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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":"f7dba3af22fa4a47bb19aa7dbd7bcfdc","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":"6545dd4f9f6e4776b0822b202ea50b30","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":0.98779296875,"confidence_rate":0.9998707225781867},{"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":"a3dcd3985fda4e5badf8ed6e66773aaa","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":0.8311810463110874,"confidence_rate":0.9982063906155139},{"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":"4b72387f0b6b407997ffe5131b1f38ac","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":"27651f4292cf470d89c09e7d0ab28504","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":"8b13873f335944879e3c73b6e7f22f9f","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":0.8971953634645055,"confidence_rate":0.9996771900782281},{"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":"557635d0309c4703a84f6e43a0c918e2","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":"b06565eb23ff472085aa96f4f602dd19","type":"section_header","conversion_output":false,"children_ids":["30ea9499ed3144c2a5525c41fec58b43"],"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":"30ea9499ed3144c2a5525c41fec58b43","type":"text","conversion_output":true,"parent_id":"b06565eb23ff472085aa96f4f602dd19","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":"e47060292e034506a364eed6ab9086e4","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":"85b58efacd6146cb9d2ad5846336a73d","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":"be66488b43ab459eab0679b676cd6124","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":"c72d50d0482b4714a6287e68ab8032eb","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":"68bbf6e19b014085ae7c330ed4293df9","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":"8001956c461f469aa7b95f5000ff4c10","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":"2165cd3a8d194b94861d589e70ab7cdd","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":"02d3373625a54fc4922e0139ef85c0a8","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":"3178ab0280b14be5ad00a1bc68482393","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":0.999994804263518},{"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":"57943586443a43dab93ee1c98db6c42e","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":"bbfc8f9bf6c64a4b900621181ddf5a37","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":"fad5472a0ebf4016808c0005b70525c5","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":"a9e12643f3a64ea6b0bb658a17447302","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":"860bdfaed08e4788846a1fdcbebd98f3","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":"0a1ec072-7df8-430e-a382-3c30097754ca-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":"2b6eb5a4729a451280f6e9f45911a443","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":"b6702ad199974f8f8a549c590933735f","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":"10a73d9a6f344b729f9b48829193322a","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":"c1be0e4d36d24e60a11717beb4aec2ec","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":"a6b2d9b78d474af3ac0a26613d03ea7f","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":0.3846872239253684,"confidence_rate":0.9976726522873356},{"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":"9f52379965ef4328b264d689a0385ca6","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":0.6208553314208984,"confidence_rate":0.9970253257317155},{"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":"7fad7c067d6c40dd8788b9918657e796","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":"9a9e97e33f8348e78163cf83f382c67d","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":"5f536eaf6b19423a992ee3db78bbd7ee","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":"04c9ec9d504e4192860510a913fd026c","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":"9ddd4c3d76e74c608eadec4c99c7c591","type":"section_header","conversion_output":false,"children_ids":["033b6a243af14f81add3534eea1732af"],"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":"033b6a243af14f81add3534eea1732af","type":"text","conversion_output":true,"parent_id":"9ddd4c3d76e74c608eadec4c99c7c591","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":"7c1c73d1682c40c1bc8b3d9c6664fd86","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":"aad6128e7a8849728c4c4a9b37fb55e7","type":"text","conversion_output":true,"text":"permuted block method. 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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":"d85dca84eeda4f7f873448d096308ee4","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":"bbb805e146b9408196ede766b2385a2d","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":"3885a7fda7fc4c8db7ac6b38fa93ced7","type":"section_header","conversion_output":false,"children_ids":["e955c2f9c42e427696e34ee792783d0b"],"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":"e955c2f9c42e427696e34ee792783d0b","type":"text","conversion_output":true,"parent_id":"3885a7fda7fc4c8db7ac6b38fa93ced7","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":"58cd04f1a7fe4594a5c1724bae163796","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":"d217fda575f1439b811b3320ac27e4d7","type":"text","conversion_output":true,"text":"subject. 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The primary efficacy","confidence":1,"confidence_rate":1},{"cnt":[[344,782],[1846,782],[1846,831],[344,831]],"region":{"top_left_x":343,"top_left_y":782,"width":1503,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cde76ac4322403fa7d7226a6f4bc333","type":"text","conversion_output":true,"text":"endpoint will be success in hair preservation, defined as CTCAE v4.0 alopecia grade < 2,","text_display":" endpoint will be success in hair preservation, defined as CTCAE v4.0 alopecia grade < 2,","confidence":0.8157672882080078,"confidence_rate":0.9978128667667746},{"cnt":[[344,829],[1738,829],[1738,879],[344,879]],"region":{"top_left_x":343,"top_left_y":829,"width":1396,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60247bde95334762843e5e3406c5b450","type":"text","conversion_output":true,"text":"and will be assessed by a healthcare professional that is blinded to study treatment.","text_display":" and will be assessed by a healthcare professional that is blinded to study treatment.","confidence":1,"confidence_rate":1},{"cnt":[[344,877],[1768,877],[1768,930],[344,930]],"region":{"top_left_x":343,"top_left_y":876,"width":1426,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fce1f2b0a1514954908076899341faec","type":"text","conversion_output":true,"text":"Although hair preservation will be assessed at baseline and after each cycle, only the","text_display":" Although hair preservation will be assessed at baseline and after each cycle, only the","confidence":1,"confidence_rate":1},{"cnt":[[344,924],[1742,924],[1742,978],[344,978]],"region":{"top_left_x":343,"top_left_y":923,"width":1400,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4abce002e6474a6e82281bf2b56e7eec","type":"text","conversion_output":true,"text":"assessment after 4th cycle of chemotherapy will be deemed as the primary efficacy","text_display":" assessment after 4th cycle of chemotherapy will be deemed as the primary efficacy","confidence":1,"confidence_rate":1},{"cnt":[[344,975],[509,975],[509,1025],[344,1025]],"region":{"top_left_x":343,"top_left_y":975,"width":167,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c690bb05618e43f592182133b4f9f0da","type":"text","conversion_output":true,"text":"endpoint.","text_display":" endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[344,1040],[1826,1040],[1826,1094],[344,1094]],"region":{"top_left_x":343,"top_left_y":1039,"width":1484,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"104f293a116f4053970c092b29844996","type":"text","conversion_output":true,"text":"Subjects who stop wearing the scalp cooling system during the study will continue to be","text_display":"\nSubjects who stop wearing the scalp cooling system during the study will continue to be","confidence":1,"confidence_rate":1},{"cnt":[[344,1091],[1824,1091],[1824,1141],[344,1141]],"region":{"top_left_x":343,"top_left_y":1091,"width":1482,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d499e756a96f4de793162b452fb145b5","type":"text","conversion_output":true,"text":"evaluated after every chemotherapy cycle. For purposes of estimating treatment success","text_display":" evaluated after every chemotherapy cycle. For purposes of estimating treatment success","confidence":1,"confidence_rate":1},{"cnt":[[344,1139],[1876,1139],[1876,1188],[344,1188]],"region":{"top_left_x":343,"top_left_y":1138,"width":1533,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fc2ce65389f4ab295313f2eadbea606","type":"text","conversion_output":true,"text":"rates, study subjects who cannot be evaluated at the post-cycle 4 time point will be deemed","text_display":" rates, study subjects who cannot be evaluated at the post-cycle 4 time point will be deemed","confidence":1,"confidence_rate":1},{"cnt":[[344,1186],[1848,1186],[1848,1235],[344,1235]],"region":{"top_left_x":343,"top_left_y":1185,"width":1505,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5ff2581a35c4d6ab4e384c5c97474d8","type":"text","conversion_output":true,"text":"treatment failures. Missing or lost hair preservation evaluations will be deemed treatment","text_display":" treatment failures. Missing or lost hair preservation evaluations will be deemed treatment","confidence":1,"confidence_rate":1},{"cnt":[[344,1233],[488,1233],[488,1278],[344,1278]],"region":{"top_left_x":343,"top_left_y":1233,"width":145,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab8524003b7048fa83c572b2130e193e","type":"text","conversion_output":true,"text":"failures.","text_display":" failures.","confidence":1,"confidence_rate":1},{"cnt":[[344,1302],[1783,1302],[1783,1354],[344,1354]],"region":{"top_left_x":343,"top_left_y":1301,"width":1441,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"222f847cdee0427da5285e809891bae6","type":"text","conversion_output":true,"text":"The rates of hair preservation in the scalp cooling group and the control group will be","text_display":"\n\nThe rates of hair preservation in the scalp cooling group and the control group will be","confidence":1,"confidence_rate":1},{"cnt":[[344,1351],[1760,1351],[1760,1399],[344,1399]],"region":{"top_left_x":343,"top_left_y":1351,"width":1417,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e9dc38f03724c80bc109af04215aa6e","type":"text","conversion_output":true,"text":"calculated and summarized. Fisher's exact test will be used to test whether there is a","text_display":" calculated and summarized. Fisher's exact test will be used to test whether there is a","confidence":1,"confidence_rate":1},{"cnt":[[344,1396],[1854,1396],[1854,1450],[344,1450]],"region":{"top_left_x":343,"top_left_y":1396,"width":1512,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90cc94353de2486a9d1ae0eaf52fade1","type":"text","conversion_output":true,"text":"difference in the rates of hair preservation. The study will be deemed as success if there is","text_display":" difference in the rates of hair preservation. The study will be deemed as success if there is","confidence":1,"confidence_rate":1},{"cnt":[[344,1448],[1830,1448],[1830,1497],[344,1497]],"region":{"top_left_x":343,"top_left_y":1448,"width":1488,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4af1a816a5c5426d9f361d239100c13c","type":"text","conversion_output":true,"text":"a significant difference in rates of hair preservation between the scalp cooling group and","text_display":" a significant difference in rates of hair preservation between the scalp cooling group and","confidence":1,"confidence_rate":1},{"cnt":[[344,1495],[1712,1495],[1712,1549],[344,1549]],"region":{"top_left_x":343,"top_left_y":1495,"width":1370,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48bf249d102246c7bdce8ee0086c6a15","type":"text","conversion_output":true,"text":"the control group. P value, the difference in rates and its \\(95 \\% CI\\) will be reported.","text_display":" the control group. 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A logistic regression model or","text_display":" about the same number of subjects to each treatment group. A logistic regression model or","confidence":1,"confidence_rate":1},{"cnt":[[344,1659],[1734,1659],[1734,1708],[344,1708]],"region":{"top_left_x":343,"top_left_y":1658,"width":1391,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08be949a34514701bed5c8baa1bee2cb","type":"text","conversion_output":true,"text":"a Cochran-Mantel-Haenszel test (CMH) stratified by center will be used to test for","text_display":" a Cochran-Mantel-Haenszel test (CMH) stratified by center will be used to test for","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[344,1706],[1760,1706],[1760,1757],[344,1757]],"region":{"top_left_x":343,"top_left_y":1705,"width":1417,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe2a9566016f4549a51f71bd4f409e11","type":"text","conversion_output":true,"text":"interaction between the treatment effect and center to confirm the consistency of the","text_display":" interaction between the treatment effect and center to confirm the consistency of the","confidence":1,"confidence_rate":1},{"cnt":[[344,1753],[627,1753],[627,1803],[344,1803]],"region":{"top_left_x":343,"top_left_y":1753,"width":285,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5009aa2564b4dc782ad8c66b6ca2f1a","type":"text","conversion_output":true,"text":"treatment effect.","text_display":" treatment effect.","confidence":1,"confidence_rate":1},{"cnt":[[236,1884],[1399,1884],[1399,1953],[236,1953]],"region":{"top_left_x":236,"top_left_y":1884,"width":1163,"height":69},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c261bcead3d445ab230faccc09a5118","type":"section_header","conversion_output":false,"children_ids":["854f83cc5e684e94ac21de526fc4440a"],"text":"","text_display":""},{"cnt":[[245,1893],[1390,1893],[1390,1944],[245,1944]],"region":{"top_left_x":244,"top_left_y":1892,"width":1147,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"854f83cc5e684e94ac21de526fc4440a","type":"text","conversion_output":true,"parent_id":"7c261bcead3d445ab230faccc09a5118","text":"6.5.2 Success in Hair Preservation by Subject Self and Oncologist","text_display":"\n\n\\subsection*{6.5.2 Success in Hair Preservation by Subject Self and Oncologist}","confidence":1,"confidence_rate":1},{"cnt":[[344,1959],[1811,1959],[1811,2013],[344,2013]],"region":{"top_left_x":343,"top_left_y":1959,"width":1469,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2afb066683f40af83d7455fb2964129","type":"text","conversion_output":true,"text":"These secondary efficacy analyses will be based on the ITT population. Missing or lost","text_display":"\n\nThese secondary efficacy analyses will be based on the ITT population. Missing or lost","confidence":1,"confidence_rate":1},{"cnt":[[344,2007],[1850,2007],[1850,2060],[344,2060]],"region":{"top_left_x":343,"top_left_y":2006,"width":1507,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3ea0034d6424eb7b7f345cf0616e28b","type":"text","conversion_output":true,"text":"hair preservation evaluations will be deemed treatment failures. Data on hair preservation","text_display":" hair preservation evaluations will be deemed treatment failures. Data on hair preservation","confidence":1,"confidence_rate":1},{"cnt":[[344,2058],[1824,2058],[1824,2108],[344,2108]],"region":{"top_left_x":343,"top_left_y":2058,"width":1482,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f24edcb181f84d0dad5ec8c9424c28e3","type":"text","conversion_output":true,"text":"assessed by subject self and oncologist will be analyzed using descriptive statistics with","text_display":" assessed by subject self and oncologist will be analyzed using descriptive statistics with","confidence":1,"confidence_rate":1},{"cnt":[[344,2105],[1846,2105],[1846,2157],[344,2157]],"region":{"top_left_x":343,"top_left_y":2105,"width":1503,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec3a52df6b374bdcb08b5401f79f5e04","type":"text","conversion_output":true,"text":"rates and their \\(95 \\% CI\\). Comparison between the scalp cooling group to the control group","text_display":" rates and their \\(95 \\% CI\\). 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Data of wigs and/or","text_display":"\n\nThis secondary efficacy analysis will be based on the ITT population. Data of wigs and/or","confidence":1,"confidence_rate":1},{"cnt":[[335,408],[1798,408],[1798,462],[335,462]],"region":{"top_left_x":335,"top_left_y":408,"width":1464,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa217001257747e399bd122840a6056c","type":"text","conversion_output":true,"text":"head wrap use will be analyzed using descriptive statistics with rates and their \\(95 \\% CI\\).","text_display":" head wrap use will be analyzed using descriptive statistics with rates and their \\(95 \\% CI\\).","confidence":0.5123519897460938,"confidence_rate":0.9932677796780516},{"cnt":[[337,458],[1824,458],[1824,509],[337,509]],"region":{"top_left_x":337,"top_left_y":457,"width":1488,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3413abf2b4d5402eb698847a55ab4d7e","type":"text","conversion_output":true,"text":"Comparison between the scalp cooling group to the control group will not be performed.","text_display":" Comparison between the scalp cooling group to the control group will not be performed.","confidence":1,"confidence_rate":1},{"cnt":[[236,587],[1334,587],[1334,655],[236,655]],"region":{"top_left_x":236,"top_left_y":586,"width":1099,"height":70},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6da585a7cd9f418687152628864aa600","type":"section_header","conversion_output":false,"children_ids":["c7197296bb0f43a6be4a6d2309c592b1"],"text":"","text_display":""},{"cnt":[[245,593],[1326,593],[1326,647],[245,647]],"region":{"top_left_x":244,"top_left_y":592,"width":1082,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7197296bb0f43a6be4a6d2309c592b1","type":"text","conversion_output":true,"parent_id":"6da585a7cd9f418687152628864aa600","text":"6.5.4 Quality of Life by EORTC QLQ C-30, HADS, and BIS","text_display":"\n\n\\subsection*{6.5.4 Quality of Life by EORTC QLQ C-30, HADS, and BIS}","confidence":1,"confidence_rate":1},{"cnt":[[344,662],[1798,662],[1798,715],[344,715]],"region":{"top_left_x":343,"top_left_y":661,"width":1456,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d02abb5b1cf46e1a31ef838bce533be","type":"text","conversion_output":true,"text":"These secondary efficacy analyses will be based on the ITT population. Quality of life","text_display":"\n\nThese secondary efficacy analyses will be based on the ITT population. Quality of life","confidence":1,"confidence_rate":1},{"cnt":[[344,711],[1884,711],[1884,763],[344,763]],"region":{"top_left_x":343,"top_left_y":711,"width":1542,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"142225f5984f42a481ce48edffe167a6","type":"text","conversion_output":true,"text":"(QOL) will be assessed at baseline, after 4 cycles of chemotherapy, and after completion of","text_display":" (QOL) will be assessed at baseline, after 4 cycles of chemotherapy, and after completion of","confidence":1,"confidence_rate":1},{"cnt":[[344,761],[1818,761],[1818,812],[344,812]],"region":{"top_left_x":343,"top_left_y":760,"width":1475,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2469906a7be2454cbcd8f1a543e82a4a","type":"text","conversion_output":true,"text":"chemotherapy (if receiving more than 4 cycles). 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":"45aa3aad3cce4f3fa02784064c7ffba8","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":"2bf96684d70049548befab06f1f8288e","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":"a90c031436514220ac53283c94185741","type":"text","conversion_output":true,"text":"measures. 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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":"cdd680162f3e49dabde7fb4246e57581","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. 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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":"2c4f7fd525a246e89205373ebbdcac8c","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":"d195fb84eddd4150a81d1882a7fd5889","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":"ffab2494072b43169efba73a9be68dab","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":"062fba98c69046bea84217013e48d8e9","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":"e72c6015a48e42998d2ad2aa7a4f7a25","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":"a917c666531047929d9b039941ddb00a","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":"1daf58ee7dd54f88b62957847f091320","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":"b7f289af6550470e9890eba378804507","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":"f9a05c14c16641088faea8cc05756921","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":"d5e4599d23ce434dbbbeae3d17eb1826","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":"bf1958211175490892e788755eaa5f8a","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":"456f2702abf2452799c51ae78241e61e","type":"section_header","conversion_output":false,"children_ids":["1f249dd046794fc89486509f0a6d0e9c"],"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":"1f249dd046794fc89486509f0a6d0e9c","type":"text","conversion_output":true,"parent_id":"456f2702abf2452799c51ae78241e61e","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":"c777380ab4174c88a828d4ab2bf32d07","type":"section_header","conversion_output":false,"children_ids":["e75587524b1f45b38faba5b33819cbd1"],"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":"e75587524b1f45b38faba5b33819cbd1","type":"text","conversion_output":true,"parent_id":"c777380ab4174c88a828d4ab2bf32d07","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":"5fc5e54e02eb42df829e746a05dc2c4e","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. 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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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Quality of Life Unit, EORTC Date","confidence":1,"confidence_rate":1},{"cnt":[[305,1555],[544,1555],[544,1601],[305,1601]],"region":{"top_left_x":305,"top_left_y":1555,"width":239,"height":46},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8499014ac97f4b5fbdb04b16aad887b8","type":"text","conversion_output":true,"text":"Center. 2001.","text_display":" Center. 2001.","confidence":1,"confidence_rate":1},{"cnt":[[243,1646],[1644,1646],[1644,1704],[243,1704]],"region":{"top_left_x":242,"top_left_y":1645,"width":1402,"height":59},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41c1c2cab0ea4aa08b65c0b9050e18df","type":"text","conversion_output":true,"text":"2. Rugo, H. M., SA. Expert statement on scalp cooling with adjuvant/neoadjuvant","text_display":"\n2. Rugo, H. M., SA. 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