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International Pharmaceutical Regulatory Monitor
> EMA Releases Guideline on Trials of Drugs to Prevent Strokes, SEEs
International Pharmaceutical Regulatory Monitor
September 2012
| Vol.
40 No.
9
EMA Releases Guideline on Trials of Drugs to Prevent Strokes, SEEs
Companies conducting clinical trials of drugs to prevent stroke and systemic embolic events (SEE) in patients with nonvalvular atrial fibrillation (AF) should use the composite primary efficacy endpoint of time from randomization to first stroke and SEEs, according to a European Medicines Agency (EMA) draft guideline.
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