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An absolute difference of \\(20 \\%\\) (i.e. \\(15 \\%\\) vs. \\(35 \\%\\) ) will be deemed a clinically","text_display":" attractive. An absolute difference of \\(20 \\%\\) (i.e. \\(15 \\%\\) vs. \\(35 \\%\\) ) will be deemed a clinically","confidence":0.9825054463374272,"confidence_rate":0.9998286613606454},{"cnt":[[344,784],[1815,784],[1815,836],[344,836]],"region":{"top_left_x":343,"top_left_y":784,"width":1473,"height":52},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c87fc543939b44f596cd2498a31d6e5d","type":"text","conversion_output":true,"text":"meaningful difference. A total sample size of 213 response evaluable study participants","text_display":" meaningful difference. A total sample size of 213 response evaluable study participants","confidence":1,"confidence_rate":1},{"cnt":[[344,831],[1790,831],[1790,883],[344,883]],"region":{"top_left_x":343,"top_left_y":831,"width":1447,"height":53},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42f6c0ee2f084d0987510a7dece808d7","type":"text","conversion_output":true,"text":"will provide \\(85 \\%\\) power to detect a difference in preservation of \\(20 \\%\\) between control","text_display":" will provide \\(85 \\%\\) power to detect a difference in preservation of \\(20 \\%\\) between control","confidence":0.98681640625,"confidence_rate":0.9998603121914003},{"cnt":[[344,881],[1783,881],[1783,930],[344,930]],"region":{"top_left_x":343,"top_left_y":880,"width":1441,"height":51},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"043e966394aa4affb2a3d0136ba0ff84","type":"text","conversion_output":true,"text":"( \\(15 \\%\\) ) and Paxman ( \\(35 \\%\\) ) at the \\(5 \\%\\) level of significance. If, as we expect, the rate of","text_display":" ( \\(15 \\%\\) ) and Paxman ( \\(35 \\%\\) ) at the \\(5 \\%\\) level of significance. If, as we expect, the rate of","confidence":0.8253709799623721,"confidence_rate":0.9981384114042836},{"cnt":[[344,928],[1841,928],[1841,982],[344,982]],"region":{"top_left_x":343,"top_left_y":928,"width":1499,"height":54},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f4357efda4346909535c0e744f20552","type":"text","conversion_output":true,"text":"preservation will be lower than \\(15 \\%\\) in the control group, then the power to detect a \\(20 \\%\\)","text_display":" preservation will be lower than \\(15 \\%\\) in the control group, then the power to detect a \\(20 \\%\\)","confidence":0.9902389049530029,"confidence_rate":0.9998967522058763},{"cnt":[[344,975],[827,975],[827,1027],[344,1027]],"region":{"top_left_x":343,"top_left_y":975,"width":485,"height":52},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5388659cbef5434fafa32fd3fba5ec35","type":"text","conversion_output":true,"text":"improvement will be higher.","text_display":" improvement will be higher.","confidence":1,"confidence_rate":1},{"cnt":[[567,1061],[1558,1061],[1558,1575],[567,1575]],"region":{"top_left_x":567,"top_left_y":1061,"width":991,"height":514},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f170d52cc474c22b631974a4ebc8582","type":"table","conversion_output":true,"text":"\\begin{tabular}{|r|c|c|}\n\\hline & Scenario 1 & Scenario 2 \\\\\n\\hline Level of Significance & \\(5 \\%\\) & \\(5 \\%\\) \\\\\n\\hline Proportion Alopecia Grade <2 & & \\\\\n\\hline Control & 0.15 & 0.10 \\\\\n\\hline Paxman Scalp Cooling & 0.35 & 0.30 \\\\\n\\hline Odds Ratio & 3.05 & 3.86 \\\\\n\\hline Power & 0.85 & 0.90 \\\\\n\\hline N control & 71 & 71 \\\\\n\\hline Total N N Paxman & 142 & 142 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|r|c|c|}\n\\hline & Scenario 1 & Scenario 2 \\\\\n\\hline Level of Significance & \\(5 \\%\\) & \\(5 \\%\\) \\\\\n\\hline Proportion Alopecia Grade <2 & & \\\\\n\\hline Control & 0.15 & 0.10 \\\\\n\\hline Paxman Scalp Cooling & 0.35 & 0.30 \\\\\n\\hline Odds Ratio & 3.05 & 3.86 \\\\\n\\hline Power & 0.85 & 0.90 \\\\\n\\hline N control & 71 & 71 \\\\\n\\hline Total N N Paxman & 142 & 142 \\\\\n\\hline\n\\end{tabular}","confidence":0.8944326380830773,"confidence_rate":0.999668014388317},{"cnt":[[344,1616],[1783,1616],[1783,1669],[344,1669]],"region":{"top_left_x":343,"top_left_y":1615,"width":1441,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"724fba185ec54373b1a16c8834853575","type":"text","conversion_output":true,"text":"Assuming at most \\(10 \\%\\) drop-outs, we expect to accrue at most 235 study participants.","text_display":"\n\nAssuming at most \\(10 \\%\\) drop-outs, we expect to accrue at most 235 study participants.","confidence":1,"confidence_rate":1},{"cnt":[[236,1727],[621,1727],[621,1792],[236,1792]],"region":{"top_left_x":236,"top_left_y":1727,"width":385,"height":65},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae0aa293b5d640fe8d1f77bd4553c9f7","type":"section_header","conversion_output":false,"children_ids":["a350196fe4f24e318e2cbace7d10c8de"],"text":"","text_display":""},{"cnt":[[245,1732],[617,1732],[617,1785],[245,1785]],"region":{"top_left_x":244,"top_left_y":1731,"width":373,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a350196fe4f24e318e2cbace7d10c8de","type":"text","conversion_output":true,"parent_id":"ae0aa293b5d640fe8d1f77bd4553c9f7","text":"4.2 Interim Analysis","text_display":"\n\n\\subsection*{4.2 Interim Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[344,1800],[1865,1800],[1865,1854],[344,1854]],"region":{"top_left_x":343,"top_left_y":1800,"width":1522,"height":55},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6679f82d6f7f48b58e022aee44735ff3","type":"text","conversion_output":true,"text":"One interim analysis will take place about two-thirds of the way through the study after 95","text_display":"\n\nOne interim analysis will take place about two-thirds of the way through the study after 95","confidence":1,"confidence_rate":1},{"cnt":[[344,1852],[1815,1852],[1815,1901],[344,1901]],"region":{"top_left_x":343,"top_left_y":1851,"width":1473,"height":51},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"43287ecedb9b4e4aac5636531eae91c8","type":"text","conversion_output":true,"text":"subjects are enrolled to the cooling group and 47 subjects are enrolled to the no cooling","text_display":" subjects are enrolled to the cooling group and 47 subjects are enrolled to the no cooling","confidence":1,"confidence_rate":1},{"cnt":[[344,1899],[1755,1899],[1755,1949],[344,1949]],"region":{"top_left_x":343,"top_left_y":1899,"width":1413,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c88fa65d51f74f78b1bf7fdbb727c506","type":"text","conversion_output":true,"text":"group and have been evaluated for the primary endpoint. The purpose of the interim","text_display":" group and have been evaluated for the primary endpoint. The purpose of the interim","confidence":1,"confidence_rate":1},{"cnt":[[344,1946],[1760,1946],[1760,1996],[344,1996]],"region":{"top_left_x":343,"top_left_y":1946,"width":1417,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff4c497fae544c85a484302c54b83816","type":"text","conversion_output":true,"text":"analysis is to allow the study to stop early for efficacy (superiority). To maintain the","text_display":" analysis is to allow the study to stop early for efficacy (superiority). To maintain the","confidence":1,"confidence_rate":1},{"cnt":[[344,1994],[1863,1994],[1863,2047],[344,2047]],"region":{"top_left_x":343,"top_left_y":1993,"width":1520,"height":55},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33a606ead21b4c29a55a4b57b3374713","type":"text","conversion_output":true,"text":"overall type 1 error rate, an O'Brien-Fleming spending function has been used to calculate","text_display":" overall type 1 error rate, an O'Brien-Fleming spending function has been used to calculate","confidence":1,"confidence_rate":1},{"cnt":[[344,2041],[1880,2041],[1880,2093],[344,2093]],"region":{"top_left_x":343,"top_left_y":2041,"width":1537,"height":52},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b8266df355c4bf08a4b6b7a6ba6dd68","type":"text","conversion_output":true,"text":"the superiority boundary. Calculations were performed using nQuery Advisor + nTerim 3.0","text_display":" the superiority boundary. Calculations were performed using nQuery Advisor + nTerim 3.0","confidence":0.9829182624816895,"confidence_rate":0.999810684808328},{"cnt":[[344,2093],[952,2093],[952,2142],[344,2142]],"region":{"top_left_x":343,"top_left_y":2092,"width":609,"height":50},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dbac197db0e64b87bbe8e2cff18a5f6d","type":"text","conversion_output":true,"text":"(Statistical Solutions. Boston, MA).","text_display":" (Statistical Solutions. Boston, MA).","confidence":1,"confidence_rate":1},{"cnt":[[344,2159],[1876,2159],[1876,2211],[344,2211]],"region":{"top_left_x":343,"top_left_y":2159,"width":1533,"height":52},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"378a0e98fad3444cbb69fb7136301b29","type":"text","conversion_output":true,"text":"The following table summarizes the superiority boundary at each of 2 looks when \\(66 \\%\\) and","text_display":"\n\nThe following table summarizes the superiority boundary at each of 2 looks when \\(66 \\%\\) and","confidence":0.99365234375,"confidence_rate":0.9999350236591895},{"cnt":[[346,2209],[1871,2209],[1871,2258],[346,2258]],"region":{"top_left_x":345,"top_left_y":2208,"width":1527,"height":51},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"534d4c0c1ac140dcbb0e53fa33b15596","type":"text","conversion_output":true,"text":"\\(100 \\%\\) subjects are enrolled and evaluated, respectively. The superiority boundary on the p-","text_display":" \\(100 \\%\\) subjects are enrolled and evaluated, respectively. The superiority boundary on the p","confidence":0.99951171875,"confidence_rate":0.9999948042635181},{"cnt":[[344,2254],[1867,2254],[1867,2305],[344,2305]],"region":{"top_left_x":343,"top_left_y":2253,"width":1524,"height":53},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf4d3b6c857e4b6b8ed5e99e9a83c473","type":"text","conversion_output":true,"text":"value scale at the interim analysis is calculated as \\(p =0.0061\\) (or \\(Z =2.509\\) ). If the one-tailed","text_display":"value scale at the interim analysis is calculated as \\(p =0.0061\\) (or \\(Z =2.509\\) ). If the one-tailed","confidence":1,"confidence_rate":1},{"cnt":[[344,2303],[1837,2303],[1837,2357],[344,2357]],"region":{"top_left_x":343,"top_left_y":2303,"width":1494,"height":54},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f01e347ffdd84ce89a1d4739ed7dcac5","type":"text","conversion_output":true,"text":"p-value from a Fisher's exact test is less than or equal to 0.0061 , it will be recommended","text_display":" p-value from a Fisher's exact test is less than or equal to 0.0061 , it will be recommended","confidence":0.6298828125,"confidence_rate":0.9953419784617675},{"cnt":[[344,2350],[1858,2350],[1858,2402],[344,2402]],"region":{"top_left_x":343,"top_left_y":2350,"width":1516,"height":52},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc970ceddc944a8491fa3652596e345f","type":"text","conversion_output":true,"text":"that the trial stop for efficacy. This interim analysis has minimal effect on the significance","text_display":" that the trial stop for efficacy. This interim analysis has minimal effect on the significance","confidence":1,"confidence_rate":1},{"cnt":[[344,2398],[1553,2398],[1553,2451],[344,2451]],"region":{"top_left_x":343,"top_left_y":2397,"width":1211,"height":55},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"71f7b632f75b4a2797c0bad876c7e340","type":"text","conversion_output":true,"text":"level of the final analysis. The power in the final analysis is maintained.","text_display":" level of the final analysis. The power in the final analysis is maintained.","confidence":1,"confidence_rate":1},{"cnt":[[1048,2531],[1079,2531],[1079,2576],[1048,2576]],"region":{"top_left_x":1048,"top_left_y":2530,"width":31,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b47d5a4a95274bd5b490f8c229c2e892","type":"page_info","conversion_output":false,"text":"8","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"7637eb9d-d2d4-47f6-8092-03a5ba8c887f-09","page":9,"lines":[{"cnt":[[245,127],[501,127],[501,161],[245,161]],"region":{"top_left_x":244,"top_left_y":126,"width":257,"height":36},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34144c1ffa2847d7b002bf0d8519fa0b","type":"page_info","conversion_output":false,"text":"CONFIDENTIAL","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1521,125],[1876,125],[1876,165],[1521,165]],"region":{"top_left_x":1521,"top_left_y":124,"width":355,"height":42},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"062a5399ca0b4a08a109d9178e7bb1fa","type":"page_info","conversion_output":false,"text":"Statistical Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1624,165],[1880,165],[1880,204],[1624,204]],"region":{"top_left_x":1624,"top_left_y":165,"width":256,"height":40},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d807c9bf2b246ac86f3fc7926d22205","type":"page_info","conversion_output":false,"text":"Protocol: SCALP","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1497,206],[1880,206],[1880,247],[1497,247]],"region":{"top_left_x":1497,"top_left_y":206,"width":383,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b99860ae6474e1db781fa3897770686","type":"page_info","conversion_output":false,"text":"Version 1.0 / Nov 30, 2015","text_display":"","confidence":0.98388671875,"confidence_rate":0.9995078632063727},{"cnt":[[312,350],[1815,350],[1815,662],[312,662]],"region":{"top_left_x":311,"top_left_y":350,"width":1505,"height":312},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a47128c7570745ad85f0f271b86635d9","type":"table","conversion_output":true,"text":"\\begin{tabular}{|c|c|c|c|c|c|}\n\\hline Looks & \\begin{tabular}{c} \nAccumulated \\\\\n'Information'\n\\end{tabular} & \\begin{tabular}{c} \nEvaluable N \\\\\n(cooling \\\\\ngroup)\n\\end{tabular} & \\begin{tabular}{c} \nEvaluable N \\\\\n(no cooling \\\\\ngroup)\n\\end{tabular} & \\begin{tabular}{c} \nSuperiority \\\\\nBoundary \\\\\n(Z value)\n\\end{tabular} & \\begin{tabular}{c} \nSuperiority \\\\\nBoundary \\\\\n(One-tailed \\\\\np-value)\n\\end{tabular} \\\\\n\\hline 1 & \\(66 \\%\\) & 95 & 47 & 2.509 & 0.0061 \\\\\n\\hline 2 & \\(100 \\%\\) & 142 & 71 & 1.993 & 0.0231 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|c|c|c|c|c|c|}\n\\hline Looks & \\begin{tabular}{c} \nAccumulated \\\\\n'Information'\n\\end{tabular} & \\begin{tabular}{c} \nEvaluable N \\\\\n(cooling \\\\\ngroup)\n\\end{tabular} & \\begin{tabular}{c} \nEvaluable N \\\\\n(no cooling \\\\\ngroup)\n\\end{tabular} & \\begin{tabular}{c} \nSuperiority \\\\\nBoundary \\\\\n(Z value)\n\\end{tabular} & \\begin{tabular}{c} \nSuperiority \\\\\nBoundary \\\\\n(One-tailed \\\\\np-value)\n\\end{tabular} \\\\\n\\hline 1 & \\(66 \\%\\) & 95 & 47 & 2.509 & 0.0061 \\\\\n\\hline 2 & \\(100 \\%\\) & 142 & 71 & 1.993 & 0.0231 \\\\\n\\hline\n\\end{tabular}","confidence":0.38516907235745484,"confidence_rate":0.9976756983280958},{"cnt":[[337,679],[1869,679],[1869,715],[337,715]],"region":{"top_left_x":337,"top_left_y":678,"width":1533,"height":38},"line":6,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"f53318e614e2489d82b221a91c2dac3b","type":"text","conversion_output":true,"text":"1. For the software, Z-value boundaries are specified assuming that a Z test for proportions (unpooled variance) will be used, however the corresponding p-","text_display":"\n1. For the software, Z-value boundaries are specified assuming that a Z test for proportions (unpooled variance) will be used, however the corresponding p","confidence":0.6140327453613281,"confidence_rate":0.9969564720685407},{"cnt":[[370,711],[1751,711],[1751,746],[370,746]],"region":{"top_left_x":369,"top_left_y":711,"width":1382,"height":35},"line":7,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"1aa593deb515492d82ab6f93030b1295","type":"text","conversion_output":true,"text":"values apply equally well to Fisher's exact test, which was used in the original sample size calculations, and is still proposed for the analysis.","text_display":"values apply equally well to Fisher's exact test, which was used in the original sample size calculations, and is still proposed for the analysis.","confidence":1,"confidence_rate":1},{"cnt":[[335,786],[1876,786],[1876,838],[335,838]],"region":{"top_left_x":335,"top_left_y":786,"width":1541,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac5b6fa9b9f749e29d8e81b6ca3e49a5","type":"text","conversion_output":true,"text":"If the interim analysis does not declare superiority, the study will continue to full accrual as","text_display":"\n\nIf the interim analysis does not declare superiority, the study will continue to full accrual as","confidence":1,"confidence_rate":1},{"cnt":[[335,836],[1854,836],[1854,887],[335,887]],"region":{"top_left_x":335,"top_left_y":835,"width":1520,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8236bbf894704b4c8b4abbbe6d721676","type":"text","conversion_output":true,"text":"planned. 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The DSMB will examine the interim results and provide","confidence":1,"confidence_rate":1},{"cnt":[[335,932],[1347,932],[1347,984],[335,984]],"region":{"top_left_x":335,"top_left_y":932,"width":1013,"height":52},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cdd19af31a94dfaab4a1fd51b39003c","type":"text","conversion_output":true,"text":"recommendations to continue the trial or stop the trial early.","text_display":" recommendations to continue the trial or stop the trial early.","confidence":1,"confidence_rate":1},{"cnt":[[236,1044],[595,1044],[595,1102],[236,1102]],"region":{"top_left_x":236,"top_left_y":1044,"width":360,"height":59},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eeb3bc3d4d1f4c0a8b6d0088946fe3b8","type":"section_header","conversion_output":false,"children_ids":["d67233663d94472a9d7e3ec241b8c56e"],"text":"","text_display":""},{"cnt":[[243,1048],[591,1048],[591,1096],[243,1096]],"region":{"top_left_x":242,"top_left_y":1048,"width":349,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d67233663d94472a9d7e3ec241b8c56e","type":"text","conversion_output":true,"parent_id":"eeb3bc3d4d1f4c0a8b6d0088946fe3b8","text":"4.3 Randomization","text_display":"\n\n\\subsection*{4.3 Randomization}","confidence":1,"confidence_rate":1},{"cnt":[[344,1117],[1790,1117],[1790,1169],[344,1169]],"region":{"top_left_x":343,"top_left_y":1117,"width":1447,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8cf1ba4f15848f8a93df28a6920d378","type":"text","conversion_output":true,"text":"Randomization will be performed prior to performing any procedures and will use the","text_display":"\n\nRandomization will be performed prior to performing any procedures and will use the","confidence":1,"confidence_rate":1},{"cnt":[[344,1164],[1846,1164],[1846,1218],[344,1218]],"region":{"top_left_x":343,"top_left_y":1164,"width":1503,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbbc04cb3d524b3491c7397a8feb53b8","type":"text","conversion_output":true,"text":"permuted block method. 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Standard statistical methods for analyzing","confidence":1,"confidence_rate":1},{"cnt":[[335,954],[1841,954],[1841,1003],[335,1003]],"region":{"top_left_x":335,"top_left_y":953,"width":1507,"height":51},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22635db06c37406d8dca08df42c475ca","type":"text","conversion_output":true,"text":"categorical data, continuous data, and survival data will be applied whenever appropriate.","text_display":" categorical data, continuous data, and survival data will be applied whenever appropriate.","confidence":1,"confidence_rate":1},{"cnt":[[335,1001],[1742,1001],[1742,1051],[335,1051]],"region":{"top_left_x":335,"top_left_y":1001,"width":1408,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3361058488d24ba3866d3a16f08259cd","type":"text","conversion_output":true,"text":"All statistical tests will be two-sided and conducted at an alpha level of 0.05 , unless","text_display":" All statistical tests will be two-sided and conducted at an alpha level of 0.05 , unless","confidence":1,"confidence_rate":1},{"cnt":[[335,1048],[627,1048],[627,1094],[335,1094]],"region":{"top_left_x":335,"top_left_y":1048,"width":293,"height":46},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a99071e79fbf4299a9c78bacee1e8349","type":"text","conversion_output":true,"text":"otherwise stated.","text_display":" otherwise stated.","confidence":1,"confidence_rate":1},{"cnt":[[335,1113],[1519,1113],[1519,1167],[335,1167]],"region":{"top_left_x":335,"top_left_y":1112,"width":1184,"height":55},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"029c305e3e70417e9bad7f19f241153c","type":"text","conversion_output":true,"text":"Unless otherwise specified, SAS 9.4 will be used for all data analyses.","text_display":"\n\nUnless otherwise specified, SAS 9.4 will be used for all data analyses.","confidence":1,"confidence_rate":1},{"cnt":[[236,1250],[668,1250],[668,1313],[236,1313]],"region":{"top_left_x":236,"top_left_y":1250,"width":433,"height":63},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed4bff75e80e403686b8678ff7fe7d34","type":"section_header","conversion_output":false,"children_ids":["01dbe4033c444cc1b967b777c4d3354e"],"text":"","text_display":""},{"cnt":[[243,1255],[662,1255],[662,1308],[243,1308]],"region":{"top_left_x":242,"top_left_y":1254,"width":420,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01dbe4033c444cc1b967b777c4d3354e","type":"text","conversion_output":true,"parent_id":"ed4bff75e80e403686b8678ff7fe7d34","text":"6.2 Subject Disposition","text_display":"\n\n\\subsection*{6.2 Subject Disposition}","confidence":1,"confidence_rate":1},{"cnt":[[335,1319],[1783,1319],[1783,1373],[335,1373]],"region":{"top_left_x":335,"top_left_y":1319,"width":1449,"height":54},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0dd3f5188f6a4fd3a672f9afe55cd3a8","type":"text","conversion_output":true,"text":"Subject enrollment and disposition will be summarized for all randomized subjects. A","text_display":"\n\nSubject enrollment and disposition will be summarized for all randomized subjects. 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Two separate tables, one listing subjects who are","confidence":1,"confidence_rate":1},{"cnt":[[337,1517],[1609,1517],[1609,1566],[337,1566]],"region":{"top_left_x":337,"top_left_y":1516,"width":1273,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a27c2234852149dc8bffd1a84aad95e0","type":"text","conversion_output":true,"text":"off study before the treatment and one summarizing the reason of treatment","text_display":" off study before the treatment and one summarizing the reason of treatment","confidence":1,"confidence_rate":1},{"cnt":[[335,1560],[986,1560],[986,1613],[335,1613]],"region":{"top_left_x":335,"top_left_y":1559,"width":652,"height":55},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9db051939c7549cdb0c3fdcef81d27f9","type":"text","conversion_output":true,"text":"discontinuation, will also be provided.","text_display":" discontinuation, will also be provided.","confidence":0.99951171875,"confidence_rate":0.9999889000502842},{"cnt":[[236,1693],[862,1693],[862,1760],[236,1760]],"region":{"top_left_x":236,"top_left_y":1692,"width":626,"height":68},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab1d5e6924bd44238534fea44380cef5","type":"section_header","conversion_output":false,"children_ids":["056f8e11ebf54f69bcf7ad731669b7f0"],"text":"","text_display":""},{"cnt":[[245,1697],[855,1697],[855,1751],[245,1751]],"region":{"top_left_x":244,"top_left_y":1697,"width":612,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"056f8e11ebf54f69bcf7ad731669b7f0","type":"text","conversion_output":true,"parent_id":"ab1d5e6924bd44238534fea44380cef5","text":"6.3 Important Protocol Violations","text_display":"\n\n\\subsection*{6.3 Important Protocol Violations}","confidence":1,"confidence_rate":1},{"cnt":[[335,1766],[1865,1766],[1865,1820],[335,1820]],"region":{"top_left_x":335,"top_left_y":1766,"width":1530,"height":54},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b944b2eb9494c4f9c05ef12589406b2","type":"text","conversion_output":true,"text":"Important protocol violations will be summarized in frequency tables using all randomized","text_display":"\n\nImportant protocol violations will be summarized in frequency tables using all randomized","confidence":1,"confidence_rate":1},{"cnt":[[337,1818],[1781,1818],[1781,1867],[337,1867]],"region":{"top_left_x":337,"top_left_y":1817,"width":1445,"height":50},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0e1efa3c3914a828a875b3c961d4c4b","type":"text","conversion_output":true,"text":"subject. 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Three widely used and validated scales","text_display":" chemotherapy (if receiving more than 4 cycles). Three widely used and validated scales","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[344,808],[1248,808],[1248,862],[344,862]],"region":{"top_left_x":343,"top_left_y":807,"width":906,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b73814e155ea45c7a46cd2ac1de94282","type":"text","conversion_output":true,"text":"will be used: the EORTC QLQ-C30, HADS and BIS.","text_display":" will be used: the EORTC QLQ-C30, HADS and BIS.","confidence":1,"confidence_rate":1},{"cnt":[[344,877],[1725,877],[1725,930],[344,930]],"region":{"top_left_x":343,"top_left_y":876,"width":1383,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3124753925a24b1387c155d6e0b9215a","type":"text","conversion_output":true,"text":"The QLQ-C30 is composed of 30 items for both multi-item scales and single-item","text_display":"\nThe QLQ-C30 is composed of 30 items for both multi-item scales and single-item","confidence":1,"confidence_rate":1},{"cnt":[[344,924],[1777,924],[1777,978],[344,978]],"region":{"top_left_x":343,"top_left_y":923,"width":1434,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a299f32906034f119e63d2331c0dd9b3","type":"text","conversion_output":true,"text":"measures. These include five functional scales, three symptom scales, a global health","text_display":" measures. These include five functional scales, three symptom scales, a global health","confidence":1,"confidence_rate":1},{"cnt":[[344,973],[1803,973],[1803,1025],[344,1025]],"region":{"top_left_x":343,"top_left_y":973,"width":1460,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a310b14e65b043798bad036aa24e5890","type":"text","conversion_output":true,"text":"status/QOL scale, and six single items. Among these, emotional functioning and social","text_display":" status/QOL scale, and six single items. Among these, emotional functioning and social","confidence":1,"confidence_rate":1},{"cnt":[[344,1021],[1837,1021],[1837,1072],[344,1072]],"region":{"top_left_x":343,"top_left_y":1020,"width":1494,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6a1b81b7f064eb499eeafc37e70a5be","type":"text","conversion_output":true,"text":"functional scores of the QLQ-C30 are deemed as the variables of interest. Calculation of","text_display":" functional scores of the QLQ-C30 are deemed as the variables of interest. Calculation of","confidence":1,"confidence_rate":1},{"cnt":[[344,1070],[1811,1070],[1811,1119],[344,1119]],"region":{"top_left_x":343,"top_left_y":1069,"width":1469,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d48680fa643486baf900114af999c91","type":"text","conversion_output":true,"text":"the QLQ scores will follow the scoring procedures described in the EORTC QLQ C-30","text_display":" the QLQ scores will follow the scoring procedures described in the EORTC QLQ C-30","confidence":1,"confidence_rate":1},{"cnt":[[344,1113],[503,1113],[503,1162],[344,1162]],"region":{"top_left_x":343,"top_left_y":1112,"width":160,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"834c082545e24f0180787e1cb06ab8be","type":"text","conversion_output":true,"text":"manual \\({ }^{1}\\).","text_display":" manual \\({ }^{1}\\).","confidence":1,"confidence_rate":1},{"cnt":[[344,1182],[1863,1182],[1863,1235],[344,1235]],"region":{"top_left_x":343,"top_left_y":1181,"width":1520,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d93e1db0f43423880b2bc76aa9190ac","type":"text","conversion_output":true,"text":"The HADS is composed of 14 items. Among them, 7 items are for assessing anxiety and 7","text_display":"\n\nThe HADS is composed of 14 items. Among them, 7 items are for assessing anxiety and 7","confidence":1,"confidence_rate":1},{"cnt":[[344,1233],[1858,1233],[1858,1285],[344,1285]],"region":{"top_left_x":343,"top_left_y":1233,"width":1516,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ebab74db2664d7c994355698e9f8a01","type":"text","conversion_output":true,"text":"items are for assessing depression. Two summary scores for anxiety and depression of the","text_display":" items are for assessing depression. Two summary scores for anxiety and depression of the","confidence":1,"confidence_rate":1},{"cnt":[[344,1280],[1399,1280],[1399,1332],[344,1332]],"region":{"top_left_x":343,"top_left_y":1280,"width":1056,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b2ff8835d494123985938bcc921d99e","type":"text","conversion_output":true,"text":"HADS will be calculated and they are the variables of interest.","text_display":" HADS will be calculated and they are the variables of interest.","confidence":1,"confidence_rate":1},{"cnt":[[344,1349],[1846,1349],[1846,1403],[344,1403]],"region":{"top_left_x":343,"top_left_y":1349,"width":1503,"height":54},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"711c97de76114cfb9b19b35ff5da557b","type":"text","conversion_output":true,"text":"The BIS is composed of 10 items. A summary score using the first 9 items and excluding","text_display":"\nThe BIS is composed of 10 items. A summary score using the first 9 items and excluding","confidence":1,"confidence_rate":1},{"cnt":[[344,1401],[1747,1401],[1747,1446],[344,1446]],"region":{"top_left_x":343,"top_left_y":1400,"width":1404,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21acd9e1661647c088987544e3675e85","type":"text","conversion_output":true,"text":"the last item which asks for scars will be calculated and it is the variable of interest.","text_display":" the last item which asks for scars will be calculated and it is the variable of interest.","confidence":1,"confidence_rate":1},{"cnt":[[344,1465],[1861,1465],[1861,1519],[344,1519]],"region":{"top_left_x":343,"top_left_y":1465,"width":1518,"height":54},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2af32e94a004625b280a0dc15195658","type":"text","conversion_output":true,"text":"Any missing questionnaire assessment will be handled as last observation carried forward.","text_display":"\n\nAny missing questionnaire assessment will be handled as last observation carried forward.","confidence":1,"confidence_rate":1},{"cnt":[[344,1534],[1841,1534],[1841,1588],[344,1588]],"region":{"top_left_x":343,"top_left_y":1533,"width":1499,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06d6b3b4bec24ac99493a605d56d4af6","type":"text","conversion_output":true,"text":"Descriptive statistics will be used to summarize the variables of interest with median and","text_display":"\nDescriptive statistics will be used to summarize the variables of interest with median and","confidence":1,"confidence_rate":1},{"cnt":[[344,1583],[1740,1583],[1740,1635],[344,1635]],"region":{"top_left_x":343,"top_left_y":1583,"width":1398,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a8d2cb3e0714507834dffa49aa0a742","type":"text","conversion_output":true,"text":"IQR by time points and treatment groups. Changes in the variables of interest from","text_display":" IQR by time points and treatment groups. Changes in the variables of interest from","confidence":1,"confidence_rate":1},{"cnt":[[344,1629],[1828,1629],[1828,1682],[344,1682]],"region":{"top_left_x":343,"top_left_y":1628,"width":1486,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17790f2215484d699f3f1cc9a021fdfb","type":"text","conversion_output":true,"text":"baseline to after 4 cycles of chemotherapy will be summarized by treatment groups with","text_display":" baseline to after 4 cycles of chemotherapy will be summarized by treatment groups with","confidence":1,"confidence_rate":1},{"cnt":[[344,1680],[1783,1680],[1783,1729],[344,1729]],"region":{"top_left_x":343,"top_left_y":1680,"width":1441,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3595af0d9f884679a3580055b202f473","type":"text","conversion_output":true,"text":"median and IQR, and compared using Wilcoxon rank sum tests. Methods such as the","text_display":" median and IQR, and compared using Wilcoxon rank sum tests. Methods such as the","confidence":1,"confidence_rate":1},{"cnt":[[344,1727],[1815,1727],[1815,1779],[344,1779]],"region":{"top_left_x":343,"top_left_y":1727,"width":1473,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9604d0680f049df837168d3f3f6dfe6","type":"text","conversion_output":true,"text":"generalized estimating equations and mixed models for analyzing the changes overtime","text_display":" generalized estimating equations and mixed models for analyzing the changes overtime","confidence":1,"confidence_rate":1},{"cnt":[[344,1775],[1308,1775],[1308,1828],[344,1828]],"region":{"top_left_x":343,"top_left_y":1774,"width":966,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37c349b6d1ed4e5b94b1bce3b2f44bd9","type":"text","conversion_output":true,"text":"and group comparison will also be applied if appropriate.","text_display":" and group comparison will also be applied if appropriate.","confidence":1,"confidence_rate":1},{"cnt":[[236,1972],[608,1972],[608,2041],[236,2041]],"region":{"top_left_x":236,"top_left_y":1972,"width":373,"height":70},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a56052b7ce9b42bd841086c97ad8b117","type":"section_header","conversion_output":false,"children_ids":["5980583bf77643f4ac95a3b9894dad60"],"text":"","text_display":""},{"cnt":[[245,1981],[599,1981],[599,2035],[245,2035]],"region":{"top_left_x":244,"top_left_y":1980,"width":356,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5980583bf77643f4ac95a3b9894dad60","type":"text","conversion_output":true,"parent_id":"a56052b7ce9b42bd841086c97ad8b117","text":"6.6 Safety Analyses","text_display":"\n\n\\subsection*{6.6 Safety Analyses}","confidence":1,"confidence_rate":1},{"cnt":[[236,2090],[1629,2090],[1629,2159],[236,2159]],"region":{"top_left_x":236,"top_left_y":2090,"width":1393,"height":70},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12a63f0138434896b722802c5a5116ae","type":"section_header","conversion_output":false,"children_ids":["7949b115f9404e95b1b3fb66f6c5f619"],"text":"","text_display":""},{"cnt":[[245,2099],[1620,2099],[1620,2151],[245,2151]],"region":{"top_left_x":244,"top_left_y":2099,"width":1376,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7949b115f9404e95b1b3fb66f6c5f619","type":"text","conversion_output":true,"parent_id":"12a63f0138434896b722802c5a5116ae","text":"6.6.1 Primary Safety Endpoint: Anticipated Adverse Devise Effects (AADEs)","text_display":"\n\n\\subsection*{6.6.1 Primary Safety Endpoint: Anticipated Adverse Devise Effects (AADEs)}","confidence":1,"confidence_rate":1},{"cnt":[[365,2166],[1824,2166],[1824,2219],[365,2219]],"region":{"top_left_x":365,"top_left_y":2165,"width":1460,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76018cc8394044e9bccf776c665a865e","type":"text","conversion_output":true,"text":"The primary safety analysis will be based on the safety population. The primary safety","text_display":"\n\nThe primary safety analysis will be based on the safety population. The primary safety","confidence":1,"confidence_rate":1},{"cnt":[[367,2213],[1876,2213],[1876,2267],[367,2267]],"region":{"top_left_x":367,"top_left_y":2212,"width":1509,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c626ce9027b4149b40aa1cc1459c9e8","type":"text","conversion_output":true,"text":"endpoint is AADE as the following complications are known to be associated with use of","text_display":" endpoint is AADE as the following complications are known to be associated with use of","confidence":1,"confidence_rate":1},{"cnt":[[365,2262],[1824,2262],[1824,2314],[365,2314]],"region":{"top_left_x":365,"top_left_y":2262,"width":1460,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b7931408f3e4632bd4eb13c8234b101","type":"text","conversion_output":true,"text":"the Orbis Paxman Hair Loss Prevention System for the management of chemotherapy-","text_display":" the Orbis Paxman Hair Loss 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Subject-reported","text_display":"\n\nThis secondary safety analysis will be based on the safety population. Subject-reported","confidence":1,"confidence_rate":1},{"cnt":[[344,838],[1794,838],[1794,887],[344,887]],"region":{"top_left_x":343,"top_left_y":837,"width":1451,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24529f0c1c6a4bddb5cbf49af86e9b4d","type":"text","conversion_output":true,"text":"comfort is categorized into 5 levels from very comfortable to very uncomfortable. The","text_display":" comfort is categorized into 5 levels from very comfortable to very uncomfortable. 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\\multirow{2}{*}{Parameter} & \\multicolumn{2}{|c|}{Center 1} & \\multicolumn{2}{|c|}{Center 2} & \\multicolumn{2}{|c|}{Center ---} \\\\\n\\hline & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) \\\\\n\\hline \\multicolumn{7}{|l|}{Age (years)} \\\\\n\\hline Mean (SD) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) \\\\\n\\hline Median (Min, Max) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{Race [n (\\%)]} \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{Ethnicity [n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{Breast Cancer Stage [n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{Scheduled Chemotherapy Regimen [ n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{ECOG performance Status [n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{Menopausal Status [n (\\%)]} \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{History of Hormone Replacement [n (\\%)]} \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{History of Oral Conceptive use [n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{TABLE 7 DEMOGRAPHIC INFORMATION AND BASELINE CHARACTERISTICS BY CENTERS (RANDOMIZED POPULATION)}\n\\begin{tabular}{|l|l|l|l|l|l|l|}\n\\hline \\multirow{2}{*}{Parameter} & \\multicolumn{2}{|c|}{Center 1} & \\multicolumn{2}{|c|}{Center 2} & \\multicolumn{2}{|c|}{Center ---} \\\\\n\\hline & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) \\\\\n\\hline \\multicolumn{7}{|l|}{Age (years)} \\\\\n\\hline Mean (SD) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) \\\\\n\\hline Median (Min, Max) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{Race [n (\\%)]} \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{Ethnicity [n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{7}{|l|}{Breast Cancer 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\\multirow{2}{*}{Parameter} & \\multicolumn{2}{|c|}{Anthracycline} & \\multicolumn{2}{|c|}{Taxane} \\\\\n\\hline & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) \\\\\n\\hline \\multicolumn{5}{|l|}{Age (years)} \\\\\n\\hline Mean (SD) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) \\\\\n\\hline Median (Min, Max) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) \\\\\n\\hline \\multicolumn{5}{|l|}{Race [n (\\%)]} \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{5}{|l|}{Ethnicity [ n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{5}{|l|}{Breast Cancer Stage [n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{5}{|l|}{Scheduled Chemotherapy Regimen [ n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{5}{|l|}{ECOG performance Status [n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{5}{|l|}{Menopausal Status [n (\\%)]} \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{5}{|l|}{History of Hormone Replacement [ n (\\%)]} \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline \\multicolumn{5}{|l|}{History of Oral Conceptive use [n (\\%)]} \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline --- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline & & & & \\\\\n\\hline ---- & & & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{TABLE 8 DEMOGRAPHIC INFORMATION AND BASELINE CHARACTERISTICS BY MAJOR CHEMOTHERAPY TYPE (RANDOMIZED POPULATION)}\n\\begin{tabular}{|l|l|l|l|l|}\n\\hline \\multirow{2}{*}{Parameter} & \\multicolumn{2}{|c|}{Anthracycline} & \\multicolumn{2}{|c|}{Taxane} \\\\\n\\hline & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) & Arm 1 \\(N = xx\\) (\\%) & Arm 2 \\(N = xx\\) (\\%) \\\\\n\\hline \\multicolumn{5}{|l|}{Age (years)} \\\\\n\\hline Mean (SD) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) & xx.x(xx.x) \\\\\n\\hline Median (Min, Max) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) & xx.x (xx.x, xx.x) \\\\\n\\hline \\multicolumn{5}{|l|}{Race [n (\\%)]} \\\\\n\\hline ---- & xx (xx.x) & xx (xx.x) & xx (xx.x) & xx (xx.x) \\\\\n\\hline ---- & xx (xx.x) & xx 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