{"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 Human papillomavirus (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":"FG000","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 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.\n\nThe Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.\n\nGroup 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.","id":"FG001","title":"Group 2 - Base Study Monovalent HPV (Type 16) 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":"FG002","title":"Group 3 - Base Study Placebo"},{"description":"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent \\[type 16\\] HPV vaccine in the base study, or subjects who received \\<=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as \"Completed Period\" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as \"Not Completed\" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.","id":"FG003","title":"Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"0"}],"type":"Randomized Not Vaccinated"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"0"}],"type":"Adverse 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Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"18"},{"groupId":"FG003","numSubjects":"0"}],"type":"Moved"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Unblinded"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"New Medical History (Not AE)"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"2723"},{"groupId":"FG001","numSubjects":"304"},{"groupId":"FG002","numSubjects":"2732"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"2583"},{"groupId":"FG001","numSubjects":"290"},{"groupId":"FG002","numSubjects":"2586"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"140"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"146"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Vaccination (Day 1 Through Month 7)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"35"},{"groupId":"FG003","numSubjects":"0"}],"type":"Subjects Continuing"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"109"},{"groupId":"FG002","numSubjects":"412"},{"groupId":"FG003","numSubjects":"0"}],"type":"Subjects in Extension"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"113"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"108"},{"groupId":"FG003","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"51"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"28"},{"groupId":"FG003","numSubjects":"0"}],"type":"Moved"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"}],"type":"Site Terminated"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Travel"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"0"}],"type":"Visits Compressed"}],"milestones":[{"achievements":[{"comment":"Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up","groupId":"FG000","numSubjects":"2599"},{"comment":"Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up","groupId":"FG001","numSubjects":"291"},{"comment":"Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up","groupId":"FG002","numSubjects":"2607"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"2353"},{"groupId":"FG001","numSubjects":"155"},{"groupId":"FG002","numSubjects":"1959"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"246"},{"groupId":"FG001","numSubjects":"136"},{"groupId":"FG002","numSubjects":"648"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Follow-Up (After Month 7)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"23"}],"type":"Excluded ineligible for extension"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"87"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"4"}],"type":"Pregnancy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"46"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"16"}],"type":"Moved"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"4"}],"type":"Site Terminated"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"25"}],"type":"Unable/unwilling to return"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"844"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"829"}],"type":"Initiated Extension Study"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"801"}],"type":"Received >=1 Dose in Extension Study"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"635"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"209"}],"type":"NOT COMPLETED"}],"title":"Extension Study (Group 4)"}],"recruitmentDetails":"The study Protocol 013 (NCT00092521) (N =5759 total randomized) was comprised of two sub-studies: Protocol 011 (NCT00517309) (N=1877 total randomized) and Protocol 012 (NCT00092482) (N=3882 total randomized). Final safety data are presented in the results for Protocol 013 (NCT00092521): the final participant visit took place on 19 January 2009."}