Ethics approval and consent to participate
This trial protocol has been reviewed and approved by a Certified Review Board (Tokyo Medical and Dental University: approval No. NR2020-005). The deliberations of this Clinical Research Review Board is to be a review of all participating facilities, and all participating facilities are approved. The protocol has also been reviewed and approved by the director of each participating institution and registered with the Japan Registry of Clinical Trials (jRCT) on March 1, 2021 (registry number jRCTs031200358). The physician in charge will obtain informed consent and written consent forms for potential trial participants before study participation. Informed consent includes consent provisions for the collection and use of participant data in ancillary research.