Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Inclusion Criteria:

- Male or female subjects older than the minimum legal adult age (country specific);

- Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by
appropriate diagnostic imaging;

- Able to provide written informed consent

Exclusion Criteria:

- thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
current episode of DVT and/or PE;

- More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;

- Calculated Creatinine clearance (CrCL) < 30 mL/min;

- significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis)
or alanine transaminase (ALT) >\= 2 times the upper limit of normal (ULN), or total
bilirubin (TBL) x 1.5 times the ULN;

- patients with active cancer for whom long term treatment with (LMW) heparin is
anticipated;

- active bleeding or high risk for bleeding contraindicating treatment with (LMW)
heparin or warfarin;

- chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);

- treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet
therapy;

- concurrent treatment with potent P-gp inhibitors;

- subjects with any condition that, as judged by the investigator, would place the
subject at increased risk of harm if he/she participated in the study