Funding for this research was provided by:
EU 7th Framework Programme (FP7-KBBE-2012)
the New Zealand Health Research Council (14/191)
NHMRC-EU Collaborative Grant, Australia (NA)
Received: 14 October 2019
Accepted: 17 February 2020
First Online: 4 March 2020
Ethics approval and consent to participate
: The study was approved by local Human Ethics Committees at all study sites.Research Ethics Committees for the Capital Region of Denmark (no. 42656).Coordinating Ethics committee Helsinki and Uusimaa Hospital (Dnro171/13/03/2013).Medical ethical committee (METC) azM /University of Maastricht (NL43054.068.13/ METC 13–3-008).Health Research Authority, NRES Committee East Midlands – Leicester (13/EM/0259).University of Navarra Ethics Committee.Commission on Ethics in Scientific Research with the Medical University Sofia (KENIMUS) (4303/13.06.2014).The University of Sydney Human Research Ethics Committee (2013/535).Health and Disability Ethics Committees Auckland (13/NTB/41/AM06).All work was carried out in full compliance with the Declaration of Helsinki (59th WMA General Assembly, Seoul, Korea, October 2008), and the ICH-GCP, The International Conference on Harmonisation (ICH) for Good Clinical Practice. All participants provided written informed consent prior to screening procedures in clinic.
: Not applicable.
: The authors declare that they have no competing interests.