Abstract
The Syst-Eur trial was stopped after the second of 4 planned interim analyses, when predefined stopping rules1 revealed that active treatment diminished the incidence of stroke, the primary endpoint. The ethics committee unanimously resolved that all endpoints that had occurred before February 14, 1997, at 5 pm should be included in the final analysis. The long communication lines between the coordinating office and 198 centers in 23 countries made the practical implementation of this recommendation very difficult. The coordinating office had to strike a delicate balance between reporting long-awaited outcome results or postponing publication until a greater number of terminating report …
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