Experts say Boehringer Ingelheim’s research on dabigatran was fundamentally flawed. The drug company conducted a study entitled Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY). This was a phase III study with 18,113 patients who participated in the trial. The RE-LY study did have a two year follow-up with those who participated in the trial. After that, there was not an additional follow-up to discover what the results or side effects of an extended long-term use of Pradaxa would be. Experts stated that the clinical trial performed by Boehringer Ingelheim was fundamentally flawed and allowed for errors in the results. As a result of the RE-LY study, the US Food and Drug Administration approved dabigatran (Pradaxa) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Boehringer Ingelheim did propose a lower 110mg dosage to the FDA, but the FDA rejected the lower dose even though Canada, Japan, and other European countries had approved the 110mg dosage.