Koopman 1996.

Methods	Study design: randomised controlled trial. Method of randomisation: stratified according to centre. Concealment of allocation: not blinded for treatment allocation, blinded for outcome assessment. Exclusions post‐randomisation: none. Lost to follow‐up: none.
Participants	Country: Netherlands, France, Italy, Australia, New Zealand. Setting: hospital. No.: 400 outpatients. Age: Mean 61 years. Sex: 203 males. Inclusion criteria: acute symptomatic proximal DVT documented by venography and/or ultrasonography. Exclusion criteria: VTE in last 2 years; suspected PE; previous treatment with heparin > 24 hours; life expectancy < 6 months; post‐thrombotic syndrome; geographic inaccessibility.
Interventions	Treatment: LMWH (Nadroparin‐Ca, Fraxiparine) in body weight‐adjusted fixed dose, s.c., twice daily. If appropriate, at home. Control: UFH: APTT‐adjusted dose, continuous i.v. infusion in hospital after initial i.v. bolus of 5000 Units. Treatment duration: at least 5 days; treatment cessation if INR was 2.0 or above in 2 measurements 24 hours apart. Oral anticoagulation: started on first day and continued for 3 months unless persistence of risk factors required its continuation beyond that period. INR 2.0 to 3.0.
Outcomes	Primary: symptomatic recurrent VTE (DVT or PE) during initial treatment, after 3 months' follow‐up and at the end of follow‐up (6 months); major haemorrhage during initial treatment and after 3 months of follow‐up. Secondary: minor haemorrhage or death during initial treatment, after 3 months of follow‐up and at the end of follow‐up (6 months); other potential outcome events; quality of life.
Notes	Follow‐up: 6 months.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation and allocation was achieved by means of a central 24‐hour telephone service.
Allocation concealment (selection bias)	Low risk	Randomisation and allocation was achieved by means of a central 24‐hour telephone service.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Not blinded for treatment allocation. Comment: given the clinical outcomes of the study, review authors judged that the non‐blinding of the participants and staff was unlikely to have affected the outcomes.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Documentation of all potential outcome events was submitted to an independent adjudication committee whose members were unaware of the treatment assignments.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data balanced in numbers across intervention groups.
Selective reporting (reporting bias)	Low risk	Published report includes all expected outcomes.
Other bias	Low risk	Study appears to be free of other sources of bias.