Bonnett, Laura J.
Spain, Thomas
Hunt, Alexandra
Hutton, Jane L.
Watson, Victoria
Marson, Anthony G.
Blakey, John
Funding for this research was provided by:
National Institute for Health and Care Research (PDF-2015-08-044)
Academy of Medical Sciences (SBF008\1060)
Article History
Received: 28 July 2024
Accepted: 5 March 2025
First Online: 17 March 2025
Declarations
:
: The OPCRD was approved by the Trent Multi-Centre Research Ethics Committee for clinical research use. This study protocol was approved by the OPCRD’s Anonymised Data Ethics Protocols and Transparency Committee. There was no direct patient and public involvement (PPI) in this study, but the OPCRD was developed with PPI and is updated by a committee that includes patient representatives.SANAD received appropriate multicentre and local ethics and research committee approvals from the National Multi-Centre Research Ethics Committee North West (MREC 98/8/62) and was managed according to the Medical Research Council’s Good Clinical Practice Guidelines. Patients gave informed written consent to inclusion and to long-term follow-up. In the case of children (< 16 years), consent was obtained from the parent or guardian.SANAD is registered as an International Standard Randomised Controlled Trial, number ISRCTN38354748, registration date 25th April 2003.
: Not applicable.
: The authors declare no competing interests.