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EF\/her institution reports grants from Avant Research Foundation, Brain Foundation Australia, Clive and Vera Ramaciotti Foundation (Ramaciotti Health Investment Grant), GPCE, LivaNova (Australia and USA); Lundbeck (Australia); Monash Partners STAR Clinician Fellowship, Monash University Early Career Postdoctoral Fellowship, National Health and Medical Research Council Investigator Grant, Royal Australasian College of Physicians Fellows Research Establishment Fellowship, Sylvia and Charles Viertel Charitable Foundation Clinical Investigator Award, and UCB, outside the submitted work. LM reports no disclosures. JG reports no disclosures. AN is a consultant of ES Therapeutics. TOB reports NHMRC Program Grant (#APP1091593), grants from UCB Pharma, grants from Eisai Pharma, grants and personal fees from Zynerba Pharmaceuticals, and grants from Biogen, outside the submitted work.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"These will be available upon reasonable request by the corresponding author.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Materials"}},{"value":"The clinical trial was conducted in Australia in full compliance with the regulatory regulations of the Therapeutic Goods Agency. Before initiating the clinical trial on January 20, 2020, it was registered on ANZCTR (ACTRN 12691001591145p) on November 19, 2019, and approved by the Human Research Ethics Committee (HREC) of the Alfred Hospital in Melbourne on November 30, 2010.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"RN: conceptualization, methodology, formal analyses, writing original draft of the protocol, project management, writing original paper. ECF: project administration, writing-review and editing, reviewing subject data collected. LM: Interpreting data, especially EEG, review of safety data. JG: collected and monitored subject samples and data. AN: developed bioinformatics, analysed data, contribute to writing and editing original draft. TO: principal investigator, methodology, data safety review committee, protocol development and review, review of original draft","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}},{"value":"All authors provide this content.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"Informed consent was obtained from all participants prior to commencing interviews.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}}]}}