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Article History

Received: 3 May 2023

Accepted: 20 June 2023

First Online: 18 July 2023

Declarations

:

: This protocol was approved by the Institutional Review Board (IRB) of Kyushu University Hospital (IRB No. 2021301, July 28, 2021) as well as the local IRBs of the participating sites. The trial was registered in the jRCT (No. jRCT2071210072: October 11, 2021). The trial protocol (version 4.0; April 22, 2022) was designed according to the SPIRIT guidelines. The trial will be conducted following guidelines established in the Declaration of Helsinki and those of Good Clinical Practice. Written informed consent will be obtained from all eligible patients prior to registration.

: The consent form can be made available upon request.

: EI belongs to the endowed course supported by the companies mentioned, including Miyarisan Pharmaceutical Co. Ltd., Fujifilm Medical Co., Ltd., Terumo Corporation, Fancl Corporation, Muta Hosipital. EI received a lecture fee from Takeda Pharmaceutical Co. The other authors declare they have no conflict of interest.The study is funded by AMED. Investigational drugs including acotiamide and placebo are provided for free by Zeria Pharmaceutical Co. Ltd. However, Zeria is not involved in the study design, data collection, analysis, or interpretation of data in this trial. The results obtained from this trial will belong of Kyushu University Hospital. The handling of the result will be determined by the contract and agreement between the two parties (Kyushu University Hospital and Zeria). Conflicts of interest of the principal investigators and sub-investigators will be appropriately managed in accordance with the Kyushu University Conflict of Interest Management Guidelines.