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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.
Files
(6.2 MB)
| Name | Size | |
|---|---|---|
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2003_FDA_r_s_DAP-Gardasil-HPV-013.pdf
md5:05c48505dce234778e2c5aa9f1e8b3e0 |
2.7 MB | Download |
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2003_FDA_r_s_DAP-Gardasil-HPV-015.pdf
md5:c9500e80ede7382540f187fc65f24ad9 |
3.5 MB | Download |
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Indexed in
- Publication date:
- March 4, 2003
- DOI:
-
- Keyword(s):
- HPV vaccine Gardasil Approval Data Analysis Plan
- License (for files):
- Creative Commons Attribution 4.0 International