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Article History

Accepted: 26 May 2025

First Online: 29 July 2025

Declarations

:

: Teva Branded Pharmaceutical Products R&D LLC.

: This study was supported by Teva Branded Pharmaceutical Products R&D LLC.

: C.U. Correll has been a consultant and/or advisor to or has received honoraria from AbbVie, Acadia, Adock Ingram, Alkermes, Allergan, Angelini, Aristo, Biogen, Boehringer-Ingelheim, Bristol-Meyers Squibb, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Darnitsa, Delpor, Denovo, Eli Lilly, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Jamjoom Pharma, Janssen/J&J, Karuna, LB Pharma, Lundbeck, MedInCell, Merck, Mindpax, Mitsubishi Tanabe Pharma, Maplight, Mylan, Neumora Therapeutics, Neurocrine, Neurelis, Newron, Noven, Novo Nordisk, Otsuka, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Sage, Saladax, Sanofi, Seqirus, SK Life Science, Sumitomo Pharma America, Sunovion, Sun Pharma, Supernus, Tabuk, Takeda, Teva, Tolmar, Vertex, Viatris, and Xenon Pharmaceuticals; provided expert testimony for Janssen, Lundbeck and Otsuka; served on a Data Safety Monitoring Board for Compass Pathways, Denovo, IntraCellular Therapies, Lundbeck, Relmada, Reviva, Rovi, Supernus, and Teva; received grant support from Boehringer-Ingelheim, Janssen, and Takeda; received royalties from UpToDate; and is a stock option holder of Cardio Diagnostics, Kuleon Biosciences, LB Pharma, Medlink, Mindpax, Quantic, and Terran. H. Knebel, E. Harary, R. Eshet, O. Tohami, N. Sharon, and K.R. Franzenburg are employees and shareholders of Teva Pharmaceuticals. M. Suett is an employee and stockholder of Teva UK. J.M. Kane has been a consultant for or received honoraria from Alkermes, Boehringer Ingelheim, Cerevel, Click Therapuetics, HLS Therapuetics, Intra-Cellular Therapies, Janssen, Johnson & Johnson, Karuna Therapeutics, LB Pharmaceuticals, Lundbeck, Lyndra Therapeutics, Merck, Neurocrine Biosciences, Newron, Otsuka, Pierre Fabre, Reviva Pharmaceuticals, Roche, Saladax Biomedical, Sunovion, Takeda, and Teva Pharmaceuticals; has received grant support from Otsuka, Lundbeck, and Janssen and is a shareholder or option holder of Health Rhythms, Intracellular Therapies, LB Pharmaceuticals, Medincell, NW PharmaTech, North Shore Therapies and Vanguard Research Group.

: Qualified researchers may request access to patient-level data and related study documents, including the study protocol and statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient-level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

: Not applicable.

: Not applicable.

: The protocol and subsequent amendments were approved before the start of the study by independent ethics committees (IECs)/institutional review boards (IRBs) according to national or local regulations. IEC/IRB organizations and approval numbers for the study include the following: Western IRB (20180568), Western IRB and WCG (ICO1-18-072), Copernicus Group (20190551), and Republic of Bulgaria/Ethics Committee for Clinical Trials (KEMI/CT-0412). This study was conducted in full accordance with the International Council for Harmonisation Good Clinical Practice Consolidated Guideline (E6) and any applicable national and local laws and regulations.

: Participants provided informed consent or assent, as applicable, at screening, before any study-related procedures or assessments were performed.

: J.M.K., R.E., E.H., O.T., and N.S. conceived and designed the study. J.M.K., R.E., E.H., O.T., H.K., N.S., M.S., K.R.F., and C.U.C. acquired, analyzed, and interpreted the data. R.E., E.H., O.T., H.K., N.S., and C.U.C. verified the data. J.M.K., R.E., E.H., O.T., H.K., N.S., M.S., K.R.F., and C.U.C. accessed the data. J.M.K., R.E., E.H., O.T., H.K., N.S., M.S., K.R.F., and C.U.C. drafted the manuscript. J.M.K., R.E., E.H., O.T., H.K., N.S., M.S., K.R.F., and C.U.C. critically revised the manuscript for important intellectual content. N.S. did the statistical analysis. G.L.D. provided administrative, technical, or material support. J.M.K., R.E., E.H., O.T., H.K., N.S., M.S., K.R.F., and C.U.C. approved the final submitted version and agree to be accountable for the work.