Faraone, Stephen V.
Gomeni, Roberto
Hull, Joseph T.
Busse, Gregory D.
Melyan, Zare
Rubin, Jonathan
Nasser, Azmi
Funding for this research was provided by:
Supernus Pharmaceuticals, Inc.
Article History
Accepted: 20 August 2021
First Online: 15 September 2021
Declarations
:
: This is a post-hoc analysis of integrated data from four clinical studies. In each study, informed consent/assent forms were signed as applicable. Each study protocol was approved by Advarra Institutional Review Board (IRB) and conducted in accordance with the Helsinki Declaration and the International Council for Harmonisation Note for Guidance on Good Clinical Practice. All versions of the informed consent/assent form were reviewed and approved by the IRB.
: The study was funded by Supernus Pharmaceuticals, Inc.
: JTH, GDB, ZM, JR, and AN are employees of Supernus Pharmaceuticals, Inc. SVF received income, potential income, travel expenses, continuing education support and/or research support in the past year from Takeda, OnDosis, Tris, Otsuka, Arbor, Ironshore, Rhodes, Akili Interactive Labs, Enzymotec, Sunovion, Supernus, and Genomind. With his institution, he has US patent US20130217707 A1 for the use of sodium-hydrogen exchange inhibitors in the treatment of ADHD. He also receives royalties from books published by Guilford Press: Straight Talk about Your Child’s Mental Health; Oxford University Press: Schizophrenia: The Facts; and Elsevier: ADHD: Non-Pharmacologic Interventions. He is Program Director of ExternalRef removed. RG was a paid consultant to Ironshore Pharmaceuticals; Sunovion Pharmaceuticals; Supernus Pharmaceuticals; Teva; Biomedical Science Institutes; Nanomi BVs; Laboratorios Liconsa; Massachusetts General Hospital; UCB; Recordati Rare Diseases; Indivior, Tris Pharma; F. Hoffmann-La Roche.
: SF—contributed to analysis plan, data interpretation, writing and reviewing the manuscript drafts. RG—data analysis, data visualization, reviewing and updating the manuscript drafts. JTH—data curation and interpretation, quality review, and updating the manuscript drafts. GDB—data interpretation, reviewing and updating the manuscript drafts, publication management. ZM—data interpretation, data visualization, writing, reviewing and updating the manuscript drafts, publication management. JR—study conceptualization, interpretation, reviewing the manuscript drafts. AN—study design and conceptualization, oversight of all aspects of the study methods, analysis, and data interpretation, reviewing the manuscript drafts. All authors approved the final version of the manuscript for submission and agree to be accountable for the work described in the manuscript.
: Not available.
: Not applicable.
: Each subject and parent(s)/legally authorized guardian(s) provided written informed consent/assent prior to screening or administration of any study-related procedures. The subject and the parent/guardian were informed about the nature and purpose of the study, as well as of its risks and benefits. It was explained that the subject could withdraw from the study at any time for any reason and that this would not have any effect on the subject’s potential future medical care.
: Not applicable.