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Abbreviation & Definition \\\\\n\\hline ERPF & effective renal plasma flow \\\\\n\\hline FDA & Food and Drug Administration \\\\\n\\hline \\(FiO _{2}\\) & fraction of inspired oxygen \\\\\n\\hline GFR & glomerular filtration rate \\\\\n\\hline GGT & gamma-glutamyl transpeptidase \\\\\n\\hline GST-alpha & alpha-glutathione s-transferase \\\\\n\\hline hCG & human chorionic gonadotropin \\\\\n\\hline ICF & informed consent form \\\\\n\\hline ICH & The International Council for Harmonisation \\\\\n\\hline ICU & intensive care unit \\\\\n\\hline IEC & independent ethics committee \\\\\n\\hline IgE & immunoglobulin E \\\\\n\\hline IgG & immunoglobulin G \\\\\n\\hline IL-6 & interleukin 6 \\\\\n\\hline IL-18 & interleukin 18 \\\\\n\\hline IRB & institutional review board \\\\\n\\hline ITT & intent to treat \\\\\n\\hline IV & Intravenous \\\\\n\\hline IVRS & interactive voice response system \\\\\n\\hline KDIGO & Kidney Disease: Improving Global Outcomes \\\\\n\\hline KIM-1 & kidney injury molecule-1 \\\\\n\\hline LBP & lipopolysaccharide-binding protein \\\\\n\\hline LDH & lactate dehydrogenase \\\\\n\\hline LOCF & last observation carried forward \\\\\n\\hline LPS & lipopolysaccharide \\\\\n\\hline MDRD & Modification of Diet in Renal Disease \\\\\n\\hline MedDRA & Medical Dictionary for Regulatory Activities \\\\\n\\hline NSAID & non-steroidal anti-inflammatory drug \\\\\n\\hline PD & pharmacodynamic(s) \\\\\n\\hline PEEP & positive end expiratory pressure \\\\\n\\hline P/F ratio & fraction \\(PaO _{2} / FiO _{2}\\) (Carrico index) \\\\\n\\hline PK & pharmacokinetic(s) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Abbreviation & Definition \\\\\n\\hline ERPF & effective renal plasma flow \\\\\n\\hline FDA & Food and Drug Administration \\\\\n\\hline \\(FiO _{2}\\) & fraction of inspired oxygen \\\\\n\\hline GFR & glomerular filtration rate \\\\\n\\hline GGT & gamma-glutamyl transpeptidase \\\\\n\\hline GST-alpha & 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Currently, renal","confidence":1,"confidence_rate":1},{"cnt":[[305,1704],[1729,1704],[1729,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1703,"width":1425,"height":53},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fe5f77bcabe419da47ff291d9a522cf","type":"text","conversion_output":true,"text":"replacement therapy (RRT) is the only supportive treatment option available for AKI","text_display":" replacement therapy (RRT) is the only supportive treatment option available for AKI","confidence":0.98974609375,"confidence_rate":0.9998828836801585},{"cnt":[[305,1762],[1319,1762],[1319,1815],[305,1815]],"region":{"top_left_x":305,"top_left_y":1761,"width":1015,"height":55},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53db1a25497043949a3b175fa2d1406f","type":"text","conversion_output":true,"text":"(Vincent et al 2006; Oppert et al 2008; Bagshaw et al 2009).","text_display":" (Vincent et al 2006; Oppert et al 2008; Bagshaw et al 2009).","confidence":1,"confidence_rate":1},{"cnt":[[305,1865],[1852,1865],[1852,1919],[305,1919]],"region":{"top_left_x":305,"top_left_y":1864,"width":1547,"height":55},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"413838da022f4d5cb800685c01709ed2","type":"text","conversion_output":true,"text":"Alkaline phosphatase (AP) is an endogenous enzyme present in many cells and organs (e.g.,","text_display":"\n\nAlkaline phosphatase (AP) is an endogenous enzyme present in many cells and organs (e.g.,","confidence":1,"confidence_rate":1},{"cnt":[[305,1925],[1790,1925],[1790,1974],[305,1974]],"region":{"top_left_x":305,"top_left_y":1925,"width":1485,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ebdf7051d4f49cda6ca6b79d8063379","type":"text","conversion_output":true,"text":"intestines, placenta, liver, bone, kidney, and granulocytes) that exerts detoxifying effects","text_display":" intestines, placenta, liver, bone, kidney, and granulocytes) that exerts detoxifying effects","confidence":1,"confidence_rate":1},{"cnt":[[305,1985],[1852,1985],[1852,2035],[305,2035]],"region":{"top_left_x":305,"top_left_y":1985,"width":1547,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3a06c28580241b29981a1aef8de6b90","type":"text","conversion_output":true,"text":"through dephosphorylation of endotoxins (Bentala et al 2002; Koyama et al 2002) and other","text_display":" through dephosphorylation of endotoxins (Bentala et al 2002; Koyama et al 2002) and other","confidence":1,"confidence_rate":1},{"cnt":[[305,2045],[1880,2045],[1880,2095],[305,2095]],"region":{"top_left_x":305,"top_left_y":2045,"width":1575,"height":50},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b171aa540d774c83a21a1e59b95a032f","type":"text","conversion_output":true,"text":"pro-inflammatory compounds including extracellular adenosine triphosphate (ATP) (Picher et","text_display":" pro-inflammatory compounds including extracellular adenosine triphosphate (ATP) (Picher et","confidence":1,"confidence_rate":1},{"cnt":[[305,2105],[1815,2105],[1815,2155],[305,2155]],"region":{"top_left_x":305,"top_left_y":2105,"width":1511,"height":50},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1c5d383c33044dc80a1568c32d2b0f1","type":"text","conversion_output":true,"text":"al 2003). Local AP concentrations reflect the host defense against endotoxin in the kidney","text_display":" al 2003). Local AP concentrations reflect the host defense against endotoxin in the kidney","confidence":1,"confidence_rate":1},{"cnt":[[305,2161],[1837,2161],[1837,2215],[305,2215]],"region":{"top_left_x":305,"top_left_y":2161,"width":1532,"height":55},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31cb8617477d42488517a88f4c1e3045","type":"text","conversion_output":true,"text":"(Kapojos et al 2003), and during ischemia enzyme levels are markedly depleted, associated","text_display":" (Kapojos et al 2003), and during ischemia enzyme levels are markedly depleted, associated","confidence":1,"confidence_rate":1},{"cnt":[[305,2224],[1852,2224],[1852,2275],[305,2275]],"region":{"top_left_x":305,"top_left_y":2223,"width":1547,"height":53},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b73c6fd3a0c94c218c9336be42065b8e","type":"text","conversion_output":true,"text":"with the development of AKI (Khundmiri et al 1997). Apart from local effects in the kidney,","text_display":" with the development of AKI (Khundmiri et al 1997). Apart from local effects in the kidney,","confidence":1,"confidence_rate":1},{"cnt":[[305,2282],[1852,2282],[1852,2335],[305,2335]],"region":{"top_left_x":305,"top_left_y":2281,"width":1547,"height":55},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab9fcdf61be8485f97aad1801de173c1","type":"text","conversion_output":true,"text":"AP may attenuate the innate immune response, as dephosphorylation of endotoxin abolishes","text_display":" AP may attenuate the innate immune response, as dephosphorylation of endotoxin abolishes","confidence":1,"confidence_rate":1},{"cnt":[[305,2344],[1854,2344],[1854,2396],[305,2396]],"region":{"top_left_x":305,"top_left_y":2343,"width":1550,"height":53},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2bfb1a71ed864b15b929f60eac0c719f","type":"text","conversion_output":true,"text":"its biological activity and acts as a toll-like receptor 4 (TLR4) antagonist (Wy et al 2000). In","text_display":" its biological activity and acts as a toll-like receptor 4 (TLR4) antagonist (Wy et al 2000). In","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[1753,2462],[1871,2462],[1871,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":119,"height":41},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"225eded0cc424eb58c2db9fe2c2ca338","type":"page_info","conversion_output":false,"text":"Page 28","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-029","page":29,"lines":[{"cnt":[[309,254],[556,254],[556,286],[309,286]],"region":{"top_left_x":309,"top_left_y":253,"width":248,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fee315ca01714873aad710d5dfdbfabe","type":"page_info","conversion_output":false,"text":"AM-Pharma B.V.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1371,254],[1863,254],[1863,294],[1371,294]],"region":{"top_left_x":1370,"top_left_y":253,"width":493,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"979bffdabffa432db4ff04765dc9b7af","type":"page_info","conversion_output":false,"text":"Recombinant alkaline phosphatase","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[621,314],[621,350],[309,350]],"region":{"top_left_x":309,"top_left_y":313,"width":312,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2523f0408d954ed3853f31ae2d9ace2f","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,314],[1863,314],[1863,350],[1573,350]],"region":{"top_left_x":1572,"top_left_y":313,"width":291,"height":38},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9ad3de58f885449ebe8d4f240c58a850","type":"page_info","conversion_output":false,"text":"Protocol Version 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,374],[1876,374],[1876,423],[309,423]],"region":{"top_left_x":309,"top_left_y":373,"width":1567,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed2cc42aa1c54f2bb1e594dfe170ba29","type":"text","conversion_output":true,"text":"animal models of sepsis, AP administration attenuates the inflammatory response and reduces","text_display":"\nanimal models of sepsis, AP administration attenuates the inflammatory response and reduces","confidence":1,"confidence_rate":1},{"cnt":[[309,434],[1811,434],[1811,483],[309,483]],"region":{"top_left_x":309,"top_left_y":433,"width":1503,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6306f6457d940df91e201a54b183c3e","type":"text","conversion_output":true,"text":"mortality (Beumer et al 2003; Su et al 2006). There is increasing evidence that the protein","text_display":" mortality (Beumer et al 2003; Su et al 2006). There is increasing evidence that the protein","confidence":1,"confidence_rate":1},{"cnt":[[307,494],[1652,494],[1652,544],[307,544]],"region":{"top_left_x":307,"top_left_y":494,"width":1346,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1c49b801c7e447fd8d8db80eeeff8bcf","type":"text","conversion_output":true,"text":"plays a significant role in host defense and innate immunity, particularly against","text_display":" plays a significant role in host defense and innate immunity, particularly against","confidence":1,"confidence_rate":1},{"cnt":[[307,552],[1854,552],[1854,604],[307,604]],"region":{"top_left_x":307,"top_left_y":552,"width":1548,"height":52},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c62ee3eddb9a4d1184287fd6dcf19275","type":"text","conversion_output":true,"text":"inflammatory reactions due to lipopolysaccharide (LPS) release (Verweij et al 2004; Su et al","text_display":" inflammatory reactions due to lipopolysaccharide (LPS) release (Verweij et al 2004; Su et al","confidence":1,"confidence_rate":1},{"cnt":[[305,614],[423,614],[423,660],[305,660]],"region":{"top_left_x":305,"top_left_y":614,"width":119,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a71556276724ce3addbd69db7d709fb","type":"text","conversion_output":true,"text":"2006).","text_display":" 2006).","confidence":1,"confidence_rate":1},{"cnt":[[307,713],[1661,713],[1661,763],[307,763]],"region":{"top_left_x":307,"top_left_y":713,"width":1354,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a48aefc7b17d4cdf82f3c09ec83c533c","type":"text","conversion_output":true,"text":"Lipopolysaccharides (also named endotoxins) are constituents of the cell wall of","text_display":"\n\nLipopolysaccharides (also named endotoxins) are constituents of the cell wall of","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[307,776],[1803,776],[1803,827],[307,827]],"region":{"top_left_x":307,"top_left_y":775,"width":1496,"height":53},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23915b86e07c4bdab07fdece2f0979d8","type":"text","conversion_output":true,"text":"gram-negative bacteria, which can also be present in the circulation during gram-positive","text_display":" gram-negative bacteria, which can also be present in the circulation during gram-positive","confidence":1,"confidence_rate":1},{"cnt":[[307,834],[1790,834],[1790,883],[307,883]],"region":{"top_left_x":307,"top_left_y":833,"width":1483,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0345dec4dd4e4967b379935a5e946ca4","type":"text","conversion_output":true,"text":"infections (Marshall et al 2004), and are released when these bacteria disintegrate. It is a","text_display":" infections (Marshall et al 2004), and are released when these bacteria disintegrate. It is a","confidence":0.9892578125,"confidence_rate":0.999888662885542},{"cnt":[[305,896],[1867,896],[1867,947],[305,947]],"region":{"top_left_x":305,"top_left_y":895,"width":1562,"height":53},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01dce2d8f3fb4dfdba13959eb76a0f61","type":"text","conversion_output":true,"text":"group of negatively charged molecules, of which the Lipid A moiety binds through 2, for this","text_display":" group of negatively charged molecules, of which the Lipid A moiety binds through 2, for this","confidence":0.99072265625,"confidence_rate":0.9999039154789536},{"cnt":[[305,954],[1723,954],[1723,1003],[305,1003]],"region":{"top_left_x":305,"top_left_y":953,"width":1419,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"961bd96148be49318afb2fddb76f7569","type":"text","conversion_output":true,"text":"purpose essential, phosphate groups to its receptor, the CD14-TLR4 complex. These","text_display":" purpose essential, phosphate groups to its receptor, the CD14-TLR4 complex. These","confidence":1,"confidence_rate":1},{"cnt":[[305,1014],[1772,1014],[1772,1063],[305,1063]],"region":{"top_left_x":305,"top_left_y":1014,"width":1468,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9de4b964b3e949038c2d5e6ebad9af95","type":"text","conversion_output":true,"text":"receptors are present on the surface of leukocytes (macrophages, white blood cells) and","text_display":" receptors are present on the surface of leukocytes (macrophages, white blood cells) and","confidence":1,"confidence_rate":1},{"cnt":[[305,1074],[1865,1074],[1865,1124],[305,1124]],"region":{"top_left_x":305,"top_left_y":1074,"width":1560,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"60afc0d293fb472da7a6e8fc9ba48a4c","type":"text","conversion_output":true,"text":"endothelial cells, and once activated they secrete a number of inflammatory cytokines. These","text_display":" endothelial cells, and once activated they secrete a number of inflammatory cytokines. These","confidence":1,"confidence_rate":1},{"cnt":[[305,1134],[1841,1134],[1841,1184],[305,1184]],"region":{"top_left_x":305,"top_left_y":1134,"width":1537,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1da1d7c9c3634f7299504eff4d6f9715","type":"text","conversion_output":true,"text":"in turn can cause a devastating and life-threatening derailment of the human innate immune","text_display":" in turn can cause a devastating and life-threatening derailment of the human innate immune","confidence":1,"confidence_rate":1},{"cnt":[[305,1199],[440,1199],[440,1244],[305,1244]],"region":{"top_left_x":305,"top_left_y":1198,"width":136,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"485c584975494785b20e0edf3c861027","type":"text","conversion_output":true,"text":"system.","text_display":" system.","confidence":1,"confidence_rate":1},{"cnt":[[305,1296],[1768,1296],[1768,1347],[305,1347]],"region":{"top_left_x":305,"top_left_y":1295,"width":1464,"height":53},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b70a529c08d4c95893a4bc0a39d486a","type":"text","conversion_output":true,"text":"Alkaline phosphatase is thought to exert a dual mode of action. First of all, it binds and","text_display":"\n\nAlkaline phosphatase is thought to exert a dual mode of action. First of all, it binds and","confidence":1,"confidence_rate":1},{"cnt":[[305,1354],[1867,1354],[1867,1407],[305,1407]],"region":{"top_left_x":305,"top_left_y":1353,"width":1562,"height":55},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ef23c196ad14dcd95c1b74c27bbd8eb","type":"text","conversion_output":true,"text":"subsequently dephosphorylates LPS (Kiffer-Moreira et al 2014), thereby eliminating the root","text_display":" subsequently dephosphorylates LPS (Kiffer-Moreira et al 2014), thereby eliminating the root","confidence":1,"confidence_rate":1},{"cnt":[[305,1414],[1790,1414],[1790,1465],[305,1465]],"region":{"top_left_x":305,"top_left_y":1413,"width":1485,"height":53},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ab64aec3ceb4740903e85cbb490ab04","type":"text","conversion_output":true,"text":"cause of the systemic inflammatory response syndrome (SIRS). Secondly, the enzymatic","text_display":" cause of the systemic inflammatory response syndrome (SIRS). Secondly, the enzymatic","confidence":1,"confidence_rate":1},{"cnt":[[305,1474],[1869,1474],[1869,1523],[305,1523]],"region":{"top_left_x":305,"top_left_y":1473,"width":1565,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e742e26217f148d7b3cc1dfcbf907696","type":"text","conversion_output":true,"text":"reaction product, dephosphorylated LPS, is a non-toxic substance for mammals, and acts as a","text_display":" reaction product, dephosphorylated LPS, is a non-toxic substance for mammals, and acts as a","confidence":1,"confidence_rate":1},{"cnt":[[305,1534],[1807,1534],[1807,1583],[305,1583]],"region":{"top_left_x":305,"top_left_y":1533,"width":1502,"height":51},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5b708e916ca4681ae5e8b636a24d01c","type":"text","conversion_output":true,"text":"partial antagonist on the LPS receptor complex. Unlike other potential treatments, AP has","text_display":" partial antagonist on the LPS receptor complex. Unlike other potential treatments, AP has","confidence":1,"confidence_rate":1},{"cnt":[[305,1594],[1878,1594],[1878,1644],[305,1644]],"region":{"top_left_x":305,"top_left_y":1594,"width":1573,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42006544f37e4a11957a5166751049aa","type":"text","conversion_output":true,"text":"been shown to act at the front end of the inflammatory cascade. By doing so, it may eliminate","text_display":" been shown to act at the front end of the inflammatory cascade. By doing so, it may eliminate","confidence":1,"confidence_rate":1},{"cnt":[[305,1654],[1858,1654],[1858,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1654,"width":1554,"height":50},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b777fad13374c508c1d5d5281d1e4f7","type":"text","conversion_output":true,"text":"the root cause of the SIRS, and prevent the progression into sepsis and septic shock. Also, in","text_display":" the root cause of the SIRS, and prevent the progression into sepsis and septic shock. 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In addition, AP acts in the","text_display":" enters the systemic circulation after a septic insult. 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In addition, the duration of mechanical ventilation tended to be","text_display":" the length of ICU stay. In addition, the duration of mechanical ventilation tended to be","confidence":1,"confidence_rate":1},{"cnt":[[307,494],[1854,494],[1854,544],[307,544]],"region":{"top_left_x":307,"top_left_y":494,"width":1548,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4650d05f3e374b958b98a7093c56325a","type":"text","conversion_output":true,"text":"reduced, although not significantly. Moreover, a range of markers of systemic inflammation,","text_display":" reduced, although not significantly. Moreover, a range of markers of systemic inflammation,","confidence":1,"confidence_rate":1},{"cnt":[[307,554],[1841,554],[1841,604],[307,604]],"region":{"top_left_x":307,"top_left_y":554,"width":1535,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d031fba479d461aa5ce5e6ba45329b4","type":"text","conversion_output":true,"text":"renal function, and renal damage in blood and urine demonstrated significant improvement,","text_display":" renal function, and renal damage in blood and urine demonstrated significant improvement,","confidence":1,"confidence_rate":1},{"cnt":[[307,614],[1850,614],[1850,664],[307,664]],"region":{"top_left_x":307,"top_left_y":614,"width":1543,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"733f19b821c549179403e8ccfb12a1de","type":"text","conversion_output":true,"text":"suggesting that a systemic anti-inflammatory effect induced by the treatment resulted in fast","text_display":" suggesting that a systemic anti-inflammatory effect induced by the treatment resulted in fast","confidence":1,"confidence_rate":1},{"cnt":[[307,675],[1841,675],[1841,724],[307,724]],"region":{"top_left_x":307,"top_left_y":674,"width":1535,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a0ce42ad965456caf1aa36db65a7933","type":"text","conversion_output":true,"text":"recovery and prevention of further kidney damage. In these relatively small studies ( \\(n =36\\),","text_display":" recovery and prevention of further kidney damage. 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Following","text_display":" end-organ failure have established the tolerability and potential efficacy of BiAP. Following","confidence":1,"confidence_rate":1},{"cnt":[[307,954],[1811,954],[1811,1003],[307,1003]],"region":{"top_left_x":307,"top_left_y":953,"width":1505,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e8faebf85bd4db1b48903007ad87555","type":"text","conversion_output":true,"text":"these encouraging positive results, AM-Pharma B.V. has developed a recombinant human","text_display":" these encouraging positive results, AM-Pharma B.V. has developed a recombinant human","confidence":1,"confidence_rate":1},{"cnt":[[307,1014],[1764,1014],[1764,1063],[307,1063]],"region":{"top_left_x":307,"top_left_y":1014,"width":1457,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb1757cbf3554ad1a2fe97843b0af944","type":"text","conversion_output":true,"text":"chimeric form of AP, from parts of the intestinal and the placental isoforms (details are","text_display":" chimeric form of AP, from parts of the intestinal and the placental isoforms (details are","confidence":0.994140625,"confidence_rate":0.999937484842569},{"cnt":[[305,1074],[1412,1074],[1412,1124],[305,1124]],"region":{"top_left_x":305,"top_left_y":1074,"width":1107,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0631826d421b4a368dffad96d26706b9","type":"text","conversion_output":true,"text":"provided in the investigator's brochure [AM-Pharma B.V. 2014]).","text_display":" provided in the investigator's brochure [AM-Pharma B.V. 2014]).","confidence":0.98486328125,"confidence_rate":0.9997757244446235},{"cnt":[[305,1177],[1717,1177],[1717,1227],[305,1227]],"region":{"top_left_x":305,"top_left_y":1177,"width":1412,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc06abac842847b88f94863defeec61c","type":"text","conversion_output":true,"text":"Recombinant human AP is encoded by a human intestinal AP sequence, wherein the","text_display":"\n\nRecombinant human AP is encoded by a human intestinal AP sequence, wherein the","confidence":1,"confidence_rate":1},{"cnt":[[305,1238],[1807,1238],[1807,1287],[305,1287]],"region":{"top_left_x":305,"top_left_y":1237,"width":1502,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e12dfae272234ebd88112603236de1bf","type":"text","conversion_output":true,"text":"sequence encoding the crown domain has been substituted with the corresponding human","text_display":" sequence encoding the crown domain has been substituted with the corresponding human","confidence":1,"confidence_rate":1},{"cnt":[[305,1298],[1841,1298],[1841,1347],[305,1347]],"region":{"top_left_x":305,"top_left_y":1297,"width":1537,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e564de3161d9462f8543dfb8fea04291","type":"text","conversion_output":true,"text":"placental AP sequence. Recombinant human AP is produced in Chinese hamster ovary cells","text_display":" placental AP sequence. Recombinant human AP is produced in Chinese hamster ovary cells","confidence":1,"confidence_rate":1},{"cnt":[[305,1358],[1807,1358],[1807,1407],[305,1407]],"region":{"top_left_x":305,"top_left_y":1357,"width":1502,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78efd810b6f2433fa7b98fc1e0b7f192","type":"text","conversion_output":true,"text":"using state-of-the-art mammalian cell culture technology. The investigational product is a","text_display":" using state-of-the-art mammalian cell culture technology. The investigational product is a","confidence":1,"confidence_rate":1},{"cnt":[[305,1416],[1863,1416],[1863,1463],[305,1463]],"region":{"top_left_x":305,"top_left_y":1415,"width":1558,"height":49},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ff91c0b5bee45de9d0b789235e90e39","type":"text","conversion_output":true,"text":"concentrate for solution for infusion-containing recAP as active ingredient. AM-Pharma B.V.","text_display":" concentrate for solution for infusion-containing recAP as active ingredient. AM-Pharma B.V.","confidence":1,"confidence_rate":1},{"cnt":[[305,1474],[1850,1474],[1850,1523],[305,1523]],"region":{"top_left_x":305,"top_left_y":1473,"width":1545,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8522b9fa1d640609f0dfab86dfda36e","type":"text","conversion_output":true,"text":"has developed recAP as a medicinal product to be used via intravenous (IV) infusion for the","text_display":" has developed recAP as a medicinal product to be used via intravenous (IV) infusion for the","confidence":1,"confidence_rate":1},{"cnt":[[305,1534],[1764,1534],[1764,1583],[305,1583]],"region":{"top_left_x":305,"top_left_y":1533,"width":1459,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea384c40d9d24fa6ab030d5eb1f1258a","type":"text","conversion_output":true,"text":"treatment of SA-AKI. In line with pre-clinical and clinical studies using purified BiAP,","text_display":" treatment of SA-AKI. In line with pre-clinical and clinical studies using purified BiAP,","confidence":1,"confidence_rate":1},{"cnt":[[305,1594],[1785,1594],[1785,1646],[305,1646]],"region":{"top_left_x":305,"top_left_y":1594,"width":1481,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3613a22afdf449b0a2f5fe0e03c548e2","type":"text","conversion_output":true,"text":"pre-clinical studies with recAP indicated that it asserts potent anti-inflammatory activity","text_display":" pre-clinical studies with recAP indicated that it asserts potent anti-inflammatory activity","confidence":1,"confidence_rate":1},{"cnt":[[305,1654],[1835,1654],[1835,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1654,"width":1530,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f69044fa235491fa67c56f0a33eb9e8","type":"text","conversion_output":true,"text":"preserving function and histological integrity of the affected kidneys. In rodent and porcine","text_display":" preserving function and histological integrity of the affected kidneys. In rodent and porcine","confidence":1,"confidence_rate":1},{"cnt":[[305,1714],[1697,1714],[1697,1764],[305,1764]],"region":{"top_left_x":305,"top_left_y":1714,"width":1393,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dc81c2d2f494d0788806784287fc02e","type":"text","conversion_output":true,"text":"models of AKI induced by ischemia-reperfusion injury or systemic endotoxemia, a","text_display":" models of AKI induced by ischemia-reperfusion injury or systemic endotoxemia, a","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[305,1775],[1779,1775],[1779,1824],[305,1824]],"region":{"top_left_x":305,"top_left_y":1774,"width":1474,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"560b5fb1e6fe4613ab861ba6c2025917","type":"text","conversion_output":true,"text":"single-dose administration of recAP consistently inhibited markers of inflammation and","text_display":" single-dose administration of recAP consistently inhibited markers of inflammation and","confidence":0.99560546875,"confidence_rate":0.9999516031977022},{"cnt":[[305,1835],[1863,1835],[1863,1884],[305,1884]],"region":{"top_left_x":305,"top_left_y":1834,"width":1558,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"726a28d284a1458c87524d32a77844e7","type":"text","conversion_output":true,"text":"reduced kidney damage and functional impairment as determined by serum creatinine, blood","text_display":" reduced kidney damage and functional impairment as determined by serum creatinine, blood","confidence":1,"confidence_rate":1},{"cnt":[[305,1895],[1609,1895],[1609,1944],[305,1944]],"region":{"top_left_x":305,"top_left_y":1894,"width":1305,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbf9719de1654e598c22904d491ef93b","type":"text","conversion_output":true,"text":"urea nitrogen (BUN), creatinine clearance, and histopathological examination","text_display":" urea nitrogen (BUN), creatinine clearance, and histopathological examination","confidence":1,"confidence_rate":1},{"cnt":[[305,1955],[1665,1955],[1665,2004],[305,2004]],"region":{"top_left_x":305,"top_left_y":1955,"width":1361,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8648040a05b04d12a33a986b79e28716","type":"text","conversion_output":true,"text":"(AM-Pharma B.V. 2014). Its therapeutic activity is thought to be exerted through","text_display":" (AM-Pharma B.V. 2014). 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Adenosine triphosphate and ADP are highly potent triggers of inflammation released in","text_display":" ADP. Adenosine triphosphate and ADP are highly potent triggers of inflammation released in","confidence":0.99609375,"confidence_rate":0.9999588019084422},{"cnt":[[305,2136],[1858,2136],[1858,2185],[305,2185]],"region":{"top_left_x":305,"top_left_y":2135,"width":1554,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1371fa02914a4817ab8da472fe9cec6e","type":"text","conversion_output":true,"text":"damaged kidney tissue. In vitro, recAP inhibits immunological activation and chemotaxis of","text_display":" damaged kidney tissue. 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agencies.","confidence":1,"confidence_rate":1},{"cnt":[[309,765],[1815,765],[1815,814],[309,814]],"region":{"top_left_x":309,"top_left_y":764,"width":1507,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc8ca81a5c594c058a80cae1fec912a8","type":"text","conversion_output":true,"text":"The dosing schedule is described in the dosing rationale section. To determine the optimal","text_display":"\n\nThe dosing schedule is described in the dosing rationale section. To determine the optimal","confidence":1,"confidence_rate":1},{"cnt":[[309,827],[1796,827],[1796,874],[309,874]],"region":{"top_left_x":309,"top_left_y":827,"width":1488,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"479d084750ff433a9b66b38270e6a053","type":"text","conversion_output":true,"text":"dose the study has been set up with an adaptive study design including 2 parts, with dose","text_display":" dose the study has been set up with an adaptive study design including 2 parts, with dose","confidence":1,"confidence_rate":1},{"cnt":[[309,881],[1777,881],[1777,935],[309,935]],"region":{"top_left_x":309,"top_left_y":880,"width":1468,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f705f00c83f541e78a1f6dabe8cb5dc3","type":"text","conversion_output":true,"text":"selection based on an interim analysis after the \\(120^{\\text {th }}\\) patient in Part 1 has completed the","text_display":" selection based on an interim analysis after the \\(120^{\\text {th }}\\) patient in Part 1 has completed the","confidence":0.8182506561279297,"confidence_rate":0.9982264722284124},{"cnt":[[309,945],[1841,945],[1841,995],[309,995]],"region":{"top_left_x":309,"top_left_y":945,"width":1533,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b97af3ff2ce4c80849beb9f809cef83","type":"text","conversion_output":true,"text":"Day 7 visit. The 3 active doses in Part 1 are selected based on a combination of information","text_display":" Day 7 visit. The 3 active doses in Part 1 are selected based on a combination of information","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[309,1005],[1846,1005],[1846,1055],[309,1055]],"region":{"top_left_x":309,"top_left_y":1005,"width":1537,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b435463595d44b4a75f2050e51b5b4f","type":"text","conversion_output":true,"text":"from previous clinical studies conducted with BiAP, and pre-clinical animal models and PK","text_display":" from previous clinical studies conducted with BiAP, and pre-clinical animal models and PK","confidence":1,"confidence_rate":1},{"cnt":[[309,1066],[1725,1066],[1725,1115],[309,1115]],"region":{"top_left_x":309,"top_left_y":1065,"width":1417,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bb614f2f6484ad89f956cea940abf58","type":"text","conversion_output":true,"text":"modeling and simulation in a Phase 1 healthy volunteer study with recAP. Assuming","text_display":" modeling and simulation in a Phase 1 healthy volunteer study with recAP. Assuming","confidence":1,"confidence_rate":1},{"cnt":[[309,1126],[1803,1126],[1803,1175],[309,1175]],"region":{"top_left_x":309,"top_left_y":1125,"width":1494,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c81a06f87334cd2b5eee05824746db9","type":"text","conversion_output":true,"text":"comparable safety profiles, the optimal dose will be selected at the interim analysis by an","text_display":" comparable safety profiles, the optimal dose will be selected at the interim analysis by an","confidence":0.9970724582672119,"confidence_rate":0.9999694605146209},{"cnt":[[309,1186],[1725,1186],[1725,1235],[309,1235]],"region":{"top_left_x":309,"top_left_y":1185,"width":1417,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b6a7fa8ba754d0c80d5fb53ceeebbb8","type":"text","conversion_output":true,"text":"independent DMC. The primary endpoint, area under the time-corrected endogenous","text_display":" independent DMC. The primary endpoint, area under the time-corrected endogenous","confidence":1,"confidence_rate":1},{"cnt":[[309,1246],[1807,1246],[1807,1291],[309,1291]],"region":{"top_left_x":309,"top_left_y":1246,"width":1498,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15944b6691a248608b43c6da0b3071d3","type":"text","conversion_output":true,"text":"creatinine clearance curve, was chosen because as a continuous variable it is sensitive for","text_display":" creatinine clearance curve, was chosen because as a continuous variable it is sensitive for","confidence":1,"confidence_rate":1},{"cnt":[[309,1306],[1800,1306],[1800,1356],[309,1356]],"region":{"top_left_x":309,"top_left_y":1306,"width":1492,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96bd314e2aac43fa8123110e073c11e1","type":"text","conversion_output":true,"text":"detecting relatively small treatment effect differences of recAP versus placebo, as well as","text_display":" detecting relatively small treatment effect differences of recAP versus placebo, as well as","confidence":1,"confidence_rate":1},{"cnt":[[309,1366],[1846,1366],[1846,1416],[309,1416]],"region":{"top_left_x":309,"top_left_y":1366,"width":1537,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a9449d61b674c888e42233c5d19ffa9","type":"text","conversion_output":true,"text":"determination of effect size differences between the different dosages. Incidence of dialysis,","text_display":" determination of effect size differences between the different dosages. Incidence of dialysis,","confidence":1,"confidence_rate":1},{"cnt":[[309,1427],[1820,1427],[1820,1472],[309,1472]],"region":{"top_left_x":309,"top_left_y":1426,"width":1511,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cff42ba559fe4fcea733c689682a39a8","type":"text","conversion_output":true,"text":"considered to be a relevant clinical endpoint for Phase 3 pivotal studies, was chosen as the","text_display":" considered to be a relevant clinical endpoint for Phase 3 pivotal studies, was chosen as the","confidence":1,"confidence_rate":1},{"cnt":[[309,1487],[1846,1487],[1846,1534],[309,1534]],"region":{"top_left_x":309,"top_left_y":1486,"width":1537,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90860b91e9b34e85825ca8a726fa9bc3","type":"text","conversion_output":true,"text":"key secondary endpoint. In the first 120 patients from Part 1 only, PK samples will be taken","text_display":" key secondary endpoint. In the first 120 patients from Part 1 only, PK samples will be taken","confidence":1,"confidence_rate":1},{"cnt":[[309,1547],[1841,1547],[1841,1594],[309,1594]],"region":{"top_left_x":309,"top_left_y":1546,"width":1533,"height":49},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc911db6ee6549c5997a3f83af7019e4","type":"text","conversion_output":true,"text":"to assess the pharmacological properties of recAP in patients, in addition to the information","text_display":" to assess the pharmacological properties of recAP in patients, in addition to the information","confidence":1,"confidence_rate":1},{"cnt":[[309,1607],[1102,1607],[1102,1652],[309,1652]],"region":{"top_left_x":309,"top_left_y":1607,"width":794,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f8e015b397343cf95820e4778dcf739","type":"text","conversion_output":true,"text":"previously derived from the healthy volunteers.","text_display":" previously derived from the healthy volunteers.","confidence":1,"confidence_rate":1},{"cnt":[[309,1706],[1841,1706],[1841,1755],[309,1755]],"region":{"top_left_x":309,"top_left_y":1705,"width":1533,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2375ea858e2c4cc6993e806139bed42e","type":"text","conversion_output":true,"text":"Currently there is no treatment available for SA-AKI; hence, recAP is considered as add-on","text_display":"\n\nCurrently there is no treatment available for SA-AKI; hence, recAP is considered as add-on","confidence":0.998046875,"confidence_rate":0.9999794208976915},{"cnt":[[309,1766],[1369,1766],[1369,1815],[309,1815]],"region":{"top_left_x":309,"top_left_y":1766,"width":1060,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6259068b34aa478f8acee27a2e17133e","type":"text","conversion_output":true,"text":"therapy and with that the use of a placebo arm is fully justified.","text_display":" therapy and with that the use of a placebo arm is fully justified.","confidence":1,"confidence_rate":1},{"cnt":[[309,1869],[1871,1869],[1871,1919],[309,1919]],"region":{"top_left_x":309,"top_left_y":1869,"width":1563,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05dbb88280f9455291353f8a0e2b1fca","type":"text","conversion_output":true,"text":"Following patients up to a period of 90 days allows for assessing potential disease-modifying","text_display":"\n\nFollowing patients up to a period of 90 days allows for assessing potential disease-modifying","confidence":1,"confidence_rate":1},{"cnt":[[309,1929],[1631,1929],[1631,1979],[309,1979]],"region":{"top_left_x":309,"top_left_y":1929,"width":1322,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e5af02b47f84c9bb538a16d749b67ca","type":"text","conversion_output":true,"text":"characteristics of recAP in kidney function (occurrence or worsening of CKD).","text_display":" characteristics of recAP in kidney function (occurrence or worsening of CKD).","confidence":0.998046875,"confidence_rate":0.9999761583959741},{"cnt":[[305,2032],[780,2032],[780,2082],[305,2082]],"region":{"top_left_x":305,"top_left_y":2032,"width":475,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d84092a13b72474d9e0764fa33fcd5b1","type":"section_header","conversion_output":false,"children_ids":["a3406beca8fa404cb92b7130b8537988"],"text":"","text_display":""},{"cnt":[[309,2035],[776,2035],[776,2078],[309,2078]],"region":{"top_left_x":309,"top_left_y":2034,"width":467,"height":44},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3406beca8fa404cb92b7130b8537988","type":"text","conversion_output":true,"parent_id":"d84092a13b72474d9e0764fa33fcd5b1","text":"3.1.2 Dose Rationale","text_display":"\n\n\\subsection*{3.1.2 Dose Rationale}","confidence":1,"confidence_rate":1},{"cnt":[[307,2121],[1837,2121],[1837,2168],[307,2168]],"region":{"top_left_x":307,"top_left_y":2120,"width":1530,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f519fe5ddc094b84877ff7444493fc32","type":"text","conversion_output":true,"text":"No dose-limiting toxicity was observed in pre-clinical and clinical studies with recAP up to","text_display":"\n\nNo dose-limiting toxicity was observed in pre-clinical and clinical studies with recAP up to","confidence":1,"confidence_rate":1},{"cnt":[[309,2179],[1841,2179],[1841,2228],[309,2228]],"region":{"top_left_x":309,"top_left_y":2178,"width":1533,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b6df3d8b2c04ae5b79e9458edb529da","type":"text","conversion_output":true,"text":"daily doses of \\(16 mg / kg (10000 U / kg )\\) and \\(32 mg / kg (20000 U / kg )\\) maintained for 14 days","text_display":" daily doses of \\(16 mg / kg (10000 U / kg )\\) and \\(32 mg / kg (20000 U / kg )\\) maintained for 14 days","confidence":0.99755859375,"confidence_rate":0.9999791079845508},{"cnt":[[309,2239],[1697,2239],[1697,2288],[309,2288]],"region":{"top_left_x":309,"top_left_y":2238,"width":1389,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e57fbf1377b48d98f1fb4e8b2364bf0","type":"text","conversion_output":true,"text":"in Göttingen mini-pigs, and in healthy volunteers for a single dose up to \\(3.2 mg / kg\\)","text_display":" in Göttingen mini-pigs, and in healthy volunteers for a single dose up to \\(3.2 mg / kg","confidence":1,"confidence_rate":1},{"cnt":[[309,2299],[1858,2299],[1858,2348],[309,2348]],"region":{"top_left_x":309,"top_left_y":2298,"width":1550,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a74718884d70431d861db5a6e16d6ec9","type":"text","conversion_output":true,"text":"\\((2000 U / kg )\\) and for multiple doses up to 3 daily doses of \\(1.6 mg / kg (1000 U / kg )\\). Therefore,","text_display":" (2000 U / kg )\\) and for multiple doses up to 3 daily doses of \\(1.6 mg / kg (1000 U / kg )\\). Therefore,","confidence":0.5078125,"confidence_rate":0.9941752798952477},{"cnt":[[309,2359],[1876,2359],[1876,2408],[309,2408]],"region":{"top_left_x":309,"top_left_y":2358,"width":1567,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"678cd62d4ee34990b9a035b621154cd6","type":"text","conversion_output":true,"text":"the dose rationale is primarily based on: 1) observed Phase 1 recAP PK parameters; 2) trough","text_display":" the dose rationale is primarily based on: 1) observed Phase 1 recAP PK parameters; 2) trough","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[1753,2462],[1871,2462],[1871,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":119,"height":41},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a617e5cd9b349f48a869ed27ee20b13","type":"page_info","conversion_output":false,"text":"Page 35","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-036","page":36,"lines":[{"cnt":[[309,254],[556,254],[556,286],[309,286]],"region":{"top_left_x":309,"top_left_y":253,"width":248,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82f60ee652d64e0a97420ddf907e877b","type":"page_info","conversion_output":false,"text":"AM-Pharma B.V.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1375,254],[1863,254],[1863,294],[1375,294]],"region":{"top_left_x":1375,"top_left_y":253,"width":488,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e2ec8a8f3a64a2eaa571c8de920ba80","type":"page_info","conversion_output":false,"text":"Recombinant alkaline phosphatase","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[621,314],[621,348],[309,348]],"region":{"top_left_x":309,"top_left_y":313,"width":312,"height":36},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"55a3aaf426864eadaee5e461029d8b0e","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,314],[1863,314],[1863,348],[1573,348]],"region":{"top_left_x":1572,"top_left_y":313,"width":291,"height":36},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"918673a140c14e9c81c863269fcb3f7b","type":"page_info","conversion_output":false,"text":"Protocol Version 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,374],[1837,374],[1837,423],[309,423]],"region":{"top_left_x":309,"top_left_y":373,"width":1528,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c46d86599d44ec3acdcb5927f7a4c7f","type":"text","conversion_output":true,"text":"levels ( \\(293 U / L\\), corresponding to \\(0.171 mg / L\\) recAP) obtained in the APREN-01-01 study;","text_display":"\nlevels ( \\(293 U / L\\), corresponding to \\(0.171 mg / L\\) recAP) obtained in the APREN-01-01 study;","confidence":0.9712052345275879,"confidence_rate":0.9997319857484861},{"cnt":[[309,434],[1785,434],[1785,483],[309,483]],"region":{"top_left_x":309,"top_left_y":433,"width":1477,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d809e8e4639245af87066ba82024c185","type":"text","conversion_output":true,"text":"and 3) exposure maintained during the APREN-01-01 study and associated with clinical","text_display":" and 3) exposure maintained during the APREN-01-01 study and associated with clinical","confidence":1,"confidence_rate":1},{"cnt":[[309,494],[1747,494],[1747,544],[309,544]],"region":{"top_left_x":309,"top_left_y":494,"width":1438,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5001dd6fbcaa4f20bf8a40ce42c4d18b","type":"text","conversion_output":true,"text":"activity. The 3 dose level schedules proposed for the first part of this Phase 2 study, in","text_display":" activity. 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etc).","text_display":"\n\\(T _{\\text {trough }}\\) reflects the time to reach trough \\(\\left( t _{\\text {trough1 }}\\right.\\) after first infusion, \\(t _{\\text {trough2 }}\\), etc).","confidence":0.5753159314172777,"confidence_rate":0.9961945972895015},{"cnt":[[309,1753],[1854,1753],[1854,1800],[309,1800]],"region":{"top_left_x":309,"top_left_y":1753,"width":1546,"height":48},"line":113,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bfb57708cd04dc9abf200808f2b416d","type":"text","conversion_output":true,"text":"Using PK simulation experiments, these schedules achieve the area under the concentration-","text_display":"\n\nUsing PK simulation experiments, these schedules achieve the area under the 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that are similar to or exceed the","text_display":" serum concentration after administration ( \\(C _{\\text {min }}\\) ) levels that are similar to or exceed the","confidence":0.92822265625,"confidence_rate":0.9993410699007281},{"cnt":[[309,1934],[1820,1934],[1820,1983],[309,1983]],"region":{"top_left_x":309,"top_left_y":1933,"width":1511,"height":51},"line":116,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"864eb3a7d5a64f429e01e16333aaaafc","type":"text","conversion_output":true,"text":"presumed minimal requirements based on BiAP studies APSEP-02-01 and APREN-01-01.","text_display":" presumed minimal requirements based on BiAP studies APSEP-02-01 and APREN-01-01.","confidence":1,"confidence_rate":1},{"cnt":[[309,1994],[1837,1994],[1837,2041],[309,2041]],"region":{"top_left_x":309,"top_left_y":1993,"width":1528,"height":49},"line":117,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac49d26a2f7f49738fcd4b3cfde1d46a","type":"text","conversion_output":true,"text":"Furthermore, these dose groups are likely to achieve significantly different exposures when","text_display":" Furthermore, these dose groups are likely to achieve significantly different exposures when","confidence":1,"confidence_rate":1},{"cnt":[[309,2054],[1807,2054],[1807,2101],[309,2101]],"region":{"top_left_x":309,"top_left_y":2053,"width":1498,"height":49},"line":118,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f691fc0e459147abbcd996a82a5336bc","type":"text","conversion_output":true,"text":"comparing 3 groups of 30 patients (as informed by the observed PK variability in Phase 1","text_display":" comparing 3 groups of 30 patients (as informed by the observed PK variability in Phase 1","confidence":1,"confidence_rate":1},{"cnt":[[309,2114],[1858,2114],[1858,2161],[309,2161]],"region":{"top_left_x":309,"top_left_y":2114,"width":1550,"height":48},"line":119,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a4550b722a141478538b68576aaf2d5","type":"text","conversion_output":true,"text":"patients). Analyzing PK simulations, compared to the APREN-01-01 study results the recAP","text_display":" patients). Analyzing PK simulations, compared to the APREN-01-01 study results the recAP","confidence":1,"confidence_rate":1},{"cnt":[[309,2174],[1824,2174],[1824,2221],[309,2221]],"region":{"top_left_x":309,"top_left_y":2174,"width":1516,"height":48},"line":120,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bc54eabef5b4e4da1f2a556cd7480fb","type":"text","conversion_output":true,"text":"low-dose group is expected to achieve sufficient exposure with \\(C _{\\text {min }}\\) dropping below target","text_display":" low-dose group is expected to achieve sufficient exposure with \\(C _{\\text {min }}\\) dropping below target","confidence":1,"confidence_rate":1},{"cnt":[[309,2234],[1721,2234],[1721,2282],[309,2282]],"region":{"top_left_x":309,"top_left_y":2234,"width":1412,"height":48},"line":121,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d95d8b10da6f41f1a2a8f4ad75180438","type":"text","conversion_output":true,"text":"trough before re-infusion, whereas the mid-dose and high-dose groups exceed target","text_display":" trough before re-infusion, whereas the mid-dose and high-dose groups exceed target","confidence":1,"confidence_rate":1},{"cnt":[[309,2295],[1732,2295],[1732,2340],[309,2340]],"region":{"top_left_x":309,"top_left_y":2294,"width":1423,"height":46},"line":122,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b4916ff3cb149c89137bde519ac01e4","type":"text","conversion_output":true,"text":"exposure and \\(C _{\\text {min }}\\). If clinical activity is observed to be different in Phase 2 at interim","text_display":" exposure and \\(C _{\\text {min }}\\). 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Lowest value within 3 months of the hospital admission. If not available:","text_display":"\n1. Lowest value within 3 months of the hospital admission. If not available:","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[466,795],[1231,795],[1231,844],[466,844]],"region":{"top_left_x":466,"top_left_y":794,"width":766,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0dfe7f41a9ea41848622e5fc2f238d2d","type":"text","conversion_output":true,"text":"2. At hospital admission. If not available:","text_display":"\n2. At hospital admission. If not available:","confidence":1,"confidence_rate":1},{"cnt":[[466,877],[1592,877],[1592,920],[466,920]],"region":{"top_left_x":466,"top_left_y":876,"width":1126,"height":44},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56826800d8194b1a9d8ac948e7c8d4ed","type":"text","conversion_output":true,"text":"3. At ICU or intermediate care unit admission. If not available:","text_display":"\n3. At ICU or intermediate care unit admission. If not available:","confidence":1,"confidence_rate":1},{"cnt":[[466,956],[1704,956],[1704,1008],[466,1008]],"region":{"top_left_x":466,"top_left_y":956,"width":1238,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66054a2f82a2445d86807ba480da559f","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":[[404,1038],[1854,1038],[1854,1087],[404,1087]],"region":{"top_left_x":403,"top_left_y":1037,"width":1452,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2490b69308ca4d4ea181e60c88888b55","type":"text","conversion_output":true,"text":"c. Urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\) hours following adequate fluid resuscitation","text_display":"\nc. 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The result must be available prior to randomization, within 24 hours after","text_display":" ( \\(\\geq 0.30 mg / dL\\) ). 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Patients who use nephrotoxic medication e.g., NSAIDs, angiotensin-converting enzyme","confidence":1,"confidence_rate":1},{"cnt":[[372,915],[1781,915],[1781,965],[372,965]],"region":{"top_left_x":371,"top_left_y":915,"width":1411,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b14a50f145864cd18828fb6e2c328ae9","type":"text","conversion_output":true,"text":"inhibitors, gentamycin, tobramycin) and who fulfill the SA-AKI inclusion criteria at","text_display":" inhibitors, gentamycin, tobramycin) and who fulfill the SA-AKI inclusion criteria at","confidence":1,"confidence_rate":1},{"cnt":[[370,975],[1818,975],[1818,1025],[370,1025]],"region":{"top_left_x":369,"top_left_y":975,"width":1449,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0f09df51f6d4bd094abbacd1909409f","type":"text","conversion_output":true,"text":"screening are not eligible if the use of this nephrotoxic medication is to continue when","text_display":" screening are not eligible if the use of this nephrotoxic medication is to continue when","confidence":1,"confidence_rate":1},{"cnt":[[370,1036],[1876,1036],[1876,1085],[370,1085]],"region":{"top_left_x":369,"top_left_y":1035,"width":1507,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e923d98b043c4ecd974174cdefcbc374","type":"text","conversion_output":true,"text":"alternative, medically appropriate, non-nephrotoxic medication is available . (Note: this is","text_display":" alternative, medically appropriate, non-nephrotoxic medication is available . (Note: this is","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[370,1096],[1798,1096],[1798,1145],[370,1145]],"region":{"top_left_x":369,"top_left_y":1095,"width":1430,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1209d491efdb46e29da21982c30d5209","type":"text","conversion_output":true,"text":"according to KDIGO Clinical Practice Guideline for AKI recommendations [KDIGO","text_display":" according to KDIGO Clinical Practice Guideline for AKI recommendations [KDIGO","confidence":0.9985356330871582,"confidence_rate":0.9999821289383974},{"cnt":[[370,1156],[1846,1156],[1846,1205],[370,1205]],"region":{"top_left_x":369,"top_left_y":1155,"width":1477,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce9df377a5ee4f9c817315c2caf960fb","type":"text","conversion_output":true,"text":"Acute Kidney Working Group 2012]) to avoid nephrotoxic medication, where possible).","text_display":" Acute Kidney Working Group 2012]) to avoid nephrotoxic medication, where possible).","confidence":1,"confidence_rate":1},{"cnt":[[309,1238],[1021,1238],[1021,1283],[309,1283]],"region":{"top_left_x":309,"top_left_y":1237,"width":712,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d14498d291514563918ab8d3b9bdc1ce","type":"text","conversion_output":true,"text":"23. Has a history of known IV drug abuse.","text_display":"\n23. Has a history of known IV drug abuse.","confidence":1,"confidence_rate":1},{"cnt":[[309,1315],[1652,1315],[1652,1364],[309,1364]],"region":{"top_left_x":309,"top_left_y":1314,"width":1344,"height":51},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c65fe3d98654d8890ac6ce21bc24da6","type":"text","conversion_output":true,"text":"24. Is an employee or family member of the investigator or study site personnel.","text_display":"\n24. Is an employee or family member of the investigator or study site personnel.","confidence":1,"confidence_rate":1},{"cnt":[[309,1396],[1010,1396],[1010,1446],[309,1446]],"region":{"top_left_x":309,"top_left_y":1396,"width":701,"height":50},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca30653e98734dc3b2e606a8c02310ee","type":"text","conversion_output":true,"text":"25. Has active hematological malignancy.","text_display":"\n25. Has active hematological malignancy.","confidence":1,"confidence_rate":1},{"cnt":[[305,1478],[1240,1478],[1240,1540],[305,1540]],"region":{"top_left_x":305,"top_left_y":1478,"width":935,"height":63},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d52e3404eb4f4b1788174da0c0aa9322","type":"section_header","conversion_output":false,"children_ids":["0a424fcfe17e4a18910a335a398aed22"],"text":"","text_display":""},{"cnt":[[309,1482],[1235,1482],[1235,1536],[309,1536]],"region":{"top_left_x":309,"top_left_y":1482,"width":927,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a424fcfe17e4a18910a335a398aed22","type":"text","conversion_output":true,"parent_id":"d52e3404eb4f4b1788174da0c0aa9322","text":"4.2 Withdrawal of Patients From the Study","text_display":"\n\n\\subsection*{4.2 Withdrawal of Patients From the Study}","confidence":1,"confidence_rate":1},{"cnt":[[309,1568],[1841,1568],[1841,1618],[309,1618]],"region":{"top_left_x":309,"top_left_y":1568,"width":1533,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9ca43ac0a624d21b261a195bae8744b","type":"text","conversion_output":true,"text":"The duration of the study for a patient is defined from the date that signed written informed","text_display":"\n\nThe duration of the study for a patient is defined from the date that signed written informed","confidence":1,"confidence_rate":1},{"cnt":[[309,1629],[1308,1629],[1308,1678],[309,1678]],"region":{"top_left_x":309,"top_left_y":1628,"width":1000,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"54e55c59a995498394d3ae47259d5747","type":"text","conversion_output":true,"text":"consent is provided until the last follow-up visit on Day 90.","text_display":" consent is provided until the last follow-up visit on Day 90.","confidence":1,"confidence_rate":1},{"cnt":[[305,1732],[1315,1732],[1315,1781],[305,1781]],"region":{"top_left_x":305,"top_left_y":1731,"width":1010,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e90c6c9e239146f888861f36b3a45032","type":"section_header","conversion_output":false,"children_ids":["993873c9ef5d465d8a46f364c4f4c86d"],"text":"","text_display":""},{"cnt":[[305,1736],[1311,1736],[1311,1779],[305,1779]],"region":{"top_left_x":305,"top_left_y":1735,"width":1006,"height":44},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"993873c9ef5d465d8a46f364c4f4c86d","type":"text","conversion_output":true,"parent_id":"e90c6c9e239146f888861f36b3a45032","text":"4.2.1 Reasons for Withdrawal/Discontinuation","text_display":"\n\n\\subsection*{4.2.1 Reasons for Withdrawal/Discontinuation}","confidence":0.9990234375,"confidence_rate":0.9999800606141427},{"cnt":[[309,1822],[1811,1822],[1811,1871],[309,1871]],"region":{"top_left_x":309,"top_left_y":1821,"width":1503,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22590c5bc8ee4799b2d22d7ad3c0223a","type":"text","conversion_output":true,"text":"Patients may withdraw from the study at any time and for any reason without prejudice to","text_display":"\n\nPatients may withdraw from the study at any time and for any reason without prejudice to","confidence":1,"confidence_rate":1},{"cnt":[[309,1882],[1858,1882],[1858,1931],[309,1931]],"region":{"top_left_x":309,"top_left_y":1882,"width":1550,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2baa70e7fa3e4cc1b2722a1ebfab4890","type":"text","conversion_output":true,"text":"their future medical care by the investigator or at the study site. Investigators should attempt","text_display":" their future medical care by the investigator or at the study site. Investigators should attempt","confidence":1,"confidence_rate":1},{"cnt":[[309,1942],[1871,1942],[1871,1989],[309,1989]],"region":{"top_left_x":309,"top_left_y":1942,"width":1563,"height":48},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33950e78e2f5437db2512a64e30f6d7b","type":"text","conversion_output":true,"text":"to determine the cause of withdrawal and, if agreed by the patient, to let the patient return for","text_display":" to determine the cause of withdrawal and, if agreed by the patient, to let the patient return for","confidence":1,"confidence_rate":1},{"cnt":[[309,2002],[1818,2002],[1818,2052],[309,2052]],"region":{"top_left_x":309,"top_left_y":2002,"width":1509,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac6ee16a8ed2458fbee041e1cd486776","type":"text","conversion_output":true,"text":"the Day 90 visit (last safety follow-up visit). 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Efforts","text_display":" the study, withdrawal from any further contact) should be documented in the eCRF. Efforts","confidence":1,"confidence_rate":1},{"cnt":[[309,2179],[1813,2179],[1813,2230],[309,2230]],"region":{"top_left_x":309,"top_left_y":2178,"width":1505,"height":53},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f74958093dc41af8596ebd27ef167bb","type":"text","conversion_output":true,"text":"should be made to follow-up the randomized and withdrawn patients as much as possible,","text_display":" should be made to follow-up the randomized and withdrawn patients as much as possible,","confidence":1,"confidence_rate":1},{"cnt":[[309,2241],[1021,2241],[1021,2288],[309,2288]],"region":{"top_left_x":309,"top_left_y":2240,"width":712,"height":49},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae4a7b3a71dc41f0865b29724b3b89db","type":"text","conversion_output":true,"text":"i.e., to the extent that the patients agree to.","text_display":" i.e., to the extent that the patients agree to.","confidence":0.98974609375,"confidence_rate":0.9998018111860867},{"cnt":[[1753,2462],[1867,2462],[1867,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":114,"height":41},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"444994d5609d478d8c6675cf147e7ceb","type":"page_info","conversion_output":false,"text":"Page 41","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-042","page":42,"lines":[{"cnt":[[309,254],[556,254],[556,286],[309,286]],"region":{"top_left_x":309,"top_left_y":253,"width":248,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"adf07ec709c743398e6870430ac13414","type":"page_info","conversion_output":false,"text":"AM-Pharma B.V.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1375,254],[1863,254],[1863,294],[1375,294]],"region":{"top_left_x":1375,"top_left_y":253,"width":488,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10fe0ffe78094226b95847652f30c2d7","type":"page_info","conversion_output":false,"text":"Recombinant alkaline phosphatase","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[621,314],[621,346],[309,346]],"region":{"top_left_x":309,"top_left_y":313,"width":312,"height":33},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"12c86ee46e4c4fb7a45c01c05ce31e77","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[1573,314],[1863,314],[1863,346],[1573,346]],"region":{"top_left_x":1572,"top_left_y":313,"width":291,"height":33},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cb96e4f05fe40d68f375980d3eea0f5","type":"page_info","conversion_output":false,"text":"Protocol Version 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,374],[1575,374],[1575,423],[309,423]],"region":{"top_left_x":309,"top_left_y":373,"width":1266,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18e5f8ad9ffd49a1b305b8e7f9f71f82","type":"text","conversion_output":true,"text":"Treatment with study drug will be stopped for any of the following reasons:","text_display":"\n\nTreatment with study drug will be stopped for any of the following reasons:","confidence":1,"confidence_rate":1},{"cnt":[[312,477],[1858,477],[1858,522],[312,522]],"region":{"top_left_x":311,"top_left_y":476,"width":1548,"height":47},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdf37bbea12b44a2864ffd72b26ee0a8","type":"text","conversion_output":true,"text":"1. Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in","text_display":"\n1. 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The patient withdraws consent or the investigator or sponsor decide to discontinue the","text_display":"\n2. The patient withdraws consent or the investigator or sponsor decide to discontinue the","confidence":1,"confidence_rate":1},{"cnt":[[370,722],[952,722],[952,771],[370,771]],"region":{"top_left_x":369,"top_left_y":721,"width":583,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3bd6f595d4247a7b6531c096b82d229","type":"text","conversion_output":true,"text":"patient's participation in the study.","text_display":" patient's participation in the study.","confidence":1,"confidence_rate":1},{"cnt":[[309,786],[1016,786],[1016,836],[309,836]],"region":{"top_left_x":309,"top_left_y":786,"width":708,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3807fbd60c0f492281db57e084331596","type":"text","conversion_output":true,"text":"3. AM-Pharma B.V. terminates the study","text_display":"\n3. AM-Pharma B.V. terminates the study","confidence":1,"confidence_rate":1},{"cnt":[[309,889],[1846,889],[1846,939],[309,939]],"region":{"top_left_x":309,"top_left_y":889,"width":1537,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a7926fd03f744f5b4bfce7d84b29347","type":"text","conversion_output":true,"text":"Additionally, treatment with study drug may be stopped in case of protocol non-compliance","text_display":"\n\nAdditionally, treatment with study drug may be stopped in case of protocol non-compliance","confidence":1,"confidence_rate":1},{"cnt":[[309,950],[1747,950],[1747,999],[309,999]],"region":{"top_left_x":309,"top_left_y":949,"width":1438,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9c8c5ad27b114d5d93e12b0e09d6bb29","type":"text","conversion_output":true,"text":"or violations. In this case, the investigator will contact the Medical Monitor to discuss","text_display":" or violations. 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All patients who withdraw from the study","text_display":" withdrawal on the relevant page of the eCRF. 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The randomization schedule will be stratified by site.","text_display":" a 1:1:1:1 allocation ratio in Part 1. The randomization schedule will be stratified by site.","confidence":0.8194239139556885,"confidence_rate":0.9979489749994427},{"cnt":[[309,1491],[1830,1491],[1830,1536],[309,1536]],"region":{"top_left_x":309,"top_left_y":1491,"width":1522,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ea66742d04a47459ad55d3053b61395","type":"text","conversion_output":true,"text":"Once it has been decided which is the optimal dose of recAP on the primary endpoint to be","text_display":" Once it has been decided which is the optimal dose of recAP on the primary endpoint to be","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[309,1551],[1803,1551],[1803,1596],[309,1596]],"region":{"top_left_x":309,"top_left_y":1551,"width":1494,"height":46},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d6f18d1dd6ff40ddb67b768e80dd3f8f","type":"text","conversion_output":true,"text":"administered in Part 2, the codes for the treatment groups corresponding to the 2 dropped","text_display":" administered in Part 2, the codes for the treatment groups corresponding to the 2 dropped","confidence":1,"confidence_rate":1},{"cnt":[[309,1611],[1794,1611],[1794,1656],[309,1656]],"region":{"top_left_x":309,"top_left_y":1611,"width":1485,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc8561a01f154218be1974ddb85033fd","type":"text","conversion_output":true,"text":"doses will be discontinued, and treatment allocation will continue using the codes for the","text_display":" doses will be discontinued, and treatment allocation will continue using the codes for the","confidence":1,"confidence_rate":1},{"cnt":[[309,1671],[1042,1671],[1042,1717],[309,1717]],"region":{"top_left_x":309,"top_left_y":1671,"width":733,"height":46},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"426b0f6b743d406aad55af817ae42b39","type":"text","conversion_output":true,"text":"remaining treatments on the same schedule.","text_display":" remaining treatments on the same schedule.","confidence":1,"confidence_rate":1},{"cnt":[[309,1775],[1820,1775],[1820,1820],[309,1820]],"region":{"top_left_x":309,"top_left_y":1774,"width":1511,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e023f4473aed4dd1bf12de4a1e75665e","type":"text","conversion_output":true,"text":"An interactive voice response system (IVRS) will be used to administer the randomization","text_display":"\n\nAn interactive voice response system (IVRS) will be used to administer the randomization","confidence":1,"confidence_rate":1},{"cnt":[[309,1833],[1798,1833],[1798,1880],[309,1880]],"region":{"top_left_x":309,"top_left_y":1832,"width":1490,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1ba2eba79b6e4cc78b5c5178228fcaeb","type":"text","conversion_output":true,"text":"schedule. An independent PPD statistician will generate a permuted block randomization","text_display":" schedule. An independent PPD statistician will generate a permuted block randomization","confidence":1,"confidence_rate":1},{"cnt":[[309,1886],[1858,1886],[1858,1940],[309,1940]],"region":{"top_left_x":309,"top_left_y":1886,"width":1550,"height":55},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a595a330f0eb4671b79da6704b6e6edd","type":"text","conversion_output":true,"text":"schedule using SAS \\({ }^{\\circledR}\\) software Version 9.2 or later (SAS Institute, Inc, Cary, North Carolina)","text_display":" schedule using SAS \\({ }^{\\circledR}\\) software Version 9.2 or later (SAS Institute, Inc, Cary, North Carolina)","confidence":0.9770617485046387,"confidence_rate":0.9997909639521398},{"cnt":[[309,1951],[1871,1951],[1871,2000],[309,2000]],"region":{"top_left_x":309,"top_left_y":1950,"width":1563,"height":51},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aaa1647abf4a42f1b66dc8ec320075c3","type":"text","conversion_output":true,"text":"for IVRS, which will link sequential patient randomization numbers to treatment codes. Each","text_display":" for IVRS, which will link sequential patient randomization numbers to treatment codes. Each","confidence":1,"confidence_rate":1},{"cnt":[[309,2011],[1785,2011],[1785,2058],[309,2058]],"region":{"top_left_x":309,"top_left_y":2010,"width":1477,"height":49},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"edfa62e0e2fd45ae8aa2d25d319642c7","type":"text","conversion_output":true,"text":"patient will be assigned a randomization number which will be separate from the patient","text_display":" patient will be assigned a randomization number which will be separate from the patient","confidence":1,"confidence_rate":1},{"cnt":[[309,2071],[1837,2071],[1837,2116],[309,2116]],"region":{"top_left_x":309,"top_left_y":2071,"width":1528,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e11cb79a7e3e43d29672b6ff959a3bb4","type":"text","conversion_output":true,"text":"identification number. Once a randomization number has been allocated to a patient, it may","text_display":" identification number. Once a randomization number has been allocated to a patient, it may","confidence":1,"confidence_rate":1},{"cnt":[[309,2131],[883,2131],[883,2176],[309,2176]],"region":{"top_left_x":309,"top_left_y":2131,"width":575,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec934868aa2948ca9f692179ea9ca0f0","type":"text","conversion_output":true,"text":"not be assigned to another patient.","text_display":" not be assigned to another patient.","confidence":1,"confidence_rate":1},{"cnt":[[305,2230],[947,2230],[947,2284],[305,2284]],"region":{"top_left_x":305,"top_left_y":2230,"width":643,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b3ad4d70fdb54812ba7a15dbee0c8436","type":"section_header","conversion_output":false,"children_ids":["bde66f4b63024f02aee989c4136d4d57"],"text":"","text_display":""},{"cnt":[[309,2234],[943,2234],[943,2279],[309,2279]],"region":{"top_left_x":309,"top_left_y":2234,"width":635,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bde66f4b63024f02aee989c4136d4d57","type":"text","conversion_output":true,"parent_id":"b3ad4d70fdb54812ba7a15dbee0c8436","text":"5.2 Treatments Administered","text_display":"\n\n\\subsection*{5.2 Treatments Administered}","confidence":1,"confidence_rate":1},{"cnt":[[309,2325],[1800,2325],[1800,2370],[309,2370]],"region":{"top_left_x":309,"top_left_y":2324,"width":1492,"height":46},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"66976e37c492491a8f6e25a538f47054","type":"text","conversion_output":true,"text":"Study drug will be administered by 1 -hour IV infusion as soon as possible on Day 1 after","text_display":"\n\nStudy drug will be administered by 1 -hour IV infusion as soon as possible on Day 1 after","confidence":0.951171875,"confidence_rate":0.9994995202622172},{"cnt":[[309,2383],[1751,2383],[1751,2430],[309,2430]],"region":{"top_left_x":309,"top_left_y":2382,"width":1442,"height":48},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"37e2b315fad54a53978df433e1a19ca4","type":"text","conversion_output":true,"text":"confirmation of continuing AKI, and on Days 2 and 3, \\(24 \\pm 1\\) hour after previous drug","text_display":" confirmation of continuing AKI, and on Days 2 and 3, \\(24 \\pm 1\\) hour after previous drug","confidence":0.9985356330871582,"confidence_rate":0.9999842427032235},{"cnt":[[1753,2462],[1867,2462],[1867,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":114,"height":41},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38e7b43f65cb4e27a55458bd2f8281bb","type":"page_info","conversion_output":false,"text":"Page 43","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-044","page":44,"lines":[{"cnt":[[305,251],[561,251],[561,290],[305,290]],"region":{"top_left_x":305,"top_left_y":251,"width":256,"height":40},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c500857f009548b09f03d3f402e534b0","type":"page_info","conversion_output":false,"text":"AM-Pharma B.V.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1371,249],[1863,249],[1863,294],[1371,294]],"region":{"top_left_x":1370,"top_left_y":249,"width":493,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f014f5aacccb43acaede34d0f84ad30c","type":"page_info","conversion_output":false,"text":"Recombinant alkaline phosphatase","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[621,314],[621,350],[309,350]],"region":{"top_left_x":309,"top_left_y":313,"width":312,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0fe1cb3dde74f11b104abd91aa7a6a2","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,314],[1863,314],[1863,350],[1573,350]],"region":{"top_left_x":1572,"top_left_y":313,"width":291,"height":38},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35c5ada601c5451194d0d838f64bb6c1","type":"page_info","conversion_output":false,"text":"Protocol Version 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,374],[1807,374],[1807,423],[309,423]],"region":{"top_left_x":309,"top_left_y":373,"width":1498,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"957e0c1d5a5f4fffbbfd13ed2bf341a2","type":"text","conversion_output":true,"text":"administration, by trained staff in the ICU or intermediate care unit. A total of 50 mL (see","text_display":"\nadministration, by trained staff in the ICU or intermediate care unit. A total of 50 mL (see","confidence":1,"confidence_rate":1},{"cnt":[[309,434],[1766,434],[1766,483],[309,483]],"region":{"top_left_x":309,"top_left_y":433,"width":1458,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22d822c5eb7a4723a3f87806fea53764","type":"text","conversion_output":true,"text":"Section 5.3) will be infused at a constant rate of \\(50 mL /\\) hour, followed by a flushing of","text_display":" Section 5.3) will be infused at a constant rate of \\(50 mL /\\) hour, followed by a flushing of","confidence":0.6596965221076306,"confidence_rate":0.9958070437300496},{"cnt":[[309,494],[1824,494],[1824,544],[309,544]],"region":{"top_left_x":309,"top_left_y":494,"width":1516,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29ca2f4e7dac44f8b0643fe8132ccea1","type":"text","conversion_output":true,"text":"infusion lines with minimal 4 mL saline. The preferred route for study drug administration","text_display":" infusion lines with minimal 4 mL saline. The preferred route for study drug administration","confidence":1,"confidence_rate":1},{"cnt":[[309,554],[1775,554],[1775,604],[309,604]],"region":{"top_left_x":309,"top_left_y":554,"width":1466,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1e9004cf49049dc8eb0301e15661005","type":"text","conversion_output":true,"text":"will be through a central line; if this is not possible, a peripheral line will be acceptable.","text_display":" will be through a central line; if this is not possible, a peripheral line will be acceptable.","confidence":1,"confidence_rate":1},{"cnt":[[309,614],[1811,614],[1811,664],[309,664]],"region":{"top_left_x":309,"top_left_y":614,"width":1503,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"086ef3191a2345afa7ea86b4bf8cc014","type":"text","conversion_output":true,"text":"Study drug will be administered separately from any concomitant drugs using a dedicated","text_display":" Study drug will be administered separately from any concomitant drugs using a dedicated","confidence":1,"confidence_rate":1},{"cnt":[[309,675],[675,675],[675,715],[309,715]],"region":{"top_left_x":309,"top_left_y":674,"width":366,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3204dfc3778b4e49b03d949887b4ce9d","type":"text","conversion_output":true,"text":"lumen of the catheter.","text_display":" lumen of the catheter.","confidence":1,"confidence_rate":1},{"cnt":[[309,776],[1755,776],[1755,827],[309,827]],"region":{"top_left_x":309,"top_left_y":775,"width":1447,"height":53},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2896c35f4a1445aa98b3ae88393cd011","type":"text","conversion_output":true,"text":"Vital signs will be monitored during infusion on all treatment days (see Section 6.3.4).","text_display":"\n\nVital signs will be monitored during infusion on all treatment days (see Section 6.3.4).","confidence":1,"confidence_rate":1},{"cnt":[[309,877],[1811,877],[1811,926],[309,926]],"region":{"top_left_x":309,"top_left_y":876,"width":1503,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8137dbff5fdf4cf284708c71c8a175b2","type":"text","conversion_output":true,"text":"Patients randomly assigned to receive recAP in Part 1 and during the interim analysis will","text_display":"\n\nPatients randomly assigned to receive recAP in Part 1 and during the interim analysis will","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[307,937],[1858,937],[1858,986],[307,986]],"region":{"top_left_x":307,"top_left_y":936,"width":1552,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16e69e2df9a24200a0e3fdf15eeb8c90","type":"text","conversion_output":true,"text":"receive one of the following 3 doses of recAP: \\(0.4 mg / kg (250 U / kg ), 0.8 mg / kg (500 U / kg )\\),","text_display":" receive one of the following 3 doses of recAP: \\(0.4 mg / kg (250 U / kg ), 0.8 mg / kg (500 U / kg )\\),","confidence":0.998046875,"confidence_rate":0.9999835712707866},{"cnt":[[307,997],[1850,997],[1850,1046],[307,1046]],"region":{"top_left_x":307,"top_left_y":996,"width":1543,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a2c1b7b96d74ef1a42f48b35e1953bc","type":"text","conversion_output":true,"text":"or \\(1.6 mg / kg (1000 U / kg )\\). 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an aqueous buffer containing 20 mM citrate, 250 mM sorbitol, \\(2 mM MgCl _{2}\\),","confidence":0.7247436046600342,"confidence_rate":0.9971038655570438},{"cnt":[[309,655],[913,655],[913,703],[309,703]],"region":{"top_left_x":309,"top_left_y":655,"width":605,"height":48},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8c924664d1b4bfcb2499c9156244d98","type":"text","conversion_output":true,"text":"\\(50 \\mu M ZnCl _{2}\\), and with a pH of 7.0 .","text_display":" \\(50 \\mu M ZnCl _{2}\\), and with a pH of 7.0 .","confidence":0.8962932812282816,"confidence_rate":0.9981140634318519},{"cnt":[[309,756],[1794,756],[1794,806],[309,806]],"region":{"top_left_x":309,"top_left_y":756,"width":1485,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d51287abbf6144b190bd54726a4064f2","type":"text","conversion_output":true,"text":"Recombinant human AP is supplied as a clear, colorless, pyrogen-free solution in \\(10- mL\\)","text_display":"\n\nRecombinant human AP is supplied as a clear, colorless, pyrogen-free solution in \\(10- mL\\)","confidence":0.9805123475459823,"confidence_rate":0.99978840905182},{"cnt":[[309,816],[1747,816],[1747,866],[309,866]],"region":{"top_left_x":309,"top_left_y":816,"width":1438,"height":50},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93bd47829eb84ccc8bbc8fbb1048bc48","type":"text","conversion_output":true,"text":"type 1 glass vials with a Teflon-coated bromobutyl rubber stopper and \"Flip-Tear Up\"","text_display":" type 1 glass vials with a Teflon-coated bromobutyl rubber stopper and \"Flip-Tear Up\"","confidence":1,"confidence_rate":1},{"cnt":[[309,877],[1858,877],[1858,926],[309,926]],"region":{"top_left_x":309,"top_left_y":876,"width":1550,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfd5a9cda5e84dda933c651885d58473","type":"text","conversion_output":true,"text":"overcap. Each vial contains 5 mL of recAP solution. Matching placebo is supplied as a clear,","text_display":" overcap. Each vial contains 5 mL of recAP solution. Matching placebo is supplied as a clear,","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[309,937],[1863,937],[1863,986],[309,986]],"region":{"top_left_x":309,"top_left_y":936,"width":1554,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e481f4dc5e484bf385cf4989067a1a63","type":"text","conversion_output":true,"text":"colorless, pyrogen-free solution in \\(10- mL\\) type 1 glass vials with a Teflon-coated bromobutyl","text_display":" colorless, pyrogen-free solution in \\(10- mL\\) type 1 glass vials with a Teflon-coated bromobutyl","confidence":0.9331698417663574,"confidence_rate":0.9993476840169891},{"cnt":[[309,997],[1798,997],[1798,1046],[309,1046]],"region":{"top_left_x":309,"top_left_y":996,"width":1490,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af3b087753ef452b8721700bc8306a8a","type":"text","conversion_output":true,"text":"rubber stopper and \"Flip-Tear Up\" overcap. Each vial contains 5 mL of placebo solution.","text_display":" rubber stopper and \"Flip-Tear Up\" overcap. Each vial contains 5 mL of placebo solution.","confidence":1,"confidence_rate":1},{"cnt":[[309,1100],[1772,1100],[1772,1147],[309,1147]],"region":{"top_left_x":309,"top_left_y":1100,"width":1464,"height":48},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a8cbabf31fa24e4cb7af7233369bd637","type":"text","conversion_output":true,"text":"Patient doses will be prepared from 4 vials in a combination of recAP drug product and","text_display":"\n\nPatient doses will be prepared from 4 vials in a combination of recAP drug product and","confidence":0.99365234375,"confidence_rate":0.9999322588021694},{"cnt":[[307,1160],[1695,1160],[1695,1207],[307,1207]],"region":{"top_left_x":307,"top_left_y":1160,"width":1389,"height":48},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d6f57e282f94efaa59349e273616934","type":"text","conversion_output":true,"text":"placebo. 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If applicable,","text_display":" 2 to \\(8^{\\circ} C\\) for up to 3 hours and/or a maximum of 1 hour at room temperature. 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the study drug preparation manual.","confidence":1,"confidence_rate":1},{"cnt":[[309,2105],[1841,2105],[1841,2151],[309,2151]],"region":{"top_left_x":309,"top_left_y":2105,"width":1533,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0912401d6cce4206b85c970045bb5b00","type":"text","conversion_output":true,"text":"The hospital/study pharmacist is responsible for receipt of the study drug from PPD and for","text_display":"\n\nThe hospital/study pharmacist is responsible for receipt of the study drug from PPD and for","confidence":1,"confidence_rate":1},{"cnt":[[309,2166],[1055,2166],[1055,2206],[309,2206]],"region":{"top_left_x":309,"top_left_y":2165,"width":746,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b530ecdbe3694beca8ce28e36f7c6c5a","type":"text","conversion_output":true,"text":"transfer to the ICU or intermediate care unit.","text_display":" transfer to the ICU or intermediate care 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Discarded volume will be collected","confidence":1,"confidence_rate":1},{"cnt":[[305,973],[1854,973],[1854,1025],[305,1025]],"region":{"top_left_x":305,"top_left_y":973,"width":1550,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85a306cbf3d043e18ce9acca930dfd33","type":"text","conversion_output":true,"text":"in a vial for review of medication administration by the monitor during a regular monitoring","text_display":" in a vial for review of medication administration by the monitor during a regular monitoring","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,1036],[397,1036],[397,1076],[305,1076]],"region":{"top_left_x":305,"top_left_y":1035,"width":93,"height":42},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00ee07ff9d564a28861a6743360c2652","type":"text","conversion_output":true,"text":"visit.","text_display":" visit.","confidence":1,"confidence_rate":1},{"cnt":[[305,1137],[1798,1137],[1798,1186],[305,1186]],"region":{"top_left_x":305,"top_left_y":1136,"width":1494,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bbb4f185661474d90e31aa59a759bfc","type":"text","conversion_output":true,"text":"No specific treatment is available for medication errors and it is unknown whether or not","text_display":"\n\nNo specific treatment is available for medication errors and it is unknown whether or not","confidence":1,"confidence_rate":1},{"cnt":[[307,1195],[1846,1195],[1846,1248],[307,1248]],"region":{"top_left_x":307,"top_left_y":1194,"width":1539,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa606100f50e46f1aca85d1c0784176c","type":"text","conversion_output":true,"text":"specific symptoms will occur. If a medication error occurs, as a general rule supportive care","text_display":" specific symptoms will occur. If a medication error occurs, as a general rule supportive care","confidence":1,"confidence_rate":1},{"cnt":[[305,1255],[1111,1255],[1111,1308],[305,1308]],"region":{"top_left_x":305,"top_left_y":1254,"width":806,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c414c91aa6f94e6abcd89c216c1e42b8","type":"text","conversion_output":true,"text":"and treatment of symptoms should be provided.","text_display":" and treatment of symptoms should be provided.","confidence":1,"confidence_rate":1},{"cnt":[[301,1354],[950,1354],[950,1414],[301,1414]],"region":{"top_left_x":300,"top_left_y":1353,"width":650,"height":61},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb3dfd6e503e423b805d9b82e2c29683","type":"section_header","conversion_output":false,"children_ids":["fb5fc40fccf242dc9935bcff1b094ac8"],"text":"","text_display":""},{"cnt":[[305,1358],[943,1358],[943,1407],[305,1407]],"region":{"top_left_x":305,"top_left_y":1357,"width":639,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb5fc40fccf242dc9935bcff1b094ac8","type":"text","conversion_output":true,"parent_id":"eb3dfd6e503e423b805d9b82e2c29683","text":"5.5.2 Treatment of Overdose","text_display":"\n\n\\subsection*{5.5.2 Treatment of Overdose}","confidence":1,"confidence_rate":1},{"cnt":[[305,1448],[1854,1448],[1854,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1448,"width":1550,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90311c306a7b47edb671f9df839fc7d1","type":"text","conversion_output":true,"text":"In healthy volunteers the maximum administered single dose that did not result in any SAEs","text_display":"\n\nIn healthy volunteers the maximum administered single dose that did not result in any SAEs","confidence":1,"confidence_rate":1},{"cnt":[[305,1508],[1828,1508],[1828,1558],[305,1558]],"region":{"top_left_x":305,"top_left_y":1508,"width":1524,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2b1dda925f341a3afe4cb0b636fe37f","type":"text","conversion_output":true,"text":"was \\(3.2 mg / kg (2000 U / kg )\\). The maximum multiple dose that was administered to healthy","text_display":" was \\(3.2 mg / kg (2000 U / kg )\\). The maximum multiple dose that was administered to healthy","confidence":1,"confidence_rate":1},{"cnt":[[305,1568],[1850,1568],[1850,1618],[305,1618]],"region":{"top_left_x":305,"top_left_y":1568,"width":1545,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8783ef9ed4dd4fd895760d81ae5d0784","type":"text","conversion_output":true,"text":"volunteers was \\(1.6 mg / kg (1000 U / kg )\\) per day for 3 days without any SAEs. As an example","text_display":" volunteers was \\(1.6 mg / kg (1000 U / kg )\\) per day for 3 days without any SAEs. As an example","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[305,1629],[1742,1629],[1742,1678],[305,1678]],"region":{"top_left_x":305,"top_left_y":1628,"width":1438,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1eee1d79123345bfabd162698a5ca33d","type":"text","conversion_output":true,"text":"of a possible dose error (e.g., administration of the highest study dose [i.e., \\(1.6 mg / kg\\)","text_display":" of a possible dose error (e.g., administration of the highest study dose [i.e., \\(1.6 mg / kg","confidence":0.822265625,"confidence_rate":0.998005137374734},{"cnt":[[309,1687],[1867,1687],[1867,1738],[309,1738]],"region":{"top_left_x":309,"top_left_y":1686,"width":1558,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7123d334cc5243b7ad129d9de9738ce9","type":"text","conversion_output":true,"text":"\\(\\{1000 U / kg \\}\\) which is the dose for a \\(100- kg\\) person] to a \\(50- kg\\) person), 1 -day administration","text_display":" \\{1000 U / kg \\}\\) which is the dose for a \\(100- kg\\) person] to a \\(50- kg\\) person), 1 -day administration","confidence":0.9737912896089256,"confidence_rate":0.9997710755174083},{"cnt":[[305,1747],[1721,1747],[1721,1798],[305,1798]],"region":{"top_left_x":305,"top_left_y":1746,"width":1416,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4c281c302d14ef3bd1d318d038857cc","type":"text","conversion_output":true,"text":"of study drug still would not exceed the tested maximum dose in healthy volunteers.","text_display":" of study drug still would not exceed the tested maximum dose in healthy volunteers.","confidence":1,"confidence_rate":1},{"cnt":[[305,1826],[1796,1826],[1796,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1826,"width":1492,"height":54},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2eac80c7662c4edba6fe29b72f01cce4","type":"text","conversion_output":true,"text":"No specific treatment is available for overdose and it is unknown whether or not specific","text_display":"\n\nNo specific treatment is available for overdose and it is unknown whether or not specific","confidence":1,"confidence_rate":1},{"cnt":[[305,1886],[1841,1886],[1841,1938],[305,1938]],"region":{"top_left_x":305,"top_left_y":1886,"width":1537,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41598e4a9da0474ca665e577dca7daac","type":"text","conversion_output":true,"text":"symptoms will occur. If an overdose occurs, as a general rule supportive care and treatment","text_display":" symptoms will occur. 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The randomization schedule will be held by an independent PPD team at a","text_display":" assignment. The randomization schedule will be held by an independent PPD team at a","confidence":0.99853515625,"confidence_rate":0.9999833419832633},{"cnt":[[305,2299],[1876,2299],[1876,2348],[305,2348]],"region":{"top_left_x":305,"top_left_y":2298,"width":1571,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"180257d3929449a09b669504083d23e9","type":"text","conversion_output":true,"text":"different regional location and will not be revealed until all patients have completed the study","text_display":" different regional location and will not be revealed until all patients have completed the study","confidence":1,"confidence_rate":1},{"cnt":[[1753,2462],[1871,2462],[1871,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":119,"height":41},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d47a6edfabab42de8294f93851bf987e","type":"page_info","conversion_output":false,"text":"Page 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erroneous interpretation of liver function, as the recAP administered will","confidence":0.9775390625,"confidence_rate":0.999772855538368},{"cnt":[[309,655],[1876,655],[1876,703],[309,703]],"region":{"top_left_x":309,"top_left_y":655,"width":1567,"height":48},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a5f180394b945ca9a0a7d3dd8277b4f","type":"text","conversion_output":true,"text":"increase the AP activity, exceeding many times the reference range AP levels. For that reason,","text_display":" increase the AP activity, exceeding many times the reference range AP levels. For that reason,","confidence":0.8306488990783691,"confidence_rate":0.9981275322538883},{"cnt":[[309,715],[1863,715],[1863,763],[309,763]],"region":{"top_left_x":309,"top_left_y":715,"width":1554,"height":48},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ffd12bc32d04f5696b7b3c807fc39b1","type":"text","conversion_output":true,"text":"AP activity levels from samples taken during the first 14 days of the study are not allowed to","text_display":" AP activity levels from samples taken during the first 14 days of the study are not allowed to","confidence":1,"confidence_rate":1},{"cnt":[[309,776],[1811,776],[1811,823],[309,823]],"region":{"top_left_x":309,"top_left_y":775,"width":1503,"height":48},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6479e8374b694015b4d7a725879db273","type":"text","conversion_output":true,"text":"be reported to the study team members or to any other study staff member involved in the","text_display":" be reported to the study team members or to any other study staff member involved in the","confidence":1,"confidence_rate":1},{"cnt":[[309,836],[1824,836],[1824,883],[309,883]],"region":{"top_left_x":309,"top_left_y":835,"width":1516,"height":49},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1b0937e292264fe4a222c3fc262552c8","type":"text","conversion_output":true,"text":"conduct of the study. After Day 14, considering the terminal half-life of recAP, AP activity","text_display":" conduct of the study. After Day 14, considering the terminal half-life of recAP, AP activity","confidence":0.9926819801330566,"confidence_rate":0.9999242819602552},{"cnt":[[309,896],[1790,896],[1790,943],[309,943]],"region":{"top_left_x":309,"top_left_y":895,"width":1481,"height":49},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6e1f7b4fdbe4dc08d582013e7baac73","type":"text","conversion_output":true,"text":"levels are expected to have returned to normal levels. Therefore, results of AP activity in","text_display":" levels are expected to have returned to normal levels. 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Blood products should be recorded separately.","text_display":" concomitant medication section in the eCRF. 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Based on findings that emerge during study conduct,","text_display":" in the study procedures manual (SPM). Based on findings that emerge during study conduct,","confidence":1,"confidence_rate":1},{"cnt":[[305,907],[1826,907],[1826,956],[305,956]],"region":{"top_left_x":305,"top_left_y":906,"width":1522,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f849bd4d07894c41a1b83d5fab2a30c5","type":"text","conversion_output":true,"text":"the SPM will be updated as appropriate to include any additional concomitant medications","text_display":" the SPM will be updated as appropriate to include any additional concomitant medications","confidence":1,"confidence_rate":1},{"cnt":[[305,967],[896,967],[896,1016],[305,1016]],"region":{"top_left_x":305,"top_left_y":966,"width":591,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9d170b613444db49aa6676bf671feeb","type":"text","conversion_output":true,"text":"that should be avoided, if possible.","text_display":" that should be avoided, if 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nephrotoxic drugs such as contrast agents, NSAIDs, angiotensin-converting enzyme","confidence":1,"confidence_rate":1},{"cnt":[[305,1186],[1865,1186],[1865,1240],[305,1240]],"region":{"top_left_x":305,"top_left_y":1185,"width":1560,"height":55},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"504221af5bc744cb87ced3f34992ef6a","type":"text","conversion_output":true,"text":"inhibitors, gentamycin, or tobramycin should be avoided where possible, as recommended in","text_display":" inhibitors, gentamycin, or tobramycin should be avoided where possible, as recommended in","confidence":1,"confidence_rate":1},{"cnt":[[305,1246],[1820,1246],[1820,1298],[305,1298]],"region":{"top_left_x":305,"top_left_y":1246,"width":1515,"height":52},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88d7fc873cf44c8590d59f03d04b4569","type":"text","conversion_output":true,"text":"the KDIGO Clinical Practice Guideline for AKI recommendations 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serum creatinine measurements","confidence":1,"confidence_rate":1},{"cnt":[[370,2007],[1835,2007],[1835,2056],[370,2056]],"region":{"top_left_x":369,"top_left_y":2006,"width":1466,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75a310b809d443f0ab622409112f9287","type":"text","conversion_output":true,"text":"will be used for the calculation of time-corrected endogenous creatinine clearance at all","text_display":" will be used for the calculation of time-corrected endogenous creatinine clearance at all","confidence":1,"confidence_rate":1},{"cnt":[[370,2067],[1745,2067],[1745,2116],[370,2116]],"region":{"top_left_x":369,"top_left_y":2066,"width":1376,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac5dbff124fe4e67a5d553167d3045e7","type":"text","conversion_output":true,"text":"visits from baseline to Day 7, and will be calculated by the central laboratory. The","text_display":" visits from baseline to Day 7, and will be calculated by the central laboratory. The","confidence":1,"confidence_rate":1},{"cnt":[[370,2127],[1772,2127],[1772,2176],[370,2176]],"region":{"top_left_x":369,"top_left_y":2126,"width":1404,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ba9c7e9d85c4230a3a55f72b6fc2890","type":"text","conversion_output":true,"text":"measurements from Day 1 to Day 7, inclusive, will be used to calculate the primary","text_display":" measurements from Day 1 to Day 7, inclusive, will be used to calculate the primary","confidence":1,"confidence_rate":1},{"cnt":[[370,2187],[1858,2187],[1858,2237],[370,2237]],"region":{"top_left_x":369,"top_left_y":2187,"width":1490,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea34dfe2b1aa49619c423e7c523e776e","type":"text","conversion_output":true,"text":"endpoint. Only if reliable urine collection is possible, urine will be collected on Days 14,","text_display":" endpoint. 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Results","confidence":1,"confidence_rate":1},{"cnt":[[309,1057],[1405,1057],[1405,1106],[309,1106]],"region":{"top_left_x":309,"top_left_y":1057,"width":1097,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c21f9f0ff50f47c585dd81abf9256128","type":"text","conversion_output":true,"text":"obtained with hand-held echography equipment may be included.","text_display":" obtained with hand-held echography equipment may be included.","confidence":1,"confidence_rate":1},{"cnt":[[309,1160],[1876,1160],[1876,1210],[309,1210]],"region":{"top_left_x":309,"top_left_y":1160,"width":1567,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e172dc6ef1f4396b0ed7d0526778f66","type":"text","conversion_output":true,"text":"The physical examination should be performed by a physician or another study team member","text_display":"\n\nThe physical examination should be performed by a physician or another study team member","confidence":1,"confidence_rate":1},{"cnt":[[309,1220],[1205,1220],[1205,1268],[309,1268]],"region":{"top_left_x":309,"top_left_y":1220,"width":897,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d141a6e3d65e43de97d7c75beb6b58c2","type":"text","conversion_output":true,"text":"with appropriate training to perform the examination.","text_display":" with appropriate training to perform the examination.","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[305,1323],[690,1323],[690,1381],[305,1381]],"region":{"top_left_x":305,"top_left_y":1323,"width":385,"height":59},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09da5c0dd3b049c78c4dba6072868479","type":"section_header","conversion_output":false,"children_ids":["c4d5728583e5411982cf50412102627b"],"text":"","text_display":""},{"cnt":[[309,1328],[685,1328],[685,1377],[309,1377]],"region":{"top_left_x":309,"top_left_y":1327,"width":377,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4d5728583e5411982cf50412102627b","type":"text","conversion_output":true,"parent_id":"09da5c0dd3b049c78c4dba6072868479","text":"6.3.4 Vital Signs","text_display":"\n\n\\subsection*{6.3.4 Vital Signs}","confidence":1,"confidence_rate":1},{"cnt":[[309,1414],[1824,1414],[1824,1459],[309,1459]],"region":{"top_left_x":309,"top_left_y":1413,"width":1516,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65823f2413014fe2888f8dba47bd3297","type":"text","conversion_output":true,"text":"Vital signs, including temperature, heart rate, oxygen saturation, respiratory rate and blood","text_display":"\n\nVital signs, including temperature, heart rate, oxygen saturation, respiratory rate and blood","confidence":1,"confidence_rate":1},{"cnt":[[309,1474],[1869,1474],[1869,1519],[309,1519]],"region":{"top_left_x":309,"top_left_y":1473,"width":1561,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a1060ce274024b68bc6f4377874f1859","type":"text","conversion_output":true,"text":"pressure, will be measured at baseline, and at all subsequent visits from Day 1 to Day 28 (see","text_display":" pressure, will be measured at baseline, and at all subsequent visits from Day 1 to Day 28 (see","confidence":1,"confidence_rate":1},{"cnt":[[309,1532],[1824,1532],[1824,1579],[309,1579]],"region":{"top_left_x":309,"top_left_y":1531,"width":1516,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fce812f026542728d9a1b5e9692475f","type":"text","conversion_output":true,"text":"Section 13.1 [Table 13-1] and Section 13.2 [Figure 13-1]). Vital signs in ambulant patients","text_display":" Section 13.1 [Table 13-1] and Section 13.2 [Figure 13-1]). Vital signs in ambulant patients","confidence":1,"confidence_rate":1},{"cnt":[[309,1592],[1876,1592],[1876,1639],[309,1639]],"region":{"top_left_x":309,"top_left_y":1591,"width":1567,"height":49},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81c6003c853c4fd78e463c9456ace72b","type":"text","conversion_output":true,"text":"will be measured with the patient in a sitting position and after 5 minutes rest. Blood pressure","text_display":" will be measured with the patient in a sitting position and after 5 minutes rest. Blood pressure","confidence":1,"confidence_rate":1},{"cnt":[[309,1652],[1858,1652],[1858,1699],[309,1699]],"region":{"top_left_x":309,"top_left_y":1652,"width":1550,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53c7148558d5492b9d0a35e4ca9a3e61","type":"text","conversion_output":true,"text":"will be monitored non-invasively. In patients who already have an arterial line placed as part","text_display":" will be monitored non-invasively. In patients who already have an arterial line placed as part","confidence":1,"confidence_rate":1},{"cnt":[[309,1712],[1798,1712],[1798,1760],[309,1760]],"region":{"top_left_x":309,"top_left_y":1712,"width":1490,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c7887ad4de24ee1bb1436ab15d7be34","type":"text","conversion_output":true,"text":"of standard of care, readings from invasive blood pressure monitoring are to be recorded.","text_display":" of standard of care, readings from invasive blood pressure monitoring are to be recorded.","confidence":1,"confidence_rate":1},{"cnt":[[309,1813],[1766,1813],[1766,1863],[309,1863]],"region":{"top_left_x":309,"top_left_y":1813,"width":1458,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49e73ae613c64096b273bb72cd0f2caf","type":"text","conversion_output":true,"text":"On visit days when study drug is administered (Days 1, 2 and 3), vital signs 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alkaline phosphatase","text_display":"\n\nRecombinant alkaline phosphatase","confidence":1,"confidence_rate":1},{"cnt":[[1573,314],[1863,314],[1863,346],[1573,346]],"region":{"top_left_x":1572,"top_left_y":313,"width":291,"height":33},"line":6,"column":2,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fb6271b72e1c41f4be9c778a9921f7ba","type":"text","conversion_output":true,"parent_id":"f67355f3cced49e09b414239d3ec9fc5","text":"Protocol Version 3.0","text_display":"\nProtocol Version 3.0","confidence":1,"confidence_rate":1},{"cnt":[[309,374],[1682,374],[1682,423],[309,423]],"region":{"top_left_x":309,"top_left_y":373,"width":1374,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f1a40c633124ca6bbb053c2d8efefa7","type":"text","conversion_output":true,"text":"Additionally, on Day 1 only, vital signs will be measured and recorded as follows:","text_display":"\n\nAdditionally, on Day 1 only, vital signs will be measured and 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The time at","text_display":"\n\nAt all other visits, the vital signs can be assessed at any moment during the day. The time at","confidence":1,"confidence_rate":1},{"cnt":[[309,597],[1446,597],[1446,647],[309,647]],"region":{"top_left_x":309,"top_left_y":597,"width":1137,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb42f7acf2624098bed08c42855d86c0","type":"text","conversion_output":true,"text":"which vital signs have been measured will be recorded in the eCRF.","text_display":" which vital signs have been measured will be recorded in the eCRF.","confidence":0.9985356330871582,"confidence_rate":0.9999793602109479},{"cnt":[[305,700],[621,700],[621,761],[305,761]],"region":{"top_left_x":305,"top_left_y":700,"width":316,"height":61},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6db44f511b6243e989f3d9107dd7c6a6","type":"section_header","conversion_output":false,"children_ids":["636c2d195960400eac3de4af8d03174a"],"text":"","text_display":""},{"cnt":[[309,705],[612,705],[612,758],[309,758]],"region":{"top_left_x":309,"top_left_y":704,"width":304,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"636c2d195960400eac3de4af8d03174a","type":"text","conversion_output":true,"parent_id":"6db44f511b6243e989f3d9107dd7c6a6","text":"6.3.5 Weight","text_display":"\n\n\\subsection*{6.3.5 Weight}","confidence":1,"confidence_rate":1},{"cnt":[[309,791],[1755,791],[1755,840],[309,840]],"region":{"top_left_x":309,"top_left_y":790,"width":1447,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0a6b9b3c7a04d319eb921c67ff30fbb","type":"text","conversion_output":true,"text":"For determination of study drug dosage, body weight (in kg or lb ) will be estimated or","text_display":"\n\nFor determination of study drug dosage, body weight (in kg or lb ) will be estimated or","confidence":0.9399704933166504,"confidence_rate":0.999404919493185},{"cnt":[[309,851],[1876,851],[1876,900],[309,900]],"region":{"top_left_x":309,"top_left_y":850,"width":1567,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"250f9d0e16aa40f1920edde859a50458","type":"text","conversion_output":true,"text":"measured. The hospital admission weight (in kg or lb ) will be used for study drug preparation","text_display":" measured. 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The recording should be printed,","text_display":" rested supine or semi-recumbent for at least 5 minutes. The recording should be printed,","confidence":0.998046875,"confidence_rate":0.9999796352611579},{"cnt":[[309,1384],[1878,1384],[1878,1433],[309,1433]],"region":{"top_left_x":309,"top_left_y":1383,"width":1569,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5f0c4dce4484f4cb19367def0c120fd","type":"text","conversion_output":true,"text":"signed, and dated by the investigator (or designee) and retained as source documentation. The","text_display":" signed, and dated by the investigator (or designee) and retained as source documentation. 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Approximately 178 to 208 mL ( 35 to 42 teaspoons) of blood will be collected","text_display":"\n[Figure 13-1]). Approximately 178 to 208 mL ( 35 to 42 teaspoons) of blood will be collected","confidence":0.9858465194702148,"confidence_rate":0.9998715884593213},{"cnt":[[309,1876],[1841,1876],[1841,1927],[309,1927]],"region":{"top_left_x":309,"top_left_y":1875,"width":1533,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70f138363e9742ed80daad3550cee4cf","type":"text","conversion_output":true,"text":"per patient in total during the study, including tests performed in the local and in the central","text_display":" per patient in total during the study, including tests performed in the local and in the central","confidence":1,"confidence_rate":1},{"cnt":[[309,1938],[522,1938],[522,1979],[309,1979]],"region":{"top_left_x":309,"top_left_y":1937,"width":214,"height":42},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"526c4a23eac64744ad746b6f55b1f73f","type":"text","conversion_output":true,"text":"laboratories.","text_display":" laboratories.","confidence":1,"confidence_rate":1},{"cnt":[[309,2037],[1807,2037],[1807,2086],[309,2086]],"region":{"top_left_x":309,"top_left_y":2036,"width":1498,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5470d1e83ba646fc8405c036e4d7319a","type":"text","conversion_output":true,"text":"To decide when to stop RRT (see Section 6.3.9), local urine creatinine, urine volume, and","text_display":"\n\nTo decide when to stop RRT (see Section 6.3.9), local urine creatinine, urine volume, and","confidence":0.9960954189300537,"confidence_rate":0.9999583814634406},{"cnt":[[309,2097],[1837,2097],[1837,2146],[309,2146]],"region":{"top_left_x":309,"top_left_y":2096,"width":1528,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24805227f8da47fb95f09fa2cce45ddd","type":"text","conversion_output":true,"text":"serum creatinine samples will be taken and the creatinine clearance calculated. This will be","text_display":" serum creatinine samples will be taken and the creatinine clearance calculated. 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Blood human chorionic gonadotropin (hCG) or urine hCG","text_display":"\n\nPregnancy test: only at baseline. Blood human chorionic gonadotropin (hCG) or urine hCG","confidence":1,"confidence_rate":1},{"cnt":[[309,920],[1119,920],[1119,969],[309,969]],"region":{"top_left_x":309,"top_left_y":919,"width":811,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f7d048de96f14d939a599a5c627d1aff","type":"text","conversion_output":true,"text":"(dipstick). See Section 6.4 for additional details.","text_display":" (dipstick). See Section 6.4 for additional details.","confidence":1,"confidence_rate":1},{"cnt":[[309,1021],[1871,1021],[1871,1068],[309,1068]],"region":{"top_left_x":309,"top_left_y":1020,"width":1563,"height":48},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ead63b4f99a2496899eef27b1897cedc","type":"text","conversion_output":true,"text":"When the diagnosis of AKI was made according to one of the AKIN serum creatinine criteria","text_display":"\n\nWhen the diagnosis of AKI was made according to one of the AKIN serum creatinine criteria","confidence":1,"confidence_rate":1},{"cnt":[[309,1079],[1644,1079],[1644,1128],[309,1128]],"region":{"top_left_x":309,"top_left_y":1078,"width":1335,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a78af5b6cf34e2db0571b9c42f19bdf","type":"text","conversion_output":true,"text":"(absolute or relative increase, see inclusion criteria 5a and 5b), the confirmative","text_display":" (absolute or relative increase, see inclusion criteria 5a and 5b), the confirmative","confidence":1,"confidence_rate":1},{"cnt":[[309,1139],[1800,1139],[1800,1188],[309,1188]],"region":{"top_left_x":309,"top_left_y":1138,"width":1492,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"157b1f71775f42c0a7aa3221c372b122","type":"text","conversion_output":true,"text":"fluid-corrected serum creatinine sample with results available prior to randomization and","text_display":" fluid-corrected serum creatinine sample with results available prior to randomization and","confidence":1,"confidence_rate":1},{"cnt":[[305,1199],[1454,1199],[1454,1248],[305,1248]],"region":{"top_left_x":305,"top_left_y":1198,"width":1150,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d8d75f0ee00c4d33bac57d4b487db875","type":"text","conversion_output":true,"text":"prior to study drug administration is to confirm continuation of 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purines, systemic markers for inflammation, PK, serology, and","confidence":1,"confidence_rate":1},{"cnt":[[309,2015],[1566,2015],[1566,2065],[309,2065]],"region":{"top_left_x":309,"top_left_y":2015,"width":1258,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"449a6751631e4df7a4dc68b5f98dfba9","type":"text","conversion_output":true,"text":"anti-drug antibodies will be collected and shipped to the central laboratory.","text_display":" anti-drug antibodies will be collected and shipped to the central laboratory.","confidence":1,"confidence_rate":1},{"cnt":[[309,2118],[1742,2118],[1742,2168],[309,2168]],"region":{"top_left_x":309,"top_left_y":2118,"width":1434,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c9968ea5b83446e91d0cc0f3c9d0e6d","type":"text","conversion_output":true,"text":"For selected sites only, detailed instructions for iohexol and related measurements are","text_display":"\n\nFor selected sites only, detailed instructions for iohexol and related measurements are","confidence":1,"confidence_rate":1},{"cnt":[[305,2174],[969,2174],[969,2224],[305,2224]],"region":{"top_left_x":305,"top_left_y":2174,"width":664,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"531cd2d4ebaf4d048efa074f8a245df5","type":"text","conversion_output":true,"text":"provided in Section 13.5 (Appendix 5).","text_display":" provided in Section 13.5 (Appendix 5).","confidence":0.99951171875,"confidence_rate":0.9999893826542317},{"cnt":[[1753,2462],[1871,2462],[1871,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":119,"height":41},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a703834e17c4245849f1c958f77bbf6","type":"page_info","conversion_output":false,"text":"Page 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Clearance}","confidence":1,"confidence_rate":1},{"cnt":[[307,464],[1695,464],[1695,513],[307,513]],"region":{"top_left_x":307,"top_left_y":464,"width":1389,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c80e02eef323489497854585ecb384dd","type":"text","conversion_output":true,"text":"The efficacy of the treatment will be investigated by calculating the time-corrected","text_display":"\n\nThe efficacy of the treatment will be investigated by calculating the time-corrected","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[307,524],[1815,524],[1815,574],[307,574]],"region":{"top_left_x":307,"top_left_y":524,"width":1509,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15a7eee09d9848c5ba1d76129c1bfaa7","type":"text","conversion_output":true,"text":"endogenous creatinine clearance. Blood urea nitrogen clearance will also be measured. To","text_display":" endogenous creatinine clearance. Blood urea nitrogen clearance will also be measured. To","confidence":1,"confidence_rate":1},{"cnt":[[305,584],[1725,584],[1725,634],[305,634]],"region":{"top_left_x":305,"top_left_y":584,"width":1421,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdbd6ecd32af49da903186fca8f674e9","type":"text","conversion_output":true,"text":"calculate the time-corrected endogenous creatinine clearance, timed urine (including","text_display":" calculate the time-corrected endogenous creatinine clearance, timed urine (including","confidence":1,"confidence_rate":1},{"cnt":[[305,645],[1403,645],[1403,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1098,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"400c85ce07a0481c83e71a934c1ffdd7","type":"text","conversion_output":true,"text":"measurement of volume) and blood samples need to be collected.","text_display":" measurement of volume) and blood samples need to be collected.","confidence":1,"confidence_rate":1},{"cnt":[[305,746],[1854,746],[1854,797],[305,797]],"region":{"top_left_x":305,"top_left_y":745,"width":1550,"height":53},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3990b75214514748920654c533bb41d6","type":"text","conversion_output":true,"text":"Urine and serum creatinine samples will be collected at all visits from baseline to Day 7 and","text_display":"\n\nUrine and serum creatinine samples will be collected at all visits from baseline to Day 7 and","confidence":1,"confidence_rate":1},{"cnt":[[305,804],[1809,804],[1809,857],[305,857]],"region":{"top_left_x":305,"top_left_y":803,"width":1504,"height":55},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c5610893c704c3b8c56a682e97f4773","type":"text","conversion_output":true,"text":"shipped to the central laboratory. Two serum creatinine samples, one right before the start","text_display":" shipped to the central laboratory. Two serum creatinine samples, one right before the start","confidence":1,"confidence_rate":1},{"cnt":[[305,866],[1854,866],[1854,917],[305,917]],"region":{"top_left_x":305,"top_left_y":865,"width":1550,"height":53},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0633f8fb08214f0cbe5d0bf2ffe48f0a","type":"text","conversion_output":true,"text":"and one after the stop of the \\(6 \\pm 1\\) hour urine collections have to be collected. Urine volume,","text_display":" and one after the stop of the \\(6 \\pm 1\\) hour urine collections have to be collected. Urine volume,","confidence":0.998535871389322,"confidence_rate":0.999985348092397},{"cnt":[[305,924],[1820,924],[1820,975],[305,975]],"region":{"top_left_x":305,"top_left_y":923,"width":1515,"height":53},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f7a28f24a85946649d93385dc8465f03","type":"text","conversion_output":true,"text":"urinary creatinine, and the average of two serum creatinine measurements will be used for","text_display":" urinary creatinine, and the average of two serum creatinine measurements will be used for","confidence":1,"confidence_rate":1},{"cnt":[[305,984],[1835,984],[1835,1033],[305,1033]],"region":{"top_left_x":305,"top_left_y":983,"width":1530,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f31b8b427af43858b69873a6a45b484","type":"text","conversion_output":true,"text":"the calculation of time corrected endogenous creatinine clearance at all visits from baseline","text_display":" the calculation of time corrected endogenous creatinine clearance at all visits from baseline","confidence":1,"confidence_rate":1},{"cnt":[[305,1044],[1841,1044],[1841,1096],[305,1096]],"region":{"top_left_x":305,"top_left_y":1044,"width":1537,"height":52},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5160c7264ed1405ea4d57b10e54ad8b5","type":"text","conversion_output":true,"text":"to Day 7, and will be calculated by the central laboratory. The measurements from Day 1 to","text_display":" to Day 7, and will be calculated by the central laboratory. The measurements from Day 1 to","confidence":1,"confidence_rate":1},{"cnt":[[305,1104],[1781,1104],[1781,1154],[305,1154]],"region":{"top_left_x":305,"top_left_y":1104,"width":1477,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd2efa53ae2340fd9cc0d97b19eec655","type":"text","conversion_output":true,"text":"Day 7, inclusive, will be used to calculate endogenous creatinine clearance, the primary","text_display":" Day 7, inclusive, will be used to calculate endogenous creatinine clearance, the primary","confidence":1,"confidence_rate":1},{"cnt":[[305,1164],[1858,1164],[1858,1214],[305,1214]],"region":{"top_left_x":305,"top_left_y":1164,"width":1554,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"295b7599e2ef4954a0d58bfbb783aac6","type":"text","conversion_output":true,"text":"endpoint. Only if reliable urine collection is possible, urine will be collected on Days 14, 21,","text_display":" endpoint. Only if reliable urine collection is possible, urine will be collected on Days 14, 21,","confidence":1,"confidence_rate":1},{"cnt":[[305,1225],[1772,1225],[1772,1274],[305,1274]],"region":{"top_left_x":305,"top_left_y":1224,"width":1468,"height":51},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5477ca2ffc741b5856bb500b8e217e6","type":"text","conversion_output":true,"text":"and 28 for time-corrected endogenous creatinine clearance (i.e., patient is in the ICU or","text_display":" and 28 for time-corrected endogenous creatinine clearance (i.e., patient is in the ICU or","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,1285],[1779,1285],[1779,1334],[305,1334]],"region":{"top_left_x":305,"top_left_y":1284,"width":1474,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd9d766b1f314ed4941fa2b0b30eff41","type":"text","conversion_output":true,"text":"intermediate care unit or hospital). If reliable urine collection is not possible, one serum","text_display":" intermediate care unit or hospital). If reliable urine collection is not possible, one serum","confidence":1,"confidence_rate":1},{"cnt":[[305,1345],[1854,1345],[1854,1394],[305,1394]],"region":{"top_left_x":305,"top_left_y":1344,"width":1550,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0557a98b21141c7939d9719f046b334","type":"text","conversion_output":true,"text":"creatinine sample still needs to be taken for calculating eGFR (see Section 13.1 [Table 13-1]","text_display":" creatinine sample still needs to be taken for calculating eGFR (see Section 13.1 [Table 13-1]","confidence":1,"confidence_rate":1},{"cnt":[[305,1403],[853,1403],[853,1454],[305,1454]],"region":{"top_left_x":305,"top_left_y":1402,"width":548,"height":53},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cca8e53c99e4789b45b6847e74b5664","type":"text","conversion_output":true,"text":"and Section 13.2 [Figure 13-1]).","text_display":" and Section 13.2 [Figure 13-1]).","confidence":1,"confidence_rate":1},{"cnt":[[305,1504],[1742,1504],[1742,1555],[305,1555]],"region":{"top_left_x":305,"top_left_y":1503,"width":1438,"height":53},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"634172a1ef964ed5918d6943b7532fb7","type":"text","conversion_output":true,"text":"Urine must be collected daily for a period of \\(6 \\pm 1\\) hour at baseline and from Day 1 to","text_display":"\n\nUrine must be collected daily for a period of \\(6 \\pm 1\\) hour at baseline and from Day 1 to","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[305,1564],[1876,1564],[1876,1618],[305,1618]],"region":{"top_left_x":305,"top_left_y":1564,"width":1571,"height":54},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4592731191d4424b9c8cc7fd6f25b112","type":"text","conversion_output":true,"text":"Day 7.The collection period will take a minimum of 5 hours, and a maximum of 7 hours. The","text_display":" Day 7.The collection period will take a minimum of 5 hours, and a maximum of 7 hours. The","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[305,1624],[1783,1624],[1783,1676],[305,1676]],"region":{"top_left_x":305,"top_left_y":1624,"width":1479,"height":52},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"86e59b9cb0ce4cd7a3c135f556462b51","type":"text","conversion_output":true,"text":"exact duration of urine collection period and of volume collected will be recorded in the","text_display":" exact duration of urine collection period and of volume collected will be recorded in the","confidence":1,"confidence_rate":1},{"cnt":[[305,1684],[1783,1684],[1783,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1684,"width":1479,"height":55},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d15057e0e644007a7811f133b874ea7","type":"text","conversion_output":true,"text":"eCRF. The volume should be corrected to account for the volume of samples previously","text_display":" eCRF. The volume should be corrected to account for the volume of samples previously","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[305,1745],[1051,1745],[1051,1794],[305,1794]],"region":{"top_left_x":305,"top_left_y":1744,"width":746,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6288aa9a726f4123a5a332f019b4bd95","type":"text","conversion_output":true,"text":"taken from the total urine initially collected.","text_display":" taken from the total urine initially collected.","confidence":1,"confidence_rate":1},{"cnt":[[305,1846],[1528,1846],[1528,1897],[305,1897]],"region":{"top_left_x":305,"top_left_y":1845,"width":1223,"height":53},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05beef601027431a95ae660caedef3a7","type":"text","conversion_output":true,"text":"Endogenous creatinine and BUN clearance will be calculated as follows:","text_display":"\n\nEndogenous creatinine and BUN clearance will be calculated as follows:","confidence":1,"confidence_rate":1},{"cnt":[[449,1946],[1738,1946],[1738,2000],[449,2000]],"region":{"top_left_x":449,"top_left_y":1946,"width":1290,"height":55},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"39961baa544f4d4eae2563e9955d3119","type":"math","conversion_output":true,"text":"\\[\n\\text { clearance }=(\\text { urine volume } \\text { × } \\text { concentration in urine }) / \\text { concentration in serum }\n\\]","text_display":"\n\\[\n\\text { clearance }=(\\text { urine volume } \\text { × } \\text { concentration in urine }) / \\text { concentration in serum }\n\\]","confidence":0.5414213245967403,"confidence_rate":0.9935623111300519},{"cnt":[[305,2050],[1846,2050],[1846,2099],[305,2099]],"region":{"top_left_x":305,"top_left_y":2049,"width":1541,"height":51},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ef42f3e6cc947f68450d6fbff7c0045","type":"text","conversion_output":true,"text":"Note: when patients during the study leave the ICU or intermediate care unit, but are still in","text_display":"\n\nNote: when patients during the study leave the ICU or intermediate care unit, but are still in","confidence":1,"confidence_rate":1},{"cnt":[[305,2110],[1790,2110],[1790,2159],[305,2159]],"region":{"top_left_x":305,"top_left_y":2109,"width":1485,"height":51},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0ca99c928a54d01af356e90028f594b","type":"text","conversion_output":true,"text":"the hospital, attempts should be made to continue with the 6-hour urine collection. If the","text_display":" the hospital, attempts should be made to continue with the 6-hour urine collection. If the","confidence":0.98046875,"confidence_rate":0.9997923951807817},{"cnt":[[305,2170],[1790,2170],[1790,2219],[305,2219]],"region":{"top_left_x":305,"top_left_y":2169,"width":1485,"height":51},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"09ff745779734f57b1a34f0754eef50c","type":"text","conversion_output":true,"text":"patient is discharged from the ICU or intermediate care unit, the Foley catheter might be","text_display":" patient is discharged from the ICU or intermediate care unit, the Foley catheter might be","confidence":1,"confidence_rate":1},{"cnt":[[305,2230],[1729,2230],[1729,2279],[305,2279]],"region":{"top_left_x":305,"top_left_y":2230,"width":1425,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d4dc62a1213447f9ec797b4490de9d2","type":"text","conversion_output":true,"text":"removed. In this case, a patient might urinate spontaneously and all efforts should be","text_display":" removed. 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The urine","text_display":"\nurine will be used for analysis, a blood sample will be drawn at this time too. The urine","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[309,434],[1790,434],[1790,483],[309,483]],"region":{"top_left_x":309,"top_left_y":433,"width":1481,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7033122b827c4be8a7b38806fc6b9895","type":"text","conversion_output":true,"text":"volume produced over the last approximately 6 hours will be entered in the eCRF. When","text_display":" volume produced over the last approximately 6 hours will be entered in the eCRF. 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Alkaline","text_display":"\n\nAlkaline phosphatase activity will only be measured at baseline (pre-dose). 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baseline","confidence":0.99560546875,"confidence_rate":0.9999531477403147},{"cnt":[[309,793],[1760,793],[1760,844],[309,844]],"region":{"top_left_x":309,"top_left_y":792,"width":1451,"height":53},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ff07372542145d283e0f0013bf59f1e","type":"text","conversion_output":true,"text":"and on Days 14 and 28 (see Section 13.1 [Table 13-1] and Section 13.2 [Figure 13-1]).","text_display":" and on Days 14 and 28 (see Section 13.1 [Table 13-1] and Section 13.2 [Figure 13-1]).","confidence":1,"confidence_rate":1},{"cnt":[[309,896],[1854,896],[1854,943],[309,943]],"region":{"top_left_x":309,"top_left_y":895,"width":1546,"height":49},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91ca21ec7cfc40afa934b4da1053f231","type":"text","conversion_output":true,"text":"Blood samples for anti-drug antibodies assessment will be taken at baseline and on Days 14,","text_display":"\n\nBlood samples 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In addition, at","text_display":" assess correlation of GFR and calculated endogenous creatinine clearance. In addition, at","confidence":1,"confidence_rate":1},{"cnt":[[309,1480],[1863,1480],[1863,1528],[309,1528]],"region":{"top_left_x":309,"top_left_y":1480,"width":1554,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"740bf99e35a84e8dbb73a24167e27d54","type":"text","conversion_output":true,"text":"these sites samples from the effluent from patients on RRT will be taken to assess exogenous","text_display":" these sites samples from the effluent from patients on RRT will be taken to assess exogenous","confidence":1,"confidence_rate":1},{"cnt":[[309,1538],[1871,1538],[1871,1588],[309,1588]],"region":{"top_left_x":309,"top_left_y":1538,"width":1563,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22834e757e5d43e3914aed671a6cf02d","type":"text","conversion_output":true,"text":"(machine) creatinine clearance. Detailed instructions to these sites for iohexol and exogenous","text_display":" (machine) creatinine clearance. Detailed instructions to these sites for iohexol and exogenous","confidence":1,"confidence_rate":1},{"cnt":[[309,1598],[1139,1598],[1139,1648],[309,1648]],"region":{"top_left_x":309,"top_left_y":1598,"width":830,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc189f423e6b4bce9d615e001ff6c85c","type":"text","conversion_output":true,"text":"creatinine clearance are provided in Section 13.5.","text_display":" creatinine clearance are provided in Section 13.5.","confidence":0.99951171875,"confidence_rate":0.9999911200303706},{"cnt":[[305,1702],[1059,1702],[1059,1762],[305,1762]],"region":{"top_left_x":305,"top_left_y":1701,"width":755,"height":61},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8e50691a7bc482a9c6797b3bb50d7b4","type":"section_header","conversion_output":false,"children_ids":["96c557ce4bc64ad3bd77fd10234d4c14"],"text":"","text_display":""},{"cnt":[[309,1706],[1057,1706],[1057,1757],[309,1757]],"region":{"top_left_x":309,"top_left_y":1705,"width":749,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96c557ce4bc64ad3bd77fd10234d4c14","type":"text","conversion_output":true,"parent_id":"f8e50691a7bc482a9c6797b3bb50d7b4","text":"6.3.9 Renal Replacement Therapy","text_display":"\n\n\\subsection*{6.3.9 Renal Replacement Therapy}","confidence":1,"confidence_rate":1},{"cnt":[[309,1792],[1837,1792],[1837,1841],[309,1841]],"region":{"top_left_x":309,"top_left_y":1791,"width":1528,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d19eb0c9c8964fd2b3427e8ab6428b0f","type":"text","conversion_output":true,"text":"From Day 1 to Day 7 only continuous modalities of RRT are allowed. From Day 8 onward,","text_display":"\n\nFrom Day 1 to Day 7 only continuous modalities of RRT are allowed. From Day 8 onward,","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[309,1852],[1745,1852],[1745,1901],[309,1901]],"region":{"top_left_x":309,"top_left_y":1851,"width":1436,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d5253111df24e4989946cdc381fd8cc","type":"text","conversion_output":true,"text":"intermittent/non-continuous modalities such as intermittent hemodialysis are allowed.","text_display":" intermittent/non-continuous modalities such as intermittent hemodialysis are allowed.","confidence":1,"confidence_rate":1},{"cnt":[[309,1934],[1803,1934],[1803,1981],[309,1981]],"region":{"top_left_x":309,"top_left_y":1933,"width":1494,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"420c7bf1f01246549b9bbb95a7924680","type":"text","conversion_output":true,"text":"Initiation of RRT: Initiation of RRT should be based on the criteria described by Bellomo","text_display":"\n\nInitiation of RRT: Initiation of RRT should be based on the criteria described by Bellomo","confidence":0.9638671875,"confidence_rate":0.9996085684786136},{"cnt":[[309,1994],[518,1994],[518,2039],[309,2039]],"region":{"top_left_x":309,"top_left_y":1993,"width":209,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38670583b6de4abf9b930311026085be","type":"text","conversion_output":true,"text":"et al (2012).","text_display":" et al (2012).","confidence":1,"confidence_rate":1},{"cnt":[[309,2075],[1824,2075],[1824,2121],[309,2121]],"region":{"top_left_x":309,"top_left_y":2075,"width":1516,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c5e22bea1a04580b18ee983340540fe","type":"text","conversion_output":true,"text":"Meeting at least one criterion of the below makes the patient eligible for initiation of RRT:","text_display":"\n\nMeeting at least one criterion of the below makes the patient eligible for initiation of RRT:","confidence":1,"confidence_rate":1},{"cnt":[[329,2127],[1119,2127],[1119,2176],[329,2176]],"region":{"top_left_x":328,"top_left_y":2126,"width":792,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6606fd643a3145de92bf74595d126fa4","type":"text","conversion_output":true,"text":"1. Anuria (negligible urine output for 6 hours)","text_display":"\n1. Anuria (negligible urine output for 6 hours)","confidence":1,"confidence_rate":1},{"cnt":[[322,2183],[1300,2183],[1300,2232],[322,2232]],"region":{"top_left_x":322,"top_left_y":2182,"width":978,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3969314b7e54b6dab1a2ab5588d21d6","type":"text","conversion_output":true,"text":"2. Severe oliguria (urine output \\(<200 mL\\) over 12 hours)","text_display":"\n2. Severe oliguria (urine output \\(<200 mL\\) over 12 hours)","confidence":0.99853515625,"confidence_rate":0.9999784426193857},{"cnt":[[322,2239],[1330,2239],[1330,2288],[322,2288]],"region":{"top_left_x":322,"top_left_y":2238,"width":1008,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ecc05bff8a3476986ed4a0d8334e963","type":"text","conversion_output":true,"text":"3. Hyperkalemia (potassium concentrations \\(>6.5 mmol / L\\) )","text_display":"\n3. Hyperkalemia (potassium concentrations \\(>6.5 mmol / L\\) )","confidence":1,"confidence_rate":1},{"cnt":[[322,2295],[1807,2295],[1807,2340],[322,2340]],"region":{"top_left_x":322,"top_left_y":2294,"width":1485,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56e0578757fb4597b4b4a364b86fc1eb","type":"text","conversion_output":true,"text":"4. Severe metabolic acidosis ( \\(pH <7.2\\) despite normal or low partial pressure of carbon","text_display":"\n4. Severe metabolic acidosis ( \\(pH <7.2\\) despite normal or low partial pressure of carbon","confidence":0.9951171875,"confidence_rate":0.9999495397022695},{"cnt":[[387,2342],[810,2342],[810,2387],[387,2387]],"region":{"top_left_x":386,"top_left_y":2341,"width":424,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a55bd1ba80a4916985c3fff7201d655","type":"text","conversion_output":true,"text":"dioxide in arterial blood)","text_display":" dioxide in arterial blood)","confidence":1,"confidence_rate":1},{"cnt":[[1753,2462],[1871,2462],[1871,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":119,"height":41},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d249c1d0e2f4494580332fdadd865ac2","type":"page_info","conversion_output":false,"text":"Page 64","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-065","page":65,"lines":[{"cnt":[[309,254],[556,254],[556,286],[309,286]],"region":{"top_left_x":309,"top_left_y":253,"width":248,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ae04366c7eb4652a85e50bab10debba","type":"page_info","conversion_output":false,"text":"AM-Pharma B.V.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1371,254],[1863,254],[1863,294],[1371,294]],"region":{"top_left_x":1370,"top_left_y":253,"width":493,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24dd3fb6645e42c9ab49c226d0a533d7","type":"page_info","conversion_output":false,"text":"Recombinant alkaline phosphatase","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[621,314],[621,350],[309,350]],"region":{"top_left_x":309,"top_left_y":313,"width":312,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9831fbca997e444d99cbfe52d93b177c","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,314],[1863,314],[1863,350],[1573,350]],"region":{"top_left_x":1572,"top_left_y":313,"width":291,"height":38},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"668820d719404f8595bd0848ed76c1c3","type":"page_info","conversion_output":false,"text":"Protocol Version 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[322,374],[1620,374],[1620,423],[322,423]],"region":{"top_left_x":322,"top_left_y":373,"width":1298,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5c101ed08754a07a48a95f68150246b","type":"text","conversion_output":true,"text":"5. Volume overload (especially pulmonary edema unresponsive to diuretics)","text_display":"\n5. Volume overload (especially pulmonary edema unresponsive to diuretics)","confidence":1,"confidence_rate":1},{"cnt":[[322,425],[1807,425],[1807,475],[322,475]],"region":{"top_left_x":322,"top_left_y":425,"width":1485,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39f0a5ed5d57423d9796c311f0dbab89","type":"text","conversion_output":true,"text":"6. Pronounced azotemia (urea concentrations \\(>30 mmol / L\\) or creatinine concentrations","text_display":"\n6. Pronounced azotemia (urea concentrations \\(>30 mmol / L\\) or creatinine concentrations","confidence":1,"confidence_rate":1},{"cnt":[[385,477],[642,477],[642,524],[385,524]],"region":{"top_left_x":384,"top_left_y":476,"width":259,"height":49},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0cb44deccccb4e288fadd241030e1d20","type":"text","conversion_output":true,"text":"\\(>300 \\mu mol / L )\\)","text_display":" \\(>300 \\mu mol / L )\\)","confidence":0.76611328125,"confidence_rate":0.9844500953339491},{"cnt":[[322,529],[1738,529],[1738,582],[322,582]],"region":{"top_left_x":322,"top_left_y":528,"width":1417,"height":55},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5ff0e781971402080aa7623a0e6bf33","type":"text","conversion_output":true,"text":"7. Clinical complications of uremia (e.g., encephalopathy, pericarditis, neuropathy)","text_display":"\n7. Clinical complications of uremia (e.g., encephalopathy, pericarditis, neuropathy)","confidence":1,"confidence_rate":1},{"cnt":[[305,621],[1848,619],[1848,672],[305,675]],"region":{"top_left_x":305,"top_left_y":618,"width":1543,"height":57},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"238bb01c5b124a08a17b90a78af5fc08","type":"text","conversion_output":true,"text":"Timing of Stopping RRT: Termination of dialysis is based on criteria as used in the VA/NIH","text_display":"\n\nTiming of Stopping RRT: Termination of dialysis is based on criteria as used in the VA/NIH","confidence":1,"confidence_rate":1},{"cnt":[[305,679],[1768,679],[1768,730],[305,730]],"region":{"top_left_x":305,"top_left_y":678,"width":1464,"height":53},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac613d6d77a041e7a1ec1f792db7e0bf","type":"text","conversion_output":true,"text":"Acute Renal Failure Trial Network Study (VA/NIH Acute Renal Failure Trial Network,","text_display":" Acute Renal Failure Trial Network Study (VA/NIH Acute Renal Failure Trial Network,","confidence":1,"confidence_rate":1},{"cnt":[[305,739],[1794,739],[1794,793],[305,793]],"region":{"top_left_x":305,"top_left_y":739,"width":1489,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2c2741fe9064ceabba8b7f05b0084cc","type":"text","conversion_output":true,"text":"2008). If (on continuous renal replacement therapy or between intermittent hemodialysis","text_display":" 2008). If (on continuous renal replacement therapy or between intermittent hemodialysis","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[305,799],[1863,799],[1863,851],[305,851]],"region":{"top_left_x":305,"top_left_y":799,"width":1558,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"202e1830dc0b4f64a165fb37f6bc04f3","type":"text","conversion_output":true,"text":"sessions) diuresis \\(>30 mL /\\) hour and there are no other indications for RRT, then endogenous","text_display":" sessions) diuresis \\(>30 mL /\\) hour and there are no other indications for RRT, then endogenous","confidence":0.9936552047729492,"confidence_rate":0.9999369820947502},{"cnt":[[305,862],[1693,859],[1693,913],[305,915]],"region":{"top_left_x":305,"top_left_y":859,"width":1389,"height":57},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09cb3f4a64964fa5a363f80011ef1e0d","type":"text","conversion_output":true,"text":"creatinine clearance should be calculated using a 6-hour urine collection period. If","text_display":" creatinine clearance should be calculated using a 6-hour urine collection period. If","confidence":0.98828125,"confidence_rate":0.9998675598299396},{"cnt":[[305,920],[1841,920],[1841,971],[305,971]],"region":{"top_left_x":305,"top_left_y":919,"width":1537,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36f706caca1b4f00bd06dd13b49e53b7","type":"text","conversion_output":true,"text":"endogenous creatinine clearance \\(\\geq 20 mL / min\\), RRT should be discontinued. If endogenous","text_display":" endogenous creatinine clearance \\(\\geq 20 mL / min\\), RRT should be discontinued. If endogenous","confidence":1,"confidence_rate":1},{"cnt":[[305,980],[1755,980],[1755,1029],[305,1029]],"region":{"top_left_x":305,"top_left_y":979,"width":1451,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8c28a1cb36942f984b9a260ff0c9e9e","type":"text","conversion_output":true,"text":"creatinine clearance \\(\\leq 12 mL / min\\), RRT should be continued. If endogenous creatinine","text_display":" creatinine clearance \\(\\leq 12 mL / min\\), RRT should be continued. If endogenous creatinine","confidence":1,"confidence_rate":1},{"cnt":[[305,1040],[1867,1040],[1867,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1562,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33b43e174c7242178c3a16d0708a3a86","type":"text","conversion_output":true,"text":"clearance \\(>12 mL / min\\) and \\(<20 mL / min\\), continuation or termination will be the decision of","text_display":" clearance \\(>12 mL / min\\) and \\(<20 mL / min\\), continuation or termination will be the decision of","confidence":0.7633834183216095,"confidence_rate":0.9975485110941168},{"cnt":[[305,1100],[1729,1100],[1729,1149],[305,1149]],"region":{"top_left_x":305,"top_left_y":1100,"width":1425,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d64912f0b394bd388cce1d97c59aff3","type":"text","conversion_output":true,"text":"the treating physician. Exact criterion or criteria, corresponding values (e.g., sodium,","text_display":" the treating physician. Exact criterion or criteria, corresponding values (e.g., sodium,","confidence":1,"confidence_rate":1},{"cnt":[[305,1160],[1858,1160],[1858,1212],[305,1212]],"region":{"top_left_x":305,"top_left_y":1160,"width":1554,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ffed20bcaed4cadaa7784eb98174db2","type":"text","conversion_output":true,"text":"potassium, or pH ) and deviations (e.g., RRT not started when indicated or RRT started when","text_display":" potassium, or pH ) and deviations (e.g., RRT not started when indicated or RRT started when","confidence":0.95654296875,"confidence_rate":0.9995645108508323},{"cnt":[[305,1220],[1330,1220],[1330,1270],[305,1270]],"region":{"top_left_x":305,"top_left_y":1220,"width":1025,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dcaff151dd14855b57a372fe8be625c","type":"text","conversion_output":true,"text":"not indicated) need to be meticulously recorded in the eCRF.","text_display":" not indicated) need to be meticulously recorded in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[305,1302],[1749,1302],[1749,1351],[305,1351]],"region":{"top_left_x":305,"top_left_y":1301,"width":1444,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1da74664144941088a767754585f2169","type":"text","conversion_output":true,"text":"However, although the criteria for starting and stopping mentioned above are strongly","text_display":"\n\nHowever, although the criteria for starting and stopping mentioned above are strongly","confidence":1,"confidence_rate":1},{"cnt":[[305,1362],[1824,1362],[1824,1412],[305,1412]],"region":{"top_left_x":305,"top_left_y":1362,"width":1520,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"740172ce176d40d6bb9bf5898aac5854","type":"text","conversion_output":true,"text":"preferred within the protocol setting, based on clinical judgment investigators may deviate","text_display":" preferred within the protocol setting, based on clinical judgment investigators may deviate","confidence":1,"confidence_rate":1},{"cnt":[[305,1420],[1841,1420],[1841,1472],[305,1472]],"region":{"top_left_x":305,"top_left_y":1420,"width":1537,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94a7bc32e1774416ab8f109de5ecc3b8","type":"text","conversion_output":true,"text":"from these criteria. For example, several individual criteria might just not meet the required","text_display":" from these criteria. For example, several individual criteria might just not meet the required","confidence":1,"confidence_rate":1},{"cnt":[[305,1480],[1828,1480],[1828,1532],[305,1532]],"region":{"top_left_x":305,"top_left_y":1480,"width":1524,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"072c0c8cc4434cec87e1f70f8e11a8f2","type":"text","conversion_output":true,"text":"threshold, but together could provide a valid clinical reason to start RRT. It is also possible","text_display":" threshold, but together could provide a valid clinical reason to start RRT. It is also possible","confidence":1,"confidence_rate":1},{"cnt":[[305,1538],[1854,1538],[1854,1592],[305,1592]],"region":{"top_left_x":305,"top_left_y":1538,"width":1550,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d4e5091d8cc4bdaa95b9554d84fe121","type":"text","conversion_output":true,"text":"that an investigator decides not to initiate RRT based on clinical judgment, although starting","text_display":" that an investigator decides not to initiate RRT based on clinical judgment, although starting","confidence":1,"confidence_rate":1},{"cnt":[[305,1598],[1869,1598],[1869,1652],[305,1652]],"region":{"top_left_x":305,"top_left_y":1598,"width":1565,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76fc43c3584a4fb6894286f6fb936754","type":"text","conversion_output":true,"text":"criteria might be met. When RRT is initiated despite not meeting criteria, or when RRT is not","text_display":" criteria might be met. 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Similarly, deviations from the protocol-defined","text_display":" decision should be provided in the eCRF. Similarly, deviations from the protocol-defined","confidence":1,"confidence_rate":1},{"cnt":[[305,1779],[1876,1779],[1876,1833],[305,1833]],"region":{"top_left_x":305,"top_left_y":1778,"width":1571,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c6954e7ed834931b43aa10693d849f2","type":"text","conversion_output":true,"text":"stopping criteria, should be recorded in the CRF, together with the reason for the deviation. A","text_display":" stopping criteria, should be recorded in the CRF, together with the reason for the deviation. 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If modes of mechanical ventilation are changed (e.g.","text_display":" mechanical ventilation is needed. 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inotropic","confidence":1,"confidence_rate":1},{"cnt":[[309,967],[952,967],[952,1016],[309,1016]],"region":{"top_left_x":309,"top_left_y":966,"width":643,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27680370a10d4212aed4534a74bbbab1","type":"text","conversion_output":true,"text":"agents or vasopressors - day and hour","text_display":" agents or vasopressors - day and hour","confidence":1,"confidence_rate":1},{"cnt":[[309,1070],[1837,1070],[1837,1115],[309,1115]],"region":{"top_left_x":309,"top_left_y":1069,"width":1528,"height":47},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf2ca5b4bb094ef4a4abd22bd300b580","type":"text","conversion_output":true,"text":"Length of ICU or intermediate care unit stay: the admission date and planned and actual","text_display":"\n\nLength of ICU or intermediate care unit stay: the admission date and planned and actual","confidence":1,"confidence_rate":1},{"cnt":[[309,1130],[1072,1130],[1072,1175],[309,1175]],"region":{"top_left_x":309,"top_left_y":1130,"width":764,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77bde59dcd004254a0faa4ae86c15edb","type":"text","conversion_output":true,"text":"discharge date of the patient will be recorded.","text_display":" discharge date of the patient will be recorded.","confidence":1,"confidence_rate":1},{"cnt":[[309,1229],[1803,1229],[1803,1278],[309,1278]],"region":{"top_left_x":309,"top_left_y":1228,"width":1494,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1ca18e7ae9d4ce2a79e8bb93ae4c738","type":"text","conversion_output":true,"text":"Length of hospital stay: the admission date and planned and actual discharge date of the","text_display":"\n\nLength of hospital stay: the admission date and planned and actual discharge date of 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Reason for hospitalization will also be recorded.","text_display":" patient will be recorded. 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Events}","confidence":1,"confidence_rate":1},{"cnt":[[309,1482],[1811,1482],[1811,1532],[309,1532]],"region":{"top_left_x":309,"top_left_y":1482,"width":1503,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a3cfc6ea58743579855f568de55afb6","type":"text","conversion_output":true,"text":"The investigator is responsible for reporting all treatment-emergent AEs (TEAEs) that are","text_display":"\n\nThe investigator is responsible for reporting all treatment-emergent AEs (TEAEs) that are","confidence":0.9951171875,"confidence_rate":0.9999479293091645},{"cnt":[[309,1543],[1830,1543],[1830,1592],[309,1592]],"region":{"top_left_x":309,"top_left_y":1542,"width":1522,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4caea0e8ae34a878fc7e05e9d1b43c7","type":"text","conversion_output":true,"text":"observed or reported during the study, regardless of their relationship to study drug or their","text_display":" observed or reported during the study, regardless of their relationship to study drug or their","confidence":1,"confidence_rate":1},{"cnt":[[309,1603],[657,1603],[657,1652],[309,1652]],"region":{"top_left_x":309,"top_left_y":1602,"width":349,"height":51},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8bfd4b1c655b44ef95a1c4178a13aeea","type":"text","conversion_output":true,"text":"clinical significance.","text_display":" clinical 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Medical and scientific judgment should be exercised in deciding whether","text_display":" in this definition. 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In case study","text_display":" first 3 days of the study) if it is considered in the best interest of the patient. In case study","confidence":1,"confidence_rate":1},{"cnt":[[307,1033],[1858,1033],[1858,1085],[307,1085]],"region":{"top_left_x":307,"top_left_y":1033,"width":1552,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"894d9dd3b1294488925880897dd050bb","type":"text","conversion_output":true,"text":"drug is discontinued early, the patient will continue follow-up in the study as per protocol. If","text_display":" drug is discontinued early, the patient will continue follow-up in the study as per protocol. 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Any AE","text_display":" Day 28 visit for all AEs (including SAEs) regardless of its relationship to study drug. 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At follow-up visits, they will also be asked if","text_display":" medically related changes in their well-being. At follow-up visits, they will also be asked if","confidence":1,"confidence_rate":1},{"cnt":[[305,1908],[1807,1908],[1807,1957],[305,1957]],"region":{"top_left_x":305,"top_left_y":1907,"width":1502,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97221b3ba1e248728e24e740149f9634","type":"text","conversion_output":true,"text":"they have been admitted to the hospital, had any accidents, used any new medications, or","text_display":" they have been admitted to the hospital, had any accidents, used any new medications, or","confidence":1,"confidence_rate":1},{"cnt":[[305,1968],[1040,1968],[1040,2017],[305,2017]],"region":{"top_left_x":305,"top_left_y":1967,"width":735,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78e652fcee044eadbb7c3ab6bcabacf5","type":"text","conversion_output":true,"text":"changed concomitant medication regimens.","text_display":" changed concomitant medication 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Information to be collected includes event term, time","text_display":" recorded on the AE page of the eCRF. Information to be collected includes event term, time","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[309,808],[1858,808],[1858,853],[309,853]],"region":{"top_left_x":309,"top_left_y":807,"width":1550,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0671affcb04648a2ab0847e940a4e285","type":"text","conversion_output":true,"text":"of onset, investigator-specified assessment of severity and relationship to study drug, date of","text_display":" of onset, investigator-specified assessment of severity and relationship to study drug, date of","confidence":1,"confidence_rate":1},{"cnt":[[309,868],[1785,868],[1785,913],[309,913]],"region":{"top_left_x":309,"top_left_y":867,"width":1477,"height":47},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de7880c38bfb4b14b4dd69d90d4efcf4","type":"text","conversion_output":true,"text":"resolution of the event, seriousness, any required treatment or evaluations, and outcome.","text_display":" resolution of the event, seriousness, any required treatment or evaluations, and outcome.","confidence":1,"confidence_rate":1},{"cnt":[[309,928],[1723,928],[1723,973],[309,973]],"region":{"top_left_x":309,"top_left_y":928,"width":1415,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10f555c368c445e895bdd92c37b41ffc","type":"text","conversion_output":true,"text":"Adverse events resulting from concurrent illnesses, reactions to concurrent illnesses,","text_display":" Adverse events resulting from concurrent illnesses, reactions to concurrent illnesses,","confidence":1,"confidence_rate":1},{"cnt":[[309,988],[1824,988],[1824,1033],[309,1033]],"region":{"top_left_x":309,"top_left_y":988,"width":1516,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7419c627c2ef41b08e561aded95580b8","type":"text","conversion_output":true,"text":"reactions to concurrent medications, or progression of disease states must also be reported.","text_display":" reactions to concurrent medications, or progression of disease states must also be reported.","confidence":1,"confidence_rate":1},{"cnt":[[309,1044],[1785,1044],[1785,1094],[309,1094]],"region":{"top_left_x":309,"top_left_y":1044,"width":1477,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16e06fd94a6d4b979665110f400a57d0","type":"text","conversion_output":true,"text":"All AEs will be followed to adequate resolution. The Medical Dictionary for Regulatory","text_display":" All AEs will be followed to adequate resolution. 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As per the International Council for Harmonisation","text_display":" time of completion of the eCRF. 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clinical experience,","confidence":1,"confidence_rate":1},{"cnt":[[535,1051],[1729,1051],[1729,1098],[535,1098]],"region":{"top_left_x":534,"top_left_y":1050,"width":1196,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ec6daa7d76045ff8ebb496438ede225","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":[[535,1096],[1798,1096],[1798,1145],[535,1145]],"region":{"top_left_x":534,"top_left_y":1095,"width":1265,"height":51},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05e14b0b841e4ff691123974fbdb7c3a","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":[[309,1160],[1878,1160],[1878,1210],[309,1210]],"region":{"top_left_x":309,"top_left_y":1160,"width":1569,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6addb60bfacd412aa9f22cb9daff0489","type":"text","conversion_output":true,"text":"Definite: This relationship suggests that a definite causal relationship exists between drug","text_display":"\n\nDefinite: This relationship suggests that a definite causal relationship exists between drug","confidence":1,"confidence_rate":1},{"cnt":[[535,1207],[1669,1207],[1669,1257],[535,1257]],"region":{"top_left_x":534,"top_left_y":1207,"width":1136,"height":50},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"63a0e7751e254cd9a15b8c6b9f628d04","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":[[535,1255],[1841,1255],[1841,1304],[535,1304]],"region":{"top_left_x":534,"top_left_y":1254,"width":1308,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc1ef6cc943d4a27be235250a17dec76","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":[[535,1302],[1803,1302],[1803,1351],[535,1351]],"region":{"top_left_x":534,"top_left_y":1301,"width":1269,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8ff2f0074a943cd8917e05e3041bebc","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":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[535,1354],[939,1354],[939,1399],[535,1399]],"region":{"top_left_x":534,"top_left_y":1353,"width":405,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"904077432d604ff79c5fae3db7ce7055","type":"text","conversion_output":true,"text":"drug is re-administered.","text_display":" drug is re-administered.","confidence":1,"confidence_rate":1},{"cnt":[[305,1427],[1534,1427],[1534,1487],[305,1487]],"region":{"top_left_x":305,"top_left_y":1426,"width":1229,"height":61},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a67fcdb6f1d4d9385ff025eb4b717d5","type":"section_header","conversion_output":false,"children_ids":["8d7f9182502e4e51810694b2486a89ad"],"text":"","text_display":""},{"cnt":[[309,1431],[1532,1431],[1532,1485],[309,1485]],"region":{"top_left_x":309,"top_left_y":1430,"width":1223,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d7f9182502e4e51810694b2486a89ad","type":"text","conversion_output":true,"parent_id":"7a67fcdb6f1d4d9385ff025eb4b717d5","text":"6.3.14.6 Follow-up of Patients Reporting Adverse Events","text_display":"\n\n\\subsection*{6.3.14.6 Follow-up of Patients Reporting Adverse Events}","confidence":1,"confidence_rate":1},{"cnt":[[309,1517],[1772,1517],[1772,1566],[309,1566]],"region":{"top_left_x":309,"top_left_y":1516,"width":1464,"height":51},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0b0ea9886e64c8f97b9f6a2a2a473fa","type":"text","conversion_output":true,"text":"All AEs must be reported in detail on the appropriate page of the eCRF and followed to","text_display":"\n\nAll AEs must be reported in detail on the appropriate page of the eCRF and followed to","confidence":1,"confidence_rate":1},{"cnt":[[309,1577],[1833,1577],[1833,1626],[309,1626]],"region":{"top_left_x":309,"top_left_y":1576,"width":1524,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3df9cd8119545aca5c22d38d198e509","type":"text","conversion_output":true,"text":"satisfactory resolution, until the investigator deems the event to be chronic or not clinically","text_display":" satisfactory resolution, until the investigator deems the event to be chronic or not clinically","confidence":1,"confidence_rate":1},{"cnt":[[309,1637],[1712,1637],[1712,1687],[309,1687]],"region":{"top_left_x":309,"top_left_y":1637,"width":1404,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aff0b0de1a9d4f6ca592143b495b8f0e","type":"text","conversion_output":true,"text":"significant, until the patient is considered to be stable or subject is lost to follow-up.","text_display":" significant, until the patient is considered to be stable or subject is lost to follow-up.","confidence":1,"confidence_rate":1},{"cnt":[[305,1740],[638,1740],[638,1798],[305,1798]],"region":{"top_left_x":305,"top_left_y":1740,"width":334,"height":59},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5717279a457c4c68b298a9cb8551d5c3","type":"section_header","conversion_output":false,"children_ids":["1f48703726b1441fb5b6f8b07fd19ae1"],"text":"","text_display":""},{"cnt":[[309,1742],[634,1742],[634,1794],[309,1794]],"region":{"top_left_x":309,"top_left_y":1742,"width":325,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f48703726b1441fb5b6f8b07fd19ae1","type":"text","conversion_output":true,"parent_id":"5717279a457c4c68b298a9cb8551d5c3","text":"6.4 Pregnancy","text_display":"\n\n\\subsection*{6.4 Pregnancy}","confidence":1,"confidence_rate":1},{"cnt":[[309,1830],[1850,1830],[1850,1878],[309,1878]],"region":{"top_left_x":309,"top_left_y":1830,"width":1541,"height":48},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77c5a10d9d0f48d3a3aa50ecd0d42e58","type":"text","conversion_output":true,"text":"The effect of recAP on pregnancies or infants is not known, as the safety of this drug during","text_display":"\n\nThe effect of recAP on pregnancies or infants is not known, as the safety of this drug during","confidence":0.99853515625,"confidence_rate":0.9999850417681765},{"cnt":[[309,1891],[1869,1891],[1869,1938],[309,1938]],"region":{"top_left_x":309,"top_left_y":1890,"width":1561,"height":48},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a70d66285984346bc04a7fe38dfc4cc","type":"text","conversion_output":true,"text":"pregnancy has not been tested previously in either human or in animal studies. Because AP is","text_display":" pregnancy has not been tested previously in either human or in animal studies. Because AP is","confidence":1,"confidence_rate":1},{"cnt":[[309,1951],[1807,1951],[1807,2000],[309,2000]],"region":{"top_left_x":309,"top_left_y":1950,"width":1498,"height":51},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d3020a97b104b22a5e243ed524ac210","type":"text","conversion_output":true,"text":"present in the human placenta it is theoretically possible that anti-placental antibodies are","text_display":" present in the human placenta it is theoretically possible that anti-placental antibodies are","confidence":1,"confidence_rate":1},{"cnt":[[309,2011],[1863,2011],[1863,2058],[309,2058]],"region":{"top_left_x":309,"top_left_y":2010,"width":1554,"height":49},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a58a6eb43b1f41f4b711a8b1c978d253","type":"text","conversion_output":true,"text":"developed after receiving study drug. Such antibodies could interfere with the ability to have","text_display":" developed after receiving study drug. Such antibodies could interfere with the ability to have","confidence":1,"confidence_rate":1},{"cnt":[[309,2071],[1861,2071],[1861,2116],[309,2116]],"region":{"top_left_x":309,"top_left_y":2071,"width":1552,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02c1e8e8c7e8443994d4c6a334fdfeca","type":"text","conversion_output":true,"text":"a successful pregnancy. While development of anti-drug antibodies has not been seen to date","text_display":" a successful pregnancy. While development of anti-drug antibodies has not been seen to date","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[309,2127],[1785,2127],[1785,2179],[309,2179]],"region":{"top_left_x":309,"top_left_y":2126,"width":1477,"height":53},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fe8d33bab5e4213b8e473a3c21a7337","type":"text","conversion_output":true,"text":"in human studies, the safety experience with this drug is limited to only 37 subjects who","text_display":" in human studies, the safety experience with this drug is limited to only 37 subjects who","confidence":1,"confidence_rate":1},{"cnt":[[309,2187],[1712,2187],[1712,2237],[309,2237]],"region":{"top_left_x":309,"top_left_y":2187,"width":1404,"height":50},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"713e1981e423442b9a54c2234e69245a","type":"text","conversion_output":true,"text":"received study drug and no data are available regarding effect of the drug on human","text_display":" received study drug and no data are available regarding effect of the drug on human","confidence":1,"confidence_rate":1},{"cnt":[[309,2247],[537,2247],[537,2297],[309,2297]],"region":{"top_left_x":309,"top_left_y":2247,"width":229,"height":50},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2bb370f54b0a4b529f75c1ba1079d30f","type":"text","conversion_output":true,"text":"reproduction.","text_display":" reproduction.","confidence":1,"confidence_rate":1},{"cnt":[[1753,2462],[1871,2462],[1871,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":119,"height":41},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a66cf242b10d4e85b7a09bb1c52f8e58","type":"page_info","conversion_output":false,"text":"Page 72","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-073","page":73,"lines":[{"cnt":[[309,254],[556,254],[556,286],[309,286]],"region":{"top_left_x":309,"top_left_y":253,"width":248,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2470b66cbe014eecafdc2ada9fed7ce2","type":"page_info","conversion_output":false,"text":"AM-Pharma B.V.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1375,254],[1863,254],[1863,294],[1375,294]],"region":{"top_left_x":1375,"top_left_y":253,"width":488,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1fa20b4cba4941ad80817d1568471696","type":"page_info","conversion_output":false,"text":"Recombinant alkaline phosphatase","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[621,314],[621,346],[309,346]],"region":{"top_left_x":309,"top_left_y":313,"width":312,"height":33},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"261e703f85c04851af6a9614ef2ec5c6","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999575209175736},{"cnt":[[1573,314],[1863,314],[1863,346],[1573,346]],"region":{"top_left_x":1572,"top_left_y":313,"width":291,"height":33},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa27358cb3ec4d3fa7505f5f55db15b2","type":"page_info","conversion_output":false,"text":"Protocol Version 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,374],[1876,374],[1876,423],[309,423]],"region":{"top_left_x":309,"top_left_y":373,"width":1567,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb31f1bb85754fca9093ad3040175182","type":"text","conversion_output":true,"text":"Therefore, female patients who are pregnant or lactating/breastfeeding at time of screening or","text_display":"\n\nTherefore, female patients who are pregnant or lactating/breastfeeding at time of screening or","confidence":1,"confidence_rate":1},{"cnt":[[309,434],[1826,434],[1826,483],[309,483]],"region":{"top_left_x":309,"top_left_y":433,"width":1518,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2278a16eca524a72a2f6f3d1081e5c1a","type":"text","conversion_output":true,"text":"who intend to become pregnant within 28 days of enrolling into the study will be excluded","text_display":" who intend to become pregnant within 28 days of enrolling into the study will be excluded","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[309,494],[1820,494],[1820,544],[309,544]],"region":{"top_left_x":309,"top_left_y":494,"width":1511,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86f311550e5c4c75a65aebf1720cc878","type":"text","conversion_output":true,"text":"from the study (see Section 4.1.2). If a pregnancy occurs while a patient is participating in","text_display":" from the study (see Section 4.1.2). If a pregnancy occurs while a patient is participating in","confidence":0.9960973262786865,"confidence_rate":0.9999600996835463},{"cnt":[[309,554],[1747,554],[1747,604],[309,604]],"region":{"top_left_x":309,"top_left_y":554,"width":1438,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"753d2b6949cd4661aab8032aea6fdbe3","type":"text","conversion_output":true,"text":"the study, it is not regarded as an AE unless there is a suspicion that an investigational","text_display":" the study, it is not regarded as an AE unless there is a suspicion that an investigational","confidence":1,"confidence_rate":1},{"cnt":[[307,614],[1755,614],[1755,664],[307,664]],"region":{"top_left_x":307,"top_left_y":614,"width":1449,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aeeba090205b4b3bb1a27c7f39d4f437","type":"text","conversion_output":true,"text":"product may have interfered with the effectiveness of a contraceptive medication. 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To ensure patient safety, each pregnancy must be reported to AM-Pharma","text_display":" pregnancy form. To ensure patient safety, each pregnancy must be reported to AM-Pharma","confidence":1,"confidence_rate":1},{"cnt":[[307,795],[1798,795],[1798,844],[307,844]],"region":{"top_left_x":307,"top_left_y":794,"width":1492,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60352372261e42c2b46c8ce8f3e6684e","type":"text","conversion_output":true,"text":"B.V. within 2 weeks of learning of its occurrence. The pregnancy must be followed-up to","text_display":" B.V. within 2 weeks of learning of its occurrence. 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(e.g., ECGs, vital sign measurements), including those that worsen from","confidence":1,"confidence_rate":1},{"cnt":[[307,1624],[1729,1624],[1729,1678],[307,1678]],"region":{"top_left_x":307,"top_left_y":1624,"width":1423,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6a717dff5074f0a982ba1671f83f33d","type":"text","conversion_output":true,"text":"baseline, felt to be clinically significant in the medical and scientific judgment of the","text_display":" baseline, felt to be clinically significant in the medical and scientific judgment of the","confidence":1,"confidence_rate":1},{"cnt":[[305,1687],[1021,1687],[1021,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1686,"width":716,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8fe4e0d0acd49a28a8edaff0c55cdc7","type":"text","conversion_output":true,"text":"investigator, are to be recorded as (S)AEs.","text_display":" investigator, 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measurement after treatment) to Day 7, inclusive.","confidence":1,"confidence_rate":1},{"cnt":[[307,2088],[1858,2088],[1858,2140],[307,2140]],"region":{"top_left_x":307,"top_left_y":2088,"width":1552,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4816a92e83bc48b7808f6402d80e2aa4","type":"text","conversion_output":true,"text":"Time-corrected endogenous creatinine clearance is assessed on each day during a \\(6 \\pm 1\\) hour","text_display":" Time-corrected endogenous creatinine clearance is assessed on each day during a \\(6 \\pm 1\\) hour","confidence":1,"confidence_rate":1},{"cnt":[[305,2148],[1833,2148],[1833,2202],[305,2202]],"region":{"top_left_x":305,"top_left_y":2148,"width":1528,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6eccbbbbec3849348b116164299fec47","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":0.6739871501922607,"confidence_rate":0.996213492417448},{"cnt":[[305,2209],[1815,2209],[1815,2258],[305,2258]],"region":{"top_left_x":305,"top_left_y":2208,"width":1511,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95b5d3336d5a4fbeb8d8eee08681af3c","type":"text","conversion_output":true,"text":"expected to be representative of the full 24 hours for that day. The primary endpoint is the","text_display":" expected to be representative of the full 24 hours for that day. 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Should a patient die or withdraw from the study during this period","text_display":" to Day 28, inclusive. Should a patient die or withdraw from the study during this period","confidence":1,"confidence_rate":1},{"cnt":[[309,1272],[1863,1272],[1863,1317],[309,1317]],"region":{"top_left_x":309,"top_left_y":1271,"width":1554,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6664aa2b9ce44bc3beff25731f358e61","type":"text","conversion_output":true,"text":"without recording RRT incidence, he or she will be counted as having not required RRT. The","text_display":" without recording RRT incidence, he or she will be counted as having not required RRT. The","confidence":1,"confidence_rate":1},{"cnt":[[309,1332],[1841,1332],[1841,1377],[309,1377]],"region":{"top_left_x":309,"top_left_y":1332,"width":1533,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e83923e294134c36a0418d331818b4c2","type":"text","conversion_output":true,"text":"analysis of this endpoint will be repeated excluding patients who died or withdrew from the","text_display":" analysis of this endpoint will be repeated excluding patients who died or withdrew from the","confidence":1,"confidence_rate":1},{"cnt":[[309,1392],[982,1392],[982,1437],[309,1437]],"region":{"top_left_x":309,"top_left_y":1392,"width":673,"height":46},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b2646f2fec946f78d2c8cd0975cce48","type":"text","conversion_output":true,"text":"study prior to completion of this period.","text_display":" study prior to completion of this 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Renal}","confidence":1,"confidence_rate":1},{"cnt":[[309,1676],[1025,1676],[1025,1723],[309,1723]],"region":{"top_left_x":309,"top_left_y":1675,"width":716,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e9c48e9ebf44dc7ad533aaa6c7ea54d","type":"text","conversion_output":true,"text":"- Renal endpoints include the following:","text_display":"\n- Renal endpoints include the following:","confidence":1,"confidence_rate":1},{"cnt":[[309,1762],[1824,1762],[1824,1807],[309,1807]],"region":{"top_left_x":309,"top_left_y":1761,"width":1516,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fecfc77ff06d422c93c2c209e413bcd6","type":"text","conversion_output":true,"text":"- Volume of urine (daily from Day 1 to Day 7, inclusive, and on subsequent visit days if","text_display":"\n- Volume of urine (daily from Day 1 to Day 7, inclusive, and on subsequent visit days if","confidence":1,"confidence_rate":1},{"cnt":[[370,1818],[973,1818],[973,1867],[370,1867]],"region":{"top_left_x":369,"top_left_y":1817,"width":605,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3c59fd0f05540abba8d22171c83f8fa","type":"text","conversion_output":true,"text":"reliable urine collection is possible)","text_display":" reliable urine collection is possible)","confidence":1,"confidence_rate":1},{"cnt":[[309,1904],[1880,1904],[1880,1953],[309,1953]],"region":{"top_left_x":309,"top_left_y":1903,"width":1571,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7348f3e871d24c879efd66cb20cc09e1","type":"text","conversion_output":true,"text":"- Serum creatinine and BUN (daily from Day 1 to Day 7, inclusive, and on subsequent visit","text_display":"\n- Serum creatinine and BUN (daily from Day 1 to Day 7, inclusive, and on subsequent visit","confidence":1,"confidence_rate":1},{"cnt":[[372,1964],[1094,1964],[1094,2013],[372,2013]],"region":{"top_left_x":371,"top_left_y":1963,"width":723,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc6d0a4ae2ab4fe7baa42eb583e36b9e","type":"text","conversion_output":true,"text":"days if reliable urine collection is possible)","text_display":" days if reliable urine collection is possible)","confidence":1,"confidence_rate":1},{"cnt":[[309,2050],[1807,2050],[1807,2095],[309,2095]],"region":{"top_left_x":309,"top_left_y":2049,"width":1498,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"618207f352e843acac912e2d8d8b3ded","type":"text","conversion_output":true,"text":"- BUN clearance (daily from Day 1 to Day 7, inclusive, and on subsequent visit days if","text_display":"\n- BUN clearance (daily from Day 1 to Day 7, inclusive, and on subsequent visit days 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inclusive)","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[309,2275],[1742,2275],[1742,2322],[309,2322]],"region":{"top_left_x":309,"top_left_y":2275,"width":1434,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcd9d7de59d24fd985493d5a8ce69205","type":"text","conversion_output":true,"text":"- RRT-free days (during the period Day 1 to Day 28 excluding patients who died or","text_display":"\n- RRT-free days (during the period Day 1 to Day 28 excluding patients who died or","confidence":1,"confidence_rate":1},{"cnt":[[372,2333],[1835,2333],[1835,2383],[372,2383]],"region":{"top_left_x":371,"top_left_y":2333,"width":1464,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea848d18b1e848fdb3531eb9d39a3bae","type":"text","conversion_output":true,"text":"withdrew from the study prior to the end of this period), i.e., 28 days minus the number","text_display":" withdrew from the study prior to the end of this period), i.e., 28 days minus the number","confidence":0.99755859375,"confidence_rate":0.9999745379143542},{"cnt":[[374,2393],[1811,2393],[1811,2443],[374,2443]],"region":{"top_left_x":373,"top_left_y":2393,"width":1439,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44b9155e407a4415a542bea9861971db","type":"text","conversion_output":true,"text":"of days a patient is on RRT during this period. An RRT-free day is defined as a day on","text_display":" of days a patient is on RRT during this period. An RRT-free day is defined as a day on","confidence":1,"confidence_rate":1},{"cnt":[[1753,2462],[1871,2462],[1871,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":119,"height":41},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98818710fbc04b65821f0fd6d3bfca4e","type":"page_info","conversion_output":false,"text":"Page 74","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-075","page":75,"lines":[{"cnt":[[309,254],[559,254],[559,286],[309,286]],"region":{"top_left_x":309,"top_left_y":253,"width":250,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42629064cbae40d1a9470fae73f196ca","type":"page_info","conversion_output":false,"text":"AM-Pharma B.V.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1371,251],[1863,251],[1863,294],[1371,294]],"region":{"top_left_x":1370,"top_left_y":251,"width":493,"height":44},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b182e309e4544a89b89655944b22ca2","type":"page_info","conversion_output":false,"text":"Recombinant alkaline phosphatase","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[621,314],[621,350],[309,350]],"region":{"top_left_x":309,"top_left_y":313,"width":312,"height":38},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b90a01a06fe34a42964dbf241ae58c44","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,314],[1863,314],[1863,350],[1573,350]],"region":{"top_left_x":1572,"top_left_y":313,"width":291,"height":38},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"129e32552e6944a29c9c5c996e780e01","type":"page_info","conversion_output":false,"text":"Protocol Version 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[370,374],[1858,374],[1858,423],[370,423]],"region":{"top_left_x":369,"top_left_y":373,"width":1490,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d143d0eb85974f8d9863fc5f3bdb4bad","type":"text","conversion_output":true,"text":"which a patient did not receive any form of RRT. Conversely, a day on RRT is defined as","text_display":"\nwhich a patient did not receive any form of RRT. Conversely, a day on RRT is defined as","confidence":1,"confidence_rate":1},{"cnt":[[370,434],[1809,434],[1809,483],[370,483]],"region":{"top_left_x":369,"top_left_y":433,"width":1440,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"033b51c627474f5c8f2d5975881b2ce9","type":"text","conversion_output":true,"text":"a day on which a patient received any form of RRT for any period of time on that day.","text_display":" a day on which a patient received any form of RRT for any period of time on that day.","confidence":1,"confidence_rate":1},{"cnt":[[370,494],[1351,494],[1351,544],[370,544]],"region":{"top_left_x":369,"top_left_y":494,"width":983,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"051e70df951e4e4cbb8860cf72468663","type":"text","conversion_output":true,"text":"For intermittent RRT, the following additional rules apply:","text_display":" For intermittent RRT, the following additional rules apply:","confidence":1,"confidence_rate":1},{"cnt":[[494,574],[1841,574],[1841,623],[494,623]],"region":{"top_left_x":494,"top_left_y":573,"width":1348,"height":51},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"481c99e4d0fd4ba49c1e3f891015bdf5","type":"text","conversion_output":true,"text":"a. Following conclusion of intermittent RRT, if the patient then has a period of","text_display":"\na. Following conclusion of intermittent RRT, if the patient then has a period of","confidence":1,"confidence_rate":1},{"cnt":[[559,632],[1828,632],[1828,683],[559,683]],"region":{"top_left_x":558,"top_left_y":631,"width":1271,"height":53},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"414bbea75874499bb0dd9a70e5fd2ee6","type":"text","conversion_output":true,"text":"six or more days before next initiation of any form of RRT, all (six or more)","text_display":" six or more days before next initiation of any form of RRT, all (six or more)","confidence":0.96044921875,"confidence_rate":0.9995079970759533},{"cnt":[[559,694],[1485,694],[1485,743],[559,743]],"region":{"top_left_x":558,"top_left_y":693,"width":927,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6d9012d138246588ec87848f5e004a8","type":"text","conversion_output":true,"text":"days in this intervening period are counted as RRT-free","text_display":" days in this intervening period are counted as RRT-free","confidence":1,"confidence_rate":1},{"cnt":[[494,776],[1841,776],[1841,823],[494,823]],"region":{"top_left_x":494,"top_left_y":775,"width":1348,"height":48},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4fcf30ac07ca4f199ca40326f3881217","type":"text","conversion_output":true,"text":"b. Following conclusion of intermittent RRT, if the patient then has a period of","text_display":"\nb. Following conclusion of intermittent RRT, if the patient then has a period of","confidence":1,"confidence_rate":1},{"cnt":[[559,834],[1815,834],[1815,883],[559,883]],"region":{"top_left_x":558,"top_left_y":833,"width":1258,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f0adb5091f5f4e82a6d3ed44a098ffeb","type":"text","conversion_output":true,"text":"five or less days before next initiation of any form of RRT, all (five or less)","text_display":" five or less days before next initiation of any form of RRT, all (five or less)","confidence":0.99658203125,"confidence_rate":0.999959241028889},{"cnt":[[559,896],[1463,896],[1463,943],[559,943]],"region":{"top_left_x":558,"top_left_y":895,"width":906,"height":49},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"966c66bb7ebe4ad0bdb35db2a8d8c0ba","type":"text","conversion_output":true,"text":"days in this intervening period are counted as on RRT","text_display":" days in this intervening period are counted as on RRT","confidence":1,"confidence_rate":1},{"cnt":[[309,975],[1824,975],[1824,1027],[309,1027]],"region":{"top_left_x":309,"top_left_y":975,"width":1516,"height":52},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c04f6b31a2c94c6b8a3229752d8d589f","type":"text","conversion_output":true,"text":"- Total number of days on RRT (during the period Day 1 to Day 28, inclusive). A day on","text_display":"\n- Total number of days on RRT (during the period Day 1 to Day 28, inclusive). A day on","confidence":1,"confidence_rate":1},{"cnt":[[370,1038],[1876,1038],[1876,1087],[370,1087]],"region":{"top_left_x":369,"top_left_y":1037,"width":1507,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1e0e462a3b240a6bf2b1dc42fabfa7f","type":"text","conversion_output":true,"text":"RRT is defined as a day on which a patient did receive any form of RRT for any period of","text_display":" RRT is defined as a day on which a patient did receive any form of RRT for any period of","confidence":0.99853515625,"confidence_rate":0.9999842375685026},{"cnt":[[370,1100],[655,1100],[655,1145],[370,1145]],"region":{"top_left_x":369,"top_left_y":1100,"width":287,"height":46},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9d913060b394e4ab30130480e09fd87","type":"text","conversion_output":true,"text":"time on that day.","text_display":" time on that day.","confidence":1,"confidence_rate":1},{"cnt":[[309,1182],[1652,1182],[1652,1231],[309,1231]],"region":{"top_left_x":309,"top_left_y":1181,"width":1344,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d84dfda7cb4d4989ad07ae3211c524b8","type":"text","conversion_output":true,"text":"- Reasons for initiation of RRT (during the period Day 1 to Day 28, inclusive)","text_display":"\n- Reasons for initiation of RRT (during the period Day 1 to Day 28, inclusive)","confidence":1,"confidence_rate":1},{"cnt":[[309,1268],[1790,1268],[1790,1315],[309,1315]],"region":{"top_left_x":309,"top_left_y":1267,"width":1481,"height":48},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01a437680dd04b83bb136d22fe9edb2e","type":"text","conversion_output":true,"text":"- Kidney function at Day 28 as assessed by measured creatinine clearance if available,","text_display":"\n- Kidney function at Day 28 as assessed by measured creatinine clearance if available,","confidence":1,"confidence_rate":1},{"cnt":[[370,1328],[1783,1328],[1783,1373],[370,1373]],"region":{"top_left_x":369,"top_left_y":1327,"width":1415,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"602000b47bd14d5e843a9aeb13a7638f","type":"text","conversion_output":true,"text":"otherwise as assessed by eGFR (estimated by the CKD-EPI formula based on serum","text_display":" otherwise as assessed by eGFR (estimated by the CKD-EPI formula based on serum","confidence":1,"confidence_rate":1},{"cnt":[[372,1384],[1818,1384],[1818,1433],[372,1433]],"region":{"top_left_x":371,"top_left_y":1383,"width":1447,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ac19a75343d4eb6a2afdb56feba4da2","type":"text","conversion_output":true,"text":"creatinine). Patients who die prior to Day 28 will be excluded from this endpoint, with","text_display":" creatinine). Patients who die prior to Day 28 will be excluded from this endpoint, with","confidence":1,"confidence_rate":1},{"cnt":[[370,1446],[1760,1446],[1760,1493],[370,1493]],"region":{"top_left_x":369,"top_left_y":1445,"width":1391,"height":49},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c01e91303c47489181decb0898a6d517","type":"text","conversion_output":true,"text":"any other missing assessments (including early withdrawals) imputed using LOCF.","text_display":" any other missing assessments (including early withdrawals) imputed using LOCF.","confidence":1,"confidence_rate":1},{"cnt":[[309,1530],[1858,1530],[1858,1579],[309,1579]],"region":{"top_left_x":309,"top_left_y":1529,"width":1550,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db698ccbf2884167af6b010a2e561a4b","type":"text","conversion_output":true,"text":"- Kidney function at Day 60 and Day 90 as assessed by eGFR (estimated by the CKD-EPI","text_display":"\n- Kidney function at Day 60 and Day 90 as assessed by eGFR (estimated by the CKD-EPI","confidence":1,"confidence_rate":1},{"cnt":[[370,1590],[1717,1590],[1717,1639],[370,1639]],"region":{"top_left_x":369,"top_left_y":1589,"width":1348,"height":51},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"69fd46e63718419a8348904ad51a1d20","type":"text","conversion_output":true,"text":"formula based on serum creatinine). Patients who die prior to Day 60 or Day 90,","text_display":" formula based on serum creatinine). 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Patients who","confidence":1,"confidence_rate":1},{"cnt":[[370,1912],[1871,1912],[1871,1962],[370,1962]],"region":{"top_left_x":369,"top_left_y":1912,"width":1503,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"337c3e0638fe4b058d75fcce3cb010c6","type":"text","conversion_output":true,"text":"die prior to Day 60 or Day 90, respectively, will be excluded from this endpoint, with any","text_display":" die prior to Day 60 or Day 90, respectively, will be excluded from this endpoint, with any","confidence":1,"confidence_rate":1},{"cnt":[[370,1972],[1818,1972],[1818,2022],[370,2022]],"region":{"top_left_x":369,"top_left_y":1972,"width":1449,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e011badd6c4465f8133acfa0256878a","type":"text","conversion_output":true,"text":"other missing assessments (including early withdrawals) at Day 60 or Day 90 imputed","text_display":" other missing assessments (including early withdrawals) at Day 60 or Day 90 imputed","confidence":1,"confidence_rate":1},{"cnt":[[370,2032],[591,2032],[591,2082],[370,2082]],"region":{"top_left_x":369,"top_left_y":2032,"width":222,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d805d4fdb1f44d48ea424498b3297c0","type":"text","conversion_output":true,"text":"using LOCF.","text_display":" using LOCF.","confidence":0.98486328125,"confidence_rate":0.999047176212315},{"cnt":[[309,2116],[1818,2116],[1818,2163],[309,2163]],"region":{"top_left_x":309,"top_left_y":2116,"width":1509,"height":48},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7440c175097a4b7ca6694b589a8955be","type":"text","conversion_output":true,"text":"- Incidence of dialysis dependency at Day 60 and Day 90. 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Should a patient die or withdraw prior to","text_display":" days a patient is on ventilator during this period. 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limited to noradrenaline, adrenaline, dobutamine, dopamine,","confidence":1,"confidence_rate":1},{"cnt":[[370,1646],[872,1646],[872,1697],[370,1697]],"region":{"top_left_x":369,"top_left_y":1645,"width":504,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64967d1301cc49e3b08f46c913ea4e8a","type":"text","conversion_output":true,"text":"vasopressin, and enoximone).","text_display":" vasopressin, and enoximone).","confidence":1,"confidence_rate":1},{"cnt":[[309,1732],[1811,1732],[1811,1781],[309,1781]],"region":{"top_left_x":309,"top_left_y":1731,"width":1503,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a1ce3fb84b248b58e642f0d9bcc1fb5","type":"text","conversion_output":true,"text":"- Time from start of first administration of treatment to being shock free (from Day 1 to","text_display":"\n- Time from start of first administration of treatment to being shock free (from Day 1 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The power was defined","text_display":" (and hence is well controlled at the 1 -sided \\(2.5 \\%\\) significance level). The power was defined","confidence":0.9975600242614746,"confidence_rate":0.9999765103015572},{"cnt":[[305,2155],[1876,2155],[1876,2206],[305,2206]],"region":{"top_left_x":305,"top_left_y":2154,"width":1571,"height":53},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5864278716ad487095281e0faae854fb","type":"text","conversion_output":true,"text":"as the probability of rejecting the null hypothesis (of no difference between treatment groups)","text_display":" as the probability of rejecting the null hypothesis (of no difference between treatment groups)","confidence":1,"confidence_rate":1},{"cnt":[[305,2213],[1846,2213],[1846,2267],[305,2267]],"region":{"top_left_x":305,"top_left_y":2212,"width":1541,"height":55},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9e08716dc264b429908587ec26b9721","type":"text","conversion_output":true,"text":"when 1 or more recAP dose groups have an effective treatment effect, defined as a response","text_display":" when 1 or more recAP dose groups have an effective treatment effect, defined as a response","confidence":1,"confidence_rate":1},{"cnt":[[305,2273],[1867,2273],[1867,2327],[305,2327]],"region":{"top_left_x":305,"top_left_y":2273,"width":1562,"height":54},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc0014bb5f3b4c339fb6cfe52384a31d","type":"text","conversion_output":true,"text":"of \\(69.5 mL / min\\). This was investigated across 7 scenarios with 10000 simulations performed","text_display":" of \\(69.5 mL / min\\). This was investigated across 7 scenarios with 10000 simulations performed","confidence":0.99462890625,"confidence_rate":0.9999505923221353},{"cnt":[[305,2333],[1775,2333],[1775,2385],[305,2385]],"region":{"top_left_x":305,"top_left_y":2333,"width":1470,"height":52},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd228a94801449f1b68f2f8966cd4c84","type":"text","conversion_output":true,"text":"for each. In the most realistic scenarios (with strong treatment effects, i.e., responses of","text_display":" for each. 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This dropped to \\(66 \\%\\) to \\(67 \\%\\) for other scenarios where only the high","text_display":" between \\(79 \\%\\) and \\(86 \\%\\). 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Continuous","text_display":"\n\nStatistical analyses will be performed using SAS software Version 9.2 or later. Continuous","confidence":1,"confidence_rate":1},{"cnt":[[309,2084],[1790,2084],[1790,2133],[309,2133]],"region":{"top_left_x":309,"top_left_y":2083,"width":1481,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73639d0a3b214109ac9e8965d983c0fd","type":"text","conversion_output":true,"text":"variables will be summarized using descriptive statistics, including but not limited to the","text_display":" variables will be summarized using descriptive statistics, including but not limited to the","confidence":1,"confidence_rate":1},{"cnt":[[309,2144],[1794,2144],[1794,2191],[309,2191]],"region":{"top_left_x":309,"top_left_y":2144,"width":1485,"height":48},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02239565d8fb4b72965744891104d707","type":"text","conversion_output":true,"text":"mean, the standard deviation, median, minimum value, and maximum value. 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All data collected","confidence":1,"confidence_rate":1},{"cnt":[[309,2264],[1646,2264],[1646,2310],[309,2310]],"region":{"top_left_x":309,"top_left_y":2264,"width":1337,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70439bb1448d4daba36aa3605736af7f","type":"text","conversion_output":true,"text":"across the 4 treatment groups throughout the study will be listed in data listings.","text_display":" across the 4 treatment groups throughout the study will be listed in data listings.","confidence":1,"confidence_rate":1},{"cnt":[[1753,2462],[1867,2462],[1867,2503],[1753,2503]],"region":{"top_left_x":1753,"top_left_y":2462,"width":114,"height":41},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"002afbdcce0f447dbfbc777ea7943358","type":"page_info","conversion_output":false,"text":"Page 81","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-082","page":82,"lines":[{"cnt":[[309,254],[556,254],[556,286],[309,286]],"region":{"top_left_x":309,"top_left_y":253,"width":248,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"157787e99ad845a9963ce6292ff25f50","type":"page_info","conversion_output":false,"text":"AM-Pharma B.V.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1375,254],[1863,254],[1863,294],[1375,294]],"region":{"top_left_x":1375,"top_left_y":253,"width":488,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20df9b0a44dc4e3dbb9cc6102ebfab68","type":"page_info","conversion_output":false,"text":"Recombinant alkaline phosphatase","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,314],[621,314],[621,348],[309,348]],"region":{"top_left_x":309,"top_left_y":313,"width":312,"height":36},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"605802e777cd4944a412692374deaa2f","type":"page_info","conversion_output":false,"text":"AP-recAP-AKI-02-01","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1573,314],[1863,314],[1863,346],[1573,346]],"region":{"top_left_x":1572,"top_left_y":313,"width":291,"height":33},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea250d8428cc4c7f8bf47e2f07fbd1c4","type":"page_info","conversion_output":false,"text":"Protocol Version 3.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,374],[1818,374],[1818,423],[309,423]],"region":{"top_left_x":309,"top_left_y":373,"width":1509,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c9d5552e6e0444db16f32694f02a0a0","type":"text","conversion_output":true,"text":"All statistical tests will be 2 -sided and performed using a \\(5 \\%\\) significance level, leading to","text_display":"\n\nAll statistical tests will be 2 -sided and performed using a \\(5 \\%\\) significance level, leading to","confidence":0.998046875,"confidence_rate":0.9999813807939509},{"cnt":[[309,434],[1876,434],[1876,483],[309,483]],"region":{"top_left_x":309,"top_left_y":433,"width":1567,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c255d6b4d2d4f1eb99a9cb59bb22668","type":"text","conversion_output":true,"text":"\\(95 \\%\\) (2-sided) CIs. As the primary efficacy endpoint is analyzed at the interim analysis and at","text_display":" \\(95 \\%\\) (2-sided) CIs. 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A hierarchical method will be employed to address any","text_display":" the results (see Section 7.7.1). A hierarchical method will be employed to address any","confidence":1,"confidence_rate":1},{"cnt":[[309,614],[1781,614],[1781,664],[309,664]],"region":{"top_left_x":309,"top_left_y":614,"width":1473,"height":50},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7bae37318f75409fa6eb4646020a153b","type":"text","conversion_output":true,"text":"multiplicity arising from the analysis of the key secondary endpoint. In other words, the","text_display":" multiplicity arising from the analysis of the key secondary endpoint. 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possible causes.","text_display":" analyses conducted to investigate the possible causes.","confidence":1,"confidence_rate":1},{"cnt":[[309,1697],[1858,1697],[1858,1745],[309,1745]],"region":{"top_left_x":309,"top_left_y":1697,"width":1550,"height":48},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8010125c1b1e46c7a1cdcc81f16659db","type":"text","conversion_output":true,"text":"Further details of the statistical analyses, methods, and data conventions will be described in","text_display":"\n\nFurther details of the statistical analyses, methods, and data conventions will be described in","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[309,1757],[458,1757],[458,1798],[309,1798]],"region":{"top_left_x":309,"top_left_y":1757,"width":149,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0e4c816389454979962ee48827e450cf","type":"text","conversion_output":true,"text":"the 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The analysis will be performed","text_display":" (ANOVA) with treatment and site as explanatory variables. 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For Part 2, the optimal recAP dose will be compared","text_display":"\nthe optimal recAP dose for use in Part2. For Part 2, the optimal recAP dose will be compared","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[309,434],[1803,434],[1803,483],[309,483]],"region":{"top_left_x":309,"top_left_y":433,"width":1494,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df07980b0d6a4caab30d958c88114f9d","type":"text","conversion_output":true,"text":"with placebo. Confirmatory testing of the single hypothesis comparing optimal dose with","text_display":" with placebo. 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This hypothesis will be rejected at level","confidence":0.99853515625,"confidence_rate":0.9999851928603086},{"cnt":[[309,554],[1852,554],[1852,604],[309,604]],"region":{"top_left_x":309,"top_left_y":554,"width":1543,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9c61db2f14342928e707450b47ca83d","type":"text","conversion_output":true,"text":"\\(\\alpha\\) if it and all intersection hypotheses involving it are all rejected at local level \\(\\alpha\\). The testing","text_display":" \\(\\alpha\\) if it and all intersection hypotheses involving it are all rejected at local level \\(\\alpha\\). The testing","confidence":1,"confidence_rate":1},{"cnt":[[309,614],[1828,614],[1828,662],[309,662]],"region":{"top_left_x":309,"top_left_y":614,"width":1520,"height":48},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca6633b4a7014e4d9de916a637e3f0ba","type":"text","conversion_output":true,"text":"strategy used to combine results from Parts 1 and 2 will be a combination test based on the","text_display":" strategy used to combine results from Parts 1 and 2 will be a combination test based on the","confidence":0.9201489959377795,"confidence_rate":0.9991844536217555},{"cnt":[[309,675],[1876,675],[1876,720],[309,720]],"region":{"top_left_x":309,"top_left_y":674,"width":1567,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0f700dcea2544a882751986e56ad93d","type":"text","conversion_output":true,"text":"inverse normal method, with the test statistic of the combination test calculated as (Bauer and","text_display":" inverse normal method, with the test statistic of the combination test calculated as (Bauer and","confidence":1,"confidence_rate":1},{"cnt":[[309,735],[544,735],[544,780],[309,780]],"region":{"top_left_x":309,"top_left_y":734,"width":235,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"76b32e54b35d4ea99c20492e41d5b270","type":"text","conversion_output":true,"text":"Köhne 1994):","text_display":" Köhne 1994):","confidence":1,"confidence_rate":1},{"cnt":[[752,825],[1433,825],[1433,939],[752,939]],"region":{"top_left_x":751,"top_left_y":825,"width":683,"height":114},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4fdf454359d48dda78d17288b8c49b4","type":"math","conversion_output":true,"text":"\\[\n\\sqrt{\\frac{n_{1}}{n}} \\Phi^{-1}\\left(1-p_{1}\\right)+\\sqrt{\\frac{n_{2}}{n}} \\Phi^{-1}\\left(1-p_{2}\\right)\n\\]","text_display":"\n\\[\n\\sqrt{\\frac{n_{1}}{n}} \\Phi^{-1}\\left(1-p_{1}\\right)+\\sqrt{\\frac{n_{2}}{n}} \\Phi^{-1}\\left(1-p_{2}\\right)\n\\]","confidence":1,"confidence_rate":1},{"cnt":[[309,1005],[1841,1005],[1841,1055],[309,1055]],"region":{"top_left_x":309,"top_left_y":1005,"width":1533,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"605dccb6a0cc40a7b01413c1237199c9","type":"text","conversion_output":true,"text":"where \\(n_{1}\\) and \\(n_{2}\\) are the sample sizes per group in Parts 1 and 2, respectively, \\(n=n_{1}+n_{2}\\),","text_display":"\nwhere \\(n_{1}\\) and \\(n_{2}\\) are the sample sizes per group in Parts 1 and 2, respectively, \\(n=n_{1}+n_{2}\\),","confidence":0.9326171875,"confidence_rate":0.9994756227584988},{"cnt":[[309,1079],[1854,1079],[1854,1130],[309,1130]],"region":{"top_left_x":309,"top_left_y":1078,"width":1546,"height":53},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4ad33dbbe4b4f31a7d5414db3237b87","type":"text","conversion_output":true,"text":"\\(\\Phi\\) refers to the standard normal distribution, and \\(p_{1}\\) and \\(p_{2}\\) are the p -values from Parts 1 and","text_display":" \\(\\Phi\\) refers to the standard normal distribution, and \\(p_{1}\\) and \\(p_{2}\\) are the p -values from Parts 1 and","confidence":1,"confidence_rate":1},{"cnt":[[309,1156],[1815,1156],[1815,1205],[309,1205]],"region":{"top_left_x":309,"top_left_y":1155,"width":1507,"height":51},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14cd26c8c81146e5b9b6df0cde34ab0a","type":"text","conversion_output":true,"text":"2 , respectively. For the single hypothesis, \\(p_{1}\\) is the unadjusted p -value to compare optimal","text_display":" 2 , respectively. For the single hypothesis, \\(p_{1}\\) is the unadjusted p -value to compare optimal","confidence":0.9888026578119025,"confidence_rate":0.9999003544838314},{"cnt":[[309,1231],[1811,1231],[1811,1280],[309,1280]],"region":{"top_left_x":309,"top_left_y":1231,"width":1503,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b314e1db90b740aeabbbf07421644ddf","type":"text","conversion_output":true,"text":"dose with placebo in Part 1. For the intersection hypotheses, \\(p_{1}\\) is the Dunnett-adjusted p-","text_display":" dose with placebo in Part 1. 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Should there be a strong","text_display":" of the residuals and a plot of the fitted values against the residuals. 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the","text_display":" will be conducted to calculate the p -values for Parts 1 and 2 (i.e., using ANOVA with the","confidence":0.6575603485107422,"confidence_rate":0.9960897329856768},{"cnt":[[309,1942],[1727,1942],[1727,1987],[309,1987]],"region":{"top_left_x":309,"top_left_y":1942,"width":1419,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0aabdf2daf924e8bb91d3f63fe733f9c","type":"text","conversion_output":true,"text":"rank-transformed values of \\(AUC _{1-7}\\) as the outcome variable and treatment and site as","text_display":" rank-transformed values of \\(AUC _{1-7}\\) as the outcome variable and treatment and site 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all","confidence":1,"confidence_rate":1},{"cnt":[[309,2166],[1463,2166],[1463,2211],[309,2211]],"region":{"top_left_x":309,"top_left_y":2165,"width":1155,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f088809d4d4b42918984062825493969","type":"text","conversion_output":true,"text":"4 treatment groups for the patients randomly assigned prior to Part 2.","text_display":" 4 treatment groups for the patients randomly assigned prior to Part 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Otherwise the results will be reported as exploratory","text_display":" group and site as explanatory variables. Otherwise the results will be reported as exploratory","confidence":1,"confidence_rate":1},{"cnt":[[309,795],[1837,795],[1837,844],[309,844]],"region":{"top_left_x":309,"top_left_y":794,"width":1528,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9c6c2c0928c746618aa16102cf8cebfd","type":"text","conversion_output":true,"text":"analyses only. The odds ratio and associated 95\\% confidence interval from this comparison","text_display":" analyses only. 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Should statistically","confidence":1,"confidence_rate":1},{"cnt":[[309,1074],[1796,1074],[1796,1124],[309,1124]],"region":{"top_left_x":309,"top_left_y":1074,"width":1488,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51bb5bb226794a2182b9ff3b477c1f57","type":"text","conversion_output":true,"text":"significant results not be obtained from both the primary endpoint and the key secondary","text_display":" significant results not be obtained from both the primary endpoint and the key secondary","confidence":1,"confidence_rate":1},{"cnt":[[309,1134],[1841,1134],[1841,1184],[309,1184]],"region":{"top_left_x":309,"top_left_y":1134,"width":1533,"height":50},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ae3d3c84c4c429fafa29b501c836358","type":"text","conversion_output":true,"text":"endpoint, the results from the logistic regression model for this comparison will be reported","text_display":" endpoint, the results from the logistic regression model for this comparison will be reported","confidence":1,"confidence_rate":1},{"cnt":[[309,1195],[793,1195],[793,1244],[309,1244]],"region":{"top_left_x":309,"top_left_y":1194,"width":484,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d60ac8caaf464a7ba3c191f1833db789","type":"text","conversion_output":true,"text":"as exploratory analyses only.","text_display":" as exploratory analyses only.","confidence":1,"confidence_rate":1},{"cnt":[[309,1298],[1777,1298],[1777,1345],[309,1345]],"region":{"top_left_x":309,"top_left_y":1297,"width":1468,"height":48},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aad8b2df70c24d74949b989ee768febd","type":"text","conversion_output":true,"text":"Descriptive statistics will be used for all other continuous secondary efficacy endpoints,","text_display":"\n\nDescriptive statistics will be used for all other continuous secondary efficacy endpoints,","confidence":1,"confidence_rate":1},{"cnt":[[309,1358],[1725,1358],[1725,1405],[309,1405]],"region":{"top_left_x":309,"top_left_y":1357,"width":1417,"height":49},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"16fd872dcf514978a0fa5cea2c9fa77d","type":"text","conversion_output":true,"text":"summarizing absolute values and/or change from baseline as required across all four","text_display":" summarizing absolute values and/or change from baseline as required across all four","confidence":1,"confidence_rate":1},{"cnt":[[309,1416],[1772,1416],[1772,1463],[309,1463]],"region":{"top_left_x":309,"top_left_y":1415,"width":1464,"height":49},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f4a68ca85a6b48b2ab4966b82e1d9387","type":"text","conversion_output":true,"text":"treatment groups in tables and/or figures as appropriate. Categorical secondary efficacy","text_display":" treatment groups in tables and/or figures as appropriate. 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Selected endpoints will be analyzed by appropriate methods; these","text_display":" tables as appropriate. Selected endpoints will be analyzed by appropriate methods; these","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[309,1594],[1510,1594],[1510,1644],[309,1644]],"region":{"top_left_x":309,"top_left_y":1594,"width":1202,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"caeb9ce97c9f4620b0a6ce11195d38d6","type":"text","conversion_output":true,"text":"analyses will be exploratory only and defined in more detail in the SAP.","text_display":" analyses will be exploratory only and defined in more detail in the SAP.","confidence":1,"confidence_rate":1},{"cnt":[[305,1697],[788,1697],[788,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1697,"width":484,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15f8d373c4864d519c639622cdaffdc0","type":"section_header","conversion_output":false,"children_ids":["924dac0538204849a5f8aa028746afd3"],"text":"","text_display":""},{"cnt":[[309,1702],[784,1702],[784,1755],[309,1755]],"region":{"top_left_x":309,"top_left_y":1701,"width":476,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"924dac0538204849a5f8aa028746afd3","type":"text","conversion_output":true,"parent_id":"15f8d373c4864d519c639622cdaffdc0","text":"7.7.3 Safety Analyses","text_display":"\n\n\\subsection*{7.7.3 Safety Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[309,1788],[1772,1788],[1772,1837],[309,1837]],"region":{"top_left_x":309,"top_left_y":1787,"width":1464,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ea3b13cc03e480baf9d64141de7bbdc","type":"text","conversion_output":true,"text":"The safety summaries will include all 4 treatment groups, comprising all patients in the","text_display":"\n\nThe safety summaries will include all 4 treatment groups, comprising all patients in the","confidence":1,"confidence_rate":1},{"cnt":[[309,1852],[479,1852],[479,1897],[309,1897]],"region":{"top_left_x":309,"top_left_y":1851,"width":171,"height":47},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a8d0a9d9b20342a1b295b33758e20cfa","type":"text","conversion_output":true,"text":"safety set.","text_display":" safety set.","confidence":1,"confidence_rate":1},{"cnt":[[309,1951],[1815,1951],[1815,1996],[309,1996]],"region":{"top_left_x":309,"top_left_y":1950,"width":1507,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3347478f4a748cb85359e514bb9dcd2","type":"text","conversion_output":true,"text":"Treatment-emergent adverse events will be tabulated by treatment group. The number and","text_display":"\n\nTreatment-emergent adverse events will be tabulated by treatment group. The number and","confidence":0.998046875,"confidence_rate":0.9999785163314827},{"cnt":[[309,2011],[1798,2011],[1798,2058],[309,2058]],"region":{"top_left_x":309,"top_left_y":2010,"width":1490,"height":49},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af674aaf2f0a4adca863a4be20bab3d1","type":"text","conversion_output":true,"text":"percentage of patients with at least 1 TEAE will be presented along with a breakdown by","text_display":" percentage of patients with at least 1 TEAE will be presented along with a breakdown by","confidence":1,"confidence_rate":1},{"cnt":[[309,2071],[1712,2071],[1712,2116],[309,2116]],"region":{"top_left_x":309,"top_left_y":2071,"width":1404,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d849b1b1f284835b7ab3602787ec8da","type":"text","conversion_output":true,"text":"system organ class and preferred term, with each patient being counted once at each","text_display":" system organ class and preferred term, with each patient being counted once at each","confidence":1,"confidence_rate":1},{"cnt":[[309,2131],[1820,2131],[1820,2179],[309,2179]],"region":{"top_left_x":309,"top_left_y":2131,"width":1511,"height":48},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b95a10c5ceb843a5af4bde8504e87fff","type":"text","conversion_output":true,"text":"summarization level. 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Other safety data will be listed only.","text_display":" tables included as appropriate. 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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 \\(( \\pm 2\\) days) & Day 21 \\(( \\pm 3\\) days) & Day 28 \\(( \\pm 3\\) days) & Day 60 \\(( \\pm 5\\) days) & Day 90 \\(( \\pm 10\\) days) \\\\\n\\hline AKI diagnosis \\({ }^{\\text {a }}\\) (pre-screening) 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 & & & & & & & & & & & & & \\\\\n\\hline Pregnancy test (urine or blood) \\({ }^{\\text {d }}\\) & X & & & & & & & & & & & & & \\\\\n\\hline Local laboratory confirmatory serum creatinine sample \\({ }^{ e }\\), or confirmatory assessment of continuation of decreased urine output & X & & & & & & & & & & & & & \\\\\n\\hline Randomization \\({ }^{ f }\\) & & X & & & & & & & & & & & & \\\\\n\\hline Vital signs (BP, HR, OS, RR, T) \\({ }^{\\text {g }}\\) & & X & X \\({ }^{ h }\\) & X \\({ }^{ h }\\) & X \\({ }^{ h }\\) & X & X & X & X & X & X & X & & \\\\\n\\hline Physical examination & & X & X & X & X & X & X & X & X & X & X & X & & \\\\\n\\hline APACHE II score & & X & & & & & & & & & & & & \\\\\n\\hline SAPS-2 score & & X & & & & & & & & & & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 13-1 Schedule of Assessments}\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline Assessment & Screening \\(( \\leq 2 4 ~ h )\\) & Baseline 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When the diagnosis of AKI is made according to one of the AKIN serum creatinine criteria (absolute or relative increase, see inclusion criteria 5.a and 5.b), patients will be }}\\)","confidence":0.9194939393472689,"confidence_rate":0.9995560148540392},{"cnt":[[294,1308],[2486,1308],[2486,1347],[294,1347]],"region":{"top_left_x":294,"top_left_y":1308,"width":2192,"height":40},"line":105,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77e9e5c9898b49558a19ef13f8e119e4","type":"text","conversion_output":true,"text":"eligible for the study and can be randomly assigned when the volume-corrected serum creatinine sample, taken at screening confirms the continuation of AKI according to the","text_display":" eligible for the study and can be randomly assigned when the volume-corrected serum creatinine sample, taken at screening confirms the continuation of AKI according to the","confidence":0.9990234375,"confidence_rate":0.9999944486537734},{"cnt":[[296,1345],[2481,1345],[2481,1381],[296,1381]],"region":{"top_left_x":296,"top_left_y":1344,"width":2186,"height":38},"line":106,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4add7b507aa4e4eb2adeb792cf3cf70","type":"text","conversion_output":true,"text":"AKIN criteria for serum creatinine. When the AKI diagnosis was made according to the AKIN urine output criteria (urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\) hours, see inclusion","text_display":" AKIN criteria for serum creatinine. When the AKI diagnosis was made according to the AKIN urine output criteria (urinary output \\(<0.5 mL / kg / h\\) for \\(>6\\) hours, see inclusion","confidence":1,"confidence_rate":1},{"cnt":[[296,1379],[2024,1379],[2024,1420],[296,1420]],"region":{"top_left_x":296,"top_left_y":1379,"width":1728,"height":42},"line":107,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26f0407037b64ce5a236d559c1d3d608","type":"text","conversion_output":true,"text":"criterion 5.c), the oliguria or anuria should still meet the AKIN urine output criteria prior to randomization and study drug administration.","text_display":" criterion 5.c), the oliguria or anuria should still meet the AKIN urine output criteria prior to randomization and study drug administration.","confidence":1,"confidence_rate":1},{"cnt":[[245,1422],[2494,1422],[2494,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1422,"width":2251,"height":42},"line":108,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d8881a7413254866be2bf08bdfe40dda","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 pressure will be monitored non-invasively. In patients who","text_display":"\ng. 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 patients who","confidence":0.9960954189300537,"confidence_rate":0.9999794095601562},{"cnt":[[292,1459],[1949,1459],[1949,1497],[292,1497]],"region":{"top_left_x":292,"top_left_y":1458,"width":1657,"height":40},"line":109,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2005c354a933462cb046b90fef4c98cb","type":"text","conversion_output":true,"text":"already have an arterial line placed as part of standard or care, readings from invasive blood pressure monitoring are to be recorded.","text_display":" already have an arterial line placed as part of standard or care, readings from invasive blood pressure monitoring are to be recorded.","confidence":0.998046875,"confidence_rate":0.9999859351000929},{"cnt":[[245,1495],[2434,1495],[2434,1540],[245,1540]],"region":{"top_left_x":244,"top_left_y":1495,"width":2191,"height":46},"line":110,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f0a38098f424a398643d6132c0e198c","type":"text","conversion_output":true,"text":"\\({ }^{\\text {h. }}\\) Additionally, vital signs (excluding temperature) will also be monitored during study drug infusion on all treatment days at the following times: a) immediately before the","text_display":"\n\\({ }^{\\text {h. }}\\) Additionally, vital signs (excluding temperature) will also be monitored during study drug infusion on all treatment days at the following times: a) immediately before the","confidence":0.8813305566835083,"confidence_rate":0.9993353656136947},{"cnt":[[294,1538],[2445,1538],[2445,1575],[294,1575]],"region":{"top_left_x":294,"top_left_y":1538,"width":2151,"height":37},"line":111,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91831dd248f84aecadcaa8346d4ce283","type":"text","conversion_output":true,"text":"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) immediately after the","text_display":" 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) immediately after the","confidence":1,"confidence_rate":1},{"cnt":[[296,1573],[2477,1573],[2477,1613],[296,1613]],"region":{"top_left_x":296,"top_left_y":1572,"width":2182,"height":42},"line":112,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc7742cba3f04433b6859e034e45b4f1","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 after completion of study drug administration, f) 2 hours, 3","text_display":" completion of the administration of the study drug, which includes post-dose saline flushing, e) 30 and 60 minutes after completion of study drug administration, f) 2 hours, 3","confidence":1,"confidence_rate":1},{"cnt":[[296,1609],[1394,1609],[1394,1648],[296,1648]],"region":{"top_left_x":296,"top_left_y":1609,"width":1099,"height":39},"line":113,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4ace38b22f443518f9272b481a26c83","type":"text","conversion_output":true,"text":"hours, 4 hours, and 5 hours after completion of study drug administration (Day 1 only).","text_display":" hours, 4 hours, and 5 hours after completion of study drug administration (Day 1 only).","confidence":1,"confidence_rate":1},{"cnt":[[245,1646],[2297,1646],[2297,1691],[245,1691]],"region":{"top_left_x":244,"top_left_y":1645,"width":2053,"height":46},"line":114,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0719b2a7ad646ad8c310e3a7c657855","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 discharge from ICU or intermediate care unit.","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 discharge from ICU or intermediate care unit.","confidence":0.44908714294433594,"confidence_rate":0.9952462260268409},{"cnt":[[245,1689],[2494,1689],[2494,1734],[245,1734]],"region":{"top_left_x":244,"top_left_y":1688,"width":2251,"height":46},"line":115,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56fad6b08bbc4240b6a1514eb8d67664","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 case the patient is unconscious, EQ-5D questionnaire will","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 case the patient is unconscious, EQ-5D questionnaire will","confidence":0.5078125,"confidence_rate":0.9963633866501771},{"cnt":[[294,1732],[681,1732],[681,1772],[294,1772]],"region":{"top_left_x":294,"top_left_y":1731,"width":388,"height":42},"line":116,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2af6d982ef10456a8250a7982c3231eb","type":"text","conversion_output":true,"text":"be completed by a next of kin.","text_display":" be completed by a next of kin.","confidence":1,"confidence_rate":1},{"cnt":[[245,1770],[973,1770],[973,1813],[245,1813]],"region":{"top_left_x":244,"top_left_y":1770,"width":730,"height":44},"line":117,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9b4ec55fb4442a292aefafcc4692bf9","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":[[1671,1835],[1809,1835],[1809,1876],[1671,1876]],"region":{"top_left_x":1671,"top_left_y":1834,"width":138,"height":42},"line":118,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90c4c7bf9bc645439cbad3839009694d","type":"page_info","conversion_output":false,"text":"Page 107","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-108","page":108,"lines":[{"cnt":[[242,247],[564,247],[564,354],[242,354]],"region":{"top_left_x":242,"top_left_y":247,"width":322,"height":107},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a5dff26012db4b999477cd208d81a8e0","type":"column","conversion_output":false,"children_ids":["3c8309b2b2524e279bed6e2f77a03eee","f635f2c9db8343d387e481684202551a"],"text":"","text_display":""},{"cnt":[[245,249],[496,249],[496,290],[245,290]],"region":{"top_left_x":244,"top_left_y":249,"width":253,"height":42},"line":2,"column":1,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c8309b2b2524e279bed6e2f77a03eee","type":"text","conversion_output":true,"parent_id":"a5dff26012db4b999477cd208d81a8e0","text":"AM-Pharma B.V.","text_display":"\n\nAM-Pharma B.V.","confidence":1,"confidence_rate":1},{"cnt":[[245,309],[561,309],[561,350],[245,350]],"region":{"top_left_x":244,"top_left_y":309,"width":317,"height":42},"line":3,"column":1,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f635f2c9db8343d387e481684202551a","type":"section_header","conversion_output":false,"parent_id":"a5dff26012db4b999477cd208d81a8e0","children_ids":["9f641ab638f945f8ae7d0481a42c5da1"],"text":"","text_display":""},{"cnt":[[247,314],[556,314],[556,350],[247,350]],"region":{"top_left_x":247,"top_left_y":313,"width":310,"height":38},"line":4,"column":1,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f641ab638f945f8ae7d0481a42c5da1","type":"text","conversion_output":true,"parent_id":"f635f2c9db8343d387e481684202551a","text":"AP-recAP-AKI-02-01","text_display":"\n\n\\section*{AP-recAP-AKI-02-01}","confidence":0.99853515625,"confidence_rate":0.9999362664796542},{"cnt":[[2011,247],[2506,247],[2506,354],[2011,354]],"region":{"top_left_x":2011,"top_left_y":247,"width":495,"height":107},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cd564062d2b148c5bc3d884a7ebc556a","type":"column","conversion_output":false,"children_ids":["dafdce5dc201433f9a7b47df3c360d84","5ab86b50aa1241b98e0d54f4caba61f3"],"text":"","text_display":""},{"cnt":[[2013,249],[2503,249],[2503,294],[2013,294]],"region":{"top_left_x":2013,"top_left_y":249,"width":490,"height":46},"line":6,"column":2,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dafdce5dc201433f9a7b47df3c360d84","type":"text","conversion_output":true,"parent_id":"cd564062d2b148c5bc3d884a7ebc556a","text":"Recombinant alkaline phosphatase","text_display":"\n\nRecombinant alkaline phosphatase","confidence":1,"confidence_rate":1},{"cnt":[[2219,314],[2503,314],[2503,350],[2219,350]],"region":{"top_left_x":2219,"top_left_y":313,"width":284,"height":38},"line":7,"column":2,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5ab86b50aa1241b98e0d54f4caba61f3","type":"text","conversion_output":true,"parent_id":"cd564062d2b148c5bc3d884a7ebc556a","text":"Protocol Version3.0","text_display":"\nProtocol Version3.0","confidence":1,"confidence_rate":1},{"cnt":[[245,365],[2391,365],[2391,410],[245,410]],"region":{"top_left_x":244,"top_left_y":365,"width":2148,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9341368033b94ab18a60715318f3c120","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 measured. When patients have a Foley catheter, serum","text_display":"\n\\({ }^{1}\\). 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, serum","confidence":0.6690849046633502,"confidence_rate":0.9978184465644581},{"cnt":[[294,408],[2454,408],[2454,449],[294,449]],"region":{"top_left_x":294,"top_left_y":408,"width":2160,"height":42},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"193f3433b93c468ab1656ee189b7b11a","type":"text","conversion_output":true,"text":"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 or intermediate","text_display":" 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 or intermediate","confidence":0.87939453125,"confidence_rate":0.9992862457272774},{"cnt":[[296,443],[2481,443],[2481,483],[296,483]],"region":{"top_left_x":296,"top_left_y":442,"width":2186,"height":42},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3e4ae284014477c97e87b5e70ba43a4","type":"text","conversion_output":true,"text":"care unit , the Foley catheter might be removed. In this case, a patient might urinate spontaneously and all efforts should be undertaken to start collecting urine produced from","text_display":" care unit , the Foley catheter might be removed. In this case, a patient might urinate spontaneously and all efforts should be undertaken to start collecting urine produced from","confidence":0.89599609375,"confidence_rate":0.9993967796717307},{"cnt":[[296,481],[2469,481],[2469,520],[296,520]],"region":{"top_left_x":296,"top_left_y":481,"width":2173,"height":39},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8c8057e080aa4700837e5f4796f9c31a","type":"text","conversion_output":true,"text":"this time point onward. Approximately 6 hours later (exact duration needs to be recorded) the patient might urinate again and this urine will be used for analysis, and a blood","text_display":" this time point onward. Approximately 6 hours later (exact duration needs to be recorded) the patient might urinate again and this urine will be used for analysis, and a blood","confidence":0.73388671875,"confidence_rate":0.9983107148095963},{"cnt":[[296,516],[1841,516],[1841,556],[296,556]],"region":{"top_left_x":296,"top_left_y":515,"width":1546,"height":42},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae56c507231947a7ac815de9507b678a","type":"text","conversion_output":true,"text":"sample will be drawn at this time too. The urine volume produced over approximately 6 hours will be entered in the eCRF.","text_display":" sample will be drawn at this time too. The urine volume produced over approximately 6 hours will be entered in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[309,554],[2477,554],[2477,599],[309,599]],"region":{"top_left_x":309,"top_left_y":554,"width":2169,"height":46},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3ba0d38c9f514e3dbd4a338f4739e74a","type":"text","conversion_output":true,"text":"m. Urine creatinine and urea will be measured by a central laboratory. The central laboratory will calculate blood urea nitrogen (BUN) clearance at all visits from Day 1 to","text_display":"\nm. Urine creatinine and urea will be measured by a central laboratory. The central laboratory will calculate blood urea nitrogen (BUN) clearance at all visits from Day 1 to","confidence":0.537109375,"confidence_rate":0.9965528798555962},{"cnt":[[370,593],[2494,593],[2494,634],[370,634]],"region":{"top_left_x":369,"top_left_y":592,"width":2126,"height":42},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"654e1e1950c341cf8cd6335847a8c105","type":"text","conversion_output":true,"text":"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 visits from Day 1 to Day 28,","text_display":" 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 visits from Day 1 to Day 28,","confidence":0.959797779762539,"confidence_rate":0.9997770212613357},{"cnt":[[370,632],[1781,632],[1781,672],[370,672]],"region":{"top_left_x":369,"top_left_y":631,"width":1413,"height":42},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91c8f0189fc14b409169d30611ecfd84","type":"text","conversion_output":true,"text":"only if reliable urine collection is possible (i.e., patient remains in the ICU or intermediate care unit or hospital).","text_display":" 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":[[245,670],[1921,670],[1921,711],[245,711]],"region":{"top_left_x":244,"top_left_y":670,"width":1677,"height":42},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96c56023ffcb4bf99661ccf2777c21c8","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 assessments.","text_display":"\n\\({ }^{\\text {n. }}\\) These assessments will be performed before treatment if possible. Treatment should not be delayed because of these assessments.","confidence":0.26568701516112014,"confidence_rate":0.9909627528212883},{"cnt":[[245,713],[2494,713],[2494,754],[245,754]],"region":{"top_left_x":244,"top_left_y":713,"width":2251,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"603495889db74befa134c6a04fa9023d","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 remains in the ICU or intermediate care unit or hospital). The","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 remains in the ICU or intermediate care unit or hospital). The","confidence":0.9912109375,"confidence_rate":0.9999562984097762},{"cnt":[[294,752],[1818,752],[1818,793],[294,793]],"region":{"top_left_x":294,"top_left_y":751,"width":1524,"height":42},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b16dc07e9f4342238bd6bf996a22ce12","type":"text","conversion_output":true,"text":"volume should be corrected to account for the volume of samples previously taken from the total urine initially collected.","text_display":" 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":[[245,791],[1446,791],[1446,836],[245,836]],"region":{"top_left_x":244,"top_left_y":790,"width":1202,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"afb3af788e61445390ecce2bb370995f","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":0.9588618278503418,"confidence_rate":0.9995800052836397},{"cnt":[[245,834],[1558,834],[1558,879],[245,879]],"region":{"top_left_x":244,"top_left_y":833,"width":1314,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e752079258b42c89065daa68faa2130","type":"text","conversion_output":true,"text":"q. Assays will be performed by a central reference laboratory. See Section 6.3.8.3 for sampling details.","text_display":"\nq. Assays will be performed by a central reference laboratory. See Section 6.3.8.3 for sampling details.","confidence":0.6037089824676514,"confidence_rate":0.9953807657202548},{"cnt":[[245,877],[2112,877],[2112,922],[245,922]],"region":{"top_left_x":244,"top_left_y":876,"width":1868,"height":46},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53a7a3eccfbb4223bac9d341624c9522","type":"text","conversion_output":true,"text":"r. 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":"\nr. 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":0.9579704700736329,"confidence_rate":0.9997316714687655},{"cnt":[[245,920],[662,920],[662,965],[245,965]],"region":{"top_left_x":244,"top_left_y":919,"width":418,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29e3cec06463437aa57bbb47e409ff3b","type":"text","conversion_output":true,"text":"s. Central reference laboratory.","text_display":"\ns. Central reference laboratory.","confidence":1,"confidence_rate":1},{"cnt":[[245,962],[1480,962],[1480,1008],[245,1008]],"region":{"top_left_x":244,"top_left_y":962,"width":1237,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ac92502dcf845268e3ae8d2fc4e2588","type":"text","conversion_output":true,"text":"t. Samples taken on Days 60 and 90 will only be analyzed in case of a positive result on Day 28.","text_display":"\nt. Samples taken on Days 60 and 90 will only be analyzed in case of a positive result on Day 28.","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,1005],[1287,1005],[1287,1046],[245,1046]],"region":{"top_left_x":244,"top_left_y":1005,"width":1043,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8dde444328e247c4a36fdc1b69c023fb","type":"text","conversion_output":true,"text":"u. Verification that no concomitant medications that should be avoided are taken.","text_display":"\nu. 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Crit Care. 2013;17(1):R7.","text_display":" missed cases of acute kidney injury following cardiac arrest. Crit Care. 2013;17(1):R7.","confidence":1,"confidence_rate":1},{"cnt":[[1021,2462],[1158,2462],[1158,2503],[1021,2503]],"region":{"top_left_x":1020,"top_left_y":2462,"width":139,"height":41},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f90f9a3541e545f1b54c4b662f564280","type":"page_info","conversion_output":false,"text":"Page 114","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-115","page":115,"lines":[{"cnt":[[245,254],[496,254],[496,286],[245,286]],"region":{"top_left_x":244,"top_left_y":253,"width":253,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d347dfcd43b449d0aa4f0aa72e4b7b29","type":"page_info","conversion_output":false,"text":"AM-Pharma 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However, creatinine clearance is not fully representative in","confidence":0.996584415435791,"confidence_rate":0.9999632110961949},{"cnt":[[309,1085],[1818,1085],[1818,1137],[309,1137]],"region":{"top_left_x":309,"top_left_y":1084,"width":1509,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df25cbdde6674605973450b340a599ee","type":"text","conversion_output":true,"text":"unstable situations, such as acute kidney injury, because it is influenced by various factors","text_display":" unstable situations, such as acute kidney injury, because it is influenced by various factors","confidence":1,"confidence_rate":1},{"cnt":[[309,1145],[1809,1145],[1809,1197],[309,1197]],"region":{"top_left_x":309,"top_left_y":1145,"width":1500,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8713071c6c9e4730a3a519085f738f09","type":"text","conversion_output":true,"text":"(e.g., diet, muscle mass, physical activity, and excretion and resorption in the kidney) and","text_display":" (e.g., diet, muscle mass, physical activity, and excretion and resorption in the kidney) and","confidence":1,"confidence_rate":1},{"cnt":[[309,1205],[1772,1205],[1772,1250],[309,1250]],"region":{"top_left_x":309,"top_left_y":1205,"width":1464,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"922e4e090b514849a8030f9c40c750e4","type":"text","conversion_output":true,"text":"therefore results of creatinine clearance can be an over- or under-estimation. Creatinine","text_display":" therefore results of creatinine clearance can be an over- or under-estimation. Creatinine","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[309,1268],[1749,1268],[1749,1317],[309,1317]],"region":{"top_left_x":309,"top_left_y":1267,"width":1440,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f5ca8786e8c4cbc8a0448698f0eee6d","type":"text","conversion_output":true,"text":"clearance is routinely used to determine the function of the kidneys irrespective of the","text_display":" clearance is routinely used to determine the function of the kidneys irrespective of the","confidence":1,"confidence_rate":1},{"cnt":[[309,1328],[1480,1328],[1480,1377],[309,1377]],"region":{"top_left_x":309,"top_left_y":1327,"width":1172,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfd627ada79740a2a813cb885a2f3a51","type":"text","conversion_output":true,"text":"drawbacks, since it is inexpensive, non-invasive, and easy to perform.","text_display":" drawbacks, since it is inexpensive, non-invasive, and easy to perform.","confidence":1,"confidence_rate":1},{"cnt":[[309,1427],[1792,1427],[1792,1476],[309,1476]],"region":{"top_left_x":309,"top_left_y":1426,"width":1483,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ab283eda0814e7b93f54e6cff80eafd","type":"text","conversion_output":true,"text":"Marker compounds such as iothalamate, iohexol, or inulin have been used extensively to","text_display":"\n\nMarker compounds such as iothalamate, iohexol, or inulin have been used extensively to","confidence":1,"confidence_rate":1},{"cnt":[[309,1487],[1768,1487],[1768,1536],[309,1536]],"region":{"top_left_x":309,"top_left_y":1486,"width":1460,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bcc162a9e9d48bdac2f4f4dca9893ae","type":"text","conversion_output":true,"text":"measure GFR. Although renal clearance of these markers during continuous infusion is","text_display":" measure GFR. Although renal clearance of these markers during continuous infusion is","confidence":1,"confidence_rate":1},{"cnt":[[309,1547],[1820,1547],[1820,1596],[309,1596]],"region":{"top_left_x":309,"top_left_y":1546,"width":1511,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5b82d7863fb4314b3d388a8354a0608","type":"text","conversion_output":true,"text":"considered the gold standard, simplified methods using limited sampling after intravenous","text_display":" considered the gold standard, simplified methods using limited sampling after intravenous","confidence":1,"confidence_rate":1},{"cnt":[[309,1607],[1571,1607],[1571,1656],[309,1656]],"region":{"top_left_x":309,"top_left_y":1607,"width":1262,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"138ca76325de4238994f32992aabf387","type":"text","conversion_output":true,"text":"bolus administration with and without urine collection have been proposed.","text_display":" bolus administration with and without urine collection have been proposed.","confidence":1,"confidence_rate":1},{"cnt":[[309,1708],[1714,1708],[1714,1755],[309,1755]],"region":{"top_left_x":309,"top_left_y":1708,"width":1406,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7af12d9a998d4d16afcb2f548277478b","type":"text","conversion_output":true,"text":"The GFR estimation methods using creatinine concentration have been described as","text_display":"\n\nThe GFR estimation methods using creatinine concentration have been described as","confidence":1,"confidence_rate":1},{"cnt":[[309,1766],[1691,1766],[1691,1818],[309,1818]],"region":{"top_left_x":309,"top_left_y":1766,"width":1382,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02678ac2d5b24f40be6f85be7aee7154","type":"text","conversion_output":true,"text":"unreliable in some subgroups of the general population, especially in patients with","text_display":" unreliable in some subgroups of the general population, especially in patients with","confidence":1,"confidence_rate":1},{"cnt":[[309,1826],[1768,1826],[1768,1876],[309,1876]],"region":{"top_left_x":309,"top_left_y":1826,"width":1460,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48ed60c30df1453e8f3419e79521f7d3","type":"text","conversion_output":true,"text":"non-steady state renal function. As iohexol has the main characteristics of a convenient","text_display":" non-steady state renal function. As iohexol has the main characteristics of a convenient","confidence":1,"confidence_rate":1},{"cnt":[[309,1886],[1745,1886],[1745,1936],[309,1936]],"region":{"top_left_x":309,"top_left_y":1886,"width":1436,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2acb4540adbc41c7a6c23fe9423bc142","type":"text","conversion_output":true,"text":"marker of GFR, its plasma clearance seems to be the best choice to determine GFR in","text_display":" marker of GFR, its plasma clearance seems to be the best choice to determine GFR in","confidence":1,"confidence_rate":1},{"cnt":[[309,1946],[1865,1946],[1865,1996],[309,1996]],"region":{"top_left_x":309,"top_left_y":1946,"width":1556,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d1e88dd8e3343b58b25cfa1ebcc8b0b","type":"text","conversion_output":true,"text":"controlled laboratory settings. Contrary to determination of renal clearance of inulin, iohexol","text_display":" controlled laboratory settings. Contrary to determination of renal clearance of inulin, iohexol","confidence":1,"confidence_rate":1},{"cnt":[[305,2007],[1433,2007],[1433,2056],[305,2056]],"region":{"top_left_x":305,"top_left_y":2006,"width":1129,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf63a0dfdf6b4af1bfb20368a111f060","type":"text","conversion_output":true,"text":"plasma clearance does not require continuous intravenous infusion.","text_display":" plasma clearance does not require continuous intravenous infusion.","confidence":1,"confidence_rate":1},{"cnt":[[309,2110],[1858,2110],[1858,2159],[309,2159]],"region":{"top_left_x":309,"top_left_y":2109,"width":1550,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84c4d6465bf34bed9a920215b567ee73","type":"text","conversion_output":true,"text":"It is generally assumed that endogenous creatinine clearance is not influenced by continuous","text_display":"\n\nIt is generally assumed that endogenous creatinine clearance is not influenced by continuous","confidence":1,"confidence_rate":1},{"cnt":[[309,2170],[1811,2170],[1811,2219],[309,2219]],"region":{"top_left_x":309,"top_left_y":2169,"width":1503,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aacbdcbaa9ca408f85992cc1c8e9efdc","type":"text","conversion_output":true,"text":"renal replacement therapy. In order to reliably determine potential changes in endogenous","text_display":" renal replacement therapy. In order to reliably determine potential changes in endogenous","confidence":1,"confidence_rate":1},{"cnt":[[309,2230],[1858,2230],[1858,2279],[309,2279]],"region":{"top_left_x":309,"top_left_y":2230,"width":1550,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa6d8f8ac14e4cfb922e23fabc32645d","type":"text","conversion_output":true,"text":"creatinine clearance, any change in creatinine clearance needs to be excluded. To evaluate if","text_display":" creatinine clearance, any change in creatinine clearance needs to be excluded. To evaluate if","confidence":1,"confidence_rate":1},{"cnt":[[309,2290],[1764,2290],[1764,2340],[309,2340]],"region":{"top_left_x":309,"top_left_y":2290,"width":1455,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5d08352523f42c3ab9e250565f491b3","type":"text","conversion_output":true,"text":"renal replacement therapy (RRT) has an effect on endogenous creatinine clearance, the","text_display":" renal replacement therapy (RRT) has an effect on endogenous creatinine clearance, the","confidence":1,"confidence_rate":1},{"cnt":[[309,2350],[1738,2350],[1738,2400],[309,2400]],"region":{"top_left_x":309,"top_left_y":2350,"width":1430,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89c9a059325e4547b4952e1e065fd08a","type":"text","conversion_output":true,"text":"exogenous creatinine clearance by RRT equipment will be assessed by measuring the","text_display":" exogenous creatinine clearance by RRT 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volume during the \\(6 \\pm 1\\) hour urine","confidence":1,"confidence_rate":1},{"cnt":[[305,434],[625,434],[625,477],[305,477]],"region":{"top_left_x":305,"top_left_y":433,"width":321,"height":44},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eee93dbd3f1e4ea4b53010e5f6721da7","type":"text","conversion_output":true,"text":"collection interval.","text_display":" collection 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and on Day 7 or discharge from the ICU, whichever","confidence":1,"confidence_rate":1},{"cnt":[[305,743],[1781,743],[1781,793],[305,793]],"region":{"top_left_x":305,"top_left_y":743,"width":1477,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7285225e6f114aa5836e0ab866382306","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. 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After centrifugation ( \\(500 \\times g , 10\\) minutes),","text_display":" administration and at 60,120 , and 360 minutes. After centrifugation ( \\(500 \\times g , 10\\) minutes),","confidence":0.8490269154779199,"confidence_rate":0.9984571876754743},{"cnt":[[305,1177],[1725,1177],[1725,1227],[305,1227]],"region":{"top_left_x":305,"top_left_y":1177,"width":1421,"height":50},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f42a759fe93e423b9794b2c36ea7c685","type":"text","conversion_output":true,"text":"the remaining approximately 1 mL of plasma will be divided into 2 Micronic \\(1.4- mL\\)","text_display":" the remaining approximately 1 mL of plasma will be divided into 2 Micronic \\(1.4- mL\\)","confidence":0.9960954189300537,"confidence_rate":0.9999592484986185},{"cnt":[[305,1233],[1852,1233],[1852,1287],[305,1287]],"region":{"top_left_x":305,"top_left_y":1233,"width":1547,"height":54},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8d98521233f4ec0b9b838f7bed65032","type":"text","conversion_output":true,"text":"cryotubes and stored at \\(-80^{\\circ} C\\), until batched shipments to the central laboratory are sent and","text_display":" cryotubes and stored at \\(-80^{\\circ} C\\), until batched shipments to the central laboratory are sent and","confidence":1,"confidence_rate":1},{"cnt":[[305,1296],[1815,1296],[1815,1347],[305,1347]],"region":{"top_left_x":305,"top_left_y":1295,"width":1511,"height":53},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8121305117894f8a96b223d4f17fe17a","type":"text","conversion_output":true,"text":"further processing of one of each cryotubes at the Hillcrest Medical Center, United States,","text_display":" further processing of one of each cryotubes at the Hillcrest Medical Center, United States,","confidence":1,"confidence_rate":1},{"cnt":[[305,1358],[524,1358],[524,1403],[305,1403]],"region":{"top_left_x":305,"top_left_y":1357,"width":220,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b4fb6ddb20d49d2a25e7b0064bacc1c","type":"text","conversion_output":true,"text":"can be done.","text_display":" can be done.","confidence":1,"confidence_rate":1},{"cnt":[[305,1457],[1848,1457],[1848,1510],[305,1510]],"region":{"top_left_x":305,"top_left_y":1456,"width":1543,"height":55},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"537112dc8f6c429ca0b0332876caac71","type":"text","conversion_output":true,"text":"Five-milliliter urine samples will be collected prior to the bolus infusions, and the urine bag","text_display":"\n\nFive-milliliter urine samples will be collected prior to the bolus infusions, and the urine bag","confidence":1,"confidence_rate":1},{"cnt":[[305,1517],[1867,1517],[1867,1568],[305,1568]],"region":{"top_left_x":305,"top_left_y":1516,"width":1562,"height":53},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3e2f16e9816f471e9ddfbf7ed19953e9","type":"text","conversion_output":true,"text":"will be emptied. Starting with freshly produced urine, \\(5- mL\\) samples will be taken at 60,120 ,","text_display":" will be emptied. Starting with freshly produced urine, \\(5- mL\\) samples will be taken at 60,120 ,","confidence":0.9219503402709961,"confidence_rate":0.9992408124619432},{"cnt":[[305,1577],[1830,1577],[1830,1629],[305,1629]],"region":{"top_left_x":305,"top_left_y":1576,"width":1526,"height":53},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8269727aa70a4a4f826aa23c3b67036e","type":"text","conversion_output":true,"text":"and 360 minutes directly from the Foley catheter. An additional \\(5- mL\\) sample will be taken","text_display":" and 360 minutes directly from the Foley catheter. An additional \\(5- mL\\) sample will be taken","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[305,1637],[1798,1637],[1798,1687],[305,1687]],"region":{"top_left_x":305,"top_left_y":1637,"width":1494,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e21ebd72b2b4666b9e176babbab87b7","type":"text","conversion_output":true,"text":"from the combined total volume that was collected during the \\(6 \\pm 1\\) hour urine collection","text_display":" from the combined total volume that was collected during the \\(6 \\pm 1\\) hour urine collection","confidence":1,"confidence_rate":1},{"cnt":[[305,1697],[1858,1697],[1858,1747],[305,1747]],"region":{"top_left_x":305,"top_left_y":1697,"width":1554,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca02bad3a8ca492eb8e8a83c54408719","type":"text","conversion_output":true,"text":"interval. The volumes of urine produced at the \\(60-, 120-\\), and 360 -minute time points will be","text_display":" interval. The volumes of urine produced at the \\(60-, 120-\\), and 360 -minute time points will be","confidence":0.6599458296392551,"confidence_rate":0.9960118438675633},{"cnt":[[305,1757],[1850,1757],[1850,1807],[305,1807]],"region":{"top_left_x":305,"top_left_y":1757,"width":1545,"height":50},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7baf375645e54df884158a2a80de5f48","type":"text","conversion_output":true,"text":"entered in the electronic case report form (eCRF). The total volume of urine collected in the","text_display":" entered in the electronic case report form (eCRF). The total volume of urine collected in the","confidence":0.9970703125,"confidence_rate":0.999970061800863},{"cnt":[[305,1818],[1863,1818],[1863,1867],[305,1867]],"region":{"top_left_x":305,"top_left_y":1817,"width":1558,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca701af63b3f4869a88ef48541610974","type":"text","conversion_output":true,"text":"\\(6 \\pm 1\\) hour interval will be corrected for the volume of samples taken during this interval and","text_display":" \\(6 \\pm 1\\) hour interval will be corrected for the volume of samples taken during this interval and","confidence":1,"confidence_rate":1},{"cnt":[[305,1878],[1854,1878],[1854,1927],[305,1927]],"region":{"top_left_x":305,"top_left_y":1877,"width":1550,"height":51},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed81a751d9124313a3bdf009e8b2d9f0","type":"text","conversion_output":true,"text":"also entered in the eCRF. Urine tubes will be stored at \\(-80^{\\circ} C\\), until batched shipments to the","text_display":" also entered in the eCRF. Urine tubes will be stored at \\(-80^{\\circ} C\\), until batched shipments to the","confidence":1,"confidence_rate":1},{"cnt":[[305,1938],[1863,1938],[1863,1987],[305,1987]],"region":{"top_left_x":305,"top_left_y":1937,"width":1558,"height":51},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7858c4ccbd774e8cbddb9804214c89e5","type":"text","conversion_output":true,"text":"central laboratory are sent and further processing of the urine at the Hillcrest Medical Center","text_display":" central laboratory are sent and further processing of the urine at the Hillcrest Medical Center","confidence":1,"confidence_rate":1},{"cnt":[[305,1998],[524,1998],[524,2043],[305,2043]],"region":{"top_left_x":305,"top_left_y":1998,"width":220,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0ca89b2d0074acfb38d8d4b23119965","type":"text","conversion_output":true,"text":"can be done.","text_display":" can be done.","confidence":1,"confidence_rate":1},{"cnt":[[305,2097],[1852,2097],[1852,2151],[305,2151]],"region":{"top_left_x":305,"top_left_y":2096,"width":1547,"height":55},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d7c427c09e04a74ae9382beb471aec2","type":"text","conversion_output":true,"text":"The sample time points of effluent will be at \\(t =360\\) minutes of the urine collection interval,","text_display":"\n\nThe sample time points of effluent will be at \\(t =360\\) minutes of the urine collection interval,","confidence":0.998046875,"confidence_rate":0.9999812017648063},{"cnt":[[305,2157],[1841,2157],[1841,2211],[305,2211]],"region":{"top_left_x":305,"top_left_y":2157,"width":1537,"height":54},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65c3c98f2f89476585d7335302d8dd37","type":"text","conversion_output":true,"text":"analogous to the time points for serum creatinine determinations, as needed for endogenous","text_display":" analogous to the time points for serum creatinine determinations, as needed for endogenous","confidence":1,"confidence_rate":1},{"cnt":[[305,2217],[1830,2217],[1830,2271],[305,2271]],"region":{"top_left_x":305,"top_left_y":2217,"width":1526,"height":54},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e29f4d46a7254c4ead09ea53d76340cd","type":"text","conversion_output":true,"text":"creatinine clearance calculations. Two samples of 1 mL will be taken from the effluent and","text_display":" creatinine clearance calculations. Two samples of 1 mL will be taken from the effluent and","confidence":1,"confidence_rate":1},{"cnt":[[305,2277],[1729,2277],[1729,2331],[305,2331]],"region":{"top_left_x":305,"top_left_y":2277,"width":1425,"height":55},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a5229e4ff8b41249ebc46ab6df2adfa","type":"text","conversion_output":true,"text":"stored in Micronic \\(1.4- mL\\) cryotubes at \\(-80^{\\circ} C\\), until batched shipments to the central","text_display":" stored in Micronic \\(1.4- mL\\) cryotubes at \\(-80^{\\circ} C\\), until batched shipments to the central","confidence":0.99755859375,"confidence_rate":0.9999775746428119},{"cnt":[[1023,2462],[1158,2462],[1158,2503],[1023,2503]],"region":{"top_left_x":1022,"top_left_y":2462,"width":137,"height":41},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2b36eccf379a4c129dfceed4d10e4763","type":"page_info","conversion_output":false,"text":"Page 117","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"033323a6-6593-47a0-acf5-0be4b3d8207d-118","page":118,"lines":[{"cnt":[[303,247],[624,247],[624,354],[303,354]],"region":{"top_left_x":303,"top_left_y":247,"width":321,"height":107},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5fe87b190a4d4a458216be28988d4211","type":"column","conversion_output":false,"children_ids":["2603fe7cd36948feb07dc22426269868","1f47ebf70e614ac7b9feb4b09d7a667f"],"text":"","text_display":""},{"cnt":[[305,249],[561,249],[561,290],[305,290]],"region":{"top_left_x":305,"top_left_y":249,"width":256,"height":42},"line":2,"column":1,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2603fe7cd36948feb07dc22426269868","type":"text","conversion_output":true,"parent_id":"5fe87b190a4d4a458216be28988d4211","text":"AM-Pharma B.V.","text_display":"\n\nAM-Pharma B.V.","confidence":1,"confidence_rate":1},{"cnt":[[305,314],[621,314],[621,350],[305,350]],"region":{"top_left_x":305,"top_left_y":313,"width":316,"height":38},"line":3,"column":1,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f47ebf70e614ac7b9feb4b09d7a667f","type":"text","conversion_output":true,"parent_id":"5fe87b190a4d4a458216be28988d4211","text":"AP-recAP-AKI-02-01","text_display":"\nAP-recAP-AKI-02-01","confidence":1,"confidence_rate":1},{"cnt":[[1377,247],[1875,247],[1875,354],[1377,354]],"region":{"top_left_x":1377,"top_left_y":247,"width":498,"height":107},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0068370735924280a7dedbceb3997ead","type":"column","conversion_output":false,"children_ids":["f67cf27e94d54d859798378817657884","c675960159df4dd9852d9ad9654adbb9"],"text":"","text_display":""},{"cnt":[[1379,249],[1871,249],[1871,294],[1379,294]],"region":{"top_left_x":1379,"top_left_y":249,"width":493,"height":46},"line":5,"column":2,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f67cf27e94d54d859798378817657884","type":"text","conversion_output":true,"parent_id":"0068370735924280a7dedbceb3997ead","text":"Recombinant alkaline phosphatase","text_display":"\n\nRecombinant alkaline phosphatase","confidence":1,"confidence_rate":1},{"cnt":[[1577,314],[1871,314],[1871,350],[1577,350]],"region":{"top_left_x":1576,"top_left_y":313,"width":296,"height":38},"line":6,"column":2,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c675960159df4dd9852d9ad9654adbb9","type":"text","conversion_output":true,"parent_id":"0068370735924280a7dedbceb3997ead","text":"Protocol Version 3.0","text_display":"\nProtocol Version 3.0","confidence":1,"confidence_rate":1},{"cnt":[[305,374],[1815,374],[1815,423],[305,423]],"region":{"top_left_x":305,"top_left_y":373,"width":1511,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19e0a0aacc3341468788c5a842e07aa0","type":"text","conversion_output":true,"text":"laboratory are sent and further processing of one of each cryotube at the Hillcrest Medical","text_display":"\nlaboratory are sent and further processing of one of each cryotube at the Hillcrest Medical","confidence":1,"confidence_rate":1},{"cnt":[[305,432],[1626,432],[1626,479],[305,479]],"region":{"top_left_x":305,"top_left_y":431,"width":1322,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2ca3cbc51a5498e8aa86d5420c1f49a","type":"text","conversion_output":true,"text":"Center can be done. The total volume of effluent will be recorded in the eCRF.","text_display":" Center can be done. The total volume of effluent will be recorded in the eCRF.","confidence":0.9990234375,"confidence_rate":0.9999882285072625},{"cnt":[[305,533],[1846,533],[1846,587],[305,587]],"region":{"top_left_x":305,"top_left_y":532,"width":1541,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0f877339b654463b18f856cc7129d26","type":"text","conversion_output":true,"text":"Although urine collection for 6 hours is preferred, a time window of \\(\\pm 1\\) hour is allowed for","text_display":"\n\nAlthough urine collection for 6 hours is preferred, a time window of \\(\\pm 1\\) hour is allowed for","confidence":0.9697692256886512,"confidence_rate":0.999699092855645},{"cnt":[[305,593],[1876,593],[1876,647],[305,647]],"region":{"top_left_x":305,"top_left_y":592,"width":1571,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c833fbe6ee84bfb8dd70b6e480eddc9","type":"text","conversion_output":true,"text":"pragmatic reasons adding flexibility to the schedule. In case the urine sampling interval is not","text_display":" pragmatic reasons adding flexibility to the schedule. In case the urine sampling interval is not","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[305,653],[1869,653],[1869,707],[305,707]],"region":{"top_left_x":305,"top_left_y":653,"width":1565,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1daff7f115854dc983a6cfd2bf1be559","type":"text","conversion_output":true,"text":"exactly 6 hours, the last urine and blood sampling time points will have to match, e.g., with a","text_display":" exactly 6 hours, the last urine and blood sampling time points will have to match, e.g., with a","confidence":1,"confidence_rate":1},{"cnt":[[305,713],[1689,713],[1689,767],[305,767]],"region":{"top_left_x":305,"top_left_y":713,"width":1384,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d66e6d3c2a74fe7b44f8276d31fc4de","type":"text","conversion_output":true,"text":"5 -hour urine collection interval the last urine and blood sample will be obtained at","text_display":" 5 -hour urine collection interval the last urine and blood sample will be obtained at","confidence":0.69921875,"confidence_rate":0.9959879391368359},{"cnt":[[305,776],[587,776],[587,821],[305,821]],"region":{"top_left_x":305,"top_left_y":775,"width":282,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8919df1159748c0b7804ec37c0e98d3","type":"text","conversion_output":true,"text":"\\(t =300\\) minutes.","text_display":" \\(t =300\\) 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adenosine triphosphate (ATP), adenosine diphosphate (ADP), adenosine","text_display":" Urinary levels of adenosine triphosphate (ATP), adenosine diphosphate (ADP), adenosine","confidence":1,"confidence_rate":1},{"cnt":[[305,1205],[1863,1205],[1863,1257],[305,1257]],"region":{"top_left_x":305,"top_left_y":1205,"width":1558,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e0be307340b43b995d79d60f7326b30","type":"text","conversion_output":true,"text":"monophosphate (AMP), cyclic AMP (cAMP), and adenosine will be analyzed centrally from","text_display":" monophosphate (AMP), cyclic AMP (cAMP), and adenosine will be analyzed centrally 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iohexol, or inulin have been used extensively to","confidence":1,"confidence_rate":1},{"cnt":[[305,1317],[1781,1317],[1781,1371],[305,1371]],"region":{"top_left_x":305,"top_left_y":1316,"width":1477,"height":55},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f6ff8e2edd2641038fc9d213cec69abd","type":"text","conversion_output":true,"text":"measure GFR, while ERPF is most commonly measured using para-aminohippuric acid","text_display":" measure GFR, while ERPF is most commonly measured using para-aminohippuric acid","confidence":0.9960987546946853,"confidence_rate":0.9999534668563572},{"cnt":[[305,1379],[432,1379],[432,1429],[305,1429]],"region":{"top_left_x":305,"top_left_y":1379,"width":127,"height":50},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82cd6ab762d448a3994a1e57cb62b524","type":"text","conversion_output":true,"text":"(PAH).","text_display":" (PAH).","confidence":0.9985356330871582,"confidence_rate":0.9998667870421855},{"cnt":[[305,1480],[1837,1480],[1837,1532],[305,1532]],"region":{"top_left_x":305,"top_left_y":1480,"width":1532,"height":52},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7516d93e33a648959de6fafef541ba41","type":"text","conversion_output":true,"text":"Para-aminohippuric acid is an ideal marker for estimating ERPF since it is freely filtered at","text_display":"\n\nPara-aminohippuric acid is an ideal marker for estimating ERPF since it is freely filtered at","confidence":0.9790653930976987,"confidence_rate":0.9997841371499765},{"cnt":[[305,1538],[1824,1538],[1824,1592],[305,1592]],"region":{"top_left_x":305,"top_left_y":1538,"width":1520,"height":54},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a19bdd1621e4953a995d7451903d224","type":"text","conversion_output":true,"text":"the glomerulus and undergoes extensive secretion and negligible reabsorption within renal","text_display":" the glomerulus and undergoes extensive secretion and negligible reabsorption within renal","confidence":0.966796875,"confidence_rate":0.9996408425712976},{"cnt":[[305,1598],[1841,1598],[1841,1652],[305,1652]],"region":{"top_left_x":305,"top_left_y":1598,"width":1537,"height":55},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f2f52f5b6b9477ba9d972e6405b6d62","type":"text","conversion_output":true,"text":"tubules. However, approximately 20\\% of PAH is metabolized to acetyl para aminohippuric","text_display":" tubules. However, approximately 20\\% of PAH is metabolized to acetyl para aminohippuric","confidence":0.5748648637372078,"confidence_rate":0.9939347290711775},{"cnt":[[305,1659],[986,1659],[986,1712],[305,1712]],"region":{"top_left_x":305,"top_left_y":1658,"width":682,"height":55},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"670c168fa4ef4680ba8c9d03102b9f37","type":"text","conversion_output":true,"text":"acid, which is also extensively secreted.","text_display":" acid, which is also extensively secreted.","confidence":1,"confidence_rate":1},{"cnt":[[305,1762],[1089,1762],[1089,1815],[305,1815]],"region":{"top_left_x":305,"top_left_y":1761,"width":785,"height":55},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2ccebe54e8254ed6a26fb6c5a64ec939","type":"text","conversion_output":true,"text":"Iohexol and Para Aminehippuric Acid Dosing","text_display":"\n\nIohexol and Para Aminehippuric Acid Dosing","confidence":0.6817454118281603,"confidence_rate":0.9918820873878973},{"cnt":[[305,1861],[1833,1861],[1833,1914],[305,1914]],"region":{"top_left_x":305,"top_left_y":1860,"width":1528,"height":55},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d23a12df0d124b70aaa687482c88307d","type":"text","conversion_output":true,"text":"PAH: A single intravenous bolus injection of \\(400- mg\\) PAH will be given over 5 minutes on","text_display":"\n\nPAH: A single intravenous bolus injection of \\(400- mg\\) PAH will be given over 5 minutes on","confidence":0.992196798324585,"confidence_rate":0.9999224405725889},{"cnt":[[305,1921],[1846,1921],[1846,1974],[305,1974]],"region":{"top_left_x":305,"top_left_y":1920,"width":1541,"height":55},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"66bfb982cf564ee7a928cc843119d039","type":"text","conversion_output":true,"text":"Day 1 and on Day 7 or discharge from the intensive care unit (ICU), whichever comes first.","text_display":" Day 1 and on Day 7 or discharge from the intensive care unit (ICU), whichever comes first.","confidence":1,"confidence_rate":1},{"cnt":[[305,1981],[1729,1981],[1729,2030],[305,2030]],"region":{"top_left_x":305,"top_left_y":1980,"width":1425,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fe651f320bd241eab9519d909e7e61db","type":"text","conversion_output":true,"text":"The bolus will be administered at the start of the \\(6 \\pm 1\\) hour urine collection interval.","text_display":" The bolus will be administered at the start of the \\(6 \\pm 1\\) hour urine collection interval.","confidence":1,"confidence_rate":1},{"cnt":[[305,2084],[1130,2084],[1130,2138],[305,2138]],"region":{"top_left_x":305,"top_left_y":2083,"width":826,"height":55},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8976e6f5c2442acbf79581f6b59ef2a","type":"text","conversion_output":true,"text":"Iohexol and Para-Aminohippuric Acid Sampling","text_display":"\n\nIohexol and Para-Aminohippuric Acid Sampling","confidence":0.9065673351287842,"confidence_rate":0.9980001661905938},{"cnt":[[305,2185],[1811,2185],[1811,2237],[305,2237]],"region":{"top_left_x":305,"top_left_y":2184,"width":1507,"height":53},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c494c25730b841a9a82b9ab10766eb3f","type":"text","conversion_output":true,"text":"For the simultaneous measurement of both iohexol and PAH, \\(2- mL\\) blood samples will be","text_display":"\n\nFor the simultaneous measurement of both iohexol and PAH, \\(2- mL\\) blood samples will be","confidence":0.6729512214660645,"confidence_rate":0.9958393906682138},{"cnt":[[305,2239],[1807,2239],[1807,2297],[305,2297]],"region":{"top_left_x":305,"top_left_y":2238,"width":1502,"height":59},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c507790f44414c239edf9ddfb1dbfa09","type":"text","conversion_output":true,"text":"collected in EDTA anticoagulated Vacutainer \\({ }^{\\circledR}\\) tubes at the following time points: prior to","text_display":" collected in EDTA anticoagulated Vacutainer \\({ }^{\\circledR}\\) tubes at the following time points: prior to","confidence":0.85205078125,"confidence_rate":0.9984763129295129},{"cnt":[[305,2303],[1506,2303],[1506,2357],[305,2357]],"region":{"top_left_x":305,"top_left_y":2303,"width":1202,"height":54},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5455d7b953b4879b3ea5fd01dec7541","type":"text","conversion_output":true,"text":"PAH and iohexol bolus administration and at 60,120 , and 360 minutes.","text_display":" PAH and iohexol bolus administration and at 60,120 , and 360 minutes.","confidence":0.9843823909759521,"confidence_rate":0.9998032587473078},{"cnt":[[1018,2462],[1158,2462],[1158,2503],[1018,2503]],"region":{"top_left_x":1018,"top_left_y":2462,"width":141,"height":41},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"514ba33145354ea680629e7b958bbd2f","type":"page_info","conversion_output":false,"text":"Page 162","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]}]}