Article History
Received: 9 April 2018
Accepted: 7 September 2018
First Online: 21 September 2018
Ethics approval and consent to participate
: The trial received full ethical approval from Health Research Authority England on 23 October 2017, registration number 198415. The study was also approved by Northumbria Healthcare NHS Foundation Trust. Any modifications to the protocol will be submitted for further ethical approval and approved changes will be documented on the ClinicalTrials.gov registry. The trial will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, 1996; the principles of Good Clinical Practice, and the Department of Health Research Governance Framework for Health and Social Care, 2005. Written informed consent will be obtained from all participants in the trial. Copies of the consent forms will be kept in the trial site files and the patients’ medical notes. Participants will be free to withdraw from the study at any time without giving a reason. All the information collected during this trial will be confidential and held in accordance with NHS Data Protection guidelines and Good Clinical Practice guidelines. Confidentiality will only be breached if patients disclose to us information that may indicate that there is a risk of harm to themselves or others.
: Not applicable.
: The authors declare that they have no competing interests.
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