Trial, ethical and governance oversight
The trial has been reviewed and approved by the South-East Scotland Research Ethics Committee (19/SS/0040). The University of Edinburgh and NHS Lothian are co-sponsoring the trial and will provide monitoring oversight. The co-sponsors do not have any role in the design of the study or collection, analysis, and interpretation of data and in writing of the manuscript. All amendments to the protocol are reviewed by the co-sponsor and site Research & Development Departments before they are added to the investigator site file. All deviations are documented in a sponsor-approved deviation log held at sites. The Edinburgh Clinical Trials Unit will manage the trial and provide oversight of the data collection and statistical analysis. A trial steering committee, data monitoring committee and project management group have been established to oversee the conduct, progress and safety of the trial. The trial steering committee and data monitoring committee meet on a 6 monthly basis whilst the project management group meet once a month. The funders of the study have no role in the study design, data collection, data management, data analysis, data interpretation, writing of the report or the decision to submit the report for publication.