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The prolonged 12-month follow-up was finished for 1323 of the 1343 patients who underwent randomization and received the study drug , of which stage the cumulative incidence of the principal efficacy outcome was 6.9 percent in the dabigatran group as compared with 10.7 percent in the placebo group . There were 2 patients with major bleeding events, both in the dabigatran group; both occasions were gastrointestinal bleeding requiring at least 2 systems of blood but with out a fall in the hemoglobin level of 20 g per liter or even more. Major or clinically relevant nonmajor bleeding occurred in 36 patients in the dabigatran group as compared with 12 patients in the placebo group .