Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki, and approved by the ethical committee expert group of Taiyo Kagaku Co., Ltd., Japan, and subsequently approved by the Suda Clinic institutional review board of IMEC RD Co., Ltd., Tokyo, Japan (approval No. IQRD-05-022; date: 19 January 2022). Finally, the protocol was registered at the University Hospital Medical Information Network-Clinical Trial Registry (UMIN-CTR; Trial ID: 