2.10. Ethics approval and patient consent
The study protocol has been approved by the Ethics Committee of Wakayama Medical University (No. W-29), which confirmed that the protocol conformed to the tenets of the Declaration of Helsinki and Ethical Guidelines for Medical and Health Research involving Human Subjects. The trial has been registered with the Japan Registry of Clinical Trials (trial registration: jRCTs052190089). Written informed consent will be obtained from all patients enrolled in the study.