Study design
This study was a phase 3, open-label, multicenter, single-arm clinical trial conducted at 20 centers in Japan between March and August 2022. Figure Study design. The institutional review board at each institution approved the study protocol. Patients provided informed consent to participate in the study; consent could be withdrawn at any time. The study conduct adhered to the ethical principles of the Declaration of Helsinki, Good Clinical Practice Guidelines, and local regulatory entities and was registered as NCT04766385.