The efficacy and safety of edoxaban has not been adequately studied in Asians versus non-Asians, who are quite different physiologically from each other. Although 1,943 patients from East Asia (1,010 were from Japan, 469 from China, 234 from Taiwan, and 230 from South Korea) were included in ENGAGE
[Changes to the protocol made until the stage of the statistical analysis plan, before data analysis and also before unblinding.]
1. Objective
1.1 Main Objective
We aim to determine, through mean INR difference between formulations, whether there is therapeutic equivalency between the branded