Thirion, Pierre G.
Dunne, Mary T. http://orcid.org/0000-0002-3723-6311
Kelly, Paul J.
Flavin, Aileen
O’Sullivan, Joe M.
Hacking, Dayle
Sasiadek, Wojciech
Small, Cormac
Pomeroy, Maeve M.
Martin, Joseph
McArdle, Orla
Parker, Imelda
O’Sullivan, Lydia S.
Shannon, Aoife M.
Clayton-Lea, Angela
Collins, Conor D.
Stevenson, Michael R.
Alvarez-Iglesias, Alberto
Armstrong, John G.
Moriarty, Michael
Article History
Received: 22 January 2019
Revised: 12 November 2019
Accepted: 13 November 2019
First Online: 11 March 2020
Ethics approval and consent to participate
: Subjects provided their informed consent to participate. ICORG 05-03 was a ICH—Good Clinical Practice (GCP) compliant prospective non-inferiority Phase 3 trial, performed in accordance with the Declaration of Helsinki and with the approval of St. Luke’s Hospital Ethics and Medical Research Committee, the Clinical REC of The Cork Teaching Hospitals, Office for RECs Northern Ireland, REC HSE South Eastern Area and Clinical REC Merlin Park Hospital Galway.
: Not applicable.
: Data supporting the results reported in this article can be requested from Cancer Trials Ireland.
: The authors declare no competing interests.
: Funding was received from St. Luke’s Institute of Cancer Research, under Grant S056, and the Health Research Board, under Grant CCT/06/10. The funding sources had no involvement in study design or conduct; in the collection, management, analysis and interpretation of data; preparation, review or approval of the paper; in the decision to submit the paper for publication.