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Article History

Received: 10 May 2026

Accepted: 7 September 2026

First Online: 8 September 2026

Declarations

Competing interests: N.M., F.B., and R.E. declare no conflicts of interest. H.M. and M.N. are employees of Ajinomoto Co., Inc. (AJI). This employment does not alter the authors’ adherence to the journal’s policies on data and material sharing. H.M. and M.N. had no role in the analysis of raw data or in the assessment of adverse events. The collection and analysis of clinical trial data were conducted by personnel who were blinded and independent of AJI. H.M. and M.N. had no access to unblinded data until the database was locked.

Ethics approval and institutional review board statement: The clinical trial procedures were conducted in accordance with the Declaration of Helsinki and the Ethical Guidelines for Medical and Biological Research Involving Human Subjects. The study was approved by the Ajinomoto Co., Inc. Human Research Ethics Review Committee (IRB No. 19000012; Study No. 2024-015) and the Medical Corporation Kanonkai Miura Clinic Ethics Review Committee (IRB No. 17000161; Study No. R2402).

Informed consent: Written informed consent was obtained from all subjects involved in the study.