Grossi, Ugo http://orcid.org/0000-0001-5372-2873
,
Stevens, Natasha
McAlees, Eleanor
Lacy-Colson, Jon
Brown, Steven
Dixon, Anthony
Di Tanna, Gian Luca
Scott, S. Mark
Norton, Christine
Marlin, Nadine
Mason, James
Knowles, Charles H.
Funding for this research was provided by:
National Institute for Health Research (RP-PG-0612-20001)
Article History
Received: 9 November 2016
Accepted: 30 December 2017
First Online: 5 February 2018
Ethics approval and consent to participate
: • Trial Registration: ISRCTN registry; registration number: 11747152.• Research Ethics Committee (REC): London – City and East; REC reference number: 15/LO/0609. There is one main ethical review for all participating sites.• Date of favourable ethical opinion: 6 July 2015.• Substantial amendment date of favourable ethical opinion: 14 March 2016.• Informed consent procedures: written informed consent will be obtained from research participants at visit 1 by an appropriately trained and delegated researcher. This will be done in a face-to-face setting in the clinic or private research environment.
: Not applicable.
: The authors declare that they have no competing of interests.
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