Ethics approval and consent to participate
The study protocol was approved by the Ethical Review Board of Osaka University Hospital (approval number: 17367, date of approval: 2018/3/29) and the institutional review board of each participating center according to the Ethical Guidelines for Medical and Health Research Involving Human Subjects issued by the Ministry of Health, Labour and Welfare in Japan. The study was conducted in accordance with the Declaration of Helsinki of 1964 (revised in 2013), the Ethical Guidelines for Medical and Health Research Involving Human Subjects, and other current legal regulations in Japan. Informed consent was obtained from all patients for inclusion in the study.