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Article History

Received: 24 October 2018

Accepted: 8 May 2019

First Online: 22 May 2019

Ethics approval and consent to participate

: Ethics approval was received from the National Research Ethics Service (reference number 11/NE/0342) and NHS research and development (R&D) approval was secured prior to commencement of the study. Local NHS approvals were secured before recruitment commenced at each site. The Newcastle Clinical Trials Unit, in its capacity as study co-ordination centre, obtained a written copy of local approval documentation before initiating each centre and accepting participants into the study. Informed consent was obtained from participants, either written or oral; if a potential participant had the capacity to consent for him/herself, but was unable to provide written consent because of visual or motor impairments, or literacy problems, oral informed consent was taken in the presence of an independent witness, who initialled, signed and dated the consent form on the participant’s behalf.

: Not applicable.

: LV and AF received competitive peer reviewed funding from the NIHR HTA programme (reference 10/82/01) for the research reported in this paper. AC was funded from the aforementioned grant. NM has no conflicts of interest.

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