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In patients receiving HDER versus warfarin with CrCl 3050 ml/min, primary efficacy (stroke/SEE, HR [95% confidence interval, CI]: 0.87 [0.651.18], p = 0.37) and safety (major bleeding, 0.76 [0.580.98], p = 0.036) outcomes as well as net clinical benefit (stroke, SEE, major bleeding or all-cause death, 0.86 [0.750.98], p = 0.027) were consistent with the overall results obtained in the trial [38]