Figure 1.
Design of meta studies with two categories and interim analyses (IAs) for evaluating the CV risk. 1Interim analysis scheduled 2 years after the first subject enrolls in the CV study. Category 1 studies are complete at this time. 2If the upper limit of the 95% CI for the hazard ratio exceeds 1.8 in the first interim analysis, a second interim analysis is scheduled 1 year after the first interim analysis (3 years after the first subject enrolls). 3Time is relative to the start of the CV study. Randomization ratio: control vs treatment.