Gaughran, Fiona
Stringer, Dominic
Berk, Michael
Smith, Shubulade
Taylor, David
Whiskey, Eromona
Landau, Sabine
Murray, Robin
McGuire, Philip
Gardner-Sood, Poonam
Wojewodka, Gabriella
Ciufolini, Simone
Jordan, Harriet
Clarke, Jessie
Allen, Lauren
Krivoy, Amir
Stubbs, Brendon
Lowe, Philippa
Arbuthnott, Maurice
Rathod, Shanaya
Boardman, Andrew
Firdosi, Mudasir
McGrath, John J.
Funding for this research was provided by:
Stanley Medical Research Institute (13T-006)
Article History
Received: 27 March 2019
Accepted: 26 September 2019
First Online: 6 January 2020
Ethics approval and consent to participate
: This protocol and related documents have been approved centrally by the National Research Ethics Committee, London Dulwich (reference 14/LO/1588), and has received clinical trial authorisation from the MHRA (reference 14523/0261/001–004). It has also been approved by the HRA (reference IRAS 147978). Substantial amendments will be sent to the research ethics committee and the HRA, and MHRA if applicable. Non-substantial amendments will be communicated to the HRA and the research ethics committee, and to the MHRA if applicable. Local approvals will be obtained at study sites prior to starting recruitment. Participants will be notified of any amendments that may affect their decision to continue in the study and will be asked to re-consent to an updated informed consent form.An ICH-GCP trained clinician (research nurse, doctor or allied health professional) will be responsible for obtaining written informed consent from all trial participants prior to baseline assessment.
: Not applicable.
: FG has received honoraria for advisory work and lectures, has received support for Continuing Medical Education (CME) activities in the last 3 years from Lundbeck, Otsaka and Sunovion, is a collaborator on an NHS Innovations project co-funded by Janssen and has a family member with professional links to Lilly and GSK, including shares. RM has received honoraria for lectures from Lundbeck, Janssen and Sunovion. SR has received honoraria for lectures from Lundbeck. All other authors declare that they have no competing interests.