Table 2. Primary and Secondary Efficacy Endpoints With Ezetimibe as Reference Group.

	Treatment Difference to Mean of Weeks 10 and 12	Treatment Difference to Week 12	Adjusted p Value§
Co-primary endpoints (LDL-C), Least squares mean % (95% CI)	−39.35 (−47.23, −31.48)	−40.14 (−48.68, −31.60)	< 0.0001
p value§§	< 0.0001	< 0.0001
Secondary endpoints, Least squares mean % (95% CI)
Total cholesterol	−25.44 (−30.80, −20.08)	−25.83 (−31.63, −20.04)	< 0.0001
p value§§§	< 0.0001
Non-HDL-C	−33.53 (−40.38, −26.68)	−33.44 (−40.94, −25.94)	< 0.0001
p value§§§	< 0.0001
ApoB	−35.67 (−42.30, −29.04)	−36.60 (−43.98, −29.22)	< 0.0001
p value§§§	< 0.0001
Triglycerides	3.49 (−11.15, 18.13)	11.79 (−7.29, 30.87)	0.27
p value§§§§	0.27
Lp(a)	−31.13 (−41.83, −20.43)	−31.21 (−43.57, −18.84)	< 0.0001
p value§§§§	< 0.0001
HDL-C	7.96 (1.78, 14.14)	5.59 (−0.82, 12.00)	0.091
p value§§§§	0.03

When the calculated LDL-C was < 40 mg/dL or triglycerides were > 400 mg/dL, calculated LDL-C was replaced with ultracentrifugation LDL-C from the same blood sample, if available.

^§Adjusted p value is based on a combination of sequential testing, the Hochberg procedure, the fallback procedure to control the overall significance level for all primary and secondary endpoints. Each individual adjusted p value is compared to 0.05 to determine statistical significance.

^§§Repeated-measures model, which includes treatment group, stratification factor of screening LDL-C level (from IVRS), scheduled visit, and the interaction of treatment with scheduled visit as covariates.

^§§§Least significant unadjusted p value of the co-secondary endpoints, using the repeated-measures model.

^§§§§The unadjusted joint p value using the union-intersection test.

Abbreviations: ApoB, apolipoprotein B; HDL-C, high-density lipoprotein-cholesterol; IVRS, interactive voice response system; LDL-C, low-density lipoprotein-cholesterol; Lp(a), lipoprotein(a).