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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>Comit\u00e9 Etico de Investigacion Clinica de Hospital Ramon y Cajal, Madrid, Spain. Ref: 382\/12.Research Ethics Committee Reykjav\u00edk, 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.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not Applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"40"}}