ETHICS STATEMENT
The protocol was approved by the independent ethics committees of participating institutions. This trial was conducted in accordance with the Ethical Guidelines for Medical and Health Research involving Human Subjects, the Declaration of Helsinki, and the Clinical Trials Act in Japan. Moreover, the written informed consent was obtained from all patients. This trial was registered with the UMIN Clinical Trials Registry (UMIN000016932) and the Japan Registry of Clinical Trials (jRCTs031180214).