In Europe, the European Medicines Agency (EMEA) approved the drug in 2002 under two conditions: (1) the implementation of an observational study (phase IV) in order to assess the use of tPA in the first 3 hours of stroke onset in clinical practice; and (2) the initiation of the third randomized clinical trial (ECASS III) to assess the effect of tPA in the 181 to 270-minute window from symptoms onset. The gene discussed is PLAT; the disease is Stroke.