{"analyses":[{"ciLowerLimit":"94.9","ciPctValue":"95","ciUpperLimit":"100","estimateComment":"CI based on binomial tail probabilities and not from a dispersion parameter","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Percent relative risk reduction","paramValue":"100","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2261"},{"groupId":"OG001","value":"2279"}],"units":"Participants"}],"groups":[{"description":"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.\n\nThe Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.","id":"OG000","title":"Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine"},{"description":"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.\n\nThe Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.","id":"OG001","title":"Group 3 - Base Study Placebo"}],"paramType":"NUMBER","populationDescription":"Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide follow-up data.\n\nGroup 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.","reportingStatus":"POSTED","timeFrame":"Follow-up through end of study (4 years)","title":"Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]","type":"PRIMARY","unitOfMeasure":"incidence rate per 100 person-years"}