2.1. Study Design
The study was a 12-week, open-label, randomized controlled trial conducted under the principles of the Declaration of Helsinki, with the approval of the ethics review board of the Ethical Committee of Nihonbashi Cardiology Clinic (NJI-021-10-01), and according to the ethical guidelines for human research (Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labor and Welfare; Ministry of Economy, Trade and Industry Japan). The trials were registered in the UMIN Clinical Trials Registry (UMIN000046306).