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Article History

Received: 14 November 2025

Accepted: 1 March 2026

First Online: 31 March 2026

Declarations

:

: All authors are full-time employees of Shionogi & Co., Ltd.

: The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.

: This study was conducted in accordance with the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, the Good Clinical Practice (GCP) Guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and other applicable laws and regulations. The protocol and other relevant documents were reviewed and approved by the institutional review board (IRB) of the study site. The study was approved by the Advarra IRB (approval date: 06 Dec 2024): 6100 Merriweather Dr., Suite 600, Columbia, MD 21044 (Phone: 877-992-4724).

: Informed consent was obtained from all individual participants included in the study.

: Consent to publish was obtained using the informed consent form for the use of anonymized data for any summary results, reports, or publications produced at the end of the study.

: Not applicable.

: RS contributed to the conception or design of the study, data interpretation, and drafting of the initial version of the manuscript. RYS and RK contributed to the conception or design of the study and data interpretation. SO contributed to the conception or design of the study, data acquisition and analysis, and data interpretation. TS contributed to data interpretation. All authors contributed to the critical revision of the manuscript for important intellectual content, agreed to be accountable for all aspects of the work, and have read and approved the final version of the manuscript.