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Article History

Received: 21 March 2019

Accepted: 15 May 2019

First Online: 30 May 2019

Ethics approval and consent to participate

: Ethical committee procedures have been followed in all study sites involved. The names of the review board and the references are:Rijeka, Croatia: The Ethical Committee - Faculty of Medicine University of Rijeka; approval on 10/01/2018; study number 21 T0–24–01-1 8_05.Treviso, Italy: Comitato Etico per la Sperimentazione Clinica delle Province di Treviso e Belluno, CESC; approval on 24/05/2018; study number 0104375.Rotterdam, the Netherlands: The research proposal regarding the study site in the Netherlands was reviewed by the Medical Ethics Committee of the Erasmus Medical Center, Rotterdam. Based on their review, the Committee concluded that the rules laid down in the Dutch Medical Research Involving Human Subjects Act (also known by the Dutch abbreviation WMO, in full ‘Wet Medisch-wetenschappelijk Onderzoek met mensen’) do not apply to this research proposal (proposal number MEC-2018-1047), and gave permission to conduct this study at Erasmus Medical Center and to submit the results for publication in a scientific journal in the future (Letter NL/sl/MEC-2018-1047; 15/02/2018).Camborne, the United Kingdom: The results page from the HRA decision tool of the NHS Health Research Authority states there is not a need for NHS Research Ethics Committee (NHS REC) approval for sites in England regarding this study; followed by e-mail of the Health Research Authority, London, UK on 16/04/2019 (Queries Line REF 81/81) saying: “… The results obtained from the HRA’s decision tools can be taken as an authoritative decision and are line with: The harmonised UK-wide edition of the Governance Arrangements for Research Ethics Committees (GAfREC) 2018; UK Policy Framework for Health and Social Care Research (2017); The National Research Ethics Service (NRES) <i>Defining Research</i> table and the algorithm <i>Does my project require review by a Research Ethics Committee? …</i>”<i>,</i> and that “<i>…</i> it may be provided to a journal or other body as evidence if required. …”.Written consent will be obtained from all participants.

: Not applicable.

: The authors declare that they have no competing interests.

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