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

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.

Keywords

Gardasil, Approval, Data Analysis Plan, HPV vaccine

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