2.4. Statistical Analysis
death
We assumed the subset of admitted patients with CSS attributes would have a very high mortality (80%) and, wishing to determine if anakinra use added to standard of care would be significantly impactful, we determined that a sample size of 32 participants (16 in each group) would provide an adequate power of 80% using a two-side alpha of 0.05 to detect a clinically relevant reduction in mortality of 60% between the two groups. The primary efficacy analysis was conducted on a modified intention-to-treat basis and was defined as all patients who underwent randomization and received either anakinra or placebo before intubation/mechanical ventilation or death. Descriptive statistics were used to characterize the participants. Continuous data were summarized by means and standard deviation (SD) or standard error of the mean (SEM, for the cytokine data) and analyzed by Student’s 