Received: 8 March 2021
Accepted: 1 September 2021
First Online: 30 September 2021
: The study was approved by South West 4 Research Ethics Committee (10/HO102/51) and was performed in accordance with the Declaration of Helsinki. The National Information Governance Board approved the use of routinely-collected patient data without specific consent and North Bristol NHS Trust acted as Sponsor. The database was anonymised by removal of all patient identifiers before being released for statistical analysis, and data collection forms were destroyed. Data entered onto the web-based system was encrypted and uploaded into a central study database. Staff other than central study managers could only access their own centre’s data through the web interface, and access to interim downloads of the central database was restricted to central data management staff.
: Not applicable.
: None of the authors have anything to disclose.