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Authors
Marian, Ioana R. https://orcid.org/0000-0002-0692-8112
Goff, Megan
Williams, Jennifer A. E.
Gulati, Malvika
Chester-Jones, Mae
Francis, Anne
Watson, Marion
Vincent, Tonia L.
Woollacott, Sue
Mackworth-Young, Charles
Glover, Victoria
Furniss, Dominic
Gardiner, Matthew
Lamb, Sarah E.
Vincent, Katy
Barber, Vicki S.
Black, Joanna
Dutton, Susan J.
Watt, Fiona E.
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Funding
Funding for this research was provided by:
National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme (PB-PG-0416-20023)
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Article History
Received: 28 July 2020
Accepted: 7 June 2021
First Online: 24 June 2021
Declarations
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: This is a feasibility study of a study medication used outside of its licensed indication. This study is not a Clinical Trial of an Investigational Medicinal Product as defined by the EU Directive 2001/20/EC, given that the outcomes are related to feasibility rather than efficacy. The MHRA confirmed that as currently designed this feasibility study did not fall under their remit.A favourable ethical opinion has been obtained from the North of Scotland Research Ethics Service on 08 October 2018 (UKREC 18/NS/0100). Health Research Authority approval was obtained on 18 October 2018. The study has already undergone full external peer review as part of the ethics approval and funding process.Written informed consent will be obtained from all participants prior to their participation in the study.
: Not applicable.
: The authors declare they have no competing interests.
