{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.224","pValueComment":"Two-sided p-value.","statisticalMethod":"Exact poisson test"},{"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 2.0 events per 100 PY, respectively.","groupIds":["OG000"],"nonInferiorityComment":"One-sided p-value.","nonInferiorityType":"SUPERIORITY","pValue":"0.361","statisticalMethod":"Exact Poisson calculation"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"2.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"description":"Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 11 positive DNA in participants without HPV-11 related AIN at baseline.","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.","id":"OG001","title":"Prior Exposure to HPV 11"}],"paramType":"NUMBER","populationDescription":"Eligible participants without prevalent HPV 11 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.","reportingStatus":"POSTED","timeFrame":"Post Month 7 through Month 24","title":"Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA","type":"PRIMARY","unitOfMeasure":"Events per 100 person years"}