2.1. Ethics
The study protocol was approved on 17 March 2022 by the Certified Clinical Research Committee of Hiroshima University (certification number: CRB210005), registered with the Japan Registry of Clinical Trials (jRCTs062220008), and submitted to the Ministry of Health, Labour and Welfare. Written informed consent was obtained from each participant, and the study was conducted in accordance with the tenets of the Declaration of Helsinki.