Study endpoints

The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke, as positively adjudicated by the clinical endpoint committee. Each component of the primary composite endpoint was also reported. The secondary endpoints were the times from randomization to (i) the composite of the primary endpoint, hospital admission for acute coronary syndrome (with ECG abnormalities), or unanticipated coronary revascularization; and (ii) the composite of the primary endpoint or hospital admission for new or worsening heart failure (see Supplementary material online, Table S4). Exploratory endpoints included changes from baseline to 6 months in blood levels of lipid subfractions and high-sensitivity C-reactive protein. Treatment safety, including effects on diabetes, was evaluated through the assessment of adverse events and laboratory measurements.