The study was conducted from January 2012 through November 2013. Of the 2120 patients who were screened, 905 underwent randomization, 901 received at least one dose of a study drug, and 800 (88.4%) completed 52 weeks of treatment (Fig. 1). Of the 901 patients who received a study drug, 111 received background lipid-lowering therapy with diet alone, 383 received 10 mg of atorvastatin daily, 218 received 80 mg of atorvastatin daily, and 189 received 80 mg of atorvastatin plus 10 mg of ezetimibe daily. Baseline demographic and clinical variables are shown in Table 1, and baseline lipid values in Table 2; baseline apolipoprotein and PCSK9 measures are shown in Tables S1 and S2 in the Supplementary Appendix. As would be anticipated, the prevalence of cardiovascular disease and of cardiovascular risk factors was higher in the groups receiving more intensive background lipid-lowering therapy (Table 1). The mean baseline levels of unbound (free) PCSK9 were lowest in the diet-alone group and increased progressively with the intensity of lipid-lowering therapy, as would be expected with statin treatment (Table S2 in the Supplementary Appendix).