Gifford, Fiona J.
Dunne, Philip D. J.
Weir, Graeme
Ireland, Hamish
Graham, Catriona
Tuck, Sharon
Hayes, Peter C.
Fallowfield, Jonathan A. http://orcid.org/0000-0002-5741-1471
Funding for this research was provided by:
Novartis Pharmaceuticals UK Limited (CRLX030C2202T)
Article History
Received: 21 August 2019
Accepted: 24 February 2020
First Online: 12 March 2020
Ethics approval and consent to participate
: The clinical trial was conducted according to the ethical principles of the Declaration of Helsinki 2013 and following approval from the West of Scotland Research Ethics Committee 1 (Ref: 16/WS/0070), NHS Lothian Research and Development department and the Medicine and Health Care Regulatory Agency (MHRA-UK, CTA number: 01384/0250/001-0001). The trial was registered in the European Clinical Trial Database (EudraCT Ref: 2015-000963-15). All participants gave written informed consent.
: All participants gave written permission for publication of de-identified study data.
: JAF reports personal fees from Ferring Pharmaceuticals, Novartis, Galecto Biotech, Caldan Therapeutics, Gilde Healthcare, Arix Bioscience and NorthSea Therapeutics, and grants from GlaxoSmithKline and Intercept Pharmaceuticals, outside the submitted work. PCH is an advisor for AbbVie, BMS, Eisai Ltd, Falk, Ferring, Gilead, Gore, Janssen, Lundbeck, MSD, Norgine, Novartis, ONO Pharmaceuticals, Pfizer and Roche, outside the submitted work. The remaining authors declare that they have no competing interests.