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Article History

Received: 25 March 2025

Accepted: 20 May 2025

First Online: 18 June 2025

Declarations

:

: Christopher Jacobson served as an advisory board consultant for MannKind Corporation and is currently an advisory board consultant and on a speakers bureau for Medtronic. Thomas Blevins serves as an advisory board consultant for MannKind and Insulet and on speakers bureau for Lilly, Novo Nordisk, Boehringer Ingelheim, Sanofi, and Astra Zeneca; and receives clinical research support from Lilly, Novo Nordisk, Insulet, Medtronic, MannKind, Tandem, and Boehringer Ingelheim. Kevin Codorniz, Mehrbod Vakhshoori, Scott Lee, and Pamela Lobo Moreno have no relevant disclosures. Kevin B. Kaiserman, Johanna Ulloa, Jennifer Pleitez, Joseph Sylvan, and Joanne Rinker are employees and stockholders of MannKind Corporation.

: The study protocol and informed consent forms at both study sites were approved by a central institutional review board (Advarra Institutional Review Board) before the start of the study (US Food and Drug Administration (FDA)/Office for Human Research Protections Institutional Review Board Registration Number IRB00000971). The study was conducted in compliance with applicable FDA regulations, local regulations (where applicable), the International Conference on Harmonisation Good Clinical Practice guidelines, and the Declaration of Helsinki. All participants provided written informed consent prior to initiation of study procedures. Manuscript development conformed to the International Committee of Medical Journal Editors Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.