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Article History

Received: 16 February 2021

Accepted: 4 June 2021

First Online: 16 June 2021

Declarations

:

: This trial has been approved by the Stanmore Research Ethics Committee London (IRAS: 234354; REC: 20/LO/0839). The trial sponsor is Reza Razavi, Vice Principal (research), King’s College London,. All participants will be given a detailed PIS by a member of the research team, sign consent forms before commencement and have the option to stop involvement in the study at any time. All participants will be anonymised using unique trial identifiers which will be used for all of their data management and reporting. Only member of the research team will have access to the trial dataset.

: In the PIS it is outlined that anonymised data will be used in all analyses and that the results of the study will be reported on. An opportunity to discuss this will be provided to all participants as part of the consent process. Anonymised findings will be disseminated via conference presentations and peer-review journal articles.

: Ulrike Schmidt is supported by a National Institute of Health Research (NIHR) Senior Investigator Award and receives salary support from the NIHR Mental Health Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and King’s College London.