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Earley, Suresh Durgam, Changzheng Chen, and Raffaele Migliore are full-time employees of Intra-Cellular Therapies, a Johnson & Johnson company. Susan G. Kozauer is a former employee of Intra-Cellular Therapies, a Johnson & Johnson company. Christoph U. Correll has been a consultant and\/or advisor to or has received honoraria from: AbbVie, Alkermes, Allergan, Angelini, Aristo, Autobahn, Axsome, Boehringer Ingelheim, Bristol Myers Squibb, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Darnytsia, Delpor, Denovo, Draig, Eli Lilly, EuMentis Therapeutics, Gedeon Richter, GH Research, Hetero, Hikma, Holmusk, Intra-Cellular Therapies, Jamjoom Pharma, Janssen\/Johnson & Johnson, Karuna, LB Pharma, Lundbeck, Medincell, MedLink Global, Merck, Mindpax, Mitsubishi Tanabe Pharmaceuticals, MapLight, Mylan, Neumora Therapeutics, Neuraxpharm, Neurocrine, Neurelis, Neurosterix, NeuShen, Neusignal Therapeutics, Newron, Noven, Novo Nordisk, Orion Pharma, Otsuka, PPD Biotech, Recognify Life Sciences, Recordati, Relmada, Response Pharmaceuticals, Reviva, Rovi, Saladax, Sanofi, Seqirus, Servier, Sumitomo Pharma America, Sunovion, Sun Pharma, Supernus, Tabuk, Takeda, Teva, Terran, Tolmar, Vertex, Viatris, and Xenon Pharmaceuticals. He provided expert testimony for Janssen, Lundbeck, Neurocrine, and Otsuka. He served on a data safety monitoring board for Compass Pathways, Intra-Cellular Therapies, Relmada, Reviva, and Rovi. He has received grant support from Boehringer Ingelheim, Janssen, and Takeda. He received royalties from UpToDate and is also a stock option holder or stockholder in Cardio Diagnostics, Kuleon Biosciences, LB Pharmaceuticals, MedLink Global, Mindpax, Quantic, and Terran.","order":1,"name":"Ethics","label":"Conflict of Interest\/Competing Interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The studies were approved by the appropriate institutional review board (IRB)\/independent ethics committee (Study 501: IRB Protocol #20213126; Study 502: IRB Protocol #20214571). The protocols were initially approved by the central IRB (WCG, Cary, NC, USA) in the USA. In addition, local ethics committees approved them in individual countries. The studies were performed in accordance with the Declaration of Helsinki and in compliance with Good Clinical Practice guidelines.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Written informed consent was obtained from each patient before entering the studies.","order":3,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Data will be made available on reasonable request, subject to review and meeting criteria.","order":5,"name":"Ethics","label":"Availability of Data and Material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":6,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"WRE, SD, SGK, CC, and RM participated in the study design and study conduct. All authors participated in data analysis\/interpretation and writing\/critical review.","order":7,"name":"Ethics","label":"Authors\u2019 Contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}