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Statistical Data Analysis Plan HPV Quadrivalent HPV Vaccine CIN/Wart Efficacy Study (Study 013) - March 2003 / Statistical Data Analysis Plan HPV Quadrivalent HPV Vaccine, Safety, Immunogeneicity and Efficacy Study (Study 015) FUTURE II - July 2003

Lupinacci, Lisa; Railkhar, Radha

2003_FDA_r_s_DAP-Gardasil-HPV-013.pdf

Statistical Data Analysis Plan HPV Quadrivalent HPV Vaccine CIN/Wart Efficacy Study (Study 013) March 2003


2003_FDA_r_s_DAP-Gardasil-HPV-015.pdf

Statistical Data Analysis Plan HPV Quadrivalent HPV Vaccine, Safety, Immunogenicity and Efficacy Study (Study 015) FUTURE II - July 2003


We obtained Gardasil® Data Analysis Plans (DAPs) from the FDA through Freedom of Information Act (FOIA) request. The above linked DAPs specified a “per protocol analysis” for the outcome CIN 2+ irrespective of HPV type.

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