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Article History

Received: 20 May 2025

Accepted: 27 March 2026

First Online: 6 April 2026

Declarations

:

: The linked dataset used in this analysis contains de-identified data as per the de-identification standard defined in Section § 164.514(a) of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The process by which the data is de-identified is attested to through a formal determination by a qualified expert as defined in Section § 164.514(b)(1) of the HIPAA Privacy Rule.U.S. law 45 Code of Federal Regulations Part 46, human participant protection regulations, and Protection of Human Subjects (45 CFR 46) requires institutional review board (IRB) approval for all research involving identifiable private information or identifiable biospecimens from human subjects as defined in 45 CFR 46.102(e)(5) and in 45 CFR 46.102(e)(6). However, protected health information that has been de-identified under the standard set for in 45 CFR 164.514(b)(1) is no longer considered to be identifiable health information and therefore is no longer subject to the IRB requirements set forth in 45 CFR 46. Because this study used only de-identified records, it is therefore no longer subject to the HIPAA Privacy Rule, the requirements for informed consent, or the IRB requirements set forth in 45 CFR 46. This study was conducted in compliance with the Declaration of Helsinki and used only de-identified data.

: Not Applicable.

: T.R., D.L., J.P.W., and M.B. are employees of Veradigm, which received fees from Madrigal Pharmaceuticals related to this work. Y.K. is an employee of Madrigal Pharmaceuticals. E.B.T. is an employee at the University of Michigan, which received unrestricted financial support to the institution related to this work.