Comparison of the hyperinsulinemic normoglycemia (HN) and standard therapy group on the composite outcome of any major morbidity/30-day mortality and individual components of the composite outcome at combined sites (A) and within individual sites (B). Interaction P value (treatment-by-site) = 0.063. CIs adjusted for group sequential design (using confidence coefficient of 2.633) to maintain overall study α of 0.05 for combined sites and confidence coefficient of 2.86 within sites. P values for combined sites: significant if P < 0.0085 for efficacy (with 99.15% CI); P values for each site: significant if P < 0.0042 for efficacy (with 99.58% CI); P values for each component: significant if P < 0.0042/5 = 0.00084 (with 99.92% CI) using Bonferroni correction.