Document is current

Article History

Received: 31 October 2017

Accepted: 14 March 2018

First Online: 17 April 2018

Ethics approval and consent to participate

: The study protocol has been conducted according to the Declaration of Helsinki and has been approved by the National Health Service (NHS) South East Coast-Surrey Research Ethics Committee (15/LO/2082). The study is registered as a current randomised controlled trial (ISRCTN45627165).The consent process will involve a full explanation of the study given by the person taking consent prior to any of the face-to-face screening processes commencing. The verbal consent is read prior to the beginning of the telephone screening interview. If the participant fails to give consent, then a telephone screen will not be done. If a participant provides verbal consent, then the assignment of a study ID number will be taken as positive evidence that initial consent was obtained. Following these discussions people who are willing to participate will be asked to complete, sign and date the written Study Consent Form which will also be signed and dated by the person obtaining consent. A copy of the signed Informed Consent Form (ICF) will be given to the participant. The original signed form will be retained in the relevant Investigator Site File (ISF).

: Not applicable.

: The authors declare that they have no competing interests.

: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.