Green, Laura http://orcid.org/0000-0003-4063-9768
Roberts, Neil
Cooper, Jackie
Field, Jane
Gill, Ravi
Klein, Andrew
Agarwal, Seema
Stanworth, Simon
Johnston, Atholl
Monk, Vivienne
O’Brien, Ben
Funding for this research was provided by:
British Heart Foundation (33368)
Article History
Received: 7 May 2019
Accepted: 26 September 2019
First Online: 9 December 2019
Ethics approval and consent to participate
: The trial was granted clinical trial authorisation by the Medicines and Healthcare products Regulatory Authority (MHRA) and has received NHS research ethics approval from the London – Fulham Research Ethics Committee (18/LO/1726) and Health Research Authority approval (IRAS no. 250632<i>)</i>. All subjects participating in the trial will provide written informed consent.
: All relevant data from this study will be submitted to peer-reviewed journals for publication following the termination of the study and in line with sponsor trust publication policy. Data will be captured for all study participants, and no patient identifiable data will be used in any publications. The sponsor retains the right to review all publications prior to submission or publication. Responsibility for ensuring accuracy of any publication from this study is delegated to the CI.
: The authors declare that they do not have any competing interests, apart from SA, who has previously completed consultancy work for Octapharma. Information regarding financial and competing interests will be collected and documented over the duration of the study.