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Authors
Antza, Christina
Ottridge, Ryan
Patel, Smitaa
Slinn, Gemma
Tearne, Sarah
Nicholls, Matthew
Cooper, Brendan
Ali, Asad
Tahrani, Abd A. https://orcid.org/0000-0001-9037-1937
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Funding
Funding for this research was provided by:
National Institute for Health Research (CS-2013-13-029)
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Article History
Received: 1 September 2020
Accepted: 9 March 2021
First Online: 22 March 2021
Declarations
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: National Research Ethics Committee West Midlands – The Black Country, reference 18/WM/0070.The conduct of the study will be in accordance with the principles of Good Clinical Practice. The participant’s written informed consent to participate in the study will be obtained before any procedures relating to the study are undertaken and after a full explanation has been given of the study, the treatment options, and the manner of treatment allocation and randomisation. Two Participant Information Sheets (PIS) will be provided to facilitate this process, one for the study as a whole, and one for the RCT. They will also stress that participation is voluntary and that the participant is free to refuse to take part and may withdraw from the study at any time. The participant will be given sufficient time to read the PIS and to discuss their participation with others outside of the site research team. The participant will be given the opportunity to ask questions prior to signing and dating the latest version of the consent form.
: Not applicable.
: The authors declare that they have no competing interests.
