2.5. Ethics Statement
ICH
The protocol was approved by the Ethics Committees of Nihonbashi Egawa Clinic (Tokyo, Japan; Ethical approval code: 16000016), and the trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice. Participants were provided with both oral and written information about the study. Written informed consent was obtained from all participants prior to the study. The study was registered at UMIN Clinical Trials Registry (UMIN-CTR) (UMIN000037160).