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. 2023 Jul 9;23(3):221–237. doi: 10.1007/s40268-023-00427-5

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© The Author(s) 2023

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

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Fig. 1 — Study design and visit schedule. *Menstrual bleeding is defined as 2 consecutive days with more than spotting. Day 1 of the menstrual cycle is defined as the first of the 2 consecutive days with more than spotting. NOTE that additional visit 7a 2 weeks after end of treatment was introduced as a result of study termination for safety monitoring. BID twice daily, EoT end of treatment, EoS end of study, OD once daily, SoT start of treatment, V visit, W week