Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Inclusion criteria:

1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study.
2. Written informed consent

Exclusion criteria:

1. Younger then 18 years of age
2. Indication for VKA other than DVT and/or PE
3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued
4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT \> 3 x ULN
5. Creatinine clearance \< 30 ml/min
6. Acute bacterial endocarditis
7. Active bleeding or high risk for bleeding.
8. Uncontrolled hypertension (investigators judgement)
9. Intake of another experimental drug within the 30 days prior to randomization into the study
10. Life expectancy \<6 months
11. Childbearing potential without proper contraceptive measures\*, pregnancy or breast feeding
B: Inclusion Criteria:

1. Hospitalized medical patients 70 years of age or older
2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
3. written informed consent

Exclusion Criteria:

1. immobilization longer than 3 days prior to randomization
2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
3. expected major surgical or invasive procedure within the next 3 weeks after randomization
4. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
5. immobilization due to cast or fracture
6. indication for anticoagulatory or thrombolytic therapy
7. acute symptomatic DVT / PE
8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures
9. Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply
C: 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
D: Inclusion Criteria:

* Patients with a diagnosis of active cancer.
* Symptomatic and objectively confirmed VTE.
* ≥ 18 years of age or above the legal age of consent as per country specific regulations.
* Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Signed informed consent.

Exclusion Criteria:

* Life expectancy \< 6 months.
* Patients with basal cell carcinoma or non-melanoma skin cancer.
* Creatinine clearance ≤ 20 ml/min.
* Contra-indications to anticoagulation.
* Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
* History of heparin-induced thrombocytopenia (HIT).
* Pre-randomisation therapeutic anticoagulant treatment for acute VTE administered for more than 72 hours prior to randomisation.
* Patients unlikely to comply with the protocol.
* Participation in another interventional study.
* Pregnant or breast-feeding women.
* Women of childbearing potential.

Answer: C