Study design and ethical considerations.
This was a prospective, randomized, open-label, blinded-endpoint, parallel-group trial conducted between July 2020 and October 2021 at 11 universities and teaching hospitals in Japan. The study was conducted in accordance with the Declaration of Helsinki and compliance with Good Clinical Practice and other applicable regulatory requirements. Its protocol was approved by the institutional review board of Nagasaki University Hospital (approval number: I20-001) and the local review board of each participating institution. All patients provided written informed consent. The study was registered with the Japan Registry of Clinical Trials (jRCT2071200023). This report follows the CONSORT guidelines (