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Article History

Received: 1 July 2025

Accepted: 5 January 2026

First Online: 29 January 2026

Declarations

:

: This work was conducted in the absence of a competing interest or financial relationship; however, the authors report the following: Zachary L. Taylor and Laura B. Ramsey have received research funding from SERB Pharmaceuticals. Erin F. Barreto serves in a consulting or advisory role for Wolters-Kluwer and Baxter-Health. Erin F. Barreto has received research funding from Numares AG. Andrew D. Rule receives royalties from UpToDate. Nelson Leung has stock or ownership interests in Senseonics, AbbVie, Verrica Pharmaceuticals, and Checkpoint Therapeutics. Nelson Leung has received research funding from Omeros. Thomas E. Witzig has received honoraria, from Curio Science, serves in a consulting or advisory rolefor Tornado Therapeutics and Salarius Pharmaceuticals, and has received research funding fromCelgene, Acerta Pharma, Kura Oncology, Acrotech Biopharma, and Karyopharm Therapeutics. Jason N. Barreto serves in a consulting or advisory role for Optum, and has received research funding from Asellas Pharma and Numares AG. Kristin C. Cole, Kianoush B. Kashani, and Carrie A. Thompson have no conflicts of interest that are directly relevant to the content of this article.

: This prospective single-center study was conducted in accordance with Good Clinical Practice guidelines and the ethical principles of the Declaration of Helsinki. The protocol was reviewed and approved by the Mayo Clinic Institutional Review Board (ID: 17-007837). Patient confidentiality was maintained in compliance with the US Health Insurance Portability and Accountability Act.

: All participants provided written informed consent prior to enrollment in accordance with the protocol that was approved by the Mayo Clinic Institutional Review Board.

: The authors affirm that human research participants provided informed consent for publication of their data at the time of study enrollment, as part of the informed consent process.

: The datasets that support the findings of this study are not publicly available because of institutional privacy policies but may be made available from the corresponding author upon reasonable request and with appropriate data use agreements.

: Population PK modeling was performed using NONMEM (Version 7.5) with Pirana and Perl-speaks-NONMEM (PsN) workbench tools. No custom code was developed for this study beyond standard model scripting within these platforms. Model scripts may be made available upon reasonable request to the corresponding author.

: ZLT, EFB, KMC, ADR, KBK, NL, CAT, TEW, LBR, and JNB contributed to the conception and design of the research. ZLT, EFB, KMC, and JNB performed the research. ZLT, EFB, KMC, ADR, KBK, CAT, TEW, LBR, and JNB analyzed the data. All authors contributed to the drafting and critical revision of the manuscript. All authors have read and approved the final version of the manuscript and agree to be accountable for all aspects of the work.