Figure 1. Patient Disposition and Outcomes.

^aThese 3 patients were randomized in error because they did not meet all of the eligibility criteria.

^bThe primary analysis set included randomized patients who received canakinumab or placebo and had at least 1 assessment of clinical status between days 3 and 29.

^cThe full analysis set included all randomized patients.

^dThe safety analysis set included all patients who received canakinumab or placebo.