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RE-LY ® & RELY-ABLE ® TRIALS IN PATIENTS WITH NVAF RE-LY ® Trial objective 1. To demonstrate non-inferiority of blinded PRADAXA (110 mg twice daily* or 150 mg twice daily) compared to open-label warfarin (INR target range 2.0-3.0) in stroke and systemic embolism prevention. After non-inferiority was established, statistical superiority was analyzed.
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Adverse Reactions | Pradaxapro.com RE-LY ® & RELY-ABLE ® TRIALS IN PATIENTS WITH NVAF RE-LY ® Trial objective 1. To demonstrate non-inferiority of blinded PRADAXA (110 mg twice daily* or 150 mg twice daily) compared to open-label warfarin (INR target range 2.0-3.0) in stroke and systemic embolism prevention. After non-inferiority was established, statistical superiority was analyzed. www.drugs.com We would like to show you a description here but the site won’t allow us.
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