The primary efficacy endpoint was the cumulative occurrence of confirmed venous thromboembolism, defined as the composite of symptomatic or asymptomatic deep vein thrombosis, or symptomatic or fatal pulmonary embolism during the study treatment phase (up to day 14). All patients had deep vein thrombosis confirmed by bilateral contrast venography at the end of the treatment period, with the exception of patients for whom this method was not practical, and