Table 1 Main inclusion and exclusion criteria

• Children aged 0.5–< 18 years at the time of administration of the study drug, who had completed treatment for VTE and were considered to be at risk of recurrence, but with no current need for anticoagulation

• Children who could take oral medication

• Written informed consent (and age-appropriate assent) as per local requirements

• Clinically stable children who could be treated on an ambulatory basis

• A normal prothrombin time and activated partial thromboplastin time

• Any condition requiring ongoing anticoagulation

• Known bleeding disorder

• Any major or clinically relevant bleeding event during previous VTE treatment

• Abnormal coagulation test results within 10 days prior to study drug administration

• Medical disorder, condition or history of such that would impair the child’s ability to participate or complete this study in the opinion of the investigator or sponsor