2.2. Procedure
All study procedures were reviewed and approved by the Ethics Committee of Medical Station Clinic (IRB no. 20000022, 8 July 2021) and were conducted in accordance with the criteria set by the declaration of Helsinki. The trial was preregistered at the UMIN Clinical Trial Registry (no. UMIN000045037). Throughout the entire period, this study was conducted according to a previously approved study protocol. This study was operated by EP Mediate Co., Ltd. (Tokyo, Japan) and performed at Iryo Hojin Shadan Kowa Clinic from August 2021 to March 2022.