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File Name Date Produced File Size Link 125742_S1_M5_CRF_c4591001 1254 12541142.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1254 12541109.pdf May 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1254 12541014.pdf May 1, 2023 3 MB 125742_S1_M5_CRF_c4591001 1254 12541006.pdf May 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1252 12521011.pdf May 1, 2023 3 MB 125742_S1_M5_CRF_c4591001 1252 12521010.pdf May 1, 2023 4 MB 125742_S1_M5_CRF_c4591001 1251 12511262.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1251 12511250.pdf May 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1251 12511239.pdf May 1, 2023 3 MB 125742_S1_M5_CRF_c4591001 1251 12511145.pdf May 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1251 12511072.pdf May 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1251 12511060.pdf May 1, 2023 3 MB 125742_S1_M5_CRF_c4591001 1251 12511050.pdf May 1, 2023 3 MB 125742_S1_M5_CRF_c4591001 1251 12511033.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1251 12511031.pdf May 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1251 12511029.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1248 12481218.pdf May 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1248 12481163.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1248 12481120.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1230 12301045.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1230 12301025.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1229 12291083.pdf May 1, 2023 4 MB 125742_S1_M5_CRF_c4591001 1224 12241065.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1223 12231252.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1223 12231182.pdf May 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1223 12231181.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1223 12231166.pdf May 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1223 12231159.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1223 12231075.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1223 12231058.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1223 12231024.pdf May 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1223 12231014.pdf May 1, 2023 2 MB 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3, 2023 998 KB 125742_S1_M5_5314_vr mvr 10081 att 01.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mvr 10081.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mvr 10080 att 02.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mvr 10080 att 01.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mvr 10080.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mqr 10214 att 03.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mqr 10214 att 02.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mqr 10214 att 01.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mqr 10214.pdf April 3, 2023 3 MB 125742_S1_M5_5314_vr mqr 10212 att 01.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mqr 10212.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mqr 10211 att 01.pdf April 3, 2023 2 MB 125742_S1_M5_5314_vr mqr 10211.pdf April 3, 2023 2 MB 125742_S14_M1_cover.pdf April 3, 2023 2 MB 125742_S7_M5_5351_bnt162 01 interim3 reports.pdf April 3, 2023 25 MB 125742_S4_M1_response 18 may 2021 datasets.pdf April 3, 2023 714 KB 125742_S4_M1_cover.pdf April 3, 2023 675 KB 125742_S3_M1_proprietary name.pdf April 3, 2023 2 MB 125742_S3_M1_cover.pdf April 3, 2023 705 KB 125742_S2_M5_5354_wi255886 protocol.pdf April 3, 2023 1 MB 125742_S2_M5_5354_c4591022 protocol.pdf April 3, 2023 3 MB 125742_S2_M5_5354_c4591014 protocol.pdf April 3, 2023 3 MB 125742_S2_M5_5354_c4591012 protocol.pdf April 3, 2023 15 MB 125742_S2_M5_5354_c4591011 protocol.pdf April 3, 2023 5 MB 125742_S2_M5_5354_c4591009 protocol synopsis.pdf April 3, 2023 2 MB 125742_S2_M5_5354_c4591008 protocol.pdf April 3, 2023 2 MB 125742_S2_M5_5351_c4591015 protocol amend2.pdf April 3, 2023 13 MB 125742_S2_M5_5351_c4591007 protocol amend1.pdf April 3, 2023 24 MB 125742_S2_M1_pllr waiver request pregnancy registry.pdf April 3, 2023 2 MB 125742_S2_M1_pllr waiver request drug utilization.pdf April 3, 2023 2 MB 125742_S2_M1_pllr lit search summary.pdf April 3, 2023 2 MB 125742_S2_M1_pllr cumulative review.pdf April 3, 2023 2 MB 125742_S2_M1_loa dmf 9543 vials.pdf April 3, 2023 609 KB 125742_S2_M1_diluent 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