Table 2.

Summary of Aims, Endpoints, Hypotheses, and Statistical Tests

Aim	Factor	Endpoints, Primary	Endpoints, Secondary	Hypothesis, Primary	Statistical Test
1	Genetic vs. Clinical Dosing	VTE, major hemorrhage, death, or INR ≥ 4	INR control	Decreased event rate associated with genetic dosing in whole population and in subpopulation whose clinical and genetic predicted doses differ by ≥1 mg/day.	Chi-square test (partitioning alpha)
2	Target INR 2.5 vs. 1.8	VTE or death	INR control, bleeding	The event rate is non-inferior in the lower target INR arm	Chi-square test

VTE = Venous Thromboembolic Event; INR = International Normalized Ratio