2.7. Ethics Committee
COVID-19 infection
MAY, COVID-19 INFECTION
The study protocol was approved by the Bioethics Committee of Hokkaido Information University (Hokkaido, Japan) per the principles of the Declaration of Helsinki (approval date: 28 April 2021; approval number: 2021-13). The study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trial Registry as UMIN000044175 (date of registration: 11 May 2021). The study involved one revision of the clinical trial protocol. The contents were (1) the postponement of the study due to the declaration of a state of emergency following the spread of the COVID-19 infection and (2) changes to the case-fixing conditions following the postponement of the study. The changes were approved by the Bioethics Committee of Hokkaido University through an expedited review (approval date: 11 June 2021; approval number: 2021–2024). Written informed consent was obtained from all participants before enrollment.