Statistical analysis
UTIs
RECURRENCES, RECURRENCE
The sample size calculation was based upon an average of 6.2 UTIs in the year pre-study, a 50% placebo response and an additional 15% StroVac effect in reducing UTIs during the study period. The number of 6.2 UTIs was calculated from data of an earlier study [The efficacy analyses were performed using the intention to treat (ITT) population. The safety evaluable population (SEP) was used for safety analysis. The primary endpoint was evaluated in an approach for testing the superiority of StroVac over placebo. The statistical test was performed using the generalized linear model. The number of recurrences was analysed analogously, the time until first recurrence was calculated using Kaplan–Meier life-tables. The difference between the treatment groups was analyzed by the log-rank test. Statistical analyses were carried out by Pharmalog– Institut für Klinische Forschung GmbH, München using SAS-System version 9.2, SAS Institute Inc.