Enrolment
PARIS 1 completed enrolment 18 months ahead of schedule – August 15th 2016.
Recruitment stats
- 1472 total recruitment
- 179 excluded (who met inclusion criteria)
- 77 ineligible
- 84 declined consent (prospective and delayed)
- 20 revoked
- 566 (26.6%) Total eligible, screened missed patients
Trial stopped fully on 15th August 2016
Adverse events – 2 x pneumothorax (one in each treatment arm)
NEWS:
Currently data has been cleaned and draft paper is being circulated prior to submitting to the NEJM
PARIS 2- pilot – just completed
PARIS 2 – RCT – just started