Table 2 Internal progression criteria

Monthly recruitment rate (averaged over months 4–6 of internal pilot)

 ≥ 80% of the target of 28 pts/month:

 ≥ 22.4

50–80% of 28 pts/month:

14–22.4 pts/month

 < 50% of target of 28 pts/month:

 < 14 pts /month

Follow-up for 6-month primary outcome

 ≥ 80%

60–80%

 < 60%

Outcome of progression review

The study will continue and outcome data from participants in the internal pilot will be included in the main study analysis

A rescue plan will be developed and approved by the TSC before submission to the funder

The TSC will consider not progressing the internal pilot to the definitive study