Acknowledgements
The COMFORT trial authors would like to acknowledge the help and support offered to it by the MMUH DPO, Mr Ronan O’Halloran, and the UCD DPO, Ms Ulrike Kolch. The authors would also like to acknowledge the assistance provided by Miss Brenda Molloy and Miss Sahar Hawamdeh, research support staff in the UCD CRC, in the setup of the REDcap database.