Document is current

Article History

Received: 4 February 2019

Accepted: 27 March 2019

First Online: 24 May 2019

Ethics approval and consent to participate

: This project received full approval from the North East - Newcastle & North Tyneside 1 Research Ethics Committee on 17th November 2017 (REC reference number 17/NE/0329). Recruitment will not begin at centres until both ethical and local R&D approvals are obtained. Written informed consent will be obtained from all study participants. Any modifications to the protocol which may impact on the conduct of the study, potential benefit of the of the patient or may affect patient safety, including changes in study objectives, study design, patient population sample size, study procedures or significant administrative aspects will require a formal amendment to protocol. Such amendment will be agreed by the Sponsor, CI, and funder and approved by the North East - Newcastle & North Tyneside 1 Research Ethics Committee prior to implementation and notified to health authorities in accordance with local regulations. The trial will be conducted according to the principles of good clinical practice provided by Research Governance Guidelines. We believe this study does not pose any specific risks to individual participants, nor does it raise any extraordinary ethical issues.

: Not applicable.

: Iain Pretty receives funding from the Colgate Palmolive company in the form of an academic grant. All other authors declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

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