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Article History

Received: 28 March 2025

Accepted: 17 December 2025

First Online: 14 March 2026

Declarations

:

: DT Plante is a consultant and advisory board member for Jazz Pharmaceuticals. He has also served as a consultant/advisory board member for Alkermes, Centessa, Harmony Biosciences, and Takeda, advisory board member for Apnimed, and a consultant for Aditum Bio and Teva Pharmaceuticals (Australia). LD Schneider has received personal compensation for serving on advisory boards and speakers bureaus for Jazz Pharmaceuticals, Eisai, and Avadel. A Cairns, DA Nichols, DS Fuller, MT Kirby, JK Alexander, and M Whalen are full-time employees of Jazz Pharmaceuticals who, in the course of this employment, have received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. S Akerman is a former full-time employee of Jazz Pharmaceuticals who, in the course of this employment, has received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. TL Steininger is a former full-time employee and current contract worker for Jazz Pharmaceuticals who has received shares of Jazz Pharmaceuticals, plc. CM Ruoff has served as an advisory board member for Alkermes, Eisai, Jazz Pharmaceuticals, and Takeda and has received grant funding from Jazz Pharmaceuticals.

: All relevant data are provided within the manuscript and supporting files. Jazz has established a process to review requests from qualified external researchers for data from Jazz-sponsored clinical trials in a responsible manner that includes protecting patient privacy, assurance of data security and integrity, and furthering scientific and medical innovation. Additional details on Jazz Pharmaceuticals data sharing criteria and process for requesting access can be found at: .

: The study ( identifier NCT05875974) was approved by institutional review boards or ethics committees at all sites (protocol approval number: Pro00071404; amendment approval numbers: MOD01782418, MOD01918961, MOD02130103) and was performed in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice and the Declaration of Helsinki.

: All participants provided written informed consent.

: Not applicable.

: Not applicable.

: All authors had full access to all the data in the study and take full responsibility for the integrity of the data and the accuracy of the data analysis. Statistical analysis: DS Fuller. All authors participated in the study. All were responsible for – study design, acquisition, analysis, or interpretation of data; drafting of the manuscript; critical review and revision of the manuscript. All authors have read and approved the final submitted manuscript and agree to be accountable for the work.