Protocol deviations
There were 263 protocol deviations due to missing a study assessment (96, 37%); COVID-19 pandemic related factors resulting in assessments out of window (67, 25%); assessment out of window for other reasons (46, 17%); scheduling of the whole visit out of window (36, 14%); other reason (wrong stratification, incorrect randomisation number, missing data, IMP dispensing, incorrect eligibility assessment) (18, 7%).