Statistical analysis A sample size of 104 participants was planned to give 90% power to detect a 5% difference in 24-week rate of change in FVC between treatment groups at a two-tailed significance level of 5%. We originally planned to aim for 10% over-recruitment to account for patient dropouts before week 24; however, because of the COVID-19 pandemic and an anticipated prolonged interruption to recruitment, study enrolment was halted in March, 2020, after randomisation of 101 participants.
