{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":">0.999","pValueComment":"Two-sided p-value.","statisticalMethod":"Exact Poisson calculation"},{"groupDescription":"This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.7 events per 100 PY, respectively.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.209","pValueComment":"One-sided p-value.","statisticalMethod":"Exact Poisson calculation"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"33"}],"units":"Participants"}],"description":"Incident events are defined as having positive PCR results with HPV 11 at 2 or more consecutive visits in those who were DNA negative for HPV 11 at baseline. Persistence was defined based on being persistent in the same anatomical site.","groups":[{"description":"HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.","id":"OG000","title":"Naive to HPV 11"},{"description":"HPV 11 positive based on serum at visit 0 from any anatomical site.","id":"OG001","title":"Prior Exposure to HPV 11"}],"paramType":"NUMBER","populationDescription":"All eligible participants who were HPV 11 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.","reportingStatus":"POSTED","timeFrame":"Post Month 7 through Month 24","title":"Incidence of Persistent Anogenital Infection With HPV 11 DNA","type":"PRIMARY","unitOfMeasure":"events per 100 person years"}