3 and received three doses within one year; cases were counted starting one month after three doses given. PPSP means per protocol susceptible population: for those women who were seronegative and PCR negative for the vaccine related HPV types at study entry regardless of entry cytology results, remained PCR negative for the vaccine relevant HPV types through one month after receipt of the third injection; cases counted one month after three doses given. USP means unrestricted susceptible population: for those women who were seronegative and PCR negative for the vaccine related HPV types at study entry regardless of entry cytology results, received one or more injections, cases counted from the first day after the first injection. ITT means intention to treat population: regardless of serostatus or HPV DNA PCR status to vaccine relevant HPV types at study entry, regardless of entry cytology, regardless of timing and number of injections received, cases were counted from day 1 after the first injection. NPS means naive population simulation: women were seronegative to HPV 6/11/16/18 and PCR negative to HPV 6/11/16/18/31/33/35/39/45/51/52/56/58/59 at baseline, had a normal Pap at baseline, received at least one injection, had at least one follow up visit; cases counted after day 1. PP means Per Protocol: women were seronegative at baseline and PCR negative for each type Day 1 through Month 7, regardless of entry cytology; cases were counted from the first day after 30 days after the third injection. PPE means per protocol for efficacy in male trials: seronegative and PCR negative to the relevant HPV type at Day 1, Free of infection with the relevant HPV type through Month 7, Received all 3 doses; cases were counted from the first day after 30 days after the third injection. PE means previously exposed population: women who were seropositive for HPV 6/11/16/18 and were PCR negative for HPV 6/11/16/18 at baseline. *Male condyloma caused by HPV 16 or 18 were not statistically significant †VIN 1 caused by HPV 6/11/16/18 was not statistically significant §Vain 2/3 caused by any HPV type was not statistically significant ¶CIN 2+, CIN 3+, AIS. VIN 1, VIN 2+, VaIN 1, VaIN 2+ caused by HPV 6/11/16/18 were not statistically significant |
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| Table 3: Significant Efficacies for Gardasil by Endpoint, Population and Time of Follow Up. |
