Funding for this research was provided by:
Medical Research Council (MR/N019067/1)
Received: 7 January 2019
Accepted: 28 March 2019
First Online: 7 June 2019
: MZ is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre.
: Central ethical approval has been confirmed from the South Central—Oxford C Research Ethics Committee (ref approval no. 16/SC/0584, 06/12/2016) and we will not begin recruiting at other centres in the trial until local ethical approval has been obtained. The Research Ethics Committee and Health Research Authority will be notified about all substantial amendments to trial protocol and related documents. The MHRA, who are responsible for regulating medicines in the UK, have also reviewed this trial (MHRA Ref. 24551/0028/001-0001, 16/01/2017).The Informed Consent Form is approved by the REC and will be in compliance with Good Clinical Practice (GCP), local regulatory requirements and legal requirements. The investigator or designee will obtain written informed consent from each patient or the patient’s legally acceptable representative before any trial-specific activity is performed. A mental health advocate may assist the participant in understanding their rights in relation to taking part in the research, if requested.The investigator will retain the original of each patient’s signed Informed Consent Form.Any new information which becomes available which might affect the patient’s willingness to continue participating in the trial will be communicated to the patient as soon as possible.
: Not applicable.
: BL, KY, GT, RP, S-AV, MS, IC, AAH, PBJ, EJ, L-MY, FD, TK, ALH, TH, CB, and AC have no conflict of interest. In the last 3 years, TREB has been a member of scientific advisory boards for Otsuka/Lundbeck, Newron Pharmaceuticals and Gedeon Richter in relation to antipsychotic medication and has received speaker fees from Janssen. MZ has received honoraria for lecturing from Eisai.
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