Conceptualization, K.Y.-M., C.H., Y.S., Y.O., M.S., H.F., R.I.-M., T.M. and M.O.; methodology, K.Y.-M., C.H., Y.S., Y.O., M.S., H.F., R.I.-M., T.M. and M.O.; software, K.Y.-M., C.H., Y.S., Y.O., M.S., H.F., R.I.-M., T.M. and M.O.; validation, K.Y.-M., C.H., Y.S., Y.O., M.S., H.F., R.I.-M., T.M. and M.O.; formal analysis, H.F.; investigation, K.Y.-M., C.H., Y.S., Y.O., M.S., R.I.-M., T.M. and M.O.; resources, K.Y.-M., C.H., Y.S., Y.O., M.S., H.F., R.I.-M., T.M. and M.O.; data curation, K.Y.-M., C.H., Y.S. and H.F.; writing—original draft preparation, K.Y.-M., C.H., Y.S. and H.F.; writing—review and editing, K.Y.-M., C.H., Y.S., Y.O., M.S., H.F., R.I.-M., T.M. and M.O.; methodology, K.Y.-M., C.H., Y.S., Y.O., M.S., H.F., R.I.-M., T.M. and M.O.; visualization, K.Y.-M., C.H., Y.S., Y.O., M.S., H.F., R.I.-M., T.M. and M.O.; methodology, K.Y.-M., C.H., Y.S., Y.O., M.S., H.F., R.I.-M., T.M. and M.O.; supervision, K.Y.-M.; project administration, K.Y.-M.; funding acquisition, K.Y.-M. All authors have read and agreed to the published version of the manuscript.
FundingThis research was funded by JSPS KAKENHI Grant, grant number 21K19685 (to K.Y.-M.).
Institutional Review Board StatementThe study will be conducted in accordance with the Declaration of Helsinki, and approved by the Research Ethics Committee of the Faculty of Medicine of the University of Tokyo (protocol code: 2022111NI, and date of approval: 31 July 2022). We registered the protocol of the main RCT in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) following the International Committee of Medical Journal Editors (No. UMIN000049037, 27 September 2022).
Informed Consent StatementInformed consent will be obtained from all subjects involved in the study.
Conflicts of InterestThe authors declare no conflict of interest. The funders had no role in the design of the study.
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