Ethics approval and consent to participate
The study was conducted at Nagasaki University Hospital with the approval of Nagasaki University’s Clinical Research Review Board (CRB7180001) and written informed consent was obtained from all subjects participating in this study. This clinical trial was registered prior to patient enrollment in the Japan Registry of Clinical Trials (jRCTs072190021; Principal investigator: Takao Ayuse; Date of registration: August 26, 2019). All methods were carried out in accordance with relevant guidelines and regulations (Declaration of Helsinki).