Clinical end points comparing the 12- and 3-month edoxaban groups in the subgroups stratified by D-dimer levels at 3 months. The primary end point is a composite of symptomatic recurrent VTE or VTE-related death. The major secondary end point is major bleeding as defined according to the International Society on Thrombosis and Haemostasis criteria, and consists of fatal bleeding, symptomatic bleeding in a critical area or organ, and bleeding causing a reduction in hemoglobin levels by ≥2 g/dL or leading to a transfusion of ≥2 units of whole blood or red cells.