Statistical analysis
We used SPSS, version 24 (IBM, Armonk, NY, USA) for all statistical
analysis except for the repeated measure analyses by Proc Genmod which
was done in SAS version 9.2. Normally distributed continuous variables
are presented as means with standard deviations (SDs). Other
participants characteristics are reported as counts with percentages.
Rates of POP and bother were analyzed with chi-squared tests. The study
was analyzed by intention-to-treat. Additional per-protocol analysis was
done. Significance levels were set to 0.05.