METHODS

Design:

randomised controlled trial (RCT).

Allocation:

{concealed}*.†

Blinding:

{unblinded}*.†

Follow-up period:

1 year.

Setting:

46 hospitals in the UK.

Patients:

810 patients ⩾18 years of age (mean age 59 y, 53% men, based on 749 patients) with DVT, PE, or both, who were to receive anticoagulant therapy. Exclusion criteria included DVT or PE in the past 3 years; severe DVT or PE requiring embolectomy or thrombolysis; neoplasia in the past 3 years; polycythaemia, thrombocythaemia, homozygous factor V Leiden, lupus anticoagulant, or deficiency of protein C, protein S, or antithrombin; advanced multiple sclerosis, orthopaedic problems of the lower limbs, or prolonged or continuous immobility for other reasons; allergy to heparin or warfarin; need …