Data monitoring and quality assurance
RECRUITMENT
The trial was coordinated by the TMG. A TSC was also established to oversee conduct and progress of the trial. The TSC met via teleconference prior to commencement of the study, after ethics approval, and every six months thereafter to assess study conduct and recruitment. Formal data monitoring was performed by a Data Safety Monitoring Committee (DSMC). The members of the DSMC were independent from the sponsor and investigators. The DSMC met via teleconference every four months to review accumulating data relating to harms and the primary outcome and advise the TSC whether the trial should be modified or discontinued.