Public Health and Medical Professionals for Transparency/Pfizer Documents

[WTPUSA]

Source; https://phmpt.org/pfizers-documents/

Pfizer’s Documents

Documents with a large file size are provided in a .zip file and will need to be uncompressed after download.

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File Name	Date Produced	File Size	Link

125742_S1_M1_356h.pdfMarch 1, 2022714 KB

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125742_S1_M1_3674.pdfMarch 1, 20225 MB

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125742_S1_M1_cover.pdfMarch 1, 20221 MB

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125742_S1_M1_debarment.pdfMarch 1, 2022656 KB

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125742_S1_M1_exclusivity-claim.pdfMarch 1, 2022616 KB

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125742_S1_M1_fast-track-designation.pdfMarch 1, 2022649 KB

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125742_S1_M1_financial-cert-3454.pdfMarch 1, 20223 MB

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125742_S1_M1_financial-cert-bias.pdfMarch 1, 2022696 KB

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125742_S1_M1_ipsp-agreed-letter.pdfMarch 1, 2022658 KB

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125742_S1_M1_priority-review-request.pdfMarch 24, 20222 MB

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125742_S1_M1_priority-review-request.pdfMarch 1, 20222 MB

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125742_S1_M1_trans-of-oblig.pdfMarch 1, 2022717 KB

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125742_S1_M1_us-agent-authorization.pdfMarch 1, 20221 MB

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125742_S1_M1_userfee.pdfMarch 1, 2022628 KB

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125742_S1_M1_waiver-req-designated-suffix.pdfMarch 1, 20223 MB

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125742_S1_M2_22_introduction.pdfMarch 1, 2022670 KB

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125742_S1_M2_24_nonclinical-overview.pdfMarch 1, 20222 MB

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125742_S1_M2_26_pharmkin-tabulated-summary.pdfMarch 1, 20221 MB

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125742_S1_M2_26_pharmkin-written-summary.pdfMarch 1, 20221 MB

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125742_S1_M2_27_literature-references.pdfMarch 1, 20222 MB

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125742_S1_M2_27_synopses-indiv-studies.pdfMarch 1, 20222 MB

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125742_S1_M4_4223_185350.pdfMarch 1, 20221 MB

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125742_S1_M4_4223_R-20-0072.pdfMarch 1, 20225 MB

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125742_S1_M5_5351_bnt162 01 interim3 adverse events.pdfMay 2, 20227 MB

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125742_S1_M5_5351_bnt162 01 interim3 compliance.pdfMay 2, 20227 MB

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125742_S1_M5_5351_bnt162 01 interim3 demographics.pdfMay 2, 20222 MB

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125742_S1_M5_5351_bnt162 01 interim3 discontinued patients.pdfMay 2, 20222 MB

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125742_S1_M5_5351_bnt162 01 interim3 excluded patients.pdfMay 2, 20222 MB

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125742_S1_M5_5351_bnt162 01 interim3 iec irb.pdfMay 2, 20221 MB

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125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdfMay 2, 2022634 KB

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125742_S1_M5_5351_bnt162 01 interim3 investigators.pdfMay 2, 20226 MB

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125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdfMay 2, 202291 MB

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125742_S1_M5_5351_bnt162 01 interim3 notes for reader.pdfMay 2, 20221 MB

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125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdfMay 2, 20223 MB

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125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdfMay 2, 20221 MB

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125742_S1_M5_5351_bnt162 01 interim3 protocol.pdfMay 2, 202210 MB

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125742_S1_M5_5351_bnt162 01 interim3 report body.pdfMay 2, 202242 MB

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125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdfMay 2, 20229 MB

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125742_S1_M5_5351_bnt162 01 interim3 sap.pdfMay 2, 20223 MB

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125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdfMay 2, 20222 MB

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125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdfMay 2, 20222 MB

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125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdfMay 2, 20224 MB

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125742_S1_M5_5351_bnt162 01_10010.pdfMay 2, 20221 MB

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125742_S1_M5_5351_bnt162 01_10075.pdfMay 2, 20222 MB

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125742_S1_M5_5351_bnt162 01_20116.pdfMay 2, 20222 MB

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125742_S1_M5_5351_bnt162 01_20215.pdfMay 2, 20222 MB

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125742_S1_M5_5351_bnt162 01_20242.pdfMay 2, 20222 MB

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125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdfMay 2, 202265 MB

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125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdfMay 2, 20225 MB

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125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdfMay 2, 202212 MB

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125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdfMarch 1, 2022889 KB

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125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdfApril 1, 2022869 KB

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125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdfMarch 1, 20221 MB

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125742_S1_M5_5351_c4591001-fa-interim-compliance.pdfMarch 1, 20222 MB

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125742_S1_M5_5351_c4591001-fa-interim-demographics.pdfApril 1, 202228 MB

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125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdfMarch 1, 20222 MB

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125742_S1_M5_5351_c4591001-fa-interim-errata.pdfMarch 1, 20222 MB

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125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdfMarch 1, 202216 MB

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125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdfMarch 1, 20222 MB

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125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdfApril 1, 20228 MB

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125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdfApril 1, 2022677 KB

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125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdfMarch 1, 20225 MB

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125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdfMarch 1, 202212 MB

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125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdfMarch 1, 20222 MB

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125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdfApril 1, 20221 MB

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125742_S1_M5_5351_c4591001-fa-interim-protocol.pdfMarch 1, 202231 MB

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125742_S1_M5_5351_c4591001-fa-interim-publications.pdfApril 1, 202210 MB

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125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdfApril 1, 202259 MB

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125742_S1_M5_5351_c4591001-fa-interim-randomization.pdfApril 1, 20222 MB

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125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdfApril 1, 20225 MB

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125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdfApril 1, 20222 MB

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125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdfApril 1, 20221 MB

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125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdfApril 1, 20221 MB

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125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdfApril 1, 202228 MB

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125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdfApril 1, 20221 MB

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125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdfMarch 1, 202213 MB

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125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdfMarch 1, 202237 MB

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125742_S1_M5_bnt162 01 A adrg.pdfMay 2, 2022891 KB

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125742_S1_M5_bnt162 01 S acrf.pdfMay 2, 20221 MB

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125742_S1_M5_bnt162 01 S csdrg.pdfMay 2, 20221 MB

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125742_S1_M5_c4591001 S acrf.pdfMay 2, 20223 MB

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125742_S1_M5_c4591001 S csdrg.pdfMay 2, 20221 MB

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125742_S1_M5_c4591001 S Supp acrf.pdfMay 2, 20223 MB

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125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdfMarch 1, 2022602 KB

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125742_S1_M5_c4591001-A-adrg.pdfMarch 1, 20222 MB

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125742_S1_M5_c4591001-A-bmi-12-15-scale.pdfMarch 1, 2022627 KB

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125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdfMarch 1, 2022634 KB

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125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdfMarch 1, 2022620 KB

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125742_S1_M5_c4591001-A-comorbidity-categories.pdfMarch 1, 2022637 KB

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125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdfMarch 1, 2022607 KB

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125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdfMarch 1, 2022846 KB

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125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdfMarch 1, 2022629 KB

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125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdfMarch 1, 2022670 KB

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125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdfMarch 1, 2022632 KB

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125742_S1_M5_c4591001-A-report-cci-chf.pdfMarch 1, 2022628 KB

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125742_S1_M5_c4591001-A-report-cci-dementia.pdfMarch 1, 2022626 KB

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125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdfMarch 1, 2022626 KB

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125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdfMarch 1, 2022627 KB

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125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdfMarch 1, 2022626 KB

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125742_S1_M5_c4591001-A-report-cci-leukemia.pdfMarch 1, 2022631 KB

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[WTPUSA]

50 MORE FILES;

125742_S1_M5_c4591001-A-report-cci-lymphoma.pdfMarch 1, 2022640 KB

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125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdfMarch 1, 2022636 KB

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125742_S1_M5_c4591001-A-report-cci-mi.pdfMarch 1, 2022624 KB

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125742_S1_M5_c4591001-A-report-cci-mild-liver.pdfMarch 1, 2022628 KB

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125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdfMarch 1, 2022626 KB

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125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdfMarch 1, 2022625 KB

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125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdfMarch 1, 2022632 KB

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125742_S1_M5_c4591001-A-report-cci-pulmonary.pdfMarch 1, 2022630 KB

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125742_S1_M5_c4591001-A-report-cci-renal.pdfMarch 1, 2022629 KB

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125742_S1_M5_c4591001-A-report-cci-rheumatic.pdfMarch 1, 2022629 KB

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125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdfMarch 1, 20222 MB

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125742_S1_M5_c4591001-T-S-roadmap.pdfMarch 1, 2022703 KB

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125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdfMarch 1, 2022667 KB

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125742_S1_M5_c4591001-T-S-suppl-arg.pdfMarch 1, 2022738 KB

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125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdfMarch 1, 202217 MB

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125742_S1_M5_CRF_c4591001 1001 10011093.pdfMay 2, 20223 MB

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125742_S1_M5_CRF_c4591001 1001 10011100.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1001 10011135.pdfMay 2, 20221 MB

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125742_S1_M5_CRF_c4591001 1003 10031038.pdfMay 2, 20223 MB

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125742_S1_M5_CRF_c4591001 1003 10031065.pdfMay 2, 20223 MB

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125742_S1_M5_CRF_c4591001 1003 10031111.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1003 10031113.pdfMay 2, 20223 MB

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125742_S1_M5_CRF_c4591001 1003 10031149.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1003 10031186.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1003 10031197.pdfMay 2, 20221 MB

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125742_S1_M5_CRF_c4591001 1003 10031207.pdfMay 2, 20221 MB

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125742_S1_M5_CRF_c4591001 1005 10051047.pdfMay 2, 20221 MB

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125742_S1_M5_CRF_c4591001 1005 10051054.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1005 10051069.pdfMay 2, 20221 MB

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125742_S1_M5_CRF_c4591001 1005 10051214.pdfMay 2, 20221 MB

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125742_S1_M5_CRF_c4591001 1005 10051293.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1005 10051347.pdfMay 2, 20221 MB

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125742_S1_M5_CRF_c4591001 1005 10051387.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1005 10051411.pdfMay 2, 20221 MB

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125742_S1_M5_CRF_c4591001 1006 10061020.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1006 10061040.pdfMay 2, 20224 MB

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125742_S1_M5_CRF_c4591001 1006 10061052.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1006 10061094.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1006 10061098.pdfMay 2, 20222 MB

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125742_S1_M5_CRF_c4591001 1006 10061176.pdfMay 2, 20223 MB

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125742_S1_M5_CRF_c4591001-1085-10851018.pdfMarch 1, 20222 MB

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125742_S1_M5_CRF_c4591001-1085-10851116.pdfMarch 1, 20221 MB

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125742_S1_M5_CRF_c4591001-1085-10851129.pdfMarch 1, 20222 MB

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125742_S1_M5_CRF_c4591001-1085-10851216March 1, 20221 MB

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125742_S1_M5_CRF_c4591001-1085-10851246.pdfMarch 1, 20221 MB

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5.2 listing of clinical sites and cvs pages 1-41.pdfNovember 17, 20218 MB

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5.2 tabular listing.pdfNovember 17, 20212 MB

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5.3.6 postmarketing experience.pdfNovember 17, 2021984 KB

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BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txtNovember 17, 20219 KB

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BATES-93_tv.xptNovember 17, 202116 KB

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[WTPUSA]

50 MORE FILES;

BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txtDecember 13, 20219 KB

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BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txtDecember 13, 20219 KB

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BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txtDecember 13, 20219 KB

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BATES-FDA-CBER-2021-5683-0002375_addv-sas.txtDecember 13, 20215 KB

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BATES-FDA-CBER-2021-5683-0002376_relrec.xptDecember 13, 2021567 KB

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BATES-FDA-CBER-2021-5683-0002377_supppr.xptDecember 13, 202172 KB

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BATES-FDA-CBER-2021-5683-0002378_ta.xptDecember 13, 20218 KB

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BATES-FDA-CBER-2021-5683-0002379_te.xptDecember 13, 20213 KB

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BATES-FDA-CBER-2021-5683-0002380_ti.xptDecember 13, 202137 KB

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CRFs for site 1055.pdfDecember 13, 20216 MB

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CRFs for site 1081.pdfDecember 30, 202113 MB

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CRFs for site 1096.pdfJanuary 18, 202211 MB

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CRFs for site 1128.pdfJanuary 31, 202214 MB

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FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xmlMay 2, 2022692 KB

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FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xmlMay 2, 2022904 KB

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FDA CBER 2021 5683 0058595 to 0058614_125742_S1_M5_c4591001 S define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xmlMay 2, 2022300 KB

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FDA CBER 2021 5683 0058653 to 0058675_125742_S1_M5_c4591001 S Supp define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xslMay 2, 2022828 KB

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FDA CBER 2021 5683 0058795 to 0058828_125742_S1_M5_bnt162 01 A define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xmlMay 2, 2022985 KB

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FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xptMay 2, 202244 MB

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FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txtMarch 1, 202214 KB

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FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sasMarch 1, 202215 KB

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FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sasMarch 1, 202215 KB

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FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sasMarch 1, 202215 KB

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FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sasMarch 1, 202235 KB

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FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sasMarch 1, 202218 KB

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FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sasMarch 1, 202281 KB

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FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sasMarch 1, 202220 KB

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FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txtMarch 1, 202219 KB

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FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txtMarch 1, 202212 KB

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FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txtMarch 1, 202272 KB

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FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txtMarch 1, 2022193 KB

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FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txtMarch 1, 202227 KB

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FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txtMarch 1, 202232 KB

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FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txtMarch 1, 2022156 KB

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FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txtMarch 1, 202211 KB

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FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txtMarch 1, 202249 KB

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FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txtMarch 1, 202224 KB

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FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txtMarch 1, 202275 KB

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FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txtMarch 1, 202275 KB

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FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txtMarch 1, 202229 KB

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FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txtMarch 1, 202275 KB

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FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txtMarch 1, 2022197 KB

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FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txtMarch 1, 202243 KB

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FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txtMarch 1, 202245 KB

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FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xslMarch 1, 2022183 KB

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[WTPUSA]

50 M ORE FILES;

BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txtDecember 13, 20219 KB

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BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txtDecember 13, 20219 KB

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BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txtDecember 13, 20219 KB

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BATES-FDA-CBER-2021-5683-0002375_addv-sas.txtDecember 13, 20215 KB

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BATES-FDA-CBER-2021-5683-0002376_relrec.xptDecember 13, 2021567 KB

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BATES-FDA-CBER-2021-5683-0002377_supppr.xptDecember 13, 202172 KB

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BATES-FDA-CBER-2021-5683-0002378_ta.xptDecember 13, 20218 KB

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BATES-FDA-CBER-2021-5683-0002379_te.xptDecember 13, 20213 KB

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BATES-FDA-CBER-2021-5683-0002380_ti.xptDecember 13, 202137 KB

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CRFs for site 1055.pdfDecember 13, 20216 MB

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CRFs for site 1081.pdfDecember 30, 202113 MB

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CRFs for site 1096.pdfJanuary 18, 202211 MB

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CRFs for site 1128.pdfJanuary 31, 202214 MB

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FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xmlMay 2, 2022692 KB

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FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xmlMay 2, 2022904 KB

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FDA CBER 2021 5683 0058595 to 0058614_125742_S1_M5_c4591001 S define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xmlMay 2, 2022300 KB

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FDA CBER 2021 5683 0058653 to 0058675_125742_S1_M5_c4591001 S Supp define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xslMay 2, 2022828 KB

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FDA CBER 2021 5683 0058795 to 0058828_125742_S1_M5_bnt162 01 A define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xmlMay 2, 2022985 KB

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FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xslMay 2, 2022183 KB

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FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xptMay 2, 202244 MB

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FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txtMarch 1, 202214 KB

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FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sasMarch 1, 202215 KB

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FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sasMarch 1, 202215 KB

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FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sasMarch 1, 202215 KB

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FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sasMarch 1, 202235 KB

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FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sasMarch 1, 202218 KB

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FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sasMarch 1, 202281 KB

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FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sasMarch 1, 202220 KB

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FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txtMarch 1, 202219 KB

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FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txtMarch 1, 202212 KB

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FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txtMarch 1, 202272 KB

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FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txtMarch 1, 2022193 KB

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FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txtMarch 1, 202227 KB

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FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txtMarch 1, 202232 KB

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FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txtMarch 1, 2022156 KB

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FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txtMarch 1, 202211 KB

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FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txtMarch 1, 202249 KB

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FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txtMarch 1, 202224 KB

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FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txtMarch 1, 202275 KB

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FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txtMarch 1, 202275 KB

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FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txtMarch 1, 202229 KB

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FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txtMarch 1, 202275 KB

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FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txtMarch 1, 2022197 KB

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FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txtMarch 1, 202243 KB

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FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txtMarch 1, 202245 KB

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FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xslMarch 1, 2022183 KB

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[WTPUSA]

FINAL FILES;

FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsxMarch 1, 202213 KB

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FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsxMarch 1, 202213 KB

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FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsxMarch 1, 202229 KB

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FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsxMarch 1, 202218 KB

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FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsxMarch 1, 202219 KB

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FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsxMarch 1, 202222 KB

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FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsxMarch 1, 202284 KB

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FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsxMarch 1, 202223 KB

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FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsxMarch 1, 202235 KB

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FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsxMarch 1, 202212 KB

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FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsxMarch 1, 202210 KB

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FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsxMarch 1, 20229 KB

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FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsxMarch 1, 20229 KB

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FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsxMarch 1, 202210 KB

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FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsxMarch 1, 202210 KB

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FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsxMarch 1, 202212 KB

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FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsxMarch 1, 202217 KB

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FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsxMarch 1, 202214 KB

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FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsxMarch 1, 20229 KB

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FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsxMarch 1, 202210 KB

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FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsxMarch 1, 20229 KB

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FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsxMarch 1, 20229 KB

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FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsxMarch 1, 202212 KB

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FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsxMarch 1, 202212 KB

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FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsxMarch 1, 202211 KB

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FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsxMarch 1, 202224 KB

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FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsxMarch 1, 202221 KB

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FDA-CBER-2021-5683-0059000 to -0065773_125742_S1_M5_c4591001-A-D-adcevd.zip (.xpt)May 2, 20229 MB

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FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt)May 2, 202281 MB

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FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt)May 2, 20227 MB

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Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part A.pdfDecember 1, 202112 MB

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Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part B.pdfDecember 1, 202114 MB

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reissue_5.3.6 postmarketing experience.pdfApril 1, 2022958 KB

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signed F21-5683 CBER Dec 13 2021 Response Letter.pdfDecember 13, 2021207 KB

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STN 125742_0_0 Section 2.5 Clinical Overview.pdfDecember 13, 20214 MB

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STN 125742_0_0 Section 2.7.3 Summary of Clinical Efficacy.pdfDecember 13, 20213 MB

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STN 125742_0_0 Section 2.7.4 summary-clin-safety.pdfDecember 13, 20216 MB

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Supplemental Index 12-22-21.pdfDecember 22, 20212 MB

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