Study progression criteria
RECRUITMENT
This study will include an internal recruitment pilot phase with stop-go recruitment milestone criteria to mitigate risk to the funder. This internal pilot will be used to confirm recruitment rates and aims to recruit the first 400 participants (almost one-fifth of the sample size) from 10 sites by the end of study month 13. By the end of study month 13, the aim is to have 400 participants (18%) enrolled with an average recruitment rate/site/month of at least five participants in the best 60% of sites, with at least 10 sites open (Internal recruitment pilot study progression criteria*Sites recruitment rate will be calculated from site opening date.If by the end of study month 19, overall recruitment is less than 1300 participants (58%), OR average recruitment rate/site/month is less than 6 participants in the best 60% of sites, OR there are less than 20 sites recruiting, we will further expand the number of NHS sites recruiting. We will also consider whether study extension is required.