Document is current

Article History

Received: 24 January 2024

Accepted: 12 September 2025

First Online: 11 November 2025

Declarations

:

: The protocols of Kansai University, Senriyama Hospital, and Nara Medical University Hospital were approved by the Ethical Review Board of Osaka University Hospital through a central review system (no. 20302(T20302(T3))-7). The protocols of the National Center of Neurology and Psychiatry Hospital, Jikei University Hospital, Hiroshima University Hospital, Kawasaki Medical School Hospital, and Kobe University Hospital were approved by the respective institutional review boards (nos. A2021-012, 33-016 (10626), C2021-0324-01, 2023-0811, and A210005, respectively). All modifications to protocols and procedures will first be reviewed by the Ethical Review Board of Osaka University Hospital. If approved, all collaborators will be notified of the modifications, and each hospital will have its own Ethical Review Board review, if necessary.All participants will be asked to sign an informed consent form to participate in the study after receiving a complete explanation of this trial by the physician, therapist, and/or a research assistant, both verbally and in writing, in accordance with the Declaration of Helsinki adopted by the 18th World Medical Assembly, Ethical Guidelines for Clinical Research, and subsequently revised in Japanese.

: No identifying images or other personal or clinical details of participants are presented here or will be included in reports of the trial results. Written informed consent to participate is obtained in person from all participants, and the patient information sheet and informed consent form are available from the corresponding author upon reasonable request.

: The authors, including all collaborators involved in trial oversight through regular steering committee meetings, declare that they have no financial or non-financial competing interests related to this trial.