Study Design and Patients
This was a randomized double-blind placebo-controlled allocation-concealed clinical trial conducted at Mater Hospital Belfast, Northern Ireland. Trial management, statistical support, and data monitoring and management was facilitated by the Northern Ireland Clinical Trials Unit (NICTU). The trial was sponsored by Belfast Health and Social Care Trust and received approval from the Office of Research Ethics Committees Northern Ireland (Identifier: 18/NI/0106). Clinical trial authorization was granted by Medicines and Healthcare Products Regulatory Agency. The study safety data were monitored every 6 months by an independent data monitoring and ethics committee. The trial was registered prospectively on EudraCT 2017-004686-28 and 