{"groups":[{"description":"Participants with histologically confirmed vulvar high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV) 16 and/or 18, received four doses of 6 mg VGX-3100 as an intramuscular (IM) injection on Day 0, Week 4, Week 12, and Week 24 followed by electroporation (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":"FG000","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":"FG001","title":"VGX-3100 + EP + Imiquimod"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"}],"type":"Withdrawal by Subject (Not Related to AE)"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Progressive Disease"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"8"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"8"}],"comment":"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.","type":"Modified Intent-to-Treat (mITT) Population"},{"achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"8"}],"comment":"Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).","type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"8"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 70 participants were screened out of which 33 participants were enrolled in the study.","recruitmentDetails":"Participants were enrolled at 20 study sites in the United States from 31 August 2017 to 18 December 2020."}