Data analysis and progression criteria
RECRUITMENT
Consent rates, recruitment rates, attrition, missing data rates and intervention fidelity were reported as proportions with 95% CIs presented for consent and recruitment rates. The analysis of clinical outcome measures was descriptive, reported as means and SD or medians and IQR and numbers and percentages for binary and categorical variables. No formal statistical testing was undertaken.A ‘traffic light’ system was used as a guide for progression to a definitive trial.