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Article History

Received: 8 September 2021

Accepted: 23 December 2021

First Online: 17 January 2022

Declarations

:

: The study conduct will comply with all relevant laws of the EU and all relevant laws and statutes of the UK including, but not limited to, the Human Rights Act 1998, the Data Protection Act 1998, the Medicines Act 1968, the Medicines for Human Use (Clinical Trial) Regulations 2004, and with all relevant guidance relating to medicines and clinical studies from time to time in force including, but not limited to, the ICH GCP, the World Medical Association Declaration of Helsinki entitled ‘Ethical Principles for Medical Research Involving Human Patients’ (2008 Version), the NHS Research Governance Framework for Health and Social Care (Version 2, April 2005). In the UK, the study received ethical approval by the London South-East Research Ethics Committee (Ref: 19/LO/1606) on 15 January 2020 with protocol version 4.0 approved on 16 June 2021. The study protocol was approved by the French Ethics Committee (<i>Comité de Protection des Personnes Sud Mediterranee III</i>; approved on July 30, 2020, under number2019.12.06 ter_19.11.15.76132) and Medicine Agency (<i>Agence Nationale de Sécurité du Médicament</i>; approved on July 3, 2020, under number 2019-A02610-57-A). The study protocol was approved by the ethics committee of Medical University of Vienna, Austria (EC No. 2056/2019) on 28 April 2020. Consent to enter this study will be obtained after a full account has been provided of its nature, purpose, risks, burdens, and potential benefits, with verbal and written explanation and after the patient’s nominated consultee has had the opportunity to consider whether to join the study.

: Not applicable.

: JH is chief executive officer for Mermaid Care A/S who manufacture the Beacon Caresystem.SR and DK are minor shareholders and SR is a board member of Mermaid Care A/S who manufacture the Beacon Caresystem.