Document is current

Article History

Received: 21 October 2018

Accepted: 6 May 2019

First Online: 3 July 2019

Ethics approval and consent to participate

: Ethical approval for this study was granted by the West of Scotland Research Ethics Service (17/WS/0192). The study is registered with ClinicalTrials.gov (). All study activities will be performed in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki, 1964, and subsequent revisions.Consent to participate in the study will be sought from patients only after a full explanation of the study has been given to them, they have been given an information leaflet and they have had sufficient time for consideration. Signed consent will be obtained from each participant. The right of any participant to refuse to participate without giving reasons will be respected. After the participant has entered the study, their clinicians may give them an alternative treatment to that specified in the protocol at any stage if they feel it is in the participant’s best interest, but the reasons for doing so will be recorded. In these cases, the participant will remain within the study for the follow-ups and data analysis. All participants are free to withdraw at any time from the protocol treatment without giving reasons and without prejudicing further treatment.

: The authors declare that they have no competing interests.