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Article History

Received: 8 May 2021

Accepted: 29 January 2022

First Online: 2 March 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) and the NHS Research Governance Framework for Health and Social Care (Version 2, April 2005). The study was approved by the UK Medicines and Healthcare Regulatory Agency (Ref: CTA 21268/0224/001-0001 – EUDRACT 2019-003571-19 – Protocol Number RBH2019/001) on 08 April 2020, in compliance with the European Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004 and its subsequent amendments. The study was provided with ethical approval by the London Brent Research Ethics Committee (Ref: 20/LO/0368) on 21 May 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 (Additional files and ) and after the patient has had the opportunity to consider whether to join the study.

: Not applicable

: The authors declare that they have no competing interests relating to this trial.