Categories of definite, probable (high or moderate probability), low probability, or negative were taken from the reports of the results.Several factors or conditions excluded patients from entry. These were deep vein thrombosis or pulmonary embolism deemed so severe by the clinician as to require thrombolysis or pulmonary embolectomy; neoplasia diagnosed or requiring treatment, or both, within the previous three years; pregnancy; deep vein thrombosis or pulmonary embolism in the preceding three years; known polycythaemia, thrombocythaemia, antithrombin III deficiency, lupus anticoagulant, homozygous factor V Leiden, protein C or protein S deficiency, or other similar predisposing haematological disorders; any condition that would result in prolonged or continuous immobility or confinement to bed, such as advanced multiple sclerosis or orthopaedic problems of the lower limbs; previous allergy to heparin or warfarin; requirement for long term anticoagulant therapy; and inability to give informed consent.DesignPatients were randomised to three or six months of warfarin, the clinicians being asked to start warfarin on day one of the scheduled five days of heparin. Participating physicians used international normalised ratios to monitor anticoagulation with warfarin according to a standardised protocol.17 The aim was to achieve ratios between 2.0 and 3.5.Within each centre randomisation was by permuted blocks of eight through a series of numbered envelopes kept at a central point in each hospital or unit.

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