At the conclusion of the first 4 weeks of the
run-in period, eligibility for randomization was
based on a fasting LDL cholesterol level of 75 mg
per deciliter or higher, as determined by the central
laboratory (for details, see the Supplementary
Appendix). Among patients who met that criterion,
those with coronary heart disease (or a coronary
heart disease risk equivalent) who had an
LDL cholesterol level of less than 100 mg per
deciliter (2.59 mmol per liter) and those without
coronary heart disease (or a coronary heart disease
risk equivalent) who had an LDL cholesterol
level of less than 130 mg per deciliter (3.36 mmol
per liter) were eligible for randomization. Among
patients in whom the lipid-lowering goal had not
been reached, therapy was increased to the next
level for an additional 4 weeks; the process was
repeated a month later if the goal had still not been reached. Patients who were receiving 80 mg
of atorvastatin plus 10 mg of ezetimibe daily but
whose LDL cholesterol level was still above the
target value were eligible for randomization.
Patients with an LDL cholesterol level of less than
75 mg per deciliter were excluded, except for
those who were receiving 80 mg of atorvastatin
plus 10 mg of ezetimibe daily. These patients
were allowed to discontinue ezetimibe and to
participate in the study if the ATP-III goal was
maintained after 4 weeks on the regimen of
80 mg of atorvastatin daily.