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Ltd., Fujifilm Medical Co., Ltd., Terumo Corporation, Fancl Corporation, and Muta Hospital; ME is a consultant for AI Medical Service Inc.; JA received lecture honoraria from Takeda Pharmaceutical Co. and Otsuka Pharmaceutical Co. The conflicts of interest of the principal investigators and sub-investigators are appropriately managed in accordance with the Kyushu University Conflict of Interest Management Guidelines. The other authors have no conflicts of interest to declare. Declaration of funding interests: This study was funded by AMED (21lk0201144h001, 22lk0201144h002, and 23lk0201144h003). Investigational drugs, including acotiamide and placebo, were provided free of charge by Zeria Pharmaceutical Co. Ltd. However, Zeria was not involved in the study design, data collection, data analysis, or interpretation of the results.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The trial was registered in the Japan Registry of Clinical Trials (JRCT2071210072: October 11, 2021).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Clinical trial registration"}},{"value":"The study protocol followed the SPIRIT guidelines and was approved by the Institutional Review Board (IRB) of Kyushu University for Clinical Trials (IRB No. 2021301; June 28, 2021) and local IRBs at participating sites. The trial complied with the Declaration of Helsinki and GCP guidelines. The trial was registered in the Japan Registry of Clinical Trials (JRCT2071210072: October 11, 2021). All authors had data access and approved the final version of the manuscript. Written informed consent was obtained from all eligible patients before their registration.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical considerations"}}]}}