Study end points The incidence of objectively documented recurrent VTE (DVT and/or PE) during the life-long follow-up is the primary outcome of this study. Contralateral DVT and PE will be computed as a recurrence. Ipsilateral DVT will be adjudicated recurrent if the results of the tests are worse than those obtained in a previous test or if the thrombus is diagnosed in another venous district of the leg. DVT of the arm; CT or MRI-documented occlusion of cerebral/abdominal veins; ultrasound-documented thrombosis of the great saphenous vein of the leg not involved in the first appearance will be also defined as a recurrence. The total (minor and major) bleeding occurrence during the life-long follow-up represents the safety end-point of this study and will be analyzed according to the thrombolysis in myocardial infarction (TIMI) bleeding score.