It is planned to screen more than 340 women aged 21-50. The randomized subjects will be allocated to two treatment arms. A total of 250 female patients will be enrolled in this study. The treatment duration will be approximately 4 weeks and the follow-up period will be 8 weeks.
An interim analysis by an independent statistician will also be provided for this project. The total duration of the study, including the enrollment period, will be approximately 18 months. The study is expected to involve up to 30 investigational sites in Russia.