Ethics approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the Research Ethics Committee of the Kitasato University School of Medicine and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. This study was approved by Kitasato University School of Medicine Hospital Ethics Committee (C20-274). For the registry and the registration no. of the study/trial, this clinical trial was registered with the University Hospital Medical Information Network Clinical Trial registry (UMIN000042579). The date of registration for prospectively registered trials is 2020/11/30.