Ethics approval and consent to participate
ADVERSE EVENTS
This study was approved by the Ethics Committee for the Intervention Study of Osaka University Hospital (approval no. 21144; 5/10/2021). Written informed consent was obtained from all the participants. This study was conducted in accordance with the principles of the Declaration of Helsinki. This project has been registered in the Clinical Trial Registry (UMIN000045483; 14/09/2021). No adverse events were reported.