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Article History

Accepted: 10 July 2025

First Online: 13 August 2025

Declarations

:

: This work and its open access publication were funded by Supernus Pharmaceuticals, Inc.

: R.L.F. receives or has received research support, acted as a consultant and/or has received honoraria from Abbvie, Ajna, Akili, American Academy of Child & Adolescent Psychiatry, American Psychiatric Press, Bioprojet, BioXcel, Bristol Myers Squibb,Corium, Elsevier, Intra-Cellular Therapies, Iqvia, Karuna, Lundbeck, Maplight, Merck, MJH Life Sciences, NIH, Novartis, Otsuka, Oxford University Press, PaxMedica, PCORI, Pfizer, Radius, Sage, Signant Health, Sumitomo Pharma, Sunovion, Supernus Pharmaceuticals, Takeda, Tris, Viatris, and Xenon. Over the past 3 years, J.W. has received research support from Supernus and served as a consultant for Iron Shore and Adlon Pharmaceuticals. M.L. is a consultant for Vistagen Therapeutics and Newleos Pharma, and in the past 3 years has conducted clinical trials for Supernus, Alto, Biohaven, Janssen, Otsuka, Compass, Abbvie, and Relmada. A.K. has received honoraria from Supernus and in the past 3 years has conducted clinical research for Abbvie, Axsome, Boehringer Ingelheim, Cingulate, Corium, Janssen, Otsuka, Pfizer, Relmada, and Supernus. N.F., P.Q., I.Y., Z.M-C., V.R.L., and J.R. are employees of Supernus Pharmaceuticals, Inc.

: The trial was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonisation (ICH) Good Clinical Practice Guidelines for biomedical research, and the United States (US) Code of Federal Regulations (21 CFR). The central IRB (Advarra) approved the trial protocol under Pro00026366.

: Each participant’s parent or legal guardian signed an informed consent form (ICF); participants signed an informed assent form, and those turning 18 years of age during the trial also signed an ICF.

: Not applicable.

: The data are not available in a repository, but data will be made available upon reasonable request directed to jrubin@supernus.com.

: Not applicable.

: Conceptualization and design: R.L.F. Methodology and data collection: R.L.F., J.W., A.K., N.F., and M.L. Analysis and interpretation: R.L.F., J.W., I.Y., Z.M.C., V.R.L., P.Q., and J.R. Writing, review, and editing: R.L.F., M.L., J.W., I.Y., Z.M.C., V.R.L., P.Q., and J.R. All authors read and approved the final submitted manuscript and agree to be accountable for this work.