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Article History

Received: 19 August 2020

Accepted: 22 September 2020

First Online: 9 October 2020

Ethics approval and consent to participate

: The study will be conducted in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions []. The project has received formal approval from the Regional Committees for Medical and Health Research Ethics, in Norway (2020/ 31837), and the Health Regulation Authority and NHS Research Ethics Committee approval, in the United Kingdom (19/SW/0210), and University of New South Wales Research Ethics Committee, in Australia (HC190440). Any amendments, e.g. changes to inclusion criteria or changes to the intervention protocol, will be submitted to the ethics committees of each participating country. The amendments will also be added to All participants will have capacity to give informed consent and will provide informed consent to study participation to one of the research nurses/researchers prior to any study-related activities. Capacity to give informed consent will be evaluated by the research nurses/researchers informing the person about the study and taking consent, in accordance with local regulations. This process will be recorded in the site file. Participants will be advised in the participant information sheets that they have the right to withdraw from the study at any time without giving reasons and without prejudice. We regard consent as an ongoing process and will check at each contact with research nurses/researchers (i.e. baseline, FU1 and FU2), that the person is willing to engage.The study may be subject to inspection and audit by the sponsor and other regulatory bodies to ensure adherence to Good Clinical Practice (GCP) and the current local Research Governance Framework for Health and Social Care.

: Not applicable.

: The authors declare that they have no competing interests.