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The MHRA gave approval for a clinical trial on 13 July 2018. The trial manager has given details to the Health Regulation Authority of each of the sites that will be included in the trial. Local site research and development departments will confirm their capacity and capability and the Oxford SITU will issue a green light to proceed before recruitment at each site can commence. Informed consent will be obtained from all study participants as detailed above.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable. This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research (PGfAR) Programme (Grant Reference Number RP-PG-0614-20011). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.","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":"246"}}