Study design and conduct
AMEERA-4 (NCT04191382) was an international, prospective, open-label, randomized Phase 2 WOO study conducted at 32 centers in 8 countries (Belgium, France, Italy, Japan, Russia, Spain, Ukraine, and the USA). The study consisted of a screening period, randomization, a 14-day treatment period, and a 30-day safety follow-up period (Additional file The study was conducted in accordance with the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Conference on Harmonisation Good Clinical Practice Guidelines, and applicable laws and regulations. All study participants provided voluntary written informed consent to participate. No interim analyses were planned; however, the protocol allowed for the study to be terminated at any time, and for any reason, by the sponsor or its designee.