Grade 3/4 adverse events Minimum 24 weeks, maximum 100 weeks [clinicaltrials_resource:a94b0d4bb4374b7567af5573902f6b9c]

The primary analysis will be the difference in proportions ever experiencing one or more grade 3 or 4 adverse events (AEs) after substudy randomisation, with non-inferiority demonstrated if the upper limit of the 90% confidence interval around the risk difference(Group 2 - Group 1) lies below +20%.

Grade 3/4 adverse events Minimum 24 weeks, maximum 100 weeks [clinicaltrials_resource:a94b0d4bb4374b7567af5573902f6b9c]

The primary analysis will be the difference in proportions ever experiencing one or more grade 3 or 4 adverse events (AEs) after substudy randomisation, with non-inferiority demonstrated if the upper limit of the 90% confidence interval around the risk difference(Group 2 - Group 1) lies below +20%.