Other Open Access
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.
Name | Size | |
---|---|---|
2003_FDA_r_s_DAP-Gardasil-HPV-013.pdf
md5:05c48505dce234778e2c5aa9f1e8b3e0 |
2.7 MB | Download |
2003_FDA_r_s_DAP-Gardasil-HPV-015.pdf
md5:c9500e80ede7382540f187fc65f24ad9 |
3.5 MB | Download |
All versions | This version | |
---|---|---|
Views | 2,024 | 2,023 |
Downloads | 302 | 302 |
Data volume | 871.0 MB | 871.0 MB |
Unique views | 1,949 | 1,948 |
Unique downloads | 232 | 232 |