*2.7. Ethical Considerations*

This study was performed in accordance with the Declaration of Helsinki. The institutional review board of Nagasaki University Hospital approved this study protocol (approval number 17032713-3). Informed consent was obtained from the patients by an opt-out system on the hospital website, in accordance with the ethical guideline presented by the Ministry of Health, Labor, and Welfare in Japan. This trial was registered with the University Hospital Medical Information Network in Japan (UMIN), registry number UMIN000026964.
