Consent to participate and ethical approval
MAY
Before conducting any study procedure, written informed consent was obtained from all patients, indicating their full comprehension of the details of the procedure. A qualified and experienced individual distributed the informed consent forms. The Clinical Research Ethics Committee approved the study protocol of Kobe University (reference number: C200024, date of approval: March 23, 2021). The study was performed in accordance with the principles of the Declaration of Helsinki and Clinical Trial Acts in Japan. The trial was registered in the Japan Registry of Clinical Trials (trial registration: jRCTs051210022, date of registration: May 10, 2021).