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. Author manuscript; available in PMC: 2016 Jan 15.
Published in final edited form as: N Engl J Med. 2014 Dec 7;372(3):232–240. doi: 10.1056/NEJMoa1405760

Figure 2. Enrollment, Randomization, and Populations for Analysis.

Figure 2

The initial protocol (Panel A) called for random assignment of patients to one of three dose regimens of FXI-ASO (100 mg, 200 mg, or 300 mg) or enoxaparin. After 14 patients had undergone randomization, the steering committee amended the protocol (Panel B) to discontinue the 100-mg dose regimen. Random assignment to the 300-mg FXI-ASO cohort was discontinued when the target sample of 70 patients was recruited in that group. Enrollment was continued in the 200-mg cohort until the study ended.