Criteria | Target |
---|---|
Number of sites open to recruitment | 7 |
Ratio of patients consented/eligible | ≥ 20% |
Number of participants randomised | ≥ 50 |
Compliance with intervention | Subjective, percentage of non-compliers to be considered |
Loss to follow-up | ≤ 30% |
Safety | Subjective, all adverse events and serious adverse events considered |