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Article History

Received: 9 December 2024

Accepted: 14 November 2025

First Online: 4 December 2025

Declarations

:

: The MEGMI-TS study was registered with the Japan Registry of Clinical Trials (jRCT1011240025) prior to enrollment. The study will be conducted in accordance with the principles of the Declaration of Helsinki and its amendments. The study protocol was approved by the Asahikawa Medical University Research Ethics Committee (No. 11000290), and the current version is 1.2 (approved on 11 April 2025). Physicians in the research team will obtain written informed consent from all eligible participants. The eligibility criteria are as stated above. The Research Committee approved the written materials consisting of a participant information leaflet and a consent document. The participants will be free to ask any questions about the trial and will have the opportunity to withdraw consent at any time during the study. Subjects will be withdrawn from the study for any of the reasons listed below (Table ). Participant enrollment will take place between 22 July 2024 and 31 March 2026 at five medical institutions in Hokkaido, Japan.

: Not applicable. This manuscript does not contain any personal information of the participants.

: Nomoto H has obtained research support from Kowa Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., and Asahi Kasei Pharma Corp., and has received honoraria for lectures from Sumitomo Pharma Co., Ltd., MSD K.K., and Novo Nordisk Pharma Ltd. Kitsunai H has obtained research support from Nippon Boehringer Ingelheim Co., Ltd. Abiko A has received honoraria for lectures from Eli Lilly Japan K.K., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., and Sumitomo Pharma Co., Ltd. Nanbu T, Maruyama F, Tasuku S, Takiyama Yuri, Sasaki T, Shukuda Y, Takiyama T, Kurigaki A, Takiyama Yumi, Miyamoto Y, Homma R, and Hirano F have no conflicts of interest to declare.