1434216
doi
10.5281/zenodo.1434216
oai:zenodo.org:1434216
Railkhar, Radha
Merck & Co. Inc
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
Merck & Co. Inc
info:eu-repo/semantics/openAccess
Creative Commons Attribution 4.0 International
https://creativecommons.org/licenses/by/4.0/legalcode
HPV vaccine
Gardasil
Approval
Data Analysis Plan
<p><strong>2003_FDA_r_s_DAP-Gardasil-HPV-013.pdf</strong></p>
<p>Statistical Data Analysis Plan HPV Quadrivalent HPV Vaccine CIN/Wart Efficacy Study (Study 013) March 2003<br>
<br>
<br>
<strong>2003_FDA_r_s_DAP-Gardasil-HPV-015.pdf</strong><br>
<br>
Statistical Data Analysis Plan HPV Quadrivalent HPV Vaccine, Safety, Immunogenicity and Efficacy Study (Study 015) FUTURE II - July 2003</p>
<p><br>
<strong>We obtained Gardasil® Data Analysis Plans (DAPs) from the FDA through Freedom of Information Act (FOIA) request.</strong> The above linked DAPs specified a “per protocol analysis” for the outcome CIN 2+ irrespective of HPV type.</p>
Zenodo
2003-03-04
info:eu-repo/semantics/other
1434215
1554819463.663705
2667041
md5:05c48505dce234778e2c5aa9f1e8b3e0
https://zenodo.org/records/1434216/files/2003_FDA_r_s_DAP-Gardasil-HPV-013.pdf
3529023
md5:c9500e80ede7382540f187fc65f24ad9
https://zenodo.org/records/1434216/files/2003_FDA_r_s_DAP-Gardasil-HPV-015.pdf
public
10.5281/zenodo.1434215
isVersionOf
doi