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Motoyuki Tamaki received speaker fees from Eli Lilly Japan K.K. Tomoyuki Yuasa received speaker fees from Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., and Mitsubishi Tanabe Pharma Corporation. Toshiaki Tamaki received speaker fees from Astellas Pharma, Inc., Ono Pharmaceutical Co., Ltd., and Mitsubishi Tanabe Pharma Corporation. Munehide Matsuhisa received speaker fees from Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan K.K., Novo Nordisk Pharma Ltd., Sumitomo Pharma\u00a0Co., Ltd., Sanofi\u00a0K.K., and Kyowa Kirin\u00a0Co., Ltd. Akiko Sekine, Ryoko Uemoto, Seijiro Tsuji, Tomoyo Hara, and Ken-ichi Aihara declare that they have no conflicts of interest to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This study complied with the Declaration of Helsinki and Good Clinical Practice guidelines and was conducted as a collaborative multicenter research effort led by Tokushima University. To ensure comprehensive ethical approval across all participating facilities, each institution sought a consolidated review by the Institutional Review Board of Tokushima University Hospital. Subsequently, the Institutional Review Board of Tokushima University Hospital granted approval for all study sites involved in this multicenter study (approval date April\u00a023, 2018; approval ID 3149). The research proceeded after securing the necessary approvals from each research institution. Additional matters requiring approval, such as protocol amendments, were evaluated and approved by the institutional review boards on the basis of need. The trial was registered with the University Hospital Medical Information Network (UMIN No. 000031947). The patients were provided with detailed explanations of the study protocol. All participants provided written informed consent for participation in the study and for publication of the study results. Nonetheless, all patient records and information were anonymized before the analysis.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}