{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0071","statisticalComment":"A 1-sided p-value was calculated to prove superiority over historical control of 2%. Superiority of VGX-3100 alone was declared if p-value is \\<0.025.","statisticalMethod":"Clopper Pearson"},{"groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0004","statisticalComment":"1-sided p-value was calculated to prove superiority over historical control of 2%.Superiority of VGX-3100+imiquimod was declared if p-value is \\<0.025.","statisticalMethod":"Clopper Pearson"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.2","upperLimit":"37.9","value":"15.0"},{"groupId":"OG001","lowerLimit":"8.5","upperLimit":"75.5","value":"37.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"A treatment responder for the primary endpoint was defined as a participant with no histologic evidence of vulvar HSIL (normal tissue or vulvar low grade squamous intraepithelial lesions (LSIL) \\[vulval intraepithelial neoplasia 1 (VIN1)\\] or condyloma) and no evidence of HPV-16 or HPV-18 (i.e., elimination of the specific genotypes \\[16, 18, or both\\]) in vulvar tissue at evaluation and who did not receive any non-study related treatment for vulvar HSIL. All lesions were evaluated for histologic evidence of vulvar HSIL or evidence of HPV-16/18 in vulvar tissue.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.","id":"OG000","title":"VGX-3100 + EP"},{"description":"Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52. In addition, participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.","id":"OG001","title":"VGX-3100 + EP + Imiquimod"}],"paramType":"NUMBER","populationDescription":"mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.","reportingStatus":"POSTED","timeFrame":"Week 48","title":"Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples","type":"PRIMARY","unitOfMeasure":"percentage of participants"}