermediate care. Patients that have transferred to another","confidence":1,"confidence_rate":1},{"cnt":[[348,1908],[1876,1908],[1876,1957],[348,1957]],"region":{"top_left_x":348,"top_left_y":1907,"width":1528,"height":51},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02a4eaf4c93b44c4b9024f660aceece6","type":"text","conversion_output":true,"text":"ICU/Intermediate care will not be classed as discharged from the ICU/Intermediate care.","text_display":" ICU/Intermediate care will not be classed as discharged from the ICU/Intermediate care.","confidence":1,"confidence_rate":1},{"cnt":[[348,1955],[1880,1955],[1880,2004],[348,2004]],"region":{"top_left_x":348,"top_left_y":1955,"width":1532,"height":50},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56b60578e9844ebcadc545a0691fde58","type":"text","conversion_output":true,"text":"Patients that have not been discharged from the ICU/Intermediate care will be censored at","text_display":" Patients that have not been discharged from the ICU/Intermediate care will be censored at","confidence":1,"confidence_rate":1},{"cnt":[[346,2002],[1878,2002],[1878,2052],[346,2052]],"region":{"top_left_x":345,"top_left_y":2002,"width":1533,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e706721341e24c9ab1834735c422be65","type":"text","conversion_output":true,"text":"Day 28 (when died or discontinued prior to Day 28) or on the date of study withdrawal","text_display":" Day 28 (when died or discontinued prior to Day 28) or on the date of study withdrawal","confidence":1,"confidence_rate":1},{"cnt":[[348,2050],[1051,2050],[1051,2101],[348,2101]],"region":{"top_left_x":348,"top_left_y":2049,"width":703,"height":53},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f22743cc57a49da8d3175dcfc1829b5","type":"text","conversion_output":true,"text":"(when died or discontinued after Day 28).","text_display":" (when died or discontinued after Day 28).","confidence":1,"confidence_rate":1},{"cnt":[[346,2148],[1878,2148],[1878,2198],[346,2198]],"region":{"top_left_x":345,"top_left_y":2148,"width":1533,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7a5e4a87c4843ed9a8003d702bc36fe","type":"text","conversion_output":true,"text":"A table of the corresponding Kaplan-Meier estimates will be presented displaying the","text_display":"\n\nA table of the corresponding Kaplan-Meier estimates will be presented displaying the","confidence":1,"confidence_rate":1},{"cnt":[[346,2196],[1880,2196],[1880,2245],[346,2245]],"region":{"top_left_x":345,"top_left_y":2195,"width":1535,"height":51},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c0e630216b349b1b01bffd5082f9329","type":"text","conversion_output":true,"text":"number of patients at risk, number of patients censored, number of patients discharged","text_display":" number of patients at risk, number of patients censored, number of patients discharged","confidence":1,"confidence_rate":1},{"cnt":[[346,2243],[1880,2243],[1880,2292],[346,2292]],"region":{"top_left_x":345,"top_left_y":2242,"width":1535,"height":51},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dfbb8e3b5c6648dca61b5ec63326c798","type":"text","conversion_output":true,"text":"from ICU/Intermediate care, cumulative number of patients discharged from","text_display":" from ICU/Intermediate care, cumulative number of patients discharged from","confidence":1,"confidence_rate":1},{"cnt":[[348,2290],[1880,2290],[1880,2342],[348,2342]],"region":{"top_left_x":348,"top_left_y":2290,"width":1532,"height":52},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f7d2b2035254374a81f146aa544530e","type":"text","conversion_output":true,"text":"ICU/Intermediate care, Kaplan-Meier estimate, and standard errors of the Kaplan-Meier","text_display":" ICU/Intermediate care, Kaplan-Meier estimate, and standard errors of the Kaplan-Meier","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1139,2582],[1139,2623],[1087,2623]],"region":{"top_left_x":1087,"top_left_y":2582,"width":52,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3dbf5196237345d6b0bfb4412a7d2e00","type":"page_info","conversion_output":false,"text":"43","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-51","page":51,"lines":[{"cnt":[[346,127],[492,127],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":126,"width":147,"height":31},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"37704a96dd5340089b5f7346c494dece","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1850,125],[1850,161],[1366,161]],"region":{"top_left_x":1366,"top_left_y":124,"width":484,"height":38},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"16e74ec2af0d434789152cbb8541884e","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"11a35e43e16542da8d0406ae205bee0c","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.998046875,"confidence_rate":0.9999150020979263},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"737383df0edc44f185aaf995a35f3bc2","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[346,329],[1880,329],[1880,376],[346,376]],"region":{"top_left_x":345,"top_left_y":328,"width":1535,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24dbea37990c4eb799a8d9b95ec29252","type":"text","conversion_output":true,"text":"estimates. Summary statistics (based on the Kaplan-Meier analysis) for the time to","text_display":"\nestimates. Summary statistics (based on the Kaplan-Meier analysis) for the time to","confidence":1,"confidence_rate":1},{"cnt":[[346,374],[1663,374],[1663,423],[346,423]],"region":{"top_left_x":345,"top_left_y":373,"width":1318,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df5eca6615954422a242411ad81047bd","type":"text","conversion_output":true,"text":"discharge from ICU/Intermediate care will also be included in a separate table.","text_display":" discharge from ICU/Intermediate care will also be included in a separate table.","confidence":0.972681999206543,"confidence_rate":0.9996703153664331},{"cnt":[[348,473],[1878,473],[1878,518],[348,518]],"region":{"top_left_x":348,"top_left_y":472,"width":1530,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbcb8197761248e3a5a0f68163c95c87","type":"text","conversion_output":true,"text":"Exploratory analysis of time to being discharged from the ICU/Intermediate care will be","text_display":"\n\nExploratory analysis of time to being discharged from the ICU/Intermediate care will be","confidence":1,"confidence_rate":1},{"cnt":[[348,520],[1880,520],[1880,569],[348,569]],"region":{"top_left_x":348,"top_left_y":519,"width":1532,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e469ded847b944b6829139a71753b153","type":"text","conversion_output":true,"text":"undertaken for the comparison of the optimal recAP dose and placebo using a log rank test","text_display":" undertaken for the comparison of the optimal recAP dose and placebo using a log rank test","confidence":1,"confidence_rate":1},{"cnt":[[348,567],[1880,567],[1880,617],[348,617]],"region":{"top_left_x":348,"top_left_y":567,"width":1532,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec8b9255b0d741a6a69674682aea8365","type":"text","conversion_output":true,"text":"stratified by site. The hazard ratio, associated \\(95 \\%\\) confidence interval and p -value from","text_display":" stratified by site. The hazard ratio, associated \\(95 \\%\\) confidence interval and p -value from","confidence":0.998046875,"confidence_rate":0.9999812017648063},{"cnt":[[346,614],[1635,614],[1635,664],[346,664]],"region":{"top_left_x":345,"top_left_y":614,"width":1290,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e73a3d0fb510406a8b1ed30459155891","type":"text","conversion_output":true,"text":"the comparisons of the optimal recAP dose versus Placebo will be presented.","text_display":" the comparisons of the optimal recAP dose versus Placebo will be presented.","confidence":0.9990234375,"confidence_rate":0.9999877870789805},{"cnt":[[346,709],[1313,709],[1313,758],[346,758]],"region":{"top_left_x":345,"top_left_y":708,"width":968,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04212e4c76d6482b81be98f107cc4656","type":"text","conversion_output":true,"text":"Discharge from ICU/Intermediate care data will be listed.","text_display":"\n\nDischarge from ICU/Intermediate care data will be listed.","confidence":1,"confidence_rate":1},{"cnt":[[339,804],[1523,804],[1523,862],[339,862]],"region":{"top_left_x":339,"top_left_y":803,"width":1185,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5166da200214cefaad378c81337dc76","type":"section_header","conversion_output":false,"children_ids":["d02d4df95be54f59af7b110f299d12cc"],"text":"","text_display":""},{"cnt":[[346,808],[1519,808],[1519,857],[346,857]],"region":{"top_left_x":345,"top_left_y":807,"width":1174,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d02d4df95be54f59af7b110f299d12cc","type":"text","conversion_output":true,"parent_id":"b5166da200214cefaad378c81337dc76","text":"Discharge from Hospital for Day 1 to Day 28 and Day 1 to Day 90","text_display":"\n\n\\section*{Discharge from Hospital for Day 1 to Day 28 and Day 1 to Day 90}","confidence":1,"confidence_rate":1},{"cnt":[[346,902],[1880,902],[1880,952],[346,952]],"region":{"top_left_x":345,"top_left_y":902,"width":1535,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e780c7105e8446b88eb37ce10d6db656","type":"text","conversion_output":true,"text":"Total time in hospital and Time to being discharged from hospital will be analyzed in an","text_display":"\n\nTotal time in hospital and Time to being discharged from hospital will be analyzed in an","confidence":1,"confidence_rate":1},{"cnt":[[348,950],[1880,950],[1880,999],[348,999]],"region":{"top_left_x":348,"top_left_y":949,"width":1532,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66a9f7ad01094cec953e1e364fb1d156","type":"text","conversion_output":true,"text":"identical fashion to the method described above, except the stratified log-rank test will not","text_display":" identical fashion to the method described above, except the stratified log-rank test will not","confidence":1,"confidence_rate":1},{"cnt":[[348,997],[1880,997],[1880,1046],[348,1046]],"region":{"top_left_x":348,"top_left_y":996,"width":1532,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4876bc32681744379c2d7f28c5d22238","type":"text","conversion_output":true,"text":"be performed. Patients that have transferred to another hospital will not be classed as","text_display":" be performed. Patients that have transferred to another hospital will not be classed as","confidence":1,"confidence_rate":1},{"cnt":[[346,1044],[1878,1044],[1878,1094],[346,1094]],"region":{"top_left_x":345,"top_left_y":1044,"width":1533,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da3b4f9c52a04458ac21bb7e0e6357d5","type":"text","conversion_output":true,"text":"discharged from the hospital. For the calculation of Total time in hospital for Day 1 to 28,","text_display":" discharged from the hospital. For the calculation of Total time in hospital for Day 1 to 28,","confidence":1,"confidence_rate":1},{"cnt":[[348,1094],[1880,1094],[1880,1143],[348,1143]],"region":{"top_left_x":348,"top_left_y":1093,"width":1532,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24bf303281a84a0691e5a5f291d0c69c","type":"text","conversion_output":true,"text":"if a subject discontinued or died prior to Day 28 whilst still in hospital, the hospital","text_display":" if a subject discontinued or died prior to Day 28 whilst still in hospital, the hospital","confidence":1,"confidence_rate":1},{"cnt":[[348,1143],[1880,1143],[1880,1190],[348,1190]],"region":{"top_left_x":348,"top_left_y":1142,"width":1532,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69243fb366dc43a6bd563387b6990879","type":"text","conversion_output":true,"text":"discharge date is assumed as Day 28. For the calculation of Total time in hospital for Day","text_display":" discharge date is assumed as Day 28. For the calculation of Total time in hospital for Day","confidence":1,"confidence_rate":1},{"cnt":[[348,1190],[1880,1190],[1880,1240],[348,1240]],"region":{"top_left_x":348,"top_left_y":1190,"width":1532,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6131a60eb44c4047b79752df363f6557","type":"text","conversion_output":true,"text":"1 to 90 , if a subject discontinued or died whilst still in hospital, then the discharge date will","text_display":" 1 to 90 , if a subject discontinued or died whilst still in hospital, then the discharge date will","confidence":0.9580078125,"confidence_rate":0.9995915182510713},{"cnt":[[346,1238],[1626,1238],[1626,1287],[346,1287]],"region":{"top_left_x":345,"top_left_y":1237,"width":1282,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acdd159a88c542bc81fae11f99dcc039","type":"text","conversion_output":true,"text":"be assumed as taking the maximum of Day 28 or study discontinuation date.","text_display":" be assumed as taking the maximum of Day 28 or study discontinuation date.","confidence":0.99072265625,"confidence_rate":0.9998849369124428},{"cnt":[[339,1379],[660,1379],[660,1435],[339,1435]],"region":{"top_left_x":339,"top_left_y":1379,"width":321,"height":57},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a0a66aaae4045b4a11e1be3e77d172c","type":"section_header","conversion_output":false,"children_ids":["62b18682a88b470cb1d6cf135711722d"],"text":"","text_display":""},{"cnt":[[348,1384],[655,1384],[655,1429],[348,1429]],"region":{"top_left_x":348,"top_left_y":1383,"width":308,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62b18682a88b470cb1d6cf135711722d","type":"text","conversion_output":true,"parent_id":"6a0a66aaae4045b4a11e1be3e77d172c","text":"Iohexol substudy","text_display":"\n\n\\section*{Iohexol substudy}","confidence":1,"confidence_rate":1},{"cnt":[[346,1478],[1878,1478],[1878,1525],[346,1525]],"region":{"top_left_x":345,"top_left_y":1478,"width":1533,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f53df05ee1da48959de823f203f4c05d","type":"text","conversion_output":true,"text":"Para-aminohippuric (PAH) will not be included in any analyses or data listings because","text_display":"\n\nPara-aminohippuric (PAH) will not be included in any analyses or data listings because","confidence":1,"confidence_rate":1},{"cnt":[[348,1525],[1008,1525],[1008,1575],[348,1575]],"region":{"top_left_x":348,"top_left_y":1525,"width":660,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dcb6a2e640a4550b0a8b5c714dc48e6","type":"text","conversion_output":true,"text":"this product is no longer manufactured.","text_display":" this product is no longer manufactured.","confidence":1,"confidence_rate":1},{"cnt":[[346,1620],[1878,1620],[1878,1669],[346,1669]],"region":{"top_left_x":345,"top_left_y":1619,"width":1533,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6de24746b3f4dfe9cd53c512bbfd780","type":"text","conversion_output":true,"text":"A single intravenous bolus injection of 5 mL iohexol (Omnipaque \\(240 mg / mL\\) ) will be","text_display":"\n\nA single intravenous bolus injection of 5 mL iohexol (Omnipaque \\(240 mg / mL\\) ) will be","confidence":1,"confidence_rate":1},{"cnt":[[348,1669],[1880,1669],[1880,1717],[348,1717]],"region":{"top_left_x":348,"top_left_y":1669,"width":1532,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b25c1d8f68f54fb59ff7ccca37c7f0a3","type":"text","conversion_output":true,"text":"administered over 5 minutes on Day 1 and on Day 7 or discharge from the ICU, whichever","text_display":" administered over 5 minutes on Day 1 and on Day 7 or discharge from the ICU, whichever","confidence":1,"confidence_rate":1},{"cnt":[[348,1714],[1880,1714],[1880,1762],[348,1762]],"region":{"top_left_x":348,"top_left_y":1714,"width":1532,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d93ab94ecb424f3a901a19fce69d0f16","type":"text","conversion_output":true,"text":"comes first. The bolus will be administered at the start of the \\(6 \\pm 1\\) hour urine collection","text_display":" comes first. The bolus will be administered at the start of the \\(6 \\pm 1\\) hour urine collection","confidence":1,"confidence_rate":1},{"cnt":[[348,1762],[1880,1762],[1880,1813],[348,1813]],"region":{"top_left_x":348,"top_left_y":1761,"width":1532,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd8f4118d3be49b48ac8e7044f9dcda9","type":"text","conversion_output":true,"text":"interval. For the measurement of iohexol, 2 mL blood samples will be collected in EDTA","text_display":" interval. For the measurement of iohexol, 2 mL blood samples will be collected in EDTA","confidence":0.99853515625,"confidence_rate":0.9999847301407262},{"cnt":[[348,1811],[1880,1811],[1880,1863],[348,1863]],"region":{"top_left_x":348,"top_left_y":1811,"width":1532,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03ed4916a9ac44d388fbeea5a8033f38","type":"text","conversion_output":true,"text":"anticoagulated Vacutainer® tubes at the following time points: prior to iohexol bolus","text_display":" anticoagulated Vacutainer® tubes at the following time points: prior to iohexol bolus","confidence":1,"confidence_rate":1},{"cnt":[[346,1861],[1145,1861],[1145,1910],[346,1910]],"region":{"top_left_x":345,"top_left_y":1860,"width":801,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77c6fc1cb09a4a1595d5ba51e34d7906","type":"text","conversion_output":true,"text":"administration and at 60,120 , and 360 minutes.","text_display":" administration and at 60,120 , and 360 minutes.","confidence":0.9931697845458984,"confidence_rate":0.9998818406341814},{"cnt":[[348,1955],[1828,1955],[1828,2004],[348,2004]],"region":{"top_left_x":348,"top_left_y":1955,"width":1481,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d53735e52d847f68fe05c34d8de5852","type":"text","conversion_output":true,"text":"\\(CL _{\\text {Iohexol }}\\) will be calculated using the concentration values from all time points according","text_display":"\n\\(CL _{\\text {Iohexol }}\\) will be calculated using the concentration values from all time points according","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[348,2004],[1510,2004],[1510,2052],[348,2052]],"region":{"top_left_x":348,"top_left_y":2004,"width":1163,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf8e74b44bff47b084a2822003379f49","type":"text","conversion_output":true,"text":"to a two-compartment or one-compartment model using the formula:","text_display":" to a two-compartment or one-compartment model using the formula:","confidence":1,"confidence_rate":1},{"cnt":[[346,2101],[1751,2101],[1751,2151],[346,2151]],"region":{"top_left_x":345,"top_left_y":2101,"width":1406,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59d9c0921ef9448982224279e01efcec","type":"text","conversion_output":true,"text":"\\(CL _{\\text {Iohexol }}=\\) Dose/AUC (with AUC: area under the plasma concentration-time curve).","text_display":"\n\\(CL _{\\text {Iohexol }}=\\) Dose/AUC (with AUC: area under the plasma concentration-time curve).","confidence":0.9733286710667609,"confidence_rate":0.9997241863864345},{"cnt":[[346,2196],[1880,2196],[1880,2245],[346,2245]],"region":{"top_left_x":345,"top_left_y":2195,"width":1535,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f110d9dd8d349a0bbaed25e19fe0bf6","type":"text","conversion_output":true,"text":"Then, in the case of a one compartment model, plasma clearance of iohexol will be","text_display":"\nThen, in the case of a one compartment model, plasma clearance of iohexol will be","confidence":1,"confidence_rate":1},{"cnt":[[346,2243],[1764,2243],[1764,2292],[346,2292]],"region":{"top_left_x":345,"top_left_y":2242,"width":1419,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c61513ac4c964d4fbd2419627583143d","type":"text","conversion_output":true,"text":"modified for the early distribution phase by the Bröchner-Mortensen (BM) formula:","text_display":" modified for the early distribution phase by the Bröchner-Mortensen (BM) formula:","confidence":1,"confidence_rate":1},{"cnt":[[346,2331],[1755,2331],[1755,2391],[346,2391]],"region":{"top_left_x":345,"top_left_y":2331,"width":1411,"height":61},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f73187e5c76c41d7a559507687e7cf22","type":"text","conversion_output":true,"text":"\\(CL _{\\text {Iohexol }} BM =\\left(0.990778 \\times CL _{\\text {Iohexol }}\\right)-\\left(0.001218 \\times CL _{\\text {Iohexol }}{ }^{2}\\right)\\) (Gaspari et al, 1995).","text_display":"\n\\(CL _{\\text {Iohexol }} BM =\\left(0.990778 \\times CL _{\\text {Iohexol }}\\right)-\\left(0.001218 \\times CL _{\\text {Iohexol }}{ }^{2}\\right)\\) (Gaspari et al, 1995).","confidence":0.3065344093169812,"confidence_rate":0.9913433827423933},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d79e8d37cbfc478c8b53a28d28db3e47","type":"page_info","conversion_output":false,"text":"44","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-52","page":52,"lines":[{"cnt":[[344,129],[492,129],[492,157],[344,157]],"region":{"top_left_x":343,"top_left_y":128,"width":149,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"0c8c4d8681be49dea4e6d4683626a795","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1850,125],[1850,161],[1366,161]],"region":{"top_left_x":1366,"top_left_y":124,"width":484,"height":38},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"231f2257762c4c0bba7aefbb440a391e","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"28c4e9bb5b5a4ebdad32fdcc050462e1","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.998046875,"confidence_rate":0.9999150020979262},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"62ba526847914400abfd4082d7010ee6","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[348,374],[1878,374],[1878,423],[348,423]],"region":{"top_left_x":348,"top_left_y":373,"width":1530,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1c4f07c363f4a1a888e065c161f968e","type":"text","conversion_output":true,"text":"Iohexol plasma concentrations will be listed and summarized using descriptive statistics by","text_display":"\n\nIohexol plasma concentrations will be listed and summarized using descriptive statistics by","confidence":1,"confidence_rate":1},{"cnt":[[348,425],[1880,425],[1880,471],[348,471]],"region":{"top_left_x":348,"top_left_y":425,"width":1532,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a6d8cf1ba124f208c2046a85d199e17","type":"text","conversion_output":true,"text":"timepoints. Iohexol PK parameters will be listed and summarized using descriptive","text_display":" timepoints. Iohexol PK parameters will be listed and summarized using descriptive","confidence":1,"confidence_rate":1},{"cnt":[[348,473],[1880,473],[1880,518],[348,518]],"region":{"top_left_x":348,"top_left_y":472,"width":1532,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36c464abd8004e6db63e07b2c3e1df31","type":"text","conversion_output":true,"text":"statistics. These summaries will include the number of patients ( n ), mean, standard","text_display":" statistics. These summaries will include the number of patients ( n ), mean, standard","confidence":0.9592660778337176,"confidence_rate":0.9995668980953263},{"cnt":[[348,520],[1876,520],[1876,569],[348,569]],"region":{"top_left_x":348,"top_left_y":519,"width":1528,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"500c9f14f6be43d890a344a084adc243","type":"text","conversion_output":true,"text":"deviation (SD), coefficient of variation (CV), minimum, median, maximum, geometric","text_display":" deviation (SD), coefficient of variation (CV), minimum, median, maximum, geometric","confidence":1,"confidence_rate":1},{"cnt":[[348,567],[1106,567],[1106,617],[348,617]],"region":{"top_left_x":348,"top_left_y":567,"width":759,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b96661260ef14afa8bb9dd316da609eb","type":"text","conversion_output":true,"text":"mean, and geometric \\%CV, when applicable.","text_display":" mean, and geometric \\%CV, when applicable.","confidence":0.9990234375,"confidence_rate":0.999978760233223},{"cnt":[[348,662],[1876,662],[1876,711],[348,711]],"region":{"top_left_x":348,"top_left_y":661,"width":1528,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69f9ff1071e74b06912c3d43e8e7a97b","type":"text","conversion_output":true,"text":"Iohexol clearance ( \\(CL _{\\text {Iohexol }}\\) ), as a gold standard measure of GFR , will be correlated to","text_display":"\n\nIohexol clearance ( \\(CL _{\\text {Iohexol }}\\) ), as a gold standard measure of GFR , will be correlated to","confidence":0.661404827310573,"confidence_rate":0.9965321682120427},{"cnt":[[348,711],[1377,711],[1377,758],[348,758]],"region":{"top_left_x":348,"top_left_y":711,"width":1030,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56a777d56a9d48fdbd4ff542c08ebe25","type":"text","conversion_output":true,"text":"creatinine clearance in a subset of patients using scatter plots.","text_display":" creatinine clearance in a subset of patients using scatter plots.","confidence":0.99951171875,"confidence_rate":0.9999930228743673},{"cnt":[[344,902],[939,902],[939,954],[344,954]],"region":{"top_left_x":343,"top_left_y":902,"width":596,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0c74128f44d4c51adb66713cd490c40","type":"section_header","conversion_output":false,"children_ids":["08002e057d764467aaff1e4005b887b6"],"text":"","text_display":""},{"cnt":[[348,907],[937,907],[937,952],[348,952]],"region":{"top_left_x":348,"top_left_y":906,"width":589,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08002e057d764467aaff1e4005b887b6","type":"text","conversion_output":true,"parent_id":"a0c74128f44d4c51adb66713cd490c40","text":"Exogenous Creatinine Clearance","text_display":"\n\n\\section*{Exogenous Creatinine Clearance}","confidence":1,"confidence_rate":1},{"cnt":[[346,999],[1878,999],[1878,1046],[346,1046]],"region":{"top_left_x":345,"top_left_y":999,"width":1533,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6145b5c644884be0919559babcd9cf6d","type":"text","conversion_output":true,"text":"To evaluate if renal replacement therapy (RRT) has an effect on endogenous creatinine","text_display":"\n\nTo evaluate if renal replacement therapy (RRT) has an effect on endogenous creatinine","confidence":1,"confidence_rate":1},{"cnt":[[348,1048],[1878,1048],[1878,1094],[348,1094]],"region":{"top_left_x":348,"top_left_y":1048,"width":1530,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"353680445d554d20acbd90ff6f3b6cd5","type":"text","conversion_output":true,"text":"clearance, the exogenous creatinine clearance by RRT equipment will be assessed by","text_display":" clearance, the exogenous creatinine clearance by RRT equipment will be assessed by","confidence":1,"confidence_rate":1},{"cnt":[[348,1096],[1876,1096],[1876,1141],[348,1141]],"region":{"top_left_x":348,"top_left_y":1095,"width":1528,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"653f5a9fed564a4fbc6066eaab8bea80","type":"text","conversion_output":true,"text":"measuring the creatinine concentration in the effluent and effluent volume during the \\(6 \\pm 1\\)","text_display":" measuring the creatinine concentration in the effluent and effluent volume during the \\(6 \\pm 1\\)","confidence":1,"confidence_rate":1},{"cnt":[[348,1143],[1876,1143],[1876,1190],[348,1190]],"region":{"top_left_x":348,"top_left_y":1142,"width":1528,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fee30ab905a44dd93cee778817f991f","type":"text","conversion_output":true,"text":"hour urine collection interval. This will be only done by the sites participating in the","text_display":" hour urine collection interval. This will be only done by the sites participating in the","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[348,1190],[647,1190],[647,1240],[348,1240]],"region":{"top_left_x":348,"top_left_y":1190,"width":299,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbda475c29b34c4791d38c9aba3bb617","type":"text","conversion_output":true,"text":"Iohexol substudy.","text_display":" Iohexol substudy.","confidence":1,"confidence_rate":1},{"cnt":[[348,1285],[1880,1285],[1880,1334],[348,1334]],"region":{"top_left_x":348,"top_left_y":1284,"width":1532,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b0775cfaa324e8abadf936ef9bd4caa","type":"text","conversion_output":true,"text":"Standardized exogenous creatinine clearance ( \\(mL / min\\) ) by the RRT equipment will be","text_display":"\n\nStandardized exogenous creatinine clearance ( \\(mL / min\\) ) by the RRT equipment will be","confidence":0.9863569575827569,"confidence_rate":0.9998583918423397},{"cnt":[[348,1334],[1360,1334],[1360,1381],[348,1381]],"region":{"top_left_x":348,"top_left_y":1334,"width":1012,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f25657c019b4e6b9518b5856aa9c5cf","type":"text","conversion_output":true,"text":"calculated by PPD Biostatistics using the following formula.","text_display":" calculated by PPD Biostatistics using the following formula.","confidence":1,"confidence_rate":1},{"cnt":[[331,1427],[1897,1427],[1897,1577],[331,1577]],"region":{"top_left_x":330,"top_left_y":1426,"width":1568,"height":151},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59b2140165c34dbf8935c69216e79c87","type":"text","conversion_output":true,"text":"\\(\\begin{aligned} & \\text { Effluent Creatinine (mg/dL) } \\\\ & \\text { Serum Creatinine }( mg / dL )\\end{aligned} \\times \\frac{\\text { Total effluent volume collected }( mL )}{\\begin{array}{l}\\text { Stop date/time - Start date/time of } \\\\ \\text { effluent collection }( min )\\end{array}}\\)","text_display":"\n\\(\\begin{aligned} & \\text { Effluent Creatinine (mg/dL) } \\\\ & \\text { Serum Creatinine }( mg / dL )\\end{aligned} \\times \\frac{\\text { Total effluent volume collected }( mL )}{\\begin{array}{l}\\text { Stop date/time - Start date/time of } \\\\ \\text { effluent collection }( min )\\end{array}}\\)","confidence":0.12263445328945434,"confidence_rate":0.98991330585489},{"cnt":[[408,1629],[1878,1629],[1878,1674],[408,1674]],"region":{"top_left_x":408,"top_left_y":1628,"width":1470,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5c5ca60bb0045919da1f11173bbf6ea","type":"text","conversion_output":true,"text":"- The effluent creatinine ( \\(mg / dL\\) ) will be assessed by the laboratory conducting the","text_display":"\n- The effluent creatinine ( \\(mg / dL\\) ) will be assessed by the laboratory conducting the","confidence":1,"confidence_rate":1},{"cnt":[[473,1676],[694,1676],[694,1712],[473,1712]],"region":{"top_left_x":472,"top_left_y":1675,"width":222,"height":38},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c68277f3c17149bb87d4e8f8c93f1703","type":"text","conversion_output":true,"text":"Ioxehol data.","text_display":" Ioxehol data.","confidence":1,"confidence_rate":1},{"cnt":[[408,1727],[1878,1727],[1878,1772],[408,1772]],"region":{"top_left_x":408,"top_left_y":1727,"width":1470,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39453a1b06d245228643f4c1a52912ce","type":"text","conversion_output":true,"text":"- The serum creatinine ( \\(mg / dL\\) ) assessed by the central laboratory and used in the","text_display":"\n- The serum creatinine ( \\(mg / dL\\) ) assessed by the central laboratory and used in the","confidence":0.9965834617614746,"confidence_rate":0.9999647182725911},{"cnt":[[473,1775],[1880,1775],[1880,1820],[473,1820]],"region":{"top_left_x":472,"top_left_y":1774,"width":1408,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f79e55e8d9a24972a4547cd473af42c6","type":"text","conversion_output":true,"text":"primary endpoint of endogenous creatinine clearance will be used to determine the","text_display":" primary endpoint of endogenous creatinine clearance will be used to determine the","confidence":1,"confidence_rate":1},{"cnt":[[473,1822],[1229,1822],[1229,1867],[473,1867]],"region":{"top_left_x":472,"top_left_y":1821,"width":757,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23ed66a8b6514bfba911a7c79c5e3fe7","type":"text","conversion_output":true,"text":"standardized exogenous creatinine clearance.","text_display":" standardized exogenous creatinine clearance.","confidence":1,"confidence_rate":1},{"cnt":[[408,1873],[1878,1873],[1878,1919],[408,1919]],"region":{"top_left_x":408,"top_left_y":1873,"width":1470,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e6501184b634e1d842abbfb7715b004","type":"text","conversion_output":true,"text":"- Per protocol, two blood samples are collected to evaluate the serum creatinine, one","text_display":"\n- Per protocol, two blood samples are collected to evaluate the serum creatinine, one","confidence":1,"confidence_rate":1},{"cnt":[[473,1921],[1880,1921],[1880,1966],[473,1966]],"region":{"top_left_x":472,"top_left_y":1920,"width":1408,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f64e0d5c913a47a388fcd16e66f68dae","type":"text","conversion_output":true,"text":"at the beginning of the urine sample collection and the other at the end of the urine","text_display":" at the beginning of the urine sample collection and the other at the end of the urine","confidence":1,"confidence_rate":1},{"cnt":[[473,1968],[1878,1968],[1878,2015],[473,2015]],"region":{"top_left_x":472,"top_left_y":1967,"width":1406,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da4c021924624df5a47ae0915b3a1352","type":"text","conversion_output":true,"text":"sample collection. The average of these two serum creatinine measurements will be","text_display":" sample collection. The average of these two serum creatinine measurements will be","confidence":1,"confidence_rate":1},{"cnt":[[473,2015],[1880,2015],[1880,2065],[473,2065]],"region":{"top_left_x":472,"top_left_y":2015,"width":1408,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88b7185464de4d759eca737d0de368ec","type":"text","conversion_output":true,"text":"used in the formula above to assess the standardized exogenous creatinine","text_display":" used in the formula above to assess the standardized exogenous creatinine","confidence":1,"confidence_rate":1},{"cnt":[[473,2065],[1880,2065],[1880,2112],[473,2112]],"region":{"top_left_x":472,"top_left_y":2064,"width":1408,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2395985381584b538cade5685f81d245","type":"text","conversion_output":true,"text":"clearance. In case there is only one serum creatinine sample available, then the","text_display":" clearance. In case there is only one serum creatinine sample available, then the","confidence":1,"confidence_rate":1},{"cnt":[[473,2114],[1824,2114],[1824,2159],[473,2159]],"region":{"top_left_x":472,"top_left_y":2114,"width":1353,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"beb5086df5b840e29fbcca5cd012496d","type":"text","conversion_output":true,"text":"serum creatinine concentration from that one sample will be used in the formula.","text_display":" serum creatinine concentration from that one sample will be used in the formula.","confidence":1,"confidence_rate":1},{"cnt":[[408,2161],[1807,2161],[1807,2211],[408,2211]],"region":{"top_left_x":408,"top_left_y":2161,"width":1399,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bac9c391ff5440387b5da67e5a5a42f","type":"text","conversion_output":true,"text":"- The number of minutes from the start date/time to the stop date/time of 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Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[344,155],[604,155],[604,191],[344,191]],"region":{"top_left_x":343,"top_left_y":154,"width":261,"height":38},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"24ae2cd76ecb473e9a33733ac633c392","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[1568,155],[1858,155],[1858,191],[1568,191]],"region":{"top_left_x":1568,"top_left_y":154,"width":291,"height":38},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a40233fb0a604bf7a9dd867b0285a0eb","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[344,327],[1882,327],[1882,376],[344,376]],"region":{"top_left_x":343,"top_left_y":326,"width":1540,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe838b12337a48b7a4a8577036d50076","type":"text","conversion_output":true,"text":"The time-corrected exogenous creatinine clearance will be listed for subjects who are on","text_display":"\n\nThe time-corrected exogenous creatinine clearance will be listed for subjects who are on","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[344,374],[874,374],[874,425],[344,425]],"region":{"top_left_x":343,"top_left_y":373,"width":532,"height":53},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c16238fa9e24c21a37ce256922dfe81","type":"text","conversion_output":true,"text":"RRT in the Iohexol population.","text_display":" RRT in the Iohexol 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Safety Analysis","text_display":"\n\n\\section*{9. 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Treatment emergent AEs will be","text_display":" at least one TEAE will be provided by treatment group. Treatment emergent AEs will be","confidence":0.99853515625,"confidence_rate":0.9999837121583983},{"cnt":[[344,2013],[1880,2013],[1880,2065],[344,2065]],"region":{"top_left_x":343,"top_left_y":2013,"width":1537,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36c77825ed0341958efa8f9b79efcd5f","type":"text","conversion_output":true,"text":"presented by SOC and PT. At each level of patient summarization, a patient is counted","text_display":" presented by SOC and PT. At each level of patient summarization, a patient is counted","confidence":1,"confidence_rate":1},{"cnt":[[344,2062],[1141,2062],[1141,2112],[344,2112]],"region":{"top_left_x":343,"top_left_y":2062,"width":798,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4d43ab2fab24b2f8e958ad50e00fa08","type":"text","conversion_output":true,"text":"once if the patient reported one or more events.","text_display":" once if the patient reported one or more events.","confidence":1,"confidence_rate":1},{"cnt":[[344,2157],[982,2157],[982,2206],[344,2206]],"region":{"top_left_x":343,"top_left_y":2157,"width":639,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9edb0b701b654880b335b96098f44d2d","type":"text","conversion_output":true,"text":"All AEs will be presented in a listing.","text_display":"\n\nAll AEs will be presented in a listing.","confidence":1,"confidence_rate":1},{"cnt":[[464,2290],[1429,2290],[1429,2353],[464,2353]],"region":{"top_left_x":464,"top_left_y":2290,"width":965,"height":63},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e57ff4e551394311a7e3e2f32ec2894e","type":"section_header","conversion_output":false,"children_ids":["2749c0c7fa8a4da3aca5d361f14ed582"],"text":"","text_display":""},{"cnt":[[468,2295],[1424,2295],[1424,2346],[468,2346]],"region":{"top_left_x":468,"top_left_y":2294,"width":957,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2749c0c7fa8a4da3aca5d361f14ed582","type":"text","conversion_output":true,"parent_id":"e57ff4e551394311a7e3e2f32ec2894e","text":"9.1.2. Relationship of Adverse Events to Study Drug","text_display":"\n\n\\subsection*{9.1.2. 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The relationship of the event to the study drug will be characterized using the","text_display":" drug. The relationship of the event to the study drug will be characterized using the","confidence":1,"confidence_rate":1},{"cnt":[[348,423],[956,423],[956,471],[348,471]],"region":{"top_left_x":348,"top_left_y":423,"width":609,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58b17bdbf5f54a1797e4728f5b7e8a55","type":"text","conversion_output":true,"text":"following classification and criteria:","text_display":" following classification and criteria:","confidence":1,"confidence_rate":1},{"cnt":[[346,520],[1919,520],[1919,569],[346,569]],"region":{"top_left_x":345,"top_left_y":519,"width":1574,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4b859b50861498daa1a560d99aa10d8","type":"text","conversion_output":true,"text":"Unrelated: This relationship suggests that there is no association between the study drug","text_display":"\n\nUnrelated: This relationship suggests that there is no association between the study drug","confidence":1,"confidence_rate":1},{"cnt":[[571,567],[960,567],[960,617],[571,617]],"region":{"top_left_x":571,"top_left_y":567,"width":390,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d6b3361de3c40f78fd2584f6e7652c0","type":"text","conversion_output":true,"text":"and the reported event.","text_display":" and the reported event.","confidence":1,"confidence_rate":1},{"cnt":[[346,614],[1916,614],[1916,664],[346,664]],"region":{"top_left_x":345,"top_left_y":614,"width":1572,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0628d6369594cdc89f418961380cfa9","type":"text","conversion_output":true,"text":"Possible: This relationship suggests that treatment with the study drug caused or","text_display":"\nPossible: This relationship suggests that treatment with the study drug caused or","confidence":1,"confidence_rate":1},{"cnt":[[571,662],[1916,662],[1916,711],[571,711]],"region":{"top_left_x":571,"top_left_y":661,"width":1346,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f24998ea62b945f084014bc1905fb1ef","type":"text","conversion_output":true,"text":"contributed to the AE; i.e., the event follows a reasonable temporal sequence","text_display":" contributed to the AE; i.e., the event follows a reasonable temporal sequence","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[571,709],[1916,709],[1916,758],[571,758]],"region":{"top_left_x":571,"top_left_y":708,"width":1346,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"890b399445f2416887777d34da16d1d4","type":"text","conversion_output":true,"text":"from the time of drug administration or follows a known response pattern to the","text_display":" from the time of drug administration or follows a known response pattern to the","confidence":1,"confidence_rate":1},{"cnt":[[571,758],[1635,758],[1635,810],[571,810]],"region":{"top_left_x":571,"top_left_y":758,"width":1064,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b189e12ad24431d884aa9f42430c94e","type":"text","conversion_output":true,"text":"study drug, but could also have been produced by other factors.","text_display":" study drug, but could also have been produced by other factors.","confidence":1,"confidence_rate":1},{"cnt":[[346,808],[1919,808],[1919,855],[346,855]],"region":{"top_left_x":345,"top_left_y":807,"width":1574,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"23261da487ae4eb6b876bb2b444d67c8","type":"text","conversion_output":true,"text":"Probable: This relationship suggests that a reasonable temporal sequence of the event","text_display":"\nProbable: This relationship suggests that a reasonable temporal sequence of the event","confidence":1,"confidence_rate":1},{"cnt":[[571,855],[1916,855],[1916,904],[571,904]],"region":{"top_left_x":571,"top_left_y":855,"width":1346,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d797497f0df446dbe8cf8f3f79939a4","type":"text","conversion_output":true,"text":"with drug administration exists and, based upon the known pharmacological","text_display":" with drug administration exists and, based upon the known pharmacological","confidence":1,"confidence_rate":1},{"cnt":[[571,902],[1916,902],[1916,952],[571,952]],"region":{"top_left_x":571,"top_left_y":902,"width":1346,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8ad5d1437c1457eaa9b83bc13c005c4","type":"text","conversion_output":true,"text":"action of the drug, known or previously reported adverse reactions to the drug","text_display":" action of the drug, known or previously reported adverse reactions to the drug","confidence":1,"confidence_rate":1},{"cnt":[[571,950],[1914,950],[1914,999],[571,999]],"region":{"top_left_x":571,"top_left_y":949,"width":1344,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4953c2f1f4084ee2a2e3754ede13875a","type":"text","conversion_output":true,"text":"or class of drugs, or judgment based on the investigator's clinical experience,","text_display":" or class of drugs, or judgment based on the investigator's clinical experience,","confidence":1,"confidence_rate":1},{"cnt":[[571,997],[1916,997],[1916,1046],[571,1046]],"region":{"top_left_x":571,"top_left_y":996,"width":1346,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46f1537eecf04239bb87d012ef55c03c","type":"text","conversion_output":true,"text":"the association of the event with the study drug seems likely. The event","text_display":" the association of the event with the study drug seems likely. The event","confidence":1,"confidence_rate":1},{"cnt":[[571,1044],[1833,1044],[1833,1096],[571,1096]],"region":{"top_left_x":571,"top_left_y":1044,"width":1262,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1ae46140b08449990c4399b519d3658","type":"text","conversion_output":true,"text":"disappears or decreases on cessation or reduction of the dose of study drug.","text_display":" disappears or decreases on cessation or reduction of the dose of study drug.","confidence":1,"confidence_rate":1},{"cnt":[[346,1094],[1919,1094],[1919,1145],[346,1145]],"region":{"top_left_x":345,"top_left_y":1093,"width":1574,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6cf9c8229c9410b910737abad2b3dff","type":"text","conversion_output":true,"text":"Definite: This relationship suggests that a definite causal relationship exists between drug","text_display":"\nDefinite: This relationship suggests that a definite causal relationship exists between drug","confidence":1,"confidence_rate":1},{"cnt":[[571,1143],[1916,1143],[1916,1192],[571,1192]],"region":{"top_left_x":571,"top_left_y":1142,"width":1346,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d2396cd79aa4605acb06dc19924c413","type":"text","conversion_output":true,"text":"administration and the AE, and other conditions (concurrent illness,","text_display":" administration and the AE, and other conditions (concurrent illness,","confidence":1,"confidence_rate":1},{"cnt":[[571,1190],[1914,1190],[1914,1240],[571,1240]],"region":{"top_left_x":571,"top_left_y":1190,"width":1344,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a554b12f29af4292a878743291882425","type":"text","conversion_output":true,"text":"progression/expression of disease state, or concurrent medication reaction) do","text_display":" progression/expression of disease state, or concurrent medication reaction) do","confidence":1,"confidence_rate":1},{"cnt":[[571,1238],[1916,1238],[1916,1287],[571,1287]],"region":{"top_left_x":571,"top_left_y":1237,"width":1346,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d27858e2300047df8cdb3fb5c091db44","type":"text","conversion_output":true,"text":"not appear to explain the event. The event reappears or worsens if the study","text_display":" not appear to explain the event. The event reappears or worsens if the study","confidence":1,"confidence_rate":1},{"cnt":[[571,1285],[975,1285],[975,1334],[571,1334]],"region":{"top_left_x":571,"top_left_y":1284,"width":405,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fccba204d44460895c877420703afcc","type":"text","conversion_output":true,"text":"drug is re-administered.","text_display":" drug is re-administered.","confidence":1,"confidence_rate":1},{"cnt":[[346,1379],[1732,1379],[1732,1431],[346,1431]],"region":{"top_left_x":345,"top_left_y":1379,"width":1387,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8912c051868d4e67837aac40ad83c639","type":"text","conversion_output":true,"text":"TEAEs that are missing a relationship will be presented in the tables as \"Definite\".","text_display":"\n\nTEAEs that are missing a relationship will be presented in the tables as \"Definite\".","confidence":0.9970715045928955,"confidence_rate":0.9999670478256327},{"cnt":[[346,1478],[1880,1478],[1880,1525],[346,1525]],"region":{"top_left_x":345,"top_left_y":1478,"width":1535,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"991296e4f09d4ff1bcc43884718a29ea","type":"text","conversion_output":true,"text":"The TEAE data will be categorized and presented by SOC, PT, and relationship in a","text_display":"\nThe TEAE data will be categorized and presented by SOC, PT, and relationship in a","confidence":1,"confidence_rate":1},{"cnt":[[344,1525],[1880,1525],[1880,1575],[344,1575]],"region":{"top_left_x":343,"top_left_y":1525,"width":1537,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbd102eee60e448f9c5d9aa2dbce9fd7","type":"text","conversion_output":true,"text":"manner similar to that described in Section 9.1.1. In the TEAE relationship table, at each","text_display":" manner similar to that described in Section 9.1.1. In the TEAE relationship table, at each","confidence":1,"confidence_rate":1},{"cnt":[[344,1573],[1880,1573],[1880,1622],[344,1622]],"region":{"top_left_x":343,"top_left_y":1572,"width":1537,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e50d3ad77c0240e79f2dd22457a74d61","type":"text","conversion_output":true,"text":"level of patient summarization, a patient is counted once for the most related event if the","text_display":" level of patient summarization, a patient is counted once for the most related event if the","confidence":1,"confidence_rate":1},{"cnt":[[344,1622],[952,1622],[952,1669],[344,1669]],"region":{"top_left_x":343,"top_left_y":1622,"width":609,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c2bfb3307ff4764ac663a6f4a4aaf0a","type":"text","conversion_output":true,"text":"patient reported one or more events.","text_display":" patient reported one or more events.","confidence":1,"confidence_rate":1},{"cnt":[[468,1757],[1068,1757],[1068,1811],[468,1811]],"region":{"top_left_x":468,"top_left_y":1757,"width":600,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf9546cd63f74e9e9f768352d1ba3610","type":"section_header","conversion_output":false,"children_ids":["cb2432a9b51a466c83ad1677eac3afda"],"text":"","text_display":""},{"cnt":[[473,1762],[1066,1762],[1066,1807],[473,1807]],"region":{"top_left_x":472,"top_left_y":1761,"width":594,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb2432a9b51a466c83ad1677eac3afda","type":"text","conversion_output":true,"parent_id":"cf9546cd63f74e9e9f768352d1ba3610","text":"9.1.3. Severity of Adverse Event","text_display":"\n\n\\subsection*{9.1.3. 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Severe events are usually incapacitating.","text_display":" drug therapy or other treatment. Severe events are usually incapacitating.","confidence":0.9990234375,"confidence_rate":0.9999876324859995},{"cnt":[[346,2295],[1880,2295],[1880,2344],[346,2344]],"region":{"top_left_x":345,"top_left_y":2294,"width":1535,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"187755e6a4bd47acac37010bb5495b76","type":"text","conversion_output":true,"text":"TEAEs that are missing severity will be presented in tables as \"Severe\" but will be","text_display":"\n\nTEAEs that are missing severity will be presented in tables as \"Severe\" but will be","confidence":0.9970729344058782,"confidence_rate":0.9999666896703874},{"cnt":[[344,2344],[1216,2344],[1216,2396],[344,2396]],"region":{"top_left_x":343,"top_left_y":2343,"width":874,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54b686ca2c2c424da10c41a490f0b278","type":"text","conversion_output":true,"text":"presented in the data listing with a missing severity.","text_display":" presented in the data listing with a missing severity.","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4f063d4bd99499782f30b3e4c0ab9c3","type":"page_info","conversion_output":false,"text":"47","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-55","page":55,"lines":[{"cnt":[[346,127],[492,127],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":126,"width":147,"height":31},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ee2dd6da1cde42d68063e4ff7c98ec7e","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1850,125],[1850,159],[1366,159]],"region":{"top_left_x":1366,"top_left_y":124,"width":484,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e8e054b44fec49eb807b63b93909f3df","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[346,159],[599,159],[599,187],[346,187]],"region":{"top_left_x":345,"top_left_y":158,"width":255,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"d75283834c374b7e9fae3de23aec1125","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.998046875,"confidence_rate":0.9999150020979262},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6405e216298c473593625881a4cd91dc","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[348,374],[1880,374],[1880,423],[348,423]],"region":{"top_left_x":348,"top_left_y":373,"width":1532,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7c07fe326594304b80d265e469669a3","type":"text","conversion_output":true,"text":"The TEAE data will be categorized and presented by SOC, PT, and severity in a manner","text_display":"\n\nThe TEAE data will be categorized and presented by SOC, PT, and severity in a manner","confidence":1,"confidence_rate":1},{"cnt":[[348,425],[1880,425],[1880,471],[348,471]],"region":{"top_left_x":348,"top_left_y":425,"width":1532,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aeacd02f6f5465298b14dec5622f323","type":"text","conversion_output":true,"text":"similar to that described in Section 9.1.1. In the table, at each level of patient","text_display":" similar to that described in Section 9.1.1. In the table, at each level of patient","confidence":1,"confidence_rate":1},{"cnt":[[348,473],[1880,473],[1880,520],[348,520]],"region":{"top_left_x":348,"top_left_y":472,"width":1532,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8b57e9860c5497ca45bf418ba6d4378","type":"text","conversion_output":true,"text":"summarization, a patient is counted once for the most severe event if the patient reported","text_display":" summarization, a patient is counted once for the most severe event if the patient reported","confidence":1,"confidence_rate":1},{"cnt":[[348,524],[679,524],[679,561],[348,561]],"region":{"top_left_x":348,"top_left_y":524,"width":331,"height":37},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f35553f7a6404f8fae33b94ef2a6b671","type":"text","conversion_output":true,"text":"one or more events.","text_display":" one or more events.","confidence":1,"confidence_rate":1},{"cnt":[[468,657],[1025,657],[1025,700],[468,700]],"region":{"top_left_x":468,"top_left_y":657,"width":557,"height":44},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"679ffe52e0054103b55ec8aefc038437","type":"section_header","conversion_output":false,"children_ids":["84dc8638543447d99fd658bec75233bd"],"text":"","text_display":""},{"cnt":[[473,660],[1021,660],[1021,698],[473,698]],"region":{"top_left_x":472,"top_left_y":659,"width":549,"height":40},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84dc8638543447d99fd658bec75233bd","type":"text","conversion_output":true,"parent_id":"679ffe52e0054103b55ec8aefc038437","text":"9.1.4. Serious Adverse Events","text_display":"\n\n\\subsection*{9.1.4. Serious Adverse Events}","confidence":0.9970703125,"confidence_rate":0.9999137099751164},{"cnt":[[348,765],[1878,765],[1878,810],[348,810]],"region":{"top_left_x":348,"top_left_y":764,"width":1530,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1883d81b28424360900b6fd736e91ceb","type":"text","conversion_output":true,"text":"The seriousness of an AE should be assessed by the Investigator independently from the","text_display":"\n\nThe seriousness of an AE should be assessed by the Investigator independently from the","confidence":0.99658203125,"confidence_rate":0.9999623762753774},{"cnt":[[348,812],[1876,812],[1876,857],[348,857]],"region":{"top_left_x":348,"top_left_y":812,"width":1528,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfc7fbe2ea20459eae10fedb2aa2ff4d","type":"text","conversion_output":true,"text":"severity of the AE. A SAE is defined as any untoward medical occurrence that at any dose","text_display":" severity of the AE. A SAE is defined as any untoward medical occurrence that at any dose","confidence":1,"confidence_rate":1},{"cnt":[[348,859],[1880,859],[1880,904],[348,904]],"region":{"top_left_x":348,"top_left_y":859,"width":1532,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5c26779737c427fa8032f3dd8d6b10a","type":"text","conversion_output":true,"text":"results in death, is life-threatening, is a congenital anomaly/birth defect, requires in-patient","text_display":" results in death, is life-threatening, is a congenital anomaly/birth defect, requires in-patient","confidence":1,"confidence_rate":1},{"cnt":[[348,907],[1626,907],[1626,954],[348,954]],"region":{"top_left_x":348,"top_left_y":906,"width":1279,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03e45453e491410db287ea31c8d9fbe7","type":"text","conversion_output":true,"text":"hospitalization or prolongation, or results in significant disability/incapacity.","text_display":" hospitalization or prolongation, or results in significant disability/incapacity.","confidence":1,"confidence_rate":1},{"cnt":[[348,1005],[1876,1005],[1876,1051],[348,1051]],"region":{"top_left_x":348,"top_left_y":1005,"width":1528,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cd2aa7b8c404d09a0e4641340398a4b","type":"text","conversion_output":true,"text":"Important medical events that may not result in death, be life-threatening, or require","text_display":"\n\nImportant medical events that may not result in death, be life-threatening, or require","confidence":1,"confidence_rate":1},{"cnt":[[348,1053],[1878,1053],[1878,1098],[348,1098]],"region":{"top_left_x":348,"top_left_y":1052,"width":1530,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"620612ea21bb4c61b74a777fe3eef1ab","type":"text","conversion_output":true,"text":"hospitalization may be considered SAEs when, based upon medical judgment, they may","text_display":" hospitalization may be considered SAEs when, based upon medical judgment, they may","confidence":1,"confidence_rate":1},{"cnt":[[344,1100],[1884,1100],[1884,1145],[344,1145]],"region":{"top_left_x":343,"top_left_y":1100,"width":1542,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cd07ee7f81846868252ba1a4b1ffbc9","type":"text","conversion_output":true,"text":"jeopardize the patient and may require medical or surgical intervention to prevent one of","text_display":" jeopardize the patient and may require medical or surgical intervention to prevent one of","confidence":1,"confidence_rate":1},{"cnt":[[348,1147],[793,1147],[793,1188],[348,1188]],"region":{"top_left_x":348,"top_left_y":1147,"width":445,"height":42},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d739a3984cb245718ee72041d250123a","type":"text","conversion_output":true,"text":"the outcomes listed above.","text_display":" the outcomes listed above.","confidence":1,"confidence_rate":1},{"cnt":[[348,1242],[1876,1242],[1876,1291],[348,1291]],"region":{"top_left_x":348,"top_left_y":1241,"width":1528,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63d2ba5017d74dd5804081efdb53e254","type":"text","conversion_output":true,"text":"Serious treatment emergent adverse events (TEAE) will be presented in a table. They will","text_display":"\n\nSerious treatment emergent adverse events (TEAE) will be presented in a table. They will","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[348,1293],[1738,1293],[1738,1338],[348,1338]],"region":{"top_left_x":348,"top_left_y":1293,"width":1391,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"335a46a0cb9e43bcba2b03e3256ce7c3","type":"text","conversion_output":true,"text":"be presented by SOC and PT in a manner similar to that described in Section 9.1.1.","text_display":" be presented by SOC and PT in a manner similar to that described in Section 9.1.1.","confidence":1,"confidence_rate":1},{"cnt":[[468,1379],[1577,1379],[1577,1431],[468,1431]],"region":{"top_left_x":468,"top_left_y":1379,"width":1109,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"761082d2583344c19408b4e9c675b2a9","type":"section_header","conversion_output":false,"children_ids":["3cb1c7177e9e4616831ab93faccd860a"],"text":"","text_display":""},{"cnt":[[473,1384],[1575,1384],[1575,1429],[473,1429]],"region":{"top_left_x":472,"top_left_y":1383,"width":1103,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3cb1c7177e9e4616831ab93faccd860a","type":"text","conversion_output":true,"parent_id":"761082d2583344c19408b4e9c675b2a9","text":"9.1.5. Adverse Events Leading to Treatment Discontinuation","text_display":"\n\n\\subsection*{9.1.5. Adverse Events Leading to Treatment Discontinuation}","confidence":0.99853515625,"confidence_rate":0.9999767317360675},{"cnt":[[348,1487],[1878,1487],[1878,1534],[348,1534]],"region":{"top_left_x":348,"top_left_y":1486,"width":1530,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2875f9c47fdd4836a47644178a94d937","type":"text","conversion_output":true,"text":"A summary of TEAEs with a study drug action taken of \"Treatment Withdrawn\" will be","text_display":"\n\nA summary of TEAEs with a study drug action taken of \"Treatment Withdrawn\" will be","confidence":1,"confidence_rate":1},{"cnt":[[348,1534],[1878,1534],[1878,1583],[348,1583]],"region":{"top_left_x":348,"top_left_y":1533,"width":1530,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8574cfb68fbd41eeb35c2f8ebcd80538","type":"text","conversion_output":true,"text":"presented in a table. They will be presented by SOC and PT in a manner similar to that","text_display":" presented in a table. They will be presented by SOC and PT in a manner similar to that","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[348,1581],[793,1581],[793,1622],[348,1622]],"region":{"top_left_x":348,"top_left_y":1581,"width":445,"height":42},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f45680bbad743879849ea0d0f014837","type":"text","conversion_output":true,"text":"described in Section 9.1.1.","text_display":" described in Section 9.1.1.","confidence":1,"confidence_rate":1},{"cnt":[[468,1719],[711,1719],[711,1764],[468,1764]],"region":{"top_left_x":468,"top_left_y":1718,"width":244,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fce8a55f6884f8c8ed8b6e9d701c2e0","type":"section_header","conversion_output":false,"children_ids":["45fbcb5067ff4d7580fd454af898db9e"],"text":"","text_display":""},{"cnt":[[473,1723],[709,1723],[709,1760],[473,1760]],"region":{"top_left_x":472,"top_left_y":1723,"width":237,"height":37},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45fbcb5067ff4d7580fd454af898db9e","type":"text","conversion_output":true,"parent_id":"0fce8a55f6884f8c8ed8b6e9d701c2e0","text":"9.1.6. Death","text_display":"\n\n\\subsection*{9.1.6. Death}","confidence":0.998046875,"confidence_rate":0.9998850045633173},{"cnt":[[348,1826],[1876,1826],[1876,1876],[348,1876]],"region":{"top_left_x":348,"top_left_y":1826,"width":1528,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceb14b72bfa64b74a1ae939d21588046","type":"text","conversion_output":true,"text":"For patients who died any time during the study or during follow-up, their cause of death","text_display":"\n\nFor patients who died any time during the study or during follow-up, their cause of death","confidence":1,"confidence_rate":1},{"cnt":[[348,1873],[1876,1873],[1876,1921],[348,1921]],"region":{"top_left_x":348,"top_left_y":1873,"width":1528,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c60481d092da49199adff492436562a8","type":"text","conversion_output":true,"text":"will be categorized and presented by SOC, PT. A listing of all deaths and associated cause","text_display":" will be categorized and presented by SOC, PT. A listing of all deaths and associated cause","confidence":1,"confidence_rate":1},{"cnt":[[348,1921],[1880,1921],[1880,1970],[348,1970]],"region":{"top_left_x":348,"top_left_y":1920,"width":1532,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c89ce901d904449a85589966be0aaf54","type":"text","conversion_output":true,"text":"of death will be provided as well. All death will be coded using MedDRA Version 16.1 or","text_display":" of death will be provided as well. All death will be coded using MedDRA Version 16.1 or","confidence":1,"confidence_rate":1},{"cnt":[[348,1972],[436,1972],[436,2009],[348,2009]],"region":{"top_left_x":348,"top_left_y":1972,"width":89,"height":37},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebd40d781aaa4e9191d3a9dc2af91e94","type":"text","conversion_output":true,"text":"later.","text_display":" later.","confidence":1,"confidence_rate":1},{"cnt":[[406,2105],[922,2105],[922,2159],[406,2159]],"region":{"top_left_x":406,"top_left_y":2105,"width":516,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c8376cac0184a8381dd89cf66e2d1f4","type":"section_header","conversion_output":false,"children_ids":["aacda34b0fd24c5e985772fcf9e14474"],"text":"","text_display":""},{"cnt":[[408,2110],[917,2110],[917,2155],[408,2155]],"region":{"top_left_x":408,"top_left_y":2109,"width":510,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aacda34b0fd24c5e985772fcf9e14474","type":"text","conversion_output":true,"parent_id":"7c8376cac0184a8381dd89cf66e2d1f4","text":"9.2. Laboratory Evaluations","text_display":"\n\n\\subsection*{9.2. 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All summaries will be based on the","text_display":" analysis and be performed by the local laboratory. All summaries will be based on the","confidence":1,"confidence_rate":1},{"cnt":[[348,2312],[1878,2312],[1878,2357],[348,2357]],"region":{"top_left_x":348,"top_left_y":2311,"width":1530,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80b5580ef23140ab907932f3bd298c2d","type":"text","conversion_output":true,"text":"units provided defined in the eCRF, no conversion will be done. Also, the out of normal","text_display":" units provided defined in the eCRF, no conversion will be done. 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On day 1 only, vital signs will additionally be assessed 2","text_display":" after completion of infusion. 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Additionally, counts and percentages of patients with","text_display":" patients in the Safety Set. 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Electrocardiogram}","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[346,434],[1687,434],[1687,483],[346,483]],"region":{"top_left_x":345,"top_left_y":433,"width":1342,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"994ccdd8b58f47518dcd7123bfe7e0d6","type":"text","conversion_output":true,"text":"All patients will have a 12-lead ECG performed at baseline, Day 3, and Day 14.","text_display":"\n\nAll patients will have a 12-lead ECG performed at baseline, Day 3, and Day 14.","confidence":0.9717190265655518,"confidence_rate":0.99965020041818},{"cnt":[[346,529],[1880,529],[1880,578],[346,578]],"region":{"top_left_x":345,"top_left_y":528,"width":1535,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"342f5c9018a84d399c1c0f26547f5f2f","type":"text","conversion_output":true,"text":"Summary tables presenting observed values and changes from baseline will be presented","text_display":"\nSummary tables presenting observed values and changes from baseline will be presented","confidence":1,"confidence_rate":1},{"cnt":[[346,578],[1878,578],[1878,625],[346,625]],"region":{"top_left_x":345,"top_left_y":577,"width":1533,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0353ae5b675a488982b0082e3329622f","type":"text","conversion_output":true,"text":"for ventricular rate (bpm), PR Interval (msec), QRS Duration (msec), QT Interval (msec),","text_display":" for ventricular rate (bpm), PR Interval (msec), QRS Duration (msec), QT Interval (msec),","confidence":1,"confidence_rate":1},{"cnt":[[346,625],[1880,625],[1880,675],[346,675]],"region":{"top_left_x":345,"top_left_y":625,"width":1535,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cdf16d236f049548fc7eba976f9ecaa","type":"text","conversion_output":true,"text":"QTcB Interval (msec), by treatment group for patients in the Safety Set. Changes from","text_display":" QTcB Interval (msec), by treatment group for patients in the Safety Set. Changes from","confidence":1,"confidence_rate":1},{"cnt":[[346,675],[1412,675],[1412,724],[346,724]],"region":{"top_left_x":345,"top_left_y":674,"width":1067,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c12122b20b0a4785b937e45acd14d8fe","type":"text","conversion_output":true,"text":"baseline to each scheduled post-baseline visit will be presented.","text_display":" baseline to each scheduled post-baseline visit will be presented.","confidence":1,"confidence_rate":1},{"cnt":[[346,769],[1884,769],[1884,819],[346,819]],"region":{"top_left_x":345,"top_left_y":769,"width":1540,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79f84bfb60d4481ab1bd466d00fb590a","type":"text","conversion_output":true,"text":"The ECG interpretations will be summarized in shift tables comparing the ECG values of","text_display":"\n\nThe ECG interpretations will be summarized in shift tables comparing the ECG values of","confidence":0.9990234375,"confidence_rate":0.9999892633582115},{"cnt":[[348,816],[1880,816],[1880,866],[348,866]],"region":{"top_left_x":348,"top_left_y":816,"width":1532,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd2ed35e51604af8a12bf42ab8c8b879","type":"text","conversion_output":true,"text":"each post-baseline visit with the value at the baseline visit for the Safety Set. The","text_display":" each post-baseline visit with the value at the baseline visit for the Safety Set. The","confidence":1,"confidence_rate":1},{"cnt":[[346,866],[1880,866],[1880,913],[346,913]],"region":{"top_left_x":345,"top_left_y":865,"width":1535,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"535167225f22456faeea60615a05f84e","type":"text","conversion_output":true,"text":"percentage will be based on the number of patients who have attended the visit. In addition","text_display":" percentage will be based on the number of patients who have attended the visit. In addition","confidence":1,"confidence_rate":1},{"cnt":[[346,913],[1880,913],[1880,965],[346,965]],"region":{"top_left_x":345,"top_left_y":913,"width":1535,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5659e9c861a64b4c89faa4d9970fe3a9","type":"text","conversion_output":true,"text":"the worst post-baseline ECG value will be compared with the value at the baseline visit","text_display":" the worst post-baseline ECG value will be compared with the value at the baseline visit","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[348,962],[1334,962],[1334,1010],[348,1010]],"region":{"top_left_x":348,"top_left_y":962,"width":987,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8cc386b95eb4f4ca25b563433a26bde","type":"text","conversion_output":true,"text":"(with worst of all being Abnormal and best being Normal).","text_display":" (with worst of all being Abnormal and best being Normal).","confidence":0.9990234375,"confidence_rate":0.9999842414201705},{"cnt":[[348,1057],[1485,1057],[1485,1106],[348,1106]],"region":{"top_left_x":348,"top_left_y":1057,"width":1137,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c662e03a18df4ddb8d628c05e6d46f64","type":"text","conversion_output":true,"text":"Electrocardiogram data for all patients will be presented in a listing.","text_display":"\n\nElectrocardiogram data for all patients will be presented in a listing.","confidence":1,"confidence_rate":1},{"cnt":[[374,1192],[1210,1192],[1210,1248],[374,1248]],"region":{"top_left_x":373,"top_left_y":1192,"width":837,"height":57},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"928ae696c08a40d0a4be0987703cb20a","type":"section_header","conversion_output":false,"children_ids":["e0e459324ac94f73a55b6a946068cf06"],"text":"","text_display":""},{"cnt":[[378,1195],[1205,1195],[1205,1244],[378,1244]],"region":{"top_left_x":378,"top_left_y":1194,"width":828,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0e459324ac94f73a55b6a946068cf06","type":"text","conversion_output":true,"parent_id":"928ae696c08a40d0a4be0987703cb20a","text":"10. 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Interim Analysis","text_display":"\n\n\\section*{11. Interim Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[346,1586],[1880,1586],[1880,1635],[346,1635]],"region":{"top_left_x":345,"top_left_y":1585,"width":1535,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76a0c4ebb991409990a15af577f0b2f5","type":"text","conversion_output":true,"text":"An unblinded interim analysis will be conducted on the Part 1 data to determine the","text_display":"\n\nAn unblinded interim analysis will be conducted on the Part 1 data to determine the","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[346,1633],[1880,1633],[1880,1682],[346,1682]],"region":{"top_left_x":345,"top_left_y":1632,"width":1535,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7cbe4577e3834d92a719bca08418e2a2","type":"text","conversion_output":true,"text":"optimal recAP dose for Part 2. This analysis will compare the 4 treatment groups from Part","text_display":" optimal recAP dose for Part 2. This analysis will compare the 4 treatment groups from Part","confidence":1,"confidence_rate":1},{"cnt":[[348,1680],[1880,1680],[1880,1729],[348,1729]],"region":{"top_left_x":348,"top_left_y":1680,"width":1532,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf91fe49f0c04a85930aaadedee9063b","type":"text","conversion_output":true,"text":"1 on the primary efficacy endpoint, and a selection of the safety data. The interim analysis","text_display":" 1 on the primary efficacy endpoint, and a selection of the safety data. 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The results will be reviewed by an independent DMC,","text_display":" personnel involved in the study. The results will be reviewed by an independent DMC,","confidence":1,"confidence_rate":1},{"cnt":[[348,2065],[1880,2065],[1880,2112],[348,2112]],"region":{"top_left_x":348,"top_left_y":2064,"width":1532,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41aeabb67a8745aabec3cbbaf2de91be","type":"text","conversion_output":true,"text":"who will make the dose selection decision. A futility analysis will also be conducted at the","text_display":" who will make the dose selection decision. A futility analysis will also be conducted at the","confidence":0.99267578125,"confidence_rate":0.9999242175878068},{"cnt":[[348,2110],[1880,2110],[1880,2159],[348,2159]],"region":{"top_left_x":348,"top_left_y":2109,"width":1532,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9495453176304509b2415196a0e5f061","type":"text","conversion_output":true,"text":"interim analysis. If none of the 3 recAP doses in Part 1 show evidence of efficacy (i.e., all","text_display":" interim analysis. 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In each case the","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53cb04b0695d41058388d56c35f22499","type":"page_info","conversion_output":false,"text":"52","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-60","page":60,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5ab39423c69f465c91e25f59bd6b4684","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1369,125],[1850,125],[1850,159],[1369,159]],"region":{"top_left_x":1368,"top_left_y":124,"width":482,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"91fa5ddeb2594977974628fb7b0f658e","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[348,159],[599,159],[599,187],[348,187]],"region":{"top_left_x":348,"top_left_y":158,"width":252,"height":29},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"f0f669616bce40d28eba9a2ad3ce4f7c","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,159],[1854,159],[1854,187],[1573,187]],"region":{"top_left_x":1572,"top_left_y":158,"width":283,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"b11b5c5a50754e0699672ea1066f49e8","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[346,329],[1878,329],[1878,376],[346,376]],"region":{"top_left_x":345,"top_left_y":328,"width":1533,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f721a2649854456e802e6489540c0e1a","type":"text","conversion_output":true,"text":"milestone will be patients with at least 7 days of laboratory data or who were randomized","text_display":"\nmilestone will be patients with at least 7 days of laboratory data or who were randomized","confidence":1,"confidence_rate":1},{"cnt":[[346,376],[1878,376],[1878,423],[346,423]],"region":{"top_left_x":345,"top_left_y":375,"width":1533,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7ed9fe8b0554cfdb9b4eaa339ee07b8","type":"text","conversion_output":true,"text":"but discontinued or died prior to completing 7 days. The following outputs will be","text_display":" but discontinued or died prior to completing 7 days. The following outputs will be","confidence":1,"confidence_rate":1},{"cnt":[[348,425],[922,425],[922,471],[348,471]],"region":{"top_left_x":348,"top_left_y":425,"width":574,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41198964a9664f7d85a335f3d9d3ecf1","type":"text","conversion_output":true,"text":"produced for these safety reviews:","text_display":" produced for these safety reviews:","confidence":1,"confidence_rate":1},{"cnt":[[346,520],[1519,520],[1519,569],[346,569]],"region":{"top_left_x":345,"top_left_y":519,"width":1174,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f59fbe4f825c43f99c45550f77ad26da","type":"text","conversion_output":true,"text":"Table 14.1.1.1.1 Disposition at Interim Analysis All Enrolled Set","text_display":"\n\nTable 14.1.1.1.1 Disposition at Interim Analysis All Enrolled 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Set","confidence":1,"confidence_rate":1},{"cnt":[[346,1332],[1755,1332],[1755,1381],[346,1381]],"region":{"top_left_x":345,"top_left_y":1332,"width":1411,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"030857b7ae6f4c30992597f9ef14e757","type":"text","conversion_output":true,"text":"Figure 14.3.6.2.1 Time-course plot of Vital Signs at Interim Analysis Safety Set","text_display":"\nFigure 14.3.6.2.1 Time-course plot of Vital Signs at Interim Analysis Safety Set","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[344,1379],[1540,1379],[1540,1429],[344,1429]],"region":{"top_left_x":343,"top_left_y":1379,"width":1198,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93f6b7d06c4b4d3e9175e8bfa4390b5b","type":"text","conversion_output":true,"text":"Table 14.3.7.1.1* APACHE II Score at Interim Analysis Safety Set","text_display":"\nTable 14.3.7.1.1* APACHE II Score at Interim Analysis Safety Set","confidence":1,"confidence_rate":1},{"cnt":[[344,1429],[1016,1429],[1016,1480],[344,1480]],"region":{"top_left_x":343,"top_left_y":1428,"width":674,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"025a6243c61f4d8080f254519f6e1fb5","type":"text","conversion_output":true,"text":"Listing 16.3.1.1.2* Deaths Safety Set","text_display":"\nListing 16.3.1.1.2* Deaths Safety Set","confidence":1,"confidence_rate":1},{"cnt":[[346,1478],[1263,1478],[1263,1528],[346,1528]],"region":{"top_left_x":345,"top_left_y":1478,"width":919,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ac7247e606c42da8361710492873075","type":"text","conversion_output":true,"text":"* Outputs were requested after the first DMC meeting.","text_display":"\n* Outputs were requested after the first DMC meeting.","confidence":1,"confidence_rate":1},{"cnt":[[346,1573],[1880,1573],[1880,1622],[346,1622]],"region":{"top_left_x":345,"top_left_y":1572,"width":1535,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22830fcc0dfa43c2b2a315dd3f712c70","type":"text","conversion_output":true,"text":"References to 'Interim Analysis' will be removed from all titles and footnotes when","text_display":"\n\nReferences to 'Interim Analysis' will be removed from all titles and footnotes when","confidence":0.990234375,"confidence_rate":0.9998884877923994},{"cnt":[[346,1620],[995,1620],[995,1669],[346,1669]],"region":{"top_left_x":345,"top_left_y":1619,"width":650,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce29b282409d4dfe864196654877bea0","type":"text","conversion_output":true,"text":"outputs are provided at safety reviews.","text_display":" outputs are provided at safety reviews.","confidence":1,"confidence_rate":1},{"cnt":[[346,1714],[1880,1714],[1880,1766],[346,1766]],"region":{"top_left_x":345,"top_left_y":1714,"width":1535,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35b7016feb8a467a82c192d505b6f425","type":"text","conversion_output":true,"text":"Additional electronic reviews of AE listings provided by pharmacovigilance (PVG) will be","text_display":"\n\nAdditional electronic reviews of AE listings provided by pharmacovigilance (PVG) will be","confidence":1,"confidence_rate":1},{"cnt":[[346,1766],[1880,1766],[1880,1815],[346,1815]],"region":{"top_left_x":345,"top_left_y":1766,"width":1535,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c67139e896d44758288a49c9c6952af","type":"text","conversion_output":true,"text":"conducted at planned time points and the DMC can request ad hoc reviews. See Table 15-2","text_display":" conducted at planned time points and the DMC can request ad hoc reviews. See Table 15-2","confidence":1,"confidence_rate":1},{"cnt":[[346,1813],[1063,1813],[1063,1863],[346,1863]],"region":{"top_left_x":345,"top_left_y":1813,"width":719,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"652e05a81cc2485ea816883906e6ed7d","type":"text","conversion_output":true,"text":"for a full summary of the planned reviews.","text_display":" for a full summary of the planned reviews.","confidence":1,"confidence_rate":1},{"cnt":[[374,1899],[1033,1899],[1033,1957],[374,1957]],"region":{"top_left_x":373,"top_left_y":1899,"width":661,"height":59},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"befb2796470f48d7bcc1b3074af107c0","type":"section_header","conversion_output":false,"children_ids":["7b1dc7091dab4f5b845bb95c9cf30518"],"text":"","text_display":""},{"cnt":[[378,1904],[1029,1904],[1029,1953],[378,1953]],"region":{"top_left_x":378,"top_left_y":1903,"width":652,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b1dc7091dab4f5b845bb95c9cf30518","type":"text","conversion_output":true,"parent_id":"befb2796470f48d7bcc1b3074af107c0","text":"12. Changes in the Planned Analysis","text_display":"\n\n\\section*{12. Changes in the Planned Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[346,2002],[1880,2002],[1880,2052],[346,2052]],"region":{"top_left_x":345,"top_left_y":2002,"width":1535,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85db03e4011c4cdabad26d3e40158f88","type":"text","conversion_output":true,"text":"As part of the primary efficacy analysis an additional analysis set PP Day 1-7 Part 1 has","text_display":"\n\nAs part of the primary efficacy analysis an additional analysis set PP Day 1-7 Part 1 has","confidence":1,"confidence_rate":1},{"cnt":[[344,2050],[1880,2050],[1880,2099],[344,2099]],"region":{"top_left_x":343,"top_left_y":2049,"width":1537,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a41a39de4b141a49e8c2e7f63ad7a05","type":"text","conversion_output":true,"text":"been added. The protocol states that primary endpoint should be carried out separately for","text_display":" been added. The protocol states that primary endpoint should be carried out separately for","confidence":1,"confidence_rate":1},{"cnt":[[346,2097],[1880,2097],[1880,2146],[346,2146]],"region":{"top_left_x":345,"top_left_y":2096,"width":1535,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3265643236ef4196afb693d990be232a","type":"text","conversion_output":true,"text":"Part 1 and Part 2, however to do this analysis on the PP Set, the PP Day 1-7 Part 1 Set is","text_display":" Part 1 and Part 2, however to do this analysis on the PP Set, the PP Day 1-7 Part 1 Set is","confidence":1,"confidence_rate":1},{"cnt":[[344,2144],[1446,2144],[1446,2194],[344,2194]],"region":{"top_left_x":343,"top_left_y":2144,"width":1103,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed29b1aaef744a1f9a6e6305daa0e56f","type":"text","conversion_output":true,"text":"needed to be defined to obtain the analysis for Part 1 of the study.","text_display":" needed to be defined to obtain the analysis for Part 1 of the study.","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[346,2239],[1412,2239],[1412,2288],[346,2288]],"region":{"top_left_x":345,"top_left_y":2238,"width":1067,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e57ad3fcbaa84ff9880d83b199a9a2de","type":"text","conversion_output":true,"text":"The following are changes from the Protocol Amendment v2.0:","text_display":"\n\nThe following are changes from the Protocol Amendment v2.0:","confidence":1,"confidence_rate":1},{"cnt":[[1087,2582],[1141,2582],[1141,2628],[1087,2628]],"region":{"top_left_x":1087,"top_left_y":2582,"width":54,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"034690a2d72449c2b4007c97fbea0a76","type":"page_info","conversion_output":false,"text":"53","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-61","page":61,"lines":[{"cnt":[[346,129],[492,129],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":128,"width":147,"height":29},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"06bb1387ece14857a27f5138391f62a3","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1369,125],[1850,125],[1850,157],[1369,157]],"region":{"top_left_x":1368,"top_left_y":124,"width":482,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"cb062215be5c4a9cb7d448914dafd86e","type":"page_info","conversion_output":false,"text":"Statistical 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Version (date) & Section & Summary of change \\\\\n\\hline 1.4 (06DEC2016) & 6.2 & Number and percentage of patients with vasopressor/inotropic therapy use added to baseline disease characteristics \\\\\n\\hline 1.4 (06DEC2016) & 6.2 & FE Urea added and creatinine clearance is using formula given in 8.1 section and CKD-EPI formula added in the appendix. \\\\\n\\hline 1.4 (06DEC2016) & 8 & Supportive analysis updated to include specific group categories as factors. \\\\\n\\hline 1.4 (06DEC2016) & 8 & Table added to provide an overall summary of the efficacy analyses \\\\\n\\hline 1.4 (06DEC2016) & 8.1 & Updated so only adjudicated Part 1 will be used in sensitivity analysis. \\\\\n\\hline 1.4 (06DEC2016) & 8.1, 8.1.2 & Adjudication committee review added for creatinine clearance data \\\\\n\\hline 1.4 (06DEC2016) & 8.1, 8.1.2 & Formula added for time-corrected endogenous creatinine clearance calculation \\\\\n\\hline 1.4 (06DEC2016) & 8.1.4 & Sensitivity analysis added to repeat primary endpoint analysis based on adjudicated Part 1 data. ANOVA analysis excluding any patients that died prior to Day 8 and descriptive statistics on the primary endpoint will be performed for the sensitivity analysis. \\\\\n\\hline 1.4 (06DEC2016) & 8.2.2.1 & Urine volume and urea clearance calculation formulas were added \\\\\n\\hline 1.4 (06DEC2016) & 8.2.2.1 & Details added on RRT-free day calculation method \\\\\n\\hline 1.4 (06DEC2016) & 8.3 & Added anti-drug antibody data as other efficacy endpoint \\\\\n\\hline 1.4 (06DEC2016) & 8.3 & Iohexol substudy details added \\\\\n\\hline 1.4 (06DEC2016) & 8.1.5 & Category for FE Urea added \\\\\n\\hline 1.4 (06DEC2016) & 9.1.2 & Separate summary of TEAEs where relationship to study drug is 'Possible', 'Probable' or 'Definite' removed \\\\\n\\hline 1.4 (06DEC2016) & 9.2 & Laboratory evaluations analyses modified to be based on shift tables as per normal ranges provided by the local laboratory \\\\\n\\hline 1.4 (06DEC2016) & 11 & Amended list of outputs provided for the interim analysis \\\\\n\\hline 1.4 (06DEC2016) & 11 & Added details of outputs provided for the DMC meetings \\\\\n\\hline 1.4 (06DEC2016) & Appendices 15.2, 15.3, 15.4 & Added appendices of schedule of DMC reviews, weight ranges and pre-calculated corresponding volumes and CKD-EPI formula used for GFR calculation \\\\\n\\hline 2.0 (13JAN2017) & 3.2 & Total time in ICU/Intermediate care and Total time in hospital endpoint analysis based on time to decision of transfer deleted. Also both periods Day 1 to 28 and Day 1 to 90 added. \\\\\n\\hline 2.0 (13JAN2017) & 4.3.3.1, 4.3.3.2, 4.3.3.2, 4.3.3.4 & 'Non-adherence to inclusion/exclusion criteria with enrollment of the patient' is used for eligibility criteria. \\\\\n\\hline 2.0 (13JAN2017) & 8.1.1 & Hyperlink for section 8.1.5 added. \\\\\n\\hline 2.0 (13JAN2017) & 8.2.2.1 & 'Urine volume' replaced with 'Urine output' and the time course plot updated to be on urine output ( \\(ml / hr\\) ) and not on volume of urine \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Version (date) & Section & Summary of change \\\\\n\\hline 1.4 (06DEC2016) & 6.2 & Number and percentage of patients with vasopressor/inotropic therapy use added to baseline disease characteristics \\\\\n\\hline 1.4 (06DEC2016) & 6.2 & FE Urea added and creatinine clearance is using formula given in 8.1 section and CKD-EPI formula added in the appendix. \\\\\n\\hline 1.4 (06DEC2016) & 8 & Supportive analysis updated to include specific group categories as factors. \\\\\n\\hline 1.4 (06DEC2016) & 8 & Table added to provide an overall summary of the efficacy analyses \\\\\n\\hline 1.4 (06DEC2016) & 8.1 & Updated so only adjudicated Part 1 will be used in sensitivity analysis. \\\\\n\\hline 1.4 (06DEC2016) & 8.1, 8.1.2 & Adjudication committee review added for creatinine clearance data \\\\\n\\hline 1.4 (06DEC2016) & 8.1, 8.1.2 & Formula added for time-corrected endogenous creatinine clearance calculation \\\\\n\\hline 1.4 (06DEC2016) & 8.1.4 & Sensitivity analysis added to repeat primary endpoint analysis based on adjudicated Part 1 data. 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Version (date) & Section & Summary of change \\\\\n\\hline 2.0 (13JAN2017) & 8.2.2.2 & Sentence 'non mechanical analysis' replaced with 'non mechanical ventilation'. \\\\\n\\hline 2.0 (13JAN2017) & 8.3 & Day 1-28 and the day1-90 for ICU discharge and hospital discharge used (like section 3.2). \\\\\n\\hline 3.0 (25SEP2017) & General & 'Time-corrected' only used for reference to AUC of Creatinine Clearance. 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Biometrics.","confidence":0.99853515625,"confidence_rate":0.9999842375685026},{"cnt":[[348,1276],[698,1276],[698,1326],[348,1326]],"region":{"top_left_x":348,"top_left_y":1276,"width":351,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21b22de08a7b4dc1856842db91038972","type":"text","conversion_output":true,"text":"1994;50(4):1029-41.","text_display":" 1994;50(4):1029-41.","confidence":0.9990234375,"confidence_rate":0.999959290843314},{"cnt":[[344,1377],[1772,1377],[1772,1431],[344,1431]],"region":{"top_left_x":343,"top_left_y":1377,"width":1430,"height":54},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2676e781a2c49a9a4f5fa0be7a2c598","type":"text","conversion_output":true,"text":"Chawla LS, Amdur RL, Amodeo S, et al. The severity of acute kidney injury predicts","text_display":"\n\nChawla LS, Amdur RL, Amodeo S, et al. The severity of acute kidney injury predicts","confidence":0.9990234375,"confidence_rate":0.9999887697222805},{"cnt":[[344,1435],[1549,1435],[1549,1489],[344,1489]],"region":{"top_left_x":343,"top_left_y":1435,"width":1207,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba73f4b1488441e994e7bcd755ccc851","type":"text","conversion_output":true,"text":"progression to chronic kidney disease. Kidney Int. 2011;79(12):1361-9.","text_display":" progression to chronic kidney disease. Kidney Int. 2011;79(12):1361-9.","confidence":1,"confidence_rate":1},{"cnt":[[344,1538],[1858,1538],[1858,1592],[344,1592]],"region":{"top_left_x":343,"top_left_y":1538,"width":1516,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb252bb541734a74b4225367e5f03f2f","type":"text","conversion_output":true,"text":"Gaspari F, Perico N, Ruggenenti, P, et al. Plasma clearance of nonradioactive iohexol as a","text_display":"\n\nGaspari F, Perico N, Ruggenenti, P, et al. Plasma clearance of nonradioactive iohexol as a","confidence":0.9609925746917725,"confidence_rate":0.9995812603623538},{"cnt":[[344,1598],[1596,1598],[1596,1652],[344,1652]],"region":{"top_left_x":343,"top_left_y":1598,"width":1254,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e23bfedb9674d4eb658889e7fd75776","type":"text","conversion_output":true,"text":"measure of glomerular filtration rate. J Am Soc Nephrol. 1995;6: 257-263.","text_display":" measure of glomerular filtration rate. 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Crit Care. 2012;16(5):R197.","text_display":" data from the prospective FINNAKI study. 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Assessment & Screening \\(( \\leq 2 4 ~ h )\\) & Baseline \\(( \\leq 2 4 ~ h )\\) & Day 1 & Day 2 & Day 3 & Day 4 & Day 5 & Day 6 & Day 7 \\(( \\pm 1\\) day) & Day 14 ( ± 2 days) & Day 21 ( ± 3 days) & Day 28 ( ± 3 days) & Day 60 \\(( \\pm 5\\) days) & Day 90 \\(( \\pm 10\\) days) \\\\\n\\hline \\begin{tabular}{l}\nAKI diagnosis \\({ }^{\\text {a }}\\) (prescreening) \\\\\nRecord site of infection and pathogen\n\\end{tabular} & X & & & & & & & & & & & & & \\\\\n\\hline Inclusion and exclusion criteria & X & X \\({ }^{\\text {b }}\\) & & & & & & & & & & & & \\\\\n\\hline Informed consent & X & & & & & & & & & & & & & \\\\\n\\hline Medical history & X & & & & & & & & & & & & & \\\\\n\\hline Demographics & X & & & & & & & & & & & & & \\\\\n\\hline Child-Pugh score \\({ }^{\\text {c }}\\) & X & & & & & & & & & & & & & \\\\\n\\hline Recent hematology and clinical chemistry results, if available & X & & & & & & & & & & & & & \\\\\n\\hline Recent microbial test results, if available & X & & & 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\\(h =\\) hour; Hct = hematocrit; Hgb = hemoglobin; HR = heart rate; ICU = intensive care unit; IgE = immunoglobulin E; IgG = immunoglobulin G;","text_display":"transferase; \\(h =\\) hour; Hct = hematocrit; Hgb = hemoglobin; HR = heart rate; ICU = intensive care unit; IgE = immunoglobulin E; IgG = immunoglobulin G;","confidence":0.7916508204901354,"confidence_rate":0.9985408476769283},{"cnt":[[320,1571],[2348,1571],[2348,1609],[320,1609]],"region":{"top_left_x":320,"top_left_y":1570,"width":2029,"height":40},"line":130,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8458ef4d98834d9488ce1512119b4b35","type":"text","conversion_output":true,"text":"IL-6 = interleukin-6; IL-18 = interleukin-18; KIM-1 = kidney injury molecule-1; LBP = lipopolysaccharide binding protein; LDH = lactate dehydrogenase; OS =","text_display":" IL-6 = interleukin-6; IL-18 = interleukin-18; KIM-1 = kidney injury molecule-1; LBP = lipopolysaccharide binding protein; LDH = lactate dehydrogenase; 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The AKI diagnosis can be made according to one of the AKIN serum creatinine criteria (absolute or relative increase, see inclusion criteria Error! Reference","text_display":"\ny. The AKI diagnosis can be made according to one of the AKIN serum creatinine criteria (absolute or relative increase, see inclusion criteria Error! Reference","confidence":0.94091796875,"confidence_rate":0.9996287316338398},{"cnt":[[370,1721],[2357,1721],[2357,1760],[370,1760]],"region":{"top_left_x":369,"top_left_y":1720,"width":1988,"height":40},"line":134,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8d1ffb1cfe346b0afe27da527c0897c","type":"text","conversion_output":true,"text":"source not found. and Error! Reference source not found.), or according to the AKIN urine output criteria (urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\) hours, see","text_display":" source not found. and Error! 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Local laboratory.","text_display":"\nbb. Local laboratory.","confidence":0.9990236759185791,"confidence_rate":0.9999624314366309},{"cnt":[[320,434],[2357,434],[2357,475],[320,475]],"region":{"top_left_x":320,"top_left_y":433,"width":2037,"height":42},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78fab29a54204a308395b582aa315bb1","type":"text","conversion_output":true,"text":"\\({ }^{\\text {cc. }}\\) See flowchart (Section Error! Reference source not found., Error! Reference source not found.) for options and preference for reference serum creatinine","text_display":"\n\\({ }^{\\text {cc. }}\\) See flowchart (Section Error! Reference source not found., Error! Reference source not found.) for options and preference for reference serum creatinine","confidence":0.7148895263671875,"confidence_rate":0.9980505813291248},{"cnt":[[370,473],[2400,473],[2400,509],[370,509]],"region":{"top_left_x":369,"top_left_y":472,"width":2031,"height":38},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f627bbebc194ff5b4ba876585d8dad4","type":"text","conversion_output":true,"text":"value. The reference creatinine value is the serum creatinine value according to the following order of preference: 1) lowest value within 3 months of the hospital","text_display":" value. The reference creatinine value is the serum creatinine value according to the following order of preference: 1) lowest value within 3 months of the hospital","confidence":0.99951171875,"confidence_rate":0.999997143860815},{"cnt":[[370,507],[2411,507],[2411,546],[370,546]],"region":{"top_left_x":369,"top_left_y":507,"width":2042,"height":39},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fa73f84b4e354a3b85ae38fc34f0ac2c","type":"text","conversion_output":true,"text":"admission. If not available, 2) at hospital admission. If not available, 3 ) at ICU or intermediate care unit admission. If not available, 4) lowest value between 3 and","text_display":" admission. If not available, 2) at hospital admission. If not available, 3 ) at ICU or intermediate care unit admission. If not available, 4) lowest value between 3 and","confidence":0.5548348668935432,"confidence_rate":0.9967144330884868},{"cnt":[[370,546],[857,546],[857,582],[370,582]],"region":{"top_left_x":369,"top_left_y":545,"width":489,"height":38},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6fa995bb156e4afc9bf4c628f782a8b2","type":"text","conversion_output":true,"text":"12 months prior to hospital admission.","text_display":" 12 months prior to hospital admission.","confidence":1,"confidence_rate":1},{"cnt":[[320,580],[2400,580],[2400,625],[320,625]],"region":{"top_left_x":320,"top_left_y":580,"width":2080,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d2774b837de45af82fee4741e552bab","type":"text","conversion_output":true,"text":"\\({ }^{\\text {dd }}\\) When the diagnosis of AKI is made according to one of the AKIN serum creatinine criteria (absolute or relative increase, see inclusion criteria Error! Reference","text_display":"\n\\({ }^{\\text {dd }}\\) When the diagnosis of AKI is made according to one of the AKIN serum creatinine criteria (absolute or relative increase, see inclusion criteria Error! Reference","confidence":0.9404897689819336,"confidence_rate":0.9996572961186537},{"cnt":[[370,623],[2361,623],[2361,662],[370,662]],"region":{"top_left_x":369,"top_left_y":623,"width":1993,"height":39},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b71d69ef060a42c1b60e95ee0fcf91c3","type":"text","conversion_output":true,"text":"source not found. and Error! Reference source not found.), patients will be eligible for the study and can be randomly assigned when the volume-corrected","text_display":" source not found. and Error! Reference source not found.), patients will be eligible for the study and can be randomly assigned when the volume-corrected","confidence":1,"confidence_rate":1},{"cnt":[[370,660],[2383,660],[2383,698],[370,698]],"region":{"top_left_x":369,"top_left_y":659,"width":2014,"height":40},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88218da56dd545bd8cc77bc911220d33","type":"text","conversion_output":true,"text":"serum creatinine sample, taken at screening confirms the continuation of AKI according to the AKIN criteria for serum creatinine. When the AKI diagnosis was","text_display":" serum creatinine sample, taken at screening confirms the continuation of AKI according to the AKIN criteria for serum creatinine. When the AKI diagnosis was","confidence":0.9970703125,"confidence_rate":0.9999817766416077},{"cnt":[[370,696],[2385,696],[2385,733],[370,733]],"region":{"top_left_x":369,"top_left_y":696,"width":2016,"height":37},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b0d660505404794954ec8c24695e57d","type":"text","conversion_output":true,"text":"made according to the AKIN urine output criteria (urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\) hours, see inclusion criterion Error! Reference source not found.), the","text_display":" made according to the AKIN urine output criteria (urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\) hours, see inclusion criterion Error! Reference source not found.), the","confidence":1,"confidence_rate":1},{"cnt":[[370,730],[1876,730],[1876,769],[370,769]],"region":{"top_left_x":369,"top_left_y":730,"width":1507,"height":40},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0556b5050a14ae499817bd312c82e61","type":"text","conversion_output":true,"text":"oliguria or anuria should still meet the AKIN urine output criteria prior to randomization and study drug administration.","text_display":" oliguria or anuria should still meet the AKIN urine output criteria prior to randomization and study drug administration.","confidence":1,"confidence_rate":1},{"cnt":[[320,812],[320,769],[2402,771],[2402,814]],"region":{"top_left_x":320,"top_left_y":769,"width":2082,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e862354506244750b1abc961e2b23d68","type":"text","conversion_output":true,"text":"ee. Vital signs in ambulant patients will be obtained with the patient in a sitting position and after 5 minutes rest. Blood pressure will be monitored non-invasively. In","text_display":"\nee. Vital signs in ambulant patients will be obtained with the patient in a sitting position and after 5 minutes rest. Blood pressure will be monitored non-invasively. In","confidence":0.72802734375,"confidence_rate":0.9982183493003464},{"cnt":[[367,810],[2189,810],[2189,849],[367,849]],"region":{"top_left_x":367,"top_left_y":809,"width":1823,"height":40},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d02b2ab69bf146e4979d4434fc72e968","type":"text","conversion_output":true,"text":"patients who already have an arterial line placed as part of standard or care, readings from invasive blood pressure monitoring are to be recorded.","text_display":" patients who already have an arterial line placed as part of standard or care, readings from invasive blood pressure monitoring are to be recorded.","confidence":0.9990234375,"confidence_rate":0.9999935721282389},{"cnt":[[322,846],[2374,846],[2374,892],[322,892]],"region":{"top_left_x":322,"top_left_y":846,"width":2053,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0118a6dbae0942639bd104c94e4b8869","type":"text","conversion_output":true,"text":"ff. Additionally, vital signs (excluding temperature) will also be monitored during study drug infusion on all treatment days at the following times: a) immediately","text_display":"\nff. Additionally, vital signs (excluding temperature) will also be monitored during study drug infusion on all treatment days at the following times: a) immediately","confidence":1,"confidence_rate":1},{"cnt":[[370,889],[2376,889],[2376,926],[370,926]],"region":{"top_left_x":369,"top_left_y":889,"width":2008,"height":37},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d79c965747947078634fe595e3a9c84","type":"text","conversion_output":true,"text":"before the administration of the study drug, b) within 5 minutes of the start of the study drug infusion, c) 30 minutes after the start of the study drug infusion, d)","text_display":" before the administration of the study drug, b) within 5 minutes of the start of the study drug infusion, c) 30 minutes after the start of the study drug infusion, d)","confidence":1,"confidence_rate":1},{"cnt":[[370,924],[2408,924],[2408,965],[370,965]],"region":{"top_left_x":369,"top_left_y":923,"width":2040,"height":42},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ee17549242514096998f3e7b2900652c","type":"text","conversion_output":true,"text":"immediately after the completion of the administration of the study drug, which includes post-dose saline flushing, e) 30 and 60 minutes after completion of study","text_display":" immediately after the completion of the administration of the study drug, which includes post-dose saline flushing, e) 30 and 60 minutes after completion of study","confidence":1,"confidence_rate":1},{"cnt":[[370,962],[1893,962],[1893,999],[370,999]],"region":{"top_left_x":369,"top_left_y":962,"width":1524,"height":38},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25a533b835ce4bf7927cc2b63bd9ca33","type":"text","conversion_output":true,"text":"drug administration, f) 2 hours, 3 hours, 4 hours, and 5 hours after completion of study drug administration (Day 1 only).","text_display":" drug administration, f) 2 hours, 3 hours, 4 hours, and 5 hours after completion of study drug administration (Day 1 only).","confidence":1,"confidence_rate":1},{"cnt":[[318,999],[2370,999],[2370,1042],[318,1042]],"region":{"top_left_x":317,"top_left_y":999,"width":2053,"height":43},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d615b26c4994aa49a0fcbdcd670a216","type":"text","conversion_output":true,"text":"gg. SOFA score to be obtained on each visit day as long as the patient is in the ICU or intermediate care unit, and at discharge from ICU or intermediate care unit .","text_display":"\ngg. SOFA score to be obtained on each visit day as long as the patient is in the ICU or intermediate care unit, and at discharge from ICU or intermediate care unit .","confidence":0.9345703125,"confidence_rate":0.9996020297162105},{"cnt":[[320,1040],[2335,1040],[2335,1085],[320,1085]],"region":{"top_left_x":320,"top_left_y":1039,"width":2016,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9287045eee24fd1b264d457d0c7fcb4","type":"text","conversion_output":true,"text":"hh. EQ-5D will be performed at baseline, at discharge from the ICU or intermediate care unit, and at the Day 90 visit. In case the patient is unconscious, EQ-5D","text_display":"\nhh. EQ-5D will be performed at baseline, at discharge from the ICU or intermediate care unit, and at the Day 90 visit. In case the patient is unconscious, EQ-5D","confidence":0.98974609375,"confidence_rate":0.9999386516455336},{"cnt":[[370,1083],[988,1083],[988,1119],[370,1119]],"region":{"top_left_x":369,"top_left_y":1082,"width":620,"height":38},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad55256230e843df9020bf2f22d5c86b","type":"text","conversion_output":true,"text":"questionnaire will be completed by a next of kin.","text_display":" questionnaire will be completed by a next of kin.","confidence":1,"confidence_rate":1},{"cnt":[[318,1119],[1051,1119],[1051,1162],[318,1162]],"region":{"top_left_x":317,"top_left_y":1119,"width":734,"height":44},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c50476a305c647d8838ac4b8820c73ef","type":"text","conversion_output":true,"text":"ii. At \\(24 \\pm 1\\) hour after the previous drug administration.","text_display":"\nii. At \\(24 \\pm 1\\) hour after the previous drug administration.","confidence":1,"confidence_rate":1},{"cnt":[[318,1162],[2380,1162],[2380,1205],[318,1205]],"region":{"top_left_x":317,"top_left_y":1162,"width":2064,"height":44},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5428375684d7494094d8089e86854171","type":"text","conversion_output":true,"text":"jj. Creatinine and BUN will be measured by a central laboratory. At Days 60 and 90 , only serum creatinine will be measured. When patients have a Foley catheter,","text_display":"\njj. Creatinine and BUN will be measured by a central laboratory. At Days 60 and 90 , only serum creatinine will be measured. When patients have a Foley catheter,","confidence":0.5455672071548179,"confidence_rate":0.99648335329479},{"cnt":[[370,1203],[2411,1203],[2411,1242],[370,1242]],"region":{"top_left_x":369,"top_left_y":1203,"width":2042,"height":39},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffb5784ffaf048a897fcf377a63eaa3b","type":"text","conversion_output":true,"text":"serum creatinine samples should be collected prior to and immediately after each urine collection for at least up to Day 7. If the patient is discharged from the ICU","text_display":" serum creatinine samples should be collected prior to and immediately after each urine collection for at least up to Day 7. If the patient is discharged from the ICU","confidence":0.9853515625,"confidence_rate":0.9999131991483188},{"cnt":[[370,1242],[2361,1242],[2361,1278],[370,1278]],"region":{"top_left_x":369,"top_left_y":1241,"width":1993,"height":38},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25cb54976a7a4317b7b057283c9c6c7f","type":"text","conversion_output":true,"text":"or intermediate care unit , the Foley catheter might be removed. In this case, a patient might urinate spontaneously and all efforts should be undertaken to start","text_display":" or intermediate care unit , the Foley catheter might be removed. In this case, a patient might urinate spontaneously and all efforts should be undertaken to start","confidence":0.994140625,"confidence_rate":0.9999648113467461},{"cnt":[[370,1276],[2391,1276],[2391,1313],[370,1313]],"region":{"top_left_x":369,"top_left_y":1276,"width":2023,"height":37},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e30bd726386a463bab0bf5109cda5b46","type":"text","conversion_output":true,"text":"collecting urine produced from this time point onward. Approximately 6 hours later (exact duration needs to be recorded) the patient might urinate again and this","text_display":" collecting urine produced from this time point onward. Approximately 6 hours later (exact duration needs to be recorded) the patient might urinate again and this","confidence":1,"confidence_rate":1},{"cnt":[[370,1311],[2374,1311],[2374,1351],[370,1351]],"region":{"top_left_x":369,"top_left_y":1310,"width":2006,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1bed945de02e4dc285b9d8da9fce6061","type":"text","conversion_output":true,"text":"urine will be used for analysis, and a blood sample will be drawn at this time too. The urine volume produced over approximately 6 hours will be entered in the","text_display":" urine will be used for analysis, and a blood sample will be drawn at this time too. The urine volume produced over approximately 6 hours will be entered in the","confidence":1,"confidence_rate":1},{"cnt":[[370,1349],[458,1349],[458,1381],[370,1381]],"region":{"top_left_x":369,"top_left_y":1349,"width":89,"height":33},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d73deaf457d34bf3bdc11c13651843c2","type":"text","conversion_output":true,"text":"eCRF.","text_display":" eCRF.","confidence":0.9990234375,"confidence_rate":0.9999023008080943},{"cnt":[[380,1384],[2368,1384],[2368,1429],[380,1429]],"region":{"top_left_x":380,"top_left_y":1383,"width":1988,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"894fa5fc9c3d427689f49bba2758e5bc","type":"text","conversion_output":true,"text":"kk. Urine creatinine and urea will be measured by a central laboratory. The central laboratory will calculate blood urea nitrogen (BUN) clearance at all visits","text_display":"\nkk. Urine creatinine and urea will be measured by a central laboratory. The central laboratory will calculate blood urea nitrogen (BUN) clearance at all visits","confidence":0.96923828125,"confidence_rate":0.9998095011164968},{"cnt":[[443,1427],[2391,1427],[2391,1465],[443,1465]],"region":{"top_left_x":442,"top_left_y":1426,"width":1950,"height":40},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ecc973ff88024ae5bbc359125bbeeab7","type":"text","conversion_output":true,"text":"from Day 1 to Day 7, inclusive, and on subsequent visit days if reliable urine collection is possible. Urine will be collected within a \\(6 \\pm 1\\) hour period at all","text_display":" from Day 1 to Day 7, inclusive, and on subsequent visit days if reliable urine collection is possible. Urine will be collected within a \\(6 \\pm 1\\) hour period at all","confidence":0.9990236759185791,"confidence_rate":0.999994220129152},{"cnt":[[443,1463],[2219,1463],[2219,1502],[443,1502]],"region":{"top_left_x":442,"top_left_y":1463,"width":1778,"height":39},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78d58c1ee5f94a2791423929b297ab6a","type":"text","conversion_output":true,"text":"visits from Day 1 to Day 28, only if reliable urine collection is possible (i.e., patient remains in the ICU or intermediate care unit or hospital).","text_display":" visits from Day 1 to Day 28, only if reliable urine collection is possible (i.e., patient remains in the ICU or intermediate care unit or hospital).","confidence":1,"confidence_rate":1},{"cnt":[[318,1500],[1996,1500],[1996,1543],[318,1543]],"region":{"top_left_x":317,"top_left_y":1499,"width":1679,"height":44},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df909c05c1a34fac8bdf057d826994d1","type":"text","conversion_output":true,"text":"\\({ }^{11}\\). These assessments will be performed before treatment if possible. Treatment should not be delayed because of these assessments.","text_display":"\n\\({ }^{11}\\). These assessments will be performed before treatment if possible. Treatment should not be delayed because of these assessments.","confidence":0.8988322844317054,"confidence_rate":0.9992544122158515},{"cnt":[[320,1543],[2387,1543],[2387,1588],[320,1588]],"region":{"top_left_x":320,"top_left_y":1542,"width":2067,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f8b6ff7220cf49fdb33e9a75fbd3f6fe","type":"text","conversion_output":true,"text":"\\({ }^{ mm .}\\) Urine volume collection in a \\(6 \\pm 1\\) hour collection period, only if reliable urine collection is possible (i.e., patient remains in the ICU or intermediate care unit or","text_display":"\n\\({ }^{ mm .}\\) Urine volume collection in a \\(6 \\pm 1\\) hour collection period, only if reliable urine collection is possible (i.e., patient remains in the ICU or intermediate care unit or","confidence":0.9713103257818148,"confidence_rate":0.999843510806238},{"cnt":[[370,1586],[2073,1586],[2073,1622],[370,1622]],"region":{"top_left_x":369,"top_left_y":1585,"width":1705,"height":38},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e03c6c6d8e7b4daabc8eb457c85a372c","type":"text","conversion_output":true,"text":"hospital). The volume should be corrected to account for the volume of samples previously taken from the total urine initially collected.","text_display":" hospital). The volume should be corrected to account for the volume of samples previously taken from the total urine initially collected.","confidence":1,"confidence_rate":1},{"cnt":[[320,1624],[1519,1624],[1519,1665],[320,1665]],"region":{"top_left_x":320,"top_left_y":1624,"width":1199,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cb6655b95044c83857c94b2637f69f7","type":"text","conversion_output":true,"text":"\\({ }^{n n}\\). Only when possible within the 24 -hour time window from first AKI diagnosis to treatment.","text_display":"\n\\({ }^{n n}\\). Only when possible within the 24 -hour time window from first AKI diagnosis to treatment.","confidence":0.6953243587257618,"confidence_rate":0.9966410535630387},{"cnt":[[320,1667],[2015,1667],[2015,1708],[320,1708]],"region":{"top_left_x":320,"top_left_y":1667,"width":1696,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6766c535eefc4ba5a3ca3fb9b60a1015","type":"text","conversion_output":true,"text":"\\({ }^{\\text {oo. }}\\) Assays will be performed by a central reference laboratory. See Section Error! Reference source not found. for sampling details.","text_display":"\n\\({ }^{\\text {oo. }}\\) Assays will be performed by a central reference laboratory. See Section Error! Reference source not found. for sampling details.","confidence":0.9858884229552132,"confidence_rate":0.9999039769612791},{"cnt":[[320,1710],[2185,1710],[2185,1751],[320,1751]],"region":{"top_left_x":320,"top_left_y":1710,"width":1865,"height":41},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98ac06a19ef34d8ebd41384d7548003e","type":"text","conversion_output":true,"text":"pp. A 12-lead ECG with at least 30 -second rhythm strip will be recorded after the patient has rested supine or semi-recumbent for at least 5 minutes.","text_display":"\npp. A 12-lead ECG with at least 30 -second rhythm strip will be recorded after the patient has rested supine or semi-recumbent for at least 5 minutes.","confidence":0.8273219602426707,"confidence_rate":0.9988232931819025},{"cnt":[[320,1753],[737,1753],[737,1794],[320,1794]],"region":{"top_left_x":320,"top_left_y":1753,"width":417,"height":41},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e9a2c8f60d4142b48b0057e8e839f97e","type":"text","conversion_output":true,"text":"qq. Central reference laboratory.","text_display":"\nqq. Central reference laboratory.","confidence":1,"confidence_rate":1},{"cnt":[[320,1796],[1553,1796],[1553,1837],[320,1837]],"region":{"top_left_x":320,"top_left_y":1796,"width":1234,"height":41},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eca5b1e1ef6e4a8d8f50acbee40df18f","type":"text","conversion_output":true,"text":"rr. Samples taken on Days 60 and 90 will only be analyzed in case of a positive result on Day 28.","text_display":"\nrr. Samples taken on Days 60 and 90 will only be analyzed in case of a positive result on Day 28.","confidence":0.9228515625,"confidence_rate":0.9992499367829609},{"cnt":[[1349,1955],[1401,1955],[1401,2007],[1349,2007]],"region":{"top_left_x":1349,"top_left_y":1955,"width":52,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccb3e385328f4b95a7309bf73bf5440f","type":"page_info","conversion_output":false,"text":"64","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-72","page":72,"lines":[{"cnt":[[322,125],[468,125],[468,157],[322,157]],"region":{"top_left_x":322,"top_left_y":124,"width":147,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"635d00d50f7d4bbf986f90837ff8040b","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1835,125],[2318,125],[2318,161],[1835,161]],"region":{"top_left_x":1834,"top_left_y":124,"width":485,"height":38},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a8d80a70cfd84150ad3230f1bfb4a925","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[320,157],[574,157],[574,191],[320,191]],"region":{"top_left_x":320,"top_left_y":156,"width":254,"height":36},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"981954f93a7243eeb9fc96c0b67f02c6","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.99658203125,"confidence_rate":0.9998511491946174},{"cnt":[[2037,159],[2322,159],[2322,191],[2037,191]],"region":{"top_left_x":2036,"top_left_y":158,"width":287,"height":34},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"4c253b4657d54f8ca9da69d4c99c0f31","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[318,348],[1364,348],[1364,385],[318,385]],"region":{"top_left_x":317,"top_left_y":348,"width":1048,"height":37},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34cdc3a841fe425ba8421185f57b93b8","type":"text","conversion_output":true,"text":"ss. Verification that no concomitant medications that should be avoided are taken.","text_display":"\nss. Verification that no concomitant medications that should be avoided are taken.","confidence":0.99658203125,"confidence_rate":0.9999606464829958},{"cnt":[[318,387],[2103,387],[2103,432],[318,432]],"region":{"top_left_x":317,"top_left_y":386,"width":1787,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6bc6e32e8dda45ea9a79d2562b81332c","type":"text","conversion_output":true,"text":"\\({ }^{\\text {tt. The actual stop date is collected for calculation of shock-free days. Only required when the patient is in the ICU or intermediate care unit. }}\\)","text_display":"\n\\({ }^{\\text {tt. The actual stop date is collected for calculation of shock-free days. Only required when the patient is in the ICU or intermediate care unit. }}\\)","confidence":0.5684102361556143,"confidence_rate":0.9964083008340033},{"cnt":[[320,432],[2408,432],[2408,475],[320,475]],"region":{"top_left_x":320,"top_left_y":431,"width":2089,"height":44},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"007ccf44e025455a8e7e04f0a2efa824","type":"text","conversion_output":true,"text":"\\({ }^{\\text {uu. Daily, as long as the patient requires mechanical ventilation. As appropriate, record start and stop dates and times of mechanical ventilation, including the settings }}\\)","text_display":"\n\\({ }^{\\text {uu. Daily, as long as the patient requires mechanical ventilation. As appropriate, record start and stop dates and times of mechanical ventilation, including the settings }}\\)","confidence":0.9834767589754847,"confidence_rate":0.9999084587375902},{"cnt":[[370,473],[788,473],[788,509],[370,509]],"region":{"top_left_x":369,"top_left_y":472,"width":420,"height":38},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7be67a9370c241a196cb086326371498","type":"text","conversion_output":true,"text":"required and the \\(O _{2}\\) in the blood.","text_display":" required and the \\(O _{2}\\) in the blood.","confidence":1,"confidence_rate":1},{"cnt":[[318,511],[2402,511],[2402,552],[318,552]],"region":{"top_left_x":317,"top_left_y":511,"width":2085,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1a93194aa1c45e5ae8674561ff96eb7","type":"text","conversion_output":true,"text":"vv. Actual admission dates and both planned and actual discharge dates from the ICU or intermediate care unit and hospital (planned meaning when decision is taken","text_display":"\nvv. Actual admission dates and both planned and actual discharge dates from the ICU or intermediate care unit and hospital (planned meaning when decision is taken","confidence":0.8916015625,"confidence_rate":0.9993131944918551},{"cnt":[[367,550],[2054,550],[2054,591],[367,591]],"region":{"top_left_x":367,"top_left_y":550,"width":1687,"height":41},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01fe1547f8ff4bd3be54928fe621906b","type":"text","conversion_output":true,"text":"to discharge the patient, not necessarily being the same as the actual discharge date, e.g., because of lack of beds on the regular ward).","text_display":" to discharge the patient, not necessarily being the same as the actual discharge date, e.g., because of lack of beds on the regular ward).","confidence":1,"confidence_rate":1},{"cnt":[[1347,1955],[1401,1955],[1401,2007],[1347,2007]],"region":{"top_left_x":1347,"top_left_y":1955,"width":54,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8858d31cdc547fc87e523d98ab7944b","type":"page_info","conversion_output":false,"text":"65","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"191892b7-dda0-4aa1-bc1f-2386433b2d17-73","page":73,"lines":[{"cnt":[[346,125],[492,125],[492,157],[346,157]],"region":{"top_left_x":345,"top_left_y":124,"width":147,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"64537061ccac4cca9b580a2224a3a033","type":"page_info","conversion_output":false,"text":"AM-Pharma","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1366,125],[1852,125],[1852,159],[1366,159]],"region":{"top_left_x":1366,"top_left_y":124,"width":486,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9b5a40a5cc4e4a53be15a0b221b5d1db","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan, Final Version 3.1","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[344,157],[599,157],[599,187],[344,187]],"region":{"top_left_x":343,"top_left_y":156,"width":257,"height":31},"line":3,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"84afec6c9fde411da4acbebe31635a74","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[1568,159],[1854,159],[1854,187],[1568,187]],"region":{"top_left_x":1568,"top_left_y":158,"width":287,"height":29},"line":4,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5f5db35642834404a82d583227b9d249","type":"page_info","conversion_output":false,"text":"Date Issued: 27SEP2017","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[404,357],[1079,357],[1079,406],[404,406]],"region":{"top_left_x":403,"top_left_y":356,"width":676,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1aa8268da21a428ab0e933637fecbe3b","type":"section_header","conversion_output":false,"children_ids":["5c446c5971b9467c9c20ea28c161fd66"],"text":"","text_display":""},{"cnt":[[408,361],[1074,361],[1074,402],[408,402]],"region":{"top_left_x":408,"top_left_y":360,"width":667,"height":42},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c446c5971b9467c9c20ea28c161fd66","type":"text","conversion_output":true,"parent_id":"1aa8268da21a428ab0e933637fecbe3b","text":"15.2. 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