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Article History

Accepted: 11 December 2024

First Online: 11 February 2025

Declarations

:

: The Research Participation Program at the U.S. Food and Drug Administration administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration (Grant no. CDER-OND-M-24-11192).

: The authors have no conflicts of interest to declare.

: The conclusions and views in this manuscript are the authors and do not represent an official position of the Food and Drug Administration.

: Not applicable. Data are not identifiable to any drug product, subject, or patient.

: Not applicable.

: Not applicable.

: Not applicable. Datasets from new drug applications are not publicly available.

: Composite coding available on GitHub. Other coding to be available on GitHub shortly.

: JA: study design, programming, data analysis, manuscript writing; BT: programming, data analysis; YVP: study design, manuscript writing; EN: study design, data analysis, manuscript writing; MIA: Study design, manuscript writing; PHH: study design, data analysis, manuscript. All authors have read and approved the final version.