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Article History

Received: 3 October 2018

Accepted: 24 January 2019

First Online: 13 February 2019

Ethics approval and consent to participate

: The patient information leaflet and informed consent documents were developed in the Trial Coordinating Centre, based in the Clinical Research Facility, Cork and approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals, (ref ECM 3 O’Mahony SENATOR 08122015). These were then translated by Site Investigators, modified as needed to meet local requirements and submitted, reviewed and approved by the local ethics committees as follows:Research Ethics Committee, Aberdeen, Scotland; R<i>EC Ref:</i> 14<i>/SS/0052.</i>Comitato Ethics Azienda Ospedaliers-Universitaria Ospedali Riuniti, Italy. Ref <i>214,297, 10,342 ARS/ARS/P.</i>Universitair Ziekenhuis, Gent Belgium. Ref: <i>B670201316481.</i>Comité Etico de Investigacion Clinica de Hospital Ramon y Cajal, Madrid, Spain. Ref: 382/12.Research Ethics Committee Reykjavík, Iceland R<i>ef: VSNb2013030007/03.11.</i>Written informed consent will be obtained by trial study staff from all participants or authorized surrogates as per local legislation and ethics committee approval. Potential participants were identified, reviewed with their clinical team and provided with study documentation. Any questions were answered and informed written consent was obtained.

: Not Applicable.

: The authors declare that they have no competing interests.

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