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Koji Sato has received payment or honoraria for lectures, presentations, speaker\u2019s bureaus, manuscript writing, or educational event fees from Daiichi Sankyo Co., Ltd., Otsuka Pharmaceutical Co., Ltd., and Ono Pharmaceutical Co., Ltd. Takashi Taguchi, Kazuhito Shiosakai, and Kotaro Sugimoto are employees of Daiichi Sankyo Co., Ltd. Kenichi Tsujita has received grant fees from PPD-Shin Nippon Biomedical Laboratories K.K., Alexion Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Abbott Medical Japan LLC., Bayer Yakuhin, Ltd., Nippon Boehringer Ingelheim Co., Ltd., Daiichi Sankyo Co., Ltd., and ITI Co., Ltd.; payment or honoraria for lectures, presentations, speaker\u2019s bureaus, manuscript writing, or educational event fees from Abbott Medical Japan LLC., Amgen K.K., AstraZeneca K.K., Bayer Yakuhin, Ltd., Daiichi Sankyo Co., Ltd., Medtronic Japan Co., Ltd., Kowa Co., Ltd., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., and Janssen Pharmaceutical K.K.; and has other financial or non-financial interests with Abbott Japan LLC., Boston Scientific Japan K.K., Fides-one Inc., GM Medical Co., Ltd., ITI Co., Ltd., Kaneka Medix Corp., Nipro Corp., Terumo Corp., Abbott Medical Japan LLC., Boston Scientific Japan K.K., Cardinal Health K.K., Fides-one Inc., FUKUDA DENSHI Co., Ltd., Japan Lifeline Co., Ltd., Medical Appliance Co., Ltd., and Medtronic Japan Co., Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The protocol for this study was approved by the Kumamoto University Certified Clinical Research Review Board (CRB7200002) and prospectively registered with the Japan Registry of Clinical Trials (jRCTs071190043;\n                      \n                      ). The study was conducted in accordance with the Declaration of Helsinki and the Clinical Trials Act in Japan. All the study participants provided written informed consent before enrollment.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}