The primary efficacy endpoint was time to first occurrence
of any event from the composite endpoint consisting of death
from vascular causes, MI, or stroke. Secondary efficacy
endpoints were individual events of MI, stroke, death from
vascular causes, and death from any cause. The primary
safety endpoint was time to first occurrence of major
bleeding, defined by the study criteria. In addition, bleeding
events defined according to the TIMI criteria, and lifethreatening
or fatal bleeding (defined by the study criteria)
were also assessed. Other adverse events, including dyspnea,
were recorded in the electronic case report form. Each on-site
investigator assessed COPD status at the time of randomization
and reported in the case report form whether the patient
had “current COPD” or “no COPD.”