{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.112","pValueComment":"Two-sided p-value","statisticalMethod":"Exact poisson test"},{"groupDescription":"This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 0.0 events per 100 person years (PY) versus 3.4 events per 100 PY, respectively.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.447","pValueComment":"One-sided test","statisticalMethod":"Exact Poisson calculation"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"11.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"34"}],"units":"Participants"}],"description":"Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.","groups":[{"description":"HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.","id":"OG000","title":"Naive to HPV 6"},{"description":"HPV 6 positive based on serum at visit 0.","id":"OG001","title":"Prior Exposure to HPV 6"}],"paramType":"NUMBER","populationDescription":"Eligible participants without prevalent HPV 6 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 6 DNA","type":"PRIMARY","unitOfMeasure":"Events per 100 person years"}