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INTRODUCTION}","confidence":1,"confidence_rate":1},{"cnt":[[305,563],[1878,563],[1878,612],[305,612]],"region":{"top_left_x":305,"top_left_y":562,"width":1573,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bf3000e918a4396b86d9315f7ecfc78","type":"text","conversion_output":true,"text":"The algorithm-based treatment study with staphylococcal blood stream infection evaluates","text_display":"\n\nThe algorithm-based treatment study with staphylococcal blood stream infection evaluates","confidence":1,"confidence_rate":1},{"cnt":[[307,610],[1880,610],[1880,660],[307,660]],"region":{"top_left_x":307,"top_left_y":610,"width":1573,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b06aa1aad72435cb3836d51b30d7bd9","type":"text","conversion_output":true,"text":"the safety and efficacy of a treatment algorithm to reduce the use of vancomycin in adult","text_display":" the safety and efficacy of a treatment algorithm to reduce the use of vancomycin in adult","confidence":1,"confidence_rate":1},{"cnt":[[305,660],[1880,660],[1880,709],[305,709]],"region":{"top_left_x":305,"top_left_y":659,"width":1575,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"746e2e1b9e8f4d1dafa630a8f56b4dd3","type":"text","conversion_output":true,"text":"patients with blood stream infections due to staphylococci. This statistical analysis plan was","text_display":" patients with blood stream infections due to staphylococci. This statistical analysis plan was","confidence":1,"confidence_rate":1},{"cnt":[[305,707],[1878,707],[1878,758],[305,758]],"region":{"top_left_x":305,"top_left_y":706,"width":1573,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3b1c0f724324c7fae176f8f90576b8e","type":"text","conversion_output":true,"text":"developed based on the information contained in the study protocol DMID 09-0080. Tables,","text_display":" developed based on the information contained in the study protocol DMID 09-0080. Tables,","confidence":1,"confidence_rate":1},{"cnt":[[305,756],[1876,756],[1876,804],[305,804]],"region":{"top_left_x":305,"top_left_y":756,"width":1571,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d1e68e82acf41bd9b3f322f41f0ca4a","type":"text","conversion_output":true,"text":"Figures and Listings of DSMB and final study reports are displayed in separate documents.","text_display":" Figures and Listings of DSMB and final study reports are displayed in separate documents.","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[305,804],[1880,804],[1880,853],[305,853]],"region":{"top_left_x":305,"top_left_y":803,"width":1575,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"128fa89d7d7f4b6b826d34647d011193","type":"text","conversion_output":true,"text":"The purpose of this analysis plan is to provide a detailed description of the planned statistical","text_display":" The purpose of this analysis plan is to provide a detailed description of the planned statistical","confidence":1,"confidence_rate":1},{"cnt":[[305,851],[1880,851],[1880,900],[305,900]],"region":{"top_left_x":305,"top_left_y":850,"width":1575,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ee4d74640484e18a022f20934524298","type":"text","conversion_output":true,"text":"analysis of the safety and efficacy endpoints presented for monthly safety monitoring,","text_display":" analysis of the safety and efficacy endpoints presented for monthly safety monitoring,","confidence":1,"confidence_rate":1},{"cnt":[[305,900],[838,900],[838,947],[305,947]],"region":{"top_left_x":305,"top_left_y":900,"width":533,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63db7084d26648eca1f199dda986c37e","type":"text","conversion_output":true,"text":"DSMB , and final study reports.","text_display":" DSMB , and final study reports.","confidence":0.91943359375,"confidence_rate":0.9977919818583386},{"cnt":[[303,984],[668,984],[668,1042],[303,1042]],"region":{"top_left_x":302,"top_left_y":983,"width":367,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a475d0e4895d43c68de82621987ba322","type":"section_header","conversion_output":false,"children_ids":["9dee0c19f8734dab8bad9a2004654714"],"text":"","text_display":""},{"cnt":[[305,988],[664,988],[664,1038],[305,1038]],"region":{"top_left_x":305,"top_left_y":988,"width":359,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9dee0c19f8734dab8bad9a2004654714","type":"text","conversion_output":true,"parent_id":"a475d0e4895d43c68de82621987ba322","text":"4.1 Study Design","text_display":"\n\n\\subsection*{4.1 Study Design}","confidence":1,"confidence_rate":1},{"cnt":[[305,1057],[1880,1057],[1880,1106],[305,1106]],"region":{"top_left_x":305,"top_left_y":1057,"width":1575,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dae7c15a9aca450aadb80cbb8a57e222","type":"text","conversion_output":true,"text":"This is a phase 2, multi-center, randomized, open-label comparative study to assess the safety","text_display":"\n\nThis is a phase 2, multi-center, randomized, open-label comparative study to assess the safety","confidence":1,"confidence_rate":1},{"cnt":[[305,1104],[1880,1104],[1880,1154],[305,1154]],"region":{"top_left_x":305,"top_left_y":1104,"width":1575,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"814de6cb4c5e4e64893e286e8a9184a1","type":"text","conversion_output":true,"text":"and efficacy of a treatment algorithm to reduce the use of vancomycin in adult patients with","text_display":" and efficacy of a treatment algorithm to reduce the use of vancomycin in adult patients with","confidence":1,"confidence_rate":1},{"cnt":[[305,1152],[1880,1152],[1880,1201],[305,1201]],"region":{"top_left_x":305,"top_left_y":1151,"width":1575,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67cc5fe16dac46789027e6028c375166","type":"text","conversion_output":true,"text":"blood stream infections due to staphylococci. It is a multicenter trial conducted in 16 sites- 15","text_display":" blood stream infections due to staphylococci. It is a multicenter trial conducted in 16 sites- 15","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[305,1199],[1880,1199],[1880,1248],[305,1248]],"region":{"top_left_x":305,"top_left_y":1198,"width":1575,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c79c293bfe34917bb9fcbccc1ff486d","type":"text","conversion_output":true,"text":"sites in the United States (US) and 1 site in Spain. The study will last about six years. The","text_display":" sites in the United States (US) and 1 site in Spain. The study will last about six years. The","confidence":1,"confidence_rate":1},{"cnt":[[305,1250],[1880,1250],[1880,1298],[305,1298]],"region":{"top_left_x":305,"top_left_y":1250,"width":1575,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f11baa1373d3443496e05edcaabde8a0","type":"text","conversion_output":true,"text":"total enrollment is of approximately 500 patients at least 18 years of age who have a blood","text_display":" total enrollment is of approximately 500 patients at least 18 years of age who have a blood","confidence":1,"confidence_rate":1},{"cnt":[[305,1298],[1878,1298],[1878,1347],[305,1347]],"region":{"top_left_x":305,"top_left_y":1297,"width":1573,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7e1b2995bfd4600b6b3b4643cb73d27","type":"text","conversion_output":true,"text":"stream infection with staphylococci (see details in Sample size and Power section).","text_display":" stream infection with staphylococci (see details in Sample size and Power section).","confidence":1,"confidence_rate":1},{"cnt":[[305,1345],[1880,1345],[1880,1394],[305,1394]],"region":{"top_left_x":305,"top_left_y":1344,"width":1575,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ad0c6263bbc4d989ae4001697e2fd1b","type":"text","conversion_output":true,"text":"Randomization will be \\(1: 1\\) Algorithm vs SOC in permuted randomized blocks by site using","text_display":" Randomization will be \\(1: 1\\) Algorithm vs SOC in permuted randomized blocks by site using","confidence":0.99755859375,"confidence_rate":0.9999739961748949},{"cnt":[[305,1392],[1880,1392],[1880,1442],[305,1442]],"region":{"top_left_x":305,"top_left_y":1392,"width":1575,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65aa55b638f840e6bb034e7b91cc22a0","type":"text","conversion_output":true,"text":"an interactive voice randomization system (IVRS). As the primary safety and efficacy","text_display":" an interactive voice randomization system (IVRS). As the primary safety and efficacy","confidence":1,"confidence_rate":1},{"cnt":[[305,1439],[1880,1439],[1880,1489],[305,1489]],"region":{"top_left_x":305,"top_left_y":1439,"width":1575,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b39c02147c44d1ba13039624576b836","type":"text","conversion_output":true,"text":"endpoint, cure rate will be recorded at Final Test of Cure (TOC) evaluation following last","text_display":" endpoint, cure rate will be recorded at Final Test of Cure (TOC) evaluation following last","confidence":1,"confidence_rate":1},{"cnt":[[305,1491],[1880,1491],[1880,1540],[305,1540]],"region":{"top_left_x":305,"top_left_y":1491,"width":1575,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f8de6a6d8a64ebcbdb4f6ba5545e4be","type":"text","conversion_output":true,"text":"dose of antibiotic, which will be evaluated at \\(28 \\pm 4\\) days for CoNS infections and at 42","text_display":" dose of antibiotic, which will be evaluated at \\(28 \\pm 4\\) days for CoNS infections and at 42","confidence":1,"confidence_rate":1},{"cnt":[[305,1543],[1880,1543],[1880,1592],[305,1592]],"region":{"top_left_x":305,"top_left_y":1542,"width":1575,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"652404fd9cd94d5c99a79a552f74383a","type":"text","conversion_output":true,"text":"\\(\\pm 4\\) days for S. aureus infections by telephone call or clinic visit. Early TOC, by telephone","text_display":" \\(\\pm 4\\) days for S. aureus infections by telephone call or clinic visit. Early TOC, by telephone","confidence":0.6176970811793581,"confidence_rate":0.9949417090736513},{"cnt":[[305,1590],[1880,1590],[1880,1639],[305,1639]],"region":{"top_left_x":305,"top_left_y":1589,"width":1575,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01971d67d3fd4c3b8867f77abfa3fd7d","type":"text","conversion_output":true,"text":"call or clinic visit, will be recorded between [10,24] days for CoNS and [17,31] days for","text_display":" call or clinic visit, will be recorded between [10,24] days for CoNS and [17,31] days for","confidence":0.5920293576082258,"confidence_rate":0.9944389346014177},{"cnt":[[305,1637],[1880,1637],[1880,1689],[305,1689]],"region":{"top_left_x":305,"top_left_y":1637,"width":1575,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"981e55b0c9f14b04936f261a29e8cf07","type":"text","conversion_output":true,"text":"S.aureus infections. If patient terminates study early for any reason, TOC assessment should","text_display":" S.aureus infections. If patient terminates study early for any reason, TOC assessment should","confidence":1,"confidence_rate":1},{"cnt":[[305,1687],[982,1687],[982,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1686,"width":677,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39b6ed900b42427390a231adb139cc7b","type":"text","conversion_output":true,"text":"be performed at the time of termination.","text_display":" be performed at the time of termination.","confidence":0.9990234375,"confidence_rate":0.9999782882435296},{"cnt":[[307,1781],[1880,1781],[1880,1833],[307,1833]],"region":{"top_left_x":307,"top_left_y":1781,"width":1573,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9779d3f92eed49ea8d9cc08fcea894a6","type":"text","conversion_output":true,"text":"Safety analysis will include analysis of all AEs leading to study drug withdrawal and all","text_display":"\n\nSafety analysis will include analysis of all AEs leading to study drug withdrawal and all","confidence":1,"confidence_rate":1},{"cnt":[[305,1830],[1880,1830],[1880,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1830,"width":1575,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1326a09c10f6425dba76bd6f4091116e","type":"text","conversion_output":true,"text":"SAEs recorded on case report form, and the incidence rates of change from vancomycin or a","text_display":" SAEs recorded on case report form, and the incidence rates of change from vancomycin or a","confidence":1,"confidence_rate":1},{"cnt":[[305,1878],[1880,1878],[1880,1927],[305,1927]],"region":{"top_left_x":305,"top_left_y":1877,"width":1575,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"636e30518e1b422b9b0274a08ef946e6","type":"text","conversion_output":true,"text":"protocol-approved study antibiotic to another protocol-approved study antibiotic due to AE","text_display":" protocol-approved study antibiotic to another protocol-approved study antibiotic due to AE","confidence":1,"confidence_rate":1},{"cnt":[[305,1927],[1880,1927],[1880,1974],[305,1974]],"region":{"top_left_x":305,"top_left_y":1927,"width":1575,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"624908cb23cb4414b3807e6125fa82aa","type":"text","conversion_output":true,"text":"associated with study drug. In order to demonstrate that algorithm-based treatment of patients","text_display":" associated with study drug. In order to demonstrate that algorithm-based treatment of patients","confidence":1,"confidence_rate":1},{"cnt":[[305,1972],[1880,1972],[1880,2022],[305,2022]],"region":{"top_left_x":305,"top_left_y":1972,"width":1575,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1439a600370945588a9b908c62394f95","type":"text","conversion_output":true,"text":"with blood stream infection can decrease antimicrobial usage when compared to current","text_display":" with blood stream infection can decrease antimicrobial usage when compared to current","confidence":1,"confidence_rate":1},{"cnt":[[305,2022],[1687,2022],[1687,2073],[305,2073]],"region":{"top_left_x":305,"top_left_y":2021,"width":1382,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb57fdcead4548e6af53f64f30cd2e83","type":"text","conversion_output":true,"text":"SOC, duration of treatments will be compared as our secondary efficacy endpoint.","text_display":" SOC, duration of treatments will be compared as our secondary efficacy endpoint.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"80b87e56-0d6c-45d4-af9b-017f297ab010-05","page":5,"lines":[{"cnt":[[305,125],[715,125],[715,157],[305,157]],"region":{"top_left_x":305,"top_left_y":124,"width":411,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1996da4731024899966937ad43c70f8b","type":"page_info","conversion_output":false,"text":"STATISTICAL ANALYSIS PLAN","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1856,277],[1886,277],[1886,309],[1856,309]],"region":{"top_left_x":1856,"top_left_y":277,"width":31,"height":33},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"9bb968ff6b6e426199fab32c0bb01cba","type":"page_info","conversion_output":false,"text":"5","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,421],[1347,421],[1347,462],[305,462]],"region":{"top_left_x":305,"top_left_y":421,"width":1043,"height":41},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"069a438ac92546d7ac3c020d7aff4e08","type":"figure_label","conversion_output":false,"text":"Table 1 Mode of treatment administration-Days of Vancomycin Use","text_display":"","confidence":0.9785258769989014,"confidence_rate":0.9996942995962197},{"cnt":[[288,458],[1803,458],[1803,960],[288,960]],"region":{"top_left_x":287,"top_left_y":457,"width":1516,"height":504},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"352da207092b4490ae1331b170a4d1c0","type":"table","conversion_output":true,"children_ids":["ca8c60a077bd49ac88b0061b6f1d8f20","a250b028740f4d3b8ee6560947505455","4dee62a513424c6799c51a9df0b781b2","6e182b4a40914b1ca0ae8e3aa3b5d438","94701baec6614c0bad8e8ad88d4f82e6","21f008231c554d1499f6d5d54a5588cd","f20a1cfb1b0846f4942a264028bab877","af5c8e0f5f684d3192085832c0b64377","05b43536aa4640c08b82731ce458d1f0","4d7e75696eb2481da0140037d84469c8","877827006a2446cf8c696f4dd0c7a514","ce953fec67ee4c448ccd927db9eea92a","5e094269ab024e28a8f8e1be9aab65ff","e2a5e35febfd497da5cc1fc9eed2f35a","6ddff87f7b69485dba6fa4200b81d51a","ec7255170c654791866a1c250285193d","f0548cb0f53546a0b41685567381d2ce","be3636d49f3d42c79d328a5ff2edb24c","dd171d94ac604c6aadd0e13dd7a701ac","a8ec727eaac346f8ab5ee4e81b072ba4","ba386d63fb7148019d5791aefa66987a","03ff04e455b74be9ac197f02770b3d8b","f223736c0f7445eb91ec921dcf06b45b","203617460e254215acd4af63866d7b09","bdd39cbee1884a9c96366c0e102f73ea","8c1ef88b46f34dbebe4cd6b9b35868cc","5ce8e7c7bbf74699a05f285785b999ae","c55c85b97f68498c8bff02943029b303","ec15d3e97fce4e24950c2c1a70b88fa0","ffd2b8bc39064cc3b03379d01de2314c","df42fefdcebe45fc86159ac7b712ac4c","409074f66db64b4e952b48b55f682955"],"selected_labels":["069a438ac92546d7ac3c020d7aff4e08"],"text":"\\begin{tabular}{|l|l|l|l|l|l|}\n\\hline 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The Executive Committee will determine an appropriate course of action.","text_display":" recommendations. 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(2) evaluate the safety of algorithm-based treatment as an","text_display":" current standard of care (SOC); (2) evaluate the safety of algorithm-based treatment as an","confidence":1,"confidence_rate":1},{"cnt":[[305,1482],[765,1482],[765,1528],[305,1528]],"region":{"top_left_x":305,"top_left_y":1482,"width":460,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bf72ddc1796443bbde9e92bc267bb74","type":"text","conversion_output":true,"text":"alternative to current SOC.","text_display":" alternative to current SOC.","confidence":0.99951171875,"confidence_rate":0.9999847376009057},{"cnt":[[305,1616],[617,1616],[617,1674],[305,1674]],"region":{"top_left_x":305,"top_left_y":1615,"width":312,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c98fcb1a29b4929b984b2b2320f57e2","type":"section_header","conversion_output":false,"children_ids":["88d28c42152642e79b1ef7e87d11b654"],"text":"","text_display":""},{"cnt":[[309,1620],[612,1620],[612,1669],[309,1669]],"region":{"top_left_x":309,"top_left_y":1619,"width":304,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88d28c42152642e79b1ef7e87d11b654","type":"text","conversion_output":true,"parent_id":"5c98fcb1a29b4929b984b2b2320f57e2","text":"5.2 Secondary","text_display":"\n\n\\subsection*{5.2 Secondary}","confidence":1,"confidence_rate":1},{"cnt":[[305,1738],[1878,1738],[1878,1790],[305,1790]],"region":{"top_left_x":305,"top_left_y":1738,"width":1573,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f83f6573325741249f3a0a0cd45d7819","type":"text","conversion_output":true,"text":"The secondary object of this trial is to demonstrate that algorithm-based treatment of patients","text_display":"\n\nThe secondary object of this trial is to demonstrate that algorithm-based treatment of patients","confidence":1,"confidence_rate":1},{"cnt":[[305,1783],[1880,1783],[1880,1837],[305,1837]],"region":{"top_left_x":305,"top_left_y":1783,"width":1575,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5129271a4c6e4e15afd6b51fd5212fe5","type":"text","conversion_output":true,"text":"with staphylococcal blood stream infection can decrease antimicrobial usage when compared","text_display":" with staphylococcal blood stream infection can decrease antimicrobial usage when compared","confidence":1,"confidence_rate":1},{"cnt":[[305,1835],[578,1835],[578,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1834,"width":273,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bfae8c509f6b4ac79636fb37b52e059c","type":"text","conversion_output":true,"text":"to current SOC.","text_display":" to current SOC.","confidence":0.98828125,"confidence_rate":0.9994107758731537},{"cnt":[[305,1998],[1119,1998],[1119,2052],[305,2052]],"region":{"top_left_x":305,"top_left_y":1998,"width":815,"height":54},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"372195ebf021410e8c9898102941389e","type":"section_header","conversion_output":false,"children_ids":["e3ce1e5b9eb04776aff3a1d38e06eaf2"],"text":"","text_display":""},{"cnt":[[305,2002],[1115,2002],[1115,2047],[305,2047]],"region":{"top_left_x":305,"top_left_y":2002,"width":811,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3ce1e5b9eb04776aff3a1d38e06eaf2","type":"text","conversion_output":true,"parent_id":"372195ebf021410e8c9898102941389e","text":"6. 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Were judged \"Failure\" at early or final TOC by the Site PI or designated SI \\\\\nb. Treatment was changed due to Unsatisfactory Clinical Response defined as failure to resolve clinical manifestations of infection (e.g. fever, elevated WBC count). \\\\\nc. Had persisting or relapsing infection (Section 3.2.3.2 and Section 3.2.3.3, respectively). \\\\\nd. Identification of a New Complicated Staphylococcal Infection (Section 3.2.3.5) not known to be present at either randomization or after completion of study treatment for their baseline clinical classification of bacteremia. These patients will be retained in their original group and counted as treatment failures. \\\\\ne. 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Treatment was changed due to Unsatisfactory","text_display":"\nb. 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Identification of a New Complicated","text_display":"\nd. 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Efficacy data will be tabulated to count 3","text_display":" within the subjects with non-missing values. 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No intra-block correlation will be assumed in statistical analysis of","text_display":" based on two-sided tests. 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All comparisons will be performed by use of the","text_display":" treatment groups within each cohort. 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If statistically significant differences in","text_display":" variance (ANOVA) for continuous variables. 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These patients will be regrouped in the complicated","confidence":1,"confidence_rate":1},{"cnt":[[305,2406],[973,2406],[973,2456],[305,2456]],"region":{"top_left_x":305,"top_left_y":2406,"width":669,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b57a869527b44c98f24fae2191c5bc6","type":"text","conversion_output":true,"text":"bacteremia population of the algorithm.","text_display":" bacteremia population of the algorithm.","confidence":0.99951171875,"confidence_rate":0.9999889000502842}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"80b87e56-0d6c-45d4-af9b-017f297ab010-15","page":15,"lines":[{"cnt":[[305,125],[715,125],[715,157],[305,157]],"region":{"top_left_x":305,"top_left_y":124,"width":411,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"dd7f65d65489468a8ba393b7d9df6aa3","type":"page_info","conversion_output":false,"text":"STATISTICAL ANALYSIS PLAN","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1843,275],[1882,275],[1882,309],[1843,309]],"region":{"top_left_x":1843,"top_left_y":275,"width":40,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7f71ff90653740c8ba1145bbcb0bcd3a","type":"page_info","conversion_output":false,"text":"15","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,370],[1880,370],[1880,419],[305,419]],"region":{"top_left_x":305,"top_left_y":369,"width":1575,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2050df980d66469fb3844a9adbe8f8a6","type":"text","conversion_output":true,"text":"Point estimates and the corresponding two-sided \\(95 \\%\\) confidence intervals for the difference","text_display":"\n\nPoint estimates and the corresponding two-sided \\(95 \\%\\) confidence intervals for the difference","confidence":0.99609375,"confidence_rate":0.9999604664448944},{"cnt":[[305,423],[1880,423],[1880,475],[305,475]],"region":{"top_left_x":305,"top_left_y":423,"width":1575,"height":52},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83d38184a56b47f082e8bb1f91152af6","type":"text","conversion_output":true,"text":"in the days of antibiotic use between the algorithm-based treatment and SOC will be","text_display":" in the days of antibiotic use between the algorithm-based treatment and SOC will be","confidence":1,"confidence_rate":1},{"cnt":[[305,477],[1880,477],[1880,529],[305,529]],"region":{"top_left_x":305,"top_left_y":476,"width":1575,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cbe536f341a4c11a4b35ace2b7f17dc","type":"text","conversion_output":true,"text":"calculated. ANCOVA will be performed to compare the days of antibiotic use between","text_display":" calculated. ANCOVA will be performed to compare the days of antibiotic use between","confidence":1,"confidence_rate":1},{"cnt":[[305,533],[1880,533],[1880,587],[305,587]],"region":{"top_left_x":305,"top_left_y":532,"width":1575,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cafbb2e939de4dd18d7e4af100d2326f","type":"text","conversion_output":true,"text":"treatments after adjusting the organism and type of infections, and any significant","text_display":" treatments after adjusting the organism and type of infections, and any significant","confidence":1,"confidence_rate":1},{"cnt":[[305,589],[690,589],[690,638],[305,638]],"region":{"top_left_x":305,"top_left_y":588,"width":385,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04ba20e00f644aa5a790fcd55ad45a16","type":"text","conversion_output":true,"text":"confounding factor(s).","text_display":" confounding factor(s).","confidence":1,"confidence_rate":1},{"cnt":[[305,692],[1846,692],[1846,741],[305,741]],"region":{"top_left_x":305,"top_left_y":691,"width":1541,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e403f71028d46bf8ad5ba6955075f31","type":"text","conversion_output":true,"text":"Extent of exposure to study medication will be presented in terms of treatment duration and","text_display":"\n\nExtent of exposure to study medication will be presented in terms of treatment duration and","confidence":1,"confidence_rate":1},{"cnt":[[305,739],[1536,739],[1536,788],[305,788]],"region":{"top_left_x":305,"top_left_y":739,"width":1232,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aac4318ae7ca468b967ad0d00fc407c3","type":"text","conversion_output":true,"text":"mean daily dose. A summary table will be provided for dose compliance.","text_display":" mean daily dose. A summary table will be provided for dose compliance.","confidence":0.9990234375,"confidence_rate":0.9999869728895492},{"cnt":[[303,872],[821,872],[821,930],[303,930]],"region":{"top_left_x":302,"top_left_y":872,"width":519,"height":59},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61947070262b48d7a3812b853ee322b5","type":"section_header","conversion_output":false,"children_ids":["3432a7d8600f461b943704270ea6041f"],"text":"","text_display":""},{"cnt":[[305,877],[814,877],[814,926],[305,926]],"region":{"top_left_x":305,"top_left_y":876,"width":510,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3432a7d8600f461b943704270ea6041f","type":"text","conversion_output":true,"parent_id":"61947070262b48d7a3812b853ee322b5","text":"9.7.3 Sensitivity Analyses","text_display":"\n\n\\subsection*{9.7.3 Sensitivity Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[305,1042],[1880,1042],[1880,1094],[305,1094]],"region":{"top_left_x":305,"top_left_y":1041,"width":1575,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7fa1edf4cf54b5cb5916323b099b4f3","type":"text","conversion_output":true,"text":"Sensitivity analysis with respect to missing data imputation will be performed. More","text_display":"\n\nSensitivity analysis with respect to missing data imputation will be performed. More","confidence":1,"confidence_rate":1},{"cnt":[[305,1091],[1880,1091],[1880,1141],[305,1141]],"region":{"top_left_x":305,"top_left_y":1091,"width":1575,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a001cfc01e248ca824bcd338004bc25","type":"text","conversion_output":true,"text":"specifically, for the first step, we will construct the primary estimates and corresponding two-","text_display":" specifically, for the first step, we will construct the primary estimates and corresponding two","confidence":1,"confidence_rate":1},{"cnt":[[305,1139],[1880,1139],[1880,1188],[305,1188]],"region":{"top_left_x":305,"top_left_y":1138,"width":1575,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b21983e64e84436aecc4446b73eb495","type":"text","conversion_output":true,"text":"sided \\(95 \\%\\) confidence intervals denoted as \\(( L , U )\\) of cure rate by imputing method specified","text_display":"sided \\(95 \\%\\) confidence intervals denoted as \\(( L , U )\\) of cure rate by imputing method specified","confidence":0.9141866758000106,"confidence_rate":0.9991539384149295},{"cnt":[[305,1186],[1880,1186],[1880,1235],[305,1235]],"region":{"top_left_x":305,"top_left_y":1185,"width":1575,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4af215d3c9ff4dda91061163fd7bcc52","type":"text","conversion_output":true,"text":"in Section 11.3.6; for the second step, we will construct the secondary estimates and","text_display":" in Section 11.3.6; for the second step, we will construct the secondary estimates and","confidence":1,"confidence_rate":1},{"cnt":[[305,1233],[1880,1233],[1880,1283],[305,1283]],"region":{"top_left_x":305,"top_left_y":1233,"width":1575,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e1c59a3782d4038b45dcb6f52cb68f7","type":"text","conversion_output":true,"text":"corresponding two-sided \\(95 \\%\\) confidence intervals of cure rate without imputing the missing","text_display":" corresponding two-sided \\(95 \\%\\) confidence intervals of cure rate without imputing the missing","confidence":1,"confidence_rate":1},{"cnt":[[305,1280],[1880,1280],[1880,1330],[305,1330]],"region":{"top_left_x":305,"top_left_y":1280,"width":1575,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6de2ab4904aa4206996a8ee951194329","type":"text","conversion_output":true,"text":"values, that is, treating missing as missing. If the secondary estimates drop in the","text_display":" values, that is, treating missing as missing. If the secondary estimates drop in the","confidence":1,"confidence_rate":1},{"cnt":[[305,1328],[1880,1328],[1880,1377],[305,1377]],"region":{"top_left_x":305,"top_left_y":1327,"width":1575,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6180a72060684e3e9bbdaed7aeed0c39","type":"text","conversion_output":true,"text":"corresponding ( \\(L , U\\) ), or their confidence intervals do overlay with the primary ones, then we","text_display":" corresponding ( \\(L , U\\) ), or their confidence intervals do overlay with the primary ones, then we","confidence":0.8819503773702309,"confidence_rate":0.9988375327997905},{"cnt":[[305,1377],[1880,1377],[1880,1429],[305,1429]],"region":{"top_left_x":305,"top_left_y":1377,"width":1575,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05f5e2260b1d452395a27f887d94b1ce","type":"text","conversion_output":true,"text":"can conclude that our primary analysis is robust. Otherwise, our conclusion based on the","text_display":" can conclude that our primary analysis is robust. Otherwise, our conclusion based on the","confidence":1,"confidence_rate":1},{"cnt":[[305,1427],[956,1427],[956,1476],[305,1476]],"region":{"top_left_x":305,"top_left_y":1426,"width":652,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"758ac4be0d5e424c8ad3393efc71ae3a","type":"text","conversion_output":true,"text":"primary analysis will have limitations.","text_display":" primary analysis will have limitations.","confidence":1,"confidence_rate":1},{"cnt":[[305,1515],[840,1515],[840,1566],[305,1566]],"region":{"top_left_x":305,"top_left_y":1514,"width":536,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6741fb5cd184d16bd30b59bfcf321eb","type":"section_header","conversion_output":false,"children_ids":["9364097ac7fa4fccaf76e1393088fc8a"],"text":"","text_display":""},{"cnt":[[305,1517],[836,1517],[836,1562],[305,1562]],"region":{"top_left_x":305,"top_left_y":1516,"width":531,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9364097ac7fa4fccaf76e1393088fc8a","type":"text","conversion_output":true,"parent_id":"e6741fb5cd184d16bd30b59bfcf321eb","text":"9.7.4 Exploratory Analyses","text_display":"\n\n\\subsection*{9.7.4 Exploratory Analyses}","confidence":0.99951171875,"confidence_rate":0.9999842452693294},{"cnt":[[305,1633],[1861,1633],[1861,1682],[305,1682]],"region":{"top_left_x":305,"top_left_y":1632,"width":1556,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cfd5e1bd12f41f78773e96f576f7fc2","type":"text","conversion_output":true,"text":"The exploratory analyses include comparisons of the treatment effects for the endpoints cure","text_display":"\n\nThe exploratory analyses include comparisons of the treatment effects for the endpoints cure","confidence":1,"confidence_rate":1},{"cnt":[[305,1680],[1790,1680],[1790,1729],[305,1729]],"region":{"top_left_x":305,"top_left_y":1680,"width":1485,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38b45c6b18624581af528f3159e1b8ed","type":"text","conversion_output":true,"text":"rate and the days of antibiotic for the following diagnostics subgroups in the ITT and PP","text_display":" rate and the days of antibiotic for the following diagnostics subgroups in the ITT and PP","confidence":1,"confidence_rate":1},{"cnt":[[305,1727],[743,1727],[743,1777],[305,1777]],"region":{"top_left_x":305,"top_left_y":1727,"width":439,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cb9fb450f8d4928a03f85cf2257008e","type":"text","conversion_output":true,"text":"populations, respectively:","text_display":" populations, respectively:","confidence":1,"confidence_rate":1},{"cnt":[[309,1779],[642,1779],[642,1824],[309,1824]],"region":{"top_left_x":309,"top_left_y":1778,"width":334,"height":47},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25034f05a46e466aa75cbf4c0cb8071b","type":"text","conversion_output":true,"text":"1. Cohort of CoNS","text_display":"\n1. Cohort of CoNS","confidence":1,"confidence_rate":1},{"cnt":[[305,1830],[831,1830],[831,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1830,"width":527,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fc43d6793d34bf1b1a41c4d1daa5cab","type":"text","conversion_output":true,"text":"2. Sub-cohort of simple CoNS","text_display":"\n2. Sub-cohort of simple CoNS","confidence":1,"confidence_rate":1},{"cnt":[[305,1882],[973,1882],[973,1931],[305,1931]],"region":{"top_left_x":305,"top_left_y":1882,"width":669,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de82a74246b440469585fdda6e60df08","type":"text","conversion_output":true,"text":"3. Sub-cohort of Uncomplicated CoNS","text_display":"\n3. Sub-cohort of Uncomplicated CoNS","confidence":1,"confidence_rate":1},{"cnt":[[305,1929],[883,1929],[883,1974],[305,1974]],"region":{"top_left_x":305,"top_left_y":1929,"width":579,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a37f15e439e4f17a8eeb824ac8a0c51","type":"text","conversion_output":true,"text":"4. Cohort of S. aureus Bacteremia","text_display":"\n4. Cohort of S. aureus Bacteremia","confidence":1,"confidence_rate":1},{"cnt":[[305,1977],[1291,1977],[1291,2026],[305,2026]],"region":{"top_left_x":305,"top_left_y":1976,"width":987,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f6a262ad0e5431cb476ecc958d7a74f","type":"text","conversion_output":true,"text":"5. Sub-Cohort within uncomplicated S. aureus Bacteremia","text_display":"\n5. Sub-Cohort within uncomplicated S. aureus Bacteremia","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"80b87e56-0d6c-45d4-af9b-017f297ab010-16","page":16,"lines":[{"cnt":[[305,125],[715,125],[715,157],[305,157]],"region":{"top_left_x":305,"top_left_y":124,"width":411,"height":33},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"beae81e59ab645faa1c3ada18675c85a","type":"page_info","conversion_output":false,"text":"STATISTICAL ANALYSIS PLAN","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1843,275],[1882,275],[1882,309],[1843,309]],"region":{"top_left_x":1843,"top_left_y":275,"width":40,"height":35},"line":2,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"251930167b2241729e161e8e7467139b","type":"page_info","conversion_output":false,"text":"16","text_display":"","confidence":0.99853515625,"confidence_rate":0.9992673097074676},{"cnt":[[305,370],[840,370],[840,419],[305,419]],"region":{"top_left_x":305,"top_left_y":369,"width":536,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"713318b9b59c44c19d05ba7cd05d77e9","type":"figure_label","conversion_output":false,"text":"Table 4 Summary of Endpoints","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,412],[1815,412],[1815,2359],[288,2359]],"region":{"top_left_x":287,"top_left_y":412,"width":1529,"height":1947},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f36ecc954552472ba3400a1ef7798a65","type":"table","conversion_output":true,"children_ids":["d63471e32c4848ef8b45a14095893872","2bc87fc1a97a44a5a038611778104daf","7fdb8cf55f9843a6b7ae4f76970142b7","8a29e4e30ed94ffc8c972c4c899aa4b0","16c35e57cf5c45c1a6b3bddbc220a122","9f1ac4b02b5146c4aeef2301c94013a6","a779da23a9d144aea10a8b29a792182e","20cd9d9ab24744dd8f51cdba6a1b4ee8","6b21e56ce474401bbc91b9f4724930ae","4107fe091a29442fa0136633f74df2b4","a45b0710fa4d45dd8d666e682c442c0a","35ce013737d44868b948ee6b0244902c","e99f90682eef41b6be1635d6c16a3c11","329d22f051e34b87aff48b6400135221","e2c5b551513c4af68acb5959ecbd4618","0c1ca95a03fe4476a6d0ab61d904dc13","7c69c88dc19143ceb696c07ad0f41b11","069c03e3013447f5b720dfc413c44272","8ea860dd698a45299beb1d561805af38","cebf189fae5446ce989bc6b7b2bd3715","e206b0a9c0374b84846904f8da140863","be0d5f6817f94702b6bed339a3b6cbf2","04ebbb5942cc446198a33d3b21440509","ae574335f5084ac99efb9ea2d18d4f23","f4c4765fb0f843afb83f16eccf9621f8","52a9acf9de874ad8ba7b48894648089c","ef3817800cef4548bb721de41d093df2","2a802aaccf95433b9510d45eeb9f755d","2b698c04c4f647b79aab79a874dc0134","e4cfb94dbf9349b096ac8877bdd5dfe9","1d8b5a66b86f40a299b7163f46bfdf09","ad8f7a6fd12e480294de45792f49253c","e47559147b644a2d9ce7f2f94986b406","b598607e86af4bcf92dce7b0bc3f088a","cdb9907d248c45ffa40981d2f4e1fc47","c7194a682c654250a3b0c00369b1545b","3129b8385c9a4989931cb59db55692b0","f7c77518f9e14ff68d7321d36699716c","4bc1d10d6c1b499b970af811e123db8f","fa3281c44ff943b5abbe9bc86acfc480","dab6fae3875348009f43d93ab0ad01cf","a468472787f243f786ea6691e2aed164","948adc82617e422899178472fcd76132","b0a474f3d22140b0a228d1cef9139fb6","48465ee520744504a068a528a3818779","efd12d69820949a993cacfa04d867aec","6a90f6a474884117b2f6835adc14ad49","a85c826f4fcd4a03be4109e6364f3a7e","41abdad9a1b14d8d815303dbeab7a0a4","32be37d0b3704731baa7e0eed86f7dd2","7235648cdbad49569000c29c47d8f04b","746c8e5d14f34baa81b9a14c8e5223d7","879943513193434f9eb8c8696c31117a","9ef20aedcdd8409b887f257d84d8764f","dc29dfcbec11435c8e5e6e90d0503eeb"],"selected_labels":["713318b9b59c44c19d05ba7cd05d77e9"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Comparison & Endpoint & Population/Analysis \\\\\n\\hline ABT vs SOC* & \\begin{tabular}{l}\nCure rate at TOC \\\\\nEvent rate of SAE \\\\\nEvent rate of AEs leading to study drug withdrawal \\\\\nAntibiotic days\n\\end{tabular} & \\begin{tabular}{l}\nITT/ Primary \\({ }^{1}\\) \\\\\nPPE/ Secondary \\({ }^{1}\\) \\\\\nITT/ Sensitivity \\({ }^{2}\\) \\\\\nITT/ Primary \\\\\nPPE/ Exploratory \\\\\nPPE/ Secondary\n\\end{tabular} \\\\\n\\hline CoNS: ABT vs SOC & Cure rate at TOC & \\begin{tabular}{l}\nITT/ Exploratory \\({ }^{1}\\) \\\\\nPPE/ Exploratory \\({ }^{1}\\)\n\\end{tabular} \\\\\n\\hline S. aureus: ABT vs SOC & Same as above & Same as above \\\\\n\\hline CoNS-simple: ABT vs SOC & Same as above & Same as above \\\\\n\\hline \\begin{tabular}{l}\nCoNS-uncomplicated: \\\\\nABT vs SOC\n\\end{tabular} & Same as above & Same as above \\\\\n\\hline S. aureus uncomplicated: ABT vs SOC & Same as above & Same as above \\\\\n\\hline CoNS: ABT vs SOC & Antibiotic days & ITT, PPE/Exploratory \\\\\n\\hline S. aureus: ABT vs SOC & Same as above & Same as above \\\\\n\\hline CoNS-simple: ABT vs SOC & Same as above & Same as above \\\\\n\\hline \\begin{tabular}{l}\nCoNS-uncomplicated: \\\\\nABT vs SOC\n\\end{tabular} & Same as above & Same as above \\\\\n\\hline S. aureus uncomplicated: ABT vs SOC & Same as above & Same as above \\\\\n\\hline ABT vs SOC & \\begin{tabular}{l}\n-associations between vancomycin MIC values and clinical outcomes \\\\\n- incidence of changing study medication due to AE \\\\\n-Days to discontinuation since the first dose\n\\end{tabular} & ITT/ Exploratory PPE/ Exploratory \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4 Summary of Endpoints}\n\\begin{tabular}{|l|l|l|}\n\\hline Comparison & Endpoint & Population/Analysis \\\\\n\\hline ABT vs SOC* & \\begin{tabular}{l}\nCure rate at TOC \\\\\nEvent rate of SAE \\\\\nEvent rate of AEs leading to study drug withdrawal \\\\\nAntibiotic 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SOC\n\\end{tabular} & Same as above & Same as above \\\\\n\\hline S. aureus uncomplicated: ABT vs SOC & Same as above & Same as above \\\\\n\\hline ABT vs SOC & \\begin{tabular}{l}\n-associations between vancomycin MIC values and clinical outcomes \\\\\n- incidence of changing study medication due to AE \\\\\n-Days to discontinuation since the first dose\n\\end{tabular} & ITT/ Exploratory PPE/ Exploratory 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The number of AEs reported by subject will be","text_display":" will be tabulated for each treatment group. The number of AEs reported by subject will be","confidence":1,"confidence_rate":1},{"cnt":[[305,1405],[1880,1405],[1880,1454],[305,1454]],"region":{"top_left_x":305,"top_left_y":1405,"width":1575,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"025f4cfef21240fa8d3cca97687c4b26","type":"text","conversion_output":true,"text":"summarized for each treatment group. Subject frequency counts and percentages by","text_display":" summarized for each treatment group. 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MONTHLY SAFETY REPORT","text_display":"\n\n\\section*{10. MONTHLY SAFETY REPORT}","confidence":1,"confidence_rate":1},{"cnt":[[305,1010],[1882,1010],[1882,1059],[305,1059]],"region":{"top_left_x":305,"top_left_y":1009,"width":1578,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70aa6601b2774418b885e39d9f2a7250","type":"text","conversion_output":true,"text":"The DSMB charter requests the DCRI to monitor the following event rates on a monthly","text_display":"\n\nThe DSMB charter requests the DCRI to monitor the following event rates on a monthly","confidence":1,"confidence_rate":1},{"cnt":[[305,1057],[410,1057],[410,1102],[305,1102]],"region":{"top_left_x":305,"top_left_y":1057,"width":106,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a14039039b41485aa3cdf21703476459","type":"text","conversion_output":true,"text":"basis:","text_display":" basis:","confidence":1,"confidence_rate":1},{"cnt":[[309,1152],[1880,1152],[1880,1203],[309,1203]],"region":{"top_left_x":309,"top_left_y":1151,"width":1571,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88ba7e165781477d9e0e27e6ffb49ee2","type":"text","conversion_output":true,"text":"1. 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