Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary: The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)


Options:
A: 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
B: 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
C: Inclusion Criteria:

* Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Indication for VKA other than DVT and/or PE
* Patients in whom anticoagulant treatment for their index PE or DVT should be continued
* Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate \< 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP \[Committee for Proprietary Medicinal Products\]/ICH \[International Conference on Harmonization\]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
D: Inclusion Criteria:

* Men and women ≥ 18 years of age;
* Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
* Anticoagulant treatment completed
* No recurrence of Venous Thromboembolism (VTE)

Exclusion Criteria:

* Subjects with indications for long-term treatment with a vitamin K antagonist
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Impaired kidney or liver function

Answer: D