Document is current

Article History

Received: 30 May 2025

Accepted: 5 October 2025

First Online: 21 November 2025

Declarations

:

: Dr. Kane has been a consultant for or received honoraria from Alkermes, Allergan, Boehringer-Ingelheim, Cerevel, Dainippon Sumitomo, H. Lundbeck, HealthRhythms, HLS Therapeutics, Indivior, Intracellular Therapies, Janssen Pharmaceutical, Johnson & Johnson, Karuna Therapeutics/Bristol Meyer-Squibb, LB Pharmaceuticals, Mapi, Maplight, Merck, Minerva, Neurocrine, Newron, Novartis, NW PharmaTech, Otsuka, Roche, Saladax, Sunovion, and Teva Pharmaceuticals; has served on advisory boards for AbbVie, Alkermes, Boehringer-Ingelheim, Cerevel, Click Therapeutics, Karuna/BMS, Lundbeck, Merck, Newron, Novartis, Otsuka, Sumitomo, Terran, and Teva Pharmaceuticals; has received grant support from H. Lundbeck, Janssen Pharmaceutical, Otsuka, and Sunovion; and is a shareholder of HealthRhythms (private/stock options), LB Pharmaceuticals, Inc. (private/stock options), Medincell, North Shore Therapeutics (private/stock), Vanguard Research Group (private/40% owner), NW Pharmatech (private/stock options), Saladax (private/stock options), Reviva (stock options), and Terran (private/stock options). Ms. Tohami, Dr. Franzenburg, Mr. Sharon, Dr. Merenlender-Wagner, Dr. Eshet, and Dr. Harary are employees and shareholders of Teva Pharmaceutical Industries Ltd. Dr. Suett is an employee and shareholder of Teva UK Limited. Dr. Correll has been a consultant for or has received honoraria from AbbVie, Acadia, Adock Ingram, Alkermes, Allergan, Angelini, Aristo, Biogen, Boehringer-Ingelheim, Bristol-Myers 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, MedLink, 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, Terran, Tolmar, Vertex, Viatris, and Xenon Pharmaceuticals. He provided expert testimony for Janssen, Lundbeck, and Otsuka. He served on a Data Safety Monitoring Board for Compass Pathways, Denovo, IntraCellular Therapies, Lundbeck, Relmada, Reviva, Rovi, Supernus, and Teva. He has received grant support from Boehringer-Ingelheim, Janssen, and Takeda. He received royalties from UpToDate and is also a stock option holder of Cardio Diagnostics, Kuleon Biosciences, LB Pharma, Medlink, Mindpax, Quantic, and Terran.

: 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.

: 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), including compliance with the ethical principles in the Declaration of Helsinki 1964 and its later amendments, and any applicable national and local laws and regulations.

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

: Not applicable.

: Not applicable.

: J.M.K., O.T., N.S., R.E., and E.H. conceived and designed the study. J.M.K., O.T., N.S., A.M-W., R.E., E.H., M.S., K.R.F., and C.U.C. acquired, analyzed, and interpreted the data. O.T., N.S., R.E., E.H., and C.U.C. verified the data. J.M.K., O.T., N.S., R.E., E.H., M.S., K.R.F., and C.U.C. accessed the data. J.M.K., O.T., N.S., R.E., E.H., M.S., K.R.F., and C.U.C. drafted the manuscript. J.M.K., O.T., N.S., A.M-W., R.E., E.H, M.S., K.R.F., and C.U.C. critically revised the manuscript for important intellectual content. N.S. did the statistical analysis. J.M.K., O.T., N.S., A.M-W., R.E., E.H., M.S., K.R.F., and C.U.C. approved the final submitted version and agree to be accountable for the work.