Data were analysed for the following populations: intention-to-treat (ITT): all randomised subjects; modified ITT (mITT): all randomised subjects who received at least one dose of study medication (this was also the Safety Analysis Set); and potential completer (PC): all subjects who were randomised ≥52 weeks prior to atacicept 150 mg arm termination.
Population Intention to treat population comprising 267 patients with a venous or mixed venous and arterial ulcers with at least 25% coverage of slough or necrotic tissue.
ITT population Intention-to-treat population, HAM-A Hamilton Anxiety Scale.
The primary outcome analysis is based on full analysis population, intention-to-treat principle and the per protocol population.
All analyses will be performed in the ITT-population (intention-to-treat). Instead of the patients, the GPs and their practices will be randomized into clusters.
The efficacy population ("intention-to-treat") consisted of all patients who received at least one dose of study medication, other than those patients coming from three study sites who, as previously described, 24 were excluded due to GCP non-compliance.
Analysing the full study population (intention-to-treat), the odds of getting pregnant in the test group were found to be 1.77 (95% CI: 0.9992, 3.1585) compared with the control group.
The data analysis will be carried out by personnel blinded to the treatment groups, and for two types of populations: (1) intention to treat (ITT), with all the patients randomized; (2) per protocol (PP), including only the patients with no more than slight variances from the protocol.
Two types of population will be analysed: (1) population per intention to treat (ITT), with all the patients randomised; (2) population per protocol (PP), including only the patients presenting minor differences from the protocol.
Analysis on this population was intention to treat.
The primary analysis population is intention to treat.
