Ethics and dissemination
ADVERSE EVENTS, MAY
This study was registered in the Japan Registry of Clinical Trials (jRCTs041210019) on May 14, 2021. The study protocol was approved by the Nagoya University Clinical Research Review Board (CRB4180004). All methods will be carried out in accordance with the Declaration of Helsinki. Informed consent will be obtained from all study participants by the primary investigator or coinvestigators. For privacy protection, all participants will be identified using an anonymous identification code. The participants will be informed by the researcher about potential benefits, risks, alternatives, and responsibility during the study throughout the consent process. If any necessary experimental data are provided to a joint research institution, it will be carefully protected using only the participant’s identification code and a corresponding table. The acquisition of informed consent, the inclusion/exclusion criteria, participant eligibility, and the occurrence of any adverse events will be confirmed by an independent monitor from the research institution. The monitor will check whether the research procedure was carried out based on the approved procedure and confirm that the data storage method is appropriate. The findings from the research will be published in peer-reviewed journals and presented at local, national, and international conferences.