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Bethesda MD: National Library of Medicine (US); Last updated March 21, 2022."}],"container-title":["Clinical Pharmacokinetics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-022-01155-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40262-022-01155-w\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-022-01155-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,2]],"date-time":"2022-09-02T23:51:03Z","timestamp":1662162663000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40262-022-01155-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,23]]},"references-count":45,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2022,9]]}},"alternative-id":["1155"],"URL":"https:\/\/doi.org\/10.1007\/s40262-022-01155-w","relation":{},"ISSN":["0312-5963","1179-1926"],"issn-type":[{"value":"0312-5963","type":"print"},{"value":"1179-1926","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,23]]},"assertion":[{"value":"30 June 2022","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 July 2022","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Jeffrey Wald, Ethan Hoffmann, Haihong Li, and Helen Colquhoun are employees of Sage Therapeutics, Inc., and hold stock and\/or stock options. Kristina Deligiannidis serves as a consultant to Sage Therapeutics, Inc., and reports grants awarded to Zucker Hillside Hospital\/Feinstein Institutes for Medical Research during the conduct of the brexanolone injection and zuranolone clinical trials. Anja Henningsson and Eva Hanze are employees at qPharmetra LLC and serve as consultants to Sage Therapeutics, Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All clinical studies described herein have been approved by the appropriate Ethics Committees of each participating center and have been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All study participants provided written informed consent prior to participation in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets generated and\/or analyzed during the current study are not publicly available because participants in this study did not agree for their data to be shared publicly.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors participated in the interpretation of the study results and in the drafting, critical revision, and approval of the final version of the manuscript. Study design, data collection, and data analyses: JW, AH, EHa, EHo, HL, HC, and KMD. Study monitoring: EHo and HC.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}},{"value":"This study was funded by Sage Therapeutics, Inc.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}}]}}