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Article History

Received: 28 May 2025

Accepted: 21 December 2025

First Online: 26 January 2026

Declarations

:

: Helen Usansky, Sam Au Yeung, Sherry Li, and Daniel S. Stein are employees and shareholders in Insmed Incorporated. Thomas C. Marbury is an employee and equity owner of Orlando Clinical Research Center. Eric Lawitz is an employee and owner of Texas Liver Institute. Zeid Kayali reports honoraria from AbbVie, Gilead, and Madrigal Pharmaceuticals.

: The datasets generated and/or analyzed during the current study are not publicly available owing to patients not providing consent to individual data being shared publicly.

: The study was performed in accordance with the ethical principles of the Declaration of Helsinki, the Good Clinical Practice guidelines of the International Council for Harmonisation, and applicable regulatory requirements. Approval was obtained from Salus IRB (Austin, TX) under the study number INS1007-105.

: Participants and/or their legally authorized representative were informed that their participation was voluntary. Participants, or their legally authorized representative, were required to sign a statement of informed consent that met the requirements of ICH E6 (R2) Guideline for GCP and any additional elements required by local regulations.

: Not applicable.

: Not applicable.

: Helen Usansky, Sam Au Yeung, Sherry Li, and Daniel S. Stein contributed to the study conception, design, and study conduct. Eric Lawitz, Zeid Kayali, and Thomas C. Marbury were principal investigators of this study. All authors contributed to data collection, analysis, and interpretation. All authors critically reviewed all manuscript drafts, approved the submitted version of the manuscript, and made the decision to submit the manuscript for publication.