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Article History

Accepted: 15 January 2025

First Online: 20 March 2025

Declarations

:

: This article has been published as part of a journal supplement wholly funded by Avadel Pharmaceuticals (Chesterfield, MO, USA). This study was funded by Avadel Pharmaceuticals. Avadel Pharmaceuticals was involved in the study design, collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Open access publication and publication costs were funded by Avadel Pharmaceuticals.

: TR is a consultant for Jazz Pharmaceuticals, Takeda Pharmaceutical Co., Orexo, Avadel Pharmaceuticals, Eisai, Merck & Co., and Idorsia. MJT is the guest editor of this supplement and played no part in the peer review or decision making of this article at the editorial level and contributed solely as an author. He has served as a consultant or on advisory boards for Axsome Therapeutics, Balance Therapeutics, Eisai, Avadel Pharmaceuticals, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences Ltd, and Takeda Pharmaceutical Co. CAK is a consultant for Avadel Pharmaceuticals and XW Pharma. JG is an employee of Avadel Pharmaceuticals.

: Institutional review board or independent ethics committee approval was obtained for each study center.

: Written informed consent was provided by all adult participants (≥ 18 years old); consent was obtained from both the participant and their legally authorized representative for participants 16 and 17 years of age.

: Not applicable.

: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

: Not applicable.

: Thomas Roth: Writing – review and editing, formal analysis. Michael J. Thorpy: Writing – review and editing, formal analysis. Clete A. Kushida: Writing – review and editing, formal analysis. Jennifer Gudeman: Writing – review and editing, formal analysis.