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Naoki Kumashiro has received honoraria from Eli Lilly Japan K.K., Novo Nordisk Pharma Ltd., Sumitomo Pharma Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., and MSD K.K.; research funding from Kowa Company, Ltd. and Taisho Pharmaceutical Co., Ltd.; and research grants from Bayer Yakuhin, Ltd., Terumo Corporation, Sumitomo Pharma Co., and LifeScan Japan K.K.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study has been registered with the Japan Registry of Clinical Trials (jRCT) (no. jRCTs041240011), which is the clinical research database of the Ministry of Health, Labor, and Welfare of Japan and is approved as a World Health Organization Primary Registry. The original study protocol (version 1.1, dated 22 February 2024) was approved by the Kanazawa Medical University Clinical Research Review Board (no. CRB4180007) on 21 March 2024, and institutional permission was granted on 27 March 2024. Protocol version 2.0, dated 22 August 2024, was subsequently approved as an amendment by the same board on 29 August 2024, with institutional permission granted on 5 September 2024. Written informed consent will be obtained from all participants.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}