Ethical 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. 19315; 14/04/2020, revised design approval 14/04/2021). This study was conducted in accordance with the principles of the Declaration of Helsinki. This project was registered in the Clinical Trial Registry (UMIN 000041743; 09/09/2020). No serious adverse events were reported, although few cases of negative program impact were observed. Written informed consent was obtained from all participants.