Statistical analysis The analyses of outcomes will be performed in accordance with the European Medicines Agency's Statistical Principles for Clinical Trials guidelines. Differences between the treatment groups regarding outcome measures will be analysed by regression analysis of variance on ranks. Other parametric and non-parametric statistical methods will be used whenever appropriate. Two-sided tests will be used and 5% statistical significance level will be chosen for all analyses. To provide unbiased comparisons between the groups the investigators will be perform an intention-to-treat analysis. Also, a per-protocol analysis on the women who complete the study according to the protocol will be performed.