The primary end points were invasive cancer of any type and major cardiovascular events (composite of myocardial infarction, stroke, and death from cardiovascular causes). Secondary cancer end points were incident colorectal, breast, and prostate cancers, and death from cancer. Secondary cardiovascular end points were an expanded composite of major cardiovascular events plus coronary revascularization and the individual components of major cardiovascular events. Participants who reported an end-point event were asked to sign a release for medical records, which were reviewed for confirmation by an end-points committee of physicians who were unaware of the trial-group assignments. Cancer was confirmed on the basis of histologic or cytologic data.Myocardial infarction and stroke were confirmed with the use of established criteria coronary revascularization was confirmed by medical record review, and death from cardiovascular causes was confirmed if there was convincing evidence of a cardiovascular event from all available sources. Analyses included only confirmed end points