Index of /ipfs/Qme2ahzN3BQmM1dN5pxsTK3MiPa5iPRnAD89roLVdf76Zh/Batch 12 - 1 June 2022
QmUza4SsUgsAFD8nD31DzU1aTivgAYGspQiTqVu2x3iETr
 1.7 GB
 
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125742_S1_M2_summary-biopharm.pdf
1.8 MB
 
125742_S1_M5_5314_shi-sop-10011.pdf
2.2 MB
 
125742_S1_M5_5351_c4591001-fa-interim-adverse-events.pdf
33 MB
 
125742_S1_M5_5351_c4591001-fa-interim-discontinued-patients.pdf
3.1 MB
 
125742_S1_M5_5351_c4591001-fa-interim-patient-batches.pdf
1.3 MB
 
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations-sensitive.pdf
1.6 MB
 
125742_S1_M5_5351_c4591001-interim-mth6-patient-batches.pdf
1.4 MB
 
125742_S1_M5_5351_c4591001-interim-mth6-publications.pdf
12 MB
 
125742_S1_M5_5351_c4591001-interim-mth6-randomization.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1007-10071050.pdf
3.1 MB
 
125742_S1_M5_CRF_c4591001-1007-10071097.pdf
2.2 MB
 
125742_S1_M5_CRF_c4591001-1007-10071101.pdf
1.5 MB
 
125742_S1_M5_CRF_c4591001-1007-10071117.pdf
2.0 MB
 
125742_S1_M5_CRF_c4591001-1007-10071124.pdf
1.8 MB
 
125742_S1_M5_CRF_c4591001-1007-10071159.pdf
1.4 MB
 
125742_S1_M5_CRF_c4591001-1007-10071192.pdf
1.9 MB
 
125742_S1_M5_CRF_c4591001-1007-10071276.pdf
1.9 MB
 
125742_S1_M5_CRF_c4591001-1007-10071280.pdf
2.0 MB
 
125742_S1_M5_CRF_c4591001-1007-10071306.pdf
2.9 MB
 
125742_S1_M5_CRF_c4591001-1007-10071315.pdf
1.5 MB
 
125742_S1_M5_CRF_c4591001-1007-10071347.pdf
1.5 MB
 
125742_S1_M5_CRF_c4591001-1007-10071441.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1007-10071443.pdf
1.4 MB
 
125742_S1_M5_CRF_c4591001-1008-10081056.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1008-10081152.pdf
1.1 MB
 
125742_S1_M5_CRF_c4591001-1008-10081184.pdf
1.2 MB
 
125742_S1_M5_CRF_c4591001-1008-10081337.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1008-10081603.pdf
1.4 MB
 
125742_S1_M5_CRF_c4591001-1008-10081628.pdf
1.2 MB
 
125742_S1_M5_CRF_c4591001-1008-10081667.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1009-10091123.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1009-10091128.pdf
1.7 MB
 
125742_S1_M5_CRF_c4591001-1009-10091135.pdf
1.8 MB
 
125742_S1_M5_CRF_c4591001-1009-10091149.pdf
1.5 MB
 
125742_S1_M5_CRF_c4591001-1011-10111029.pdf
1.6 MB
 
125742_S1_M5_CRF_c4591001-1011-10111181.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1012-10121097.pdf
1.9 MB
 
125742_S1_M5_CRF_c4591001-1012-10121112.pdf
1.8 MB
 
125742_S1_M5_CRF_c4591001-1012-10121163.pdf
1.6 MB
 
125742_S1_M5_CRF_c4591001-1013-10131084.pdf
1.4 MB
 
125742_S1_M5_CRF_c4591001-1013-10131089.pdf
1.5 MB
 
125742_S1_M5_CRF_c4591001-1013-10131165.pdf
1.4 MB
 
125742_S1_M5_CRF_c4591001-1013-10131176.pdf
2.9 MB
 
125742_S1_M5_CRF_c4591001-1013-10131190.pdf
2.4 MB
 
125742_S1_M5_CRF_c4591001-1013-10131229.pdf
1.2 MB
 
125742_S1_M5_CRF_c4591001-1013-10131255.pdf
1.4 MB
 
125742_S1_M5_CRF_c4591001-1013-10131386.pdf
1.0 MB
 
125742_S1_M5_CRF_c4591001-1013-10131517.pdf
1.2 MB
 
125742_S1_M5_CRF_c4591001-1013-10131554.pdf
2.4 MB
 
125742_S1_M5_CRF_c4591001-1013-10131653.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1013-10131656.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1013-10131658.pdf
1.1 MB
 
125742_S1_M5_CRF_c4591001-1013-10131699.pdf
2.5 MB
 
125742_S1_M5_CRF_c4591001-1013-10131718.pdf
2.3 MB
 
125742_S1_M5_CRF_c4591001-1013-10131786.pdf
3.3 MB
 
125742_S1_M5_CRF_c4591001-1015-10151011.pdf
1.4 MB
 
125742_S1_M5_CRF_c4591001-1015-10151035.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1015-10151047.pdf
1.2 MB
 
125742_S1_M5_CRF_c4591001-1015-10151071.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1015-10151089.pdf
1.3 MB
 
125742_S1_M5_CRF_c4591001-1015-10151101.pdf
1.1 MB
 
125742_S1_M5_CRF_c4591001-1015-10151134.pdf
1.5 MB
 
125742_S1_M5_CRF_c4591001-1015-10151225.pdf
1.5 MB
 
125742_S1_M5_CRF_c4591001-1015-10151238.pdf
2.6 MB
 
125742_S1_M5_CRF_c4591001-1081-10811194 reissue.pdf
1.8 MB
 
125742_S1_M5_CRF_c4591001-1128-11281009 reissue.pdf
2.0 MB
 
FDA-CBER-2021-5683-0142307 to -0149081_125742_S1_M5_c4591001-A-Supp-D-adcevd.xpt
447 MB
 
FDA-CBER-2021-5683-0149082 to -0158559_125742_S1_M5_c4591001-S-D-ce.xpt
386 MB
 
FDA-CBER-2021-5683-0158560 to -0159486_125742_S1_M5_c4591001-S-D-dv.xpt
12 MB
 
FDA-CBER-2021-5683-0159487 to -0162689_125742_S1_M5_c4591001-S-D-ec.xpt
49 MB
 
FDA-CBER-2021-5683-0162690 to -0165892_125742_S1_M5_c4591001-S-D-ex.xpt
47 MB
 
FDA-CBER-2021-5683-0165893 to -0168682_125742_S1_M5_c4591001-S-D-is.xpt
31 MB
 
FDA-CBER-2021-5683-0168683 to -0169081_125742_S1_M5_c4591001-S-D-suppcm.xpt
2.9 MB
 
FDA-CBER-2021-5683-0169082 to -0171523_125742_S1_M5_c4591001-S-D-suppdm.xpt
14 MB
 
FDA-CBER-2021-5683-0171524 to -0174606_125742_S1_M5_c4591001-S-D-suppds.xpt
18 MB
 
FDA-CBER-2021-5683-0174607 to -0178318_125742_S1_M5_c4591001-S-D-suppdv.xpt
24 MB
 
FDA-CBER-2021-5683-0178319 to -0180190_125742_S1_M5_c4591001-S-D-suppho.xpt
8.6 MB
 
FDA-CBER-2021-5683-0180191 to -0182980_125742_S1_M5_c4591001-S-D-suppis.xpt
8.4 MB
 
FDA-CBER-2021-5683-0182981 to -0187905_125742_S1_M5_c4591001-S-D-suppmh.xpt
23 MB
 
FDA-CBER-2021-5683-0187906 to -0196048_125742_S1_M5_c4591001-S-D-suppvs.xpt
41 MB
 
FDA-CBER-2021-5683-0196049 to -0205317_125742_S1_M5_c4591001-S-Supp-D-ce.xpt
379 MB
 
FDA-CBER-2021-5683-0205318 to -0208520_125742_S1_M5_c4591001-S-Supp-D-ex.xpt
47 MB
 
FDA-CBER-2021-5683-0208521 to -0216666_125742_S1_M5_c4591001-S-Supp-D-suppvs.xpt
41 MB
 
STN 125742-0-0 Section 2.5 Clinical Overview reissue.pdf
4.9 MB