Vijapurapu, Ravi http://orcid.org/0000-0002-2472-5538
Kozor, Rebecca
Hughes, Derralynn A.
Woolfson, Peter
Jovanovic, Ana
Deegan, Patrick
Rusk, Rosemary
Figtree, Gemma A.
Tchan, Michel
Whalley, David
Kotecha, Dipak
Leyva, Francisco
Moon, James
Geberhiwot, Tarekegn
Steeds, Richard P.
Funding for this research was provided by:
Genzyme (GZ-2017-11698)
Shire (IIR-GBR-001662)
Article History
Received: 16 October 2018
Accepted: 11 May 2019
First Online: 31 May 2019
Ethics approval and consent to participate
: This study was granted ethical approval by the NHS Health Research Authority and local NHS Research Ethics Committee (Integrated Research Application System project code 224749, REC reference 17/WM/0421) and the Human Research Ethics Committee of the Northern Sydney Local Health District (HREC Reference: HREC/18/HAWKE/27). The study is registered on ClinicalTrials.gov (NCT03305250). The study protocol version 3.0 has been granted ethical approval by the above-mentioned regulatory bodies. Informed consent will be obtained in accordance with Good Clinical Practice guidelines, and all participants will be provided with a patient information sheet to review prior to consent.
: By providing informed consent for participation in this study, all participants agree to have study results published in clinical meetings and scientific journal articles. Data will be anonymised prior to analysis and publication.
: RK has received honoraria from Sanofi-Genzyme. DH has received honoraria from Shire, Sanofi-Genzyme and Amicus. The other authors declare that they have no competing interests.