Ethics approval and consent to participate
The research was conducted in accordance with the Declaration of Helsinki and the protocol for this study was approved by St. Luke’s International University Ethics Review Committee (approval number: 20-A095). The trial protocol was registered with UMIN-CTR (ID: UMIN000045883). The first date of the registration was on 06/02,2021. All participants signed the research informed consent from prior to participating in this study.