Screening, randomisation and consent
RECRUITMENT
The CTU team regularly reviewed screening logs, which contained details about patient ineligibility criteria (i.e., met one or more exclusion criteria) or reasons for eligible patients not being recruited such as limited research capacity, missed patients, site being near or reached recruitment target and gastro-intestinal contra-indications to enteric medication).Randomisation of sites for SDD intervention was undertaken on week 5 by the trial statistician using computer-based randomisation. Sites were later informed of the outcome on week 8.