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. 2020 Apr 9;2020(4):CD013422. doi: 10.1002/14651858.CD013422.pub2

Schulman 1995.

Methods Randomised, open‐label trial
Participants Number: 347 participants
176 participants received anticoagulation treatment for 6 weeks and 171 participants received anticoagulation treatment for 6 months
Age: not stratified by distal thrombosis
Gender: not stratified by distal thrombosis
Interventions VKA for 6 months vs 6 weeks
The initial treatment with UFH or LMWH administered intravenously or subcutaneously for ≥ 5 days, until a prothrombin time within the target range had been achieved. Participants with DVT were provided with a graded compression stocking and instructed to wear it on the affected leg during the day for ≥ 1 year. Oral anticoagulation with warfarin sodium or dicumarol was usually started at the same time as heparin. Oral anticoagulation was targeted to an INR of 2.0–2.85.
Outcomes Recurrent VTE at 2 years
Notes People with previous VTE or cancer were excluded.
The data came from a larger study which included people with proximal and distal DVT. We only had stratified data for the outcome recurrent VTE at 2 years.
Funding/support: quote: "Supported by grants from Swedish Heart Lung Foundation, the Swedish Society of Medicine, the Karolinska Institute, Skandia, Trygg–Hansa, Triolab, Karolinska Hospital, Nycomed, and Stago."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated allocation.
Allocation concealment (selection bias) Low risk Central allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk No blinding of outcome assessment but the review authors judged that the outcome measurement was unlikely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing data.
Selective reporting (reporting bias) Low risk Published report included all expected outcomes.
Other bias Low risk Study appeared free of other sources of bias.