Published March 4, 2003
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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
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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.