Clinical Trial Inclusion and Exclusion Criteria Quiz

3.3.2 Inclusion criteria 1. Signed Informed Consent consistent with ICH-GCP and local laws prior to trial participation. 2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit. 3.3.3 Exclusion criteria 1. AST, ALT > 1.5 fold ULN Patients who completed the parent trial with transaminase values > 1.5 fold ULN but < 3 fold ULN are considered eligible. 2. Bilirubin > 1.5 fold ULN 3. Bleeding risk a. Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin), or high dose antiplatelet therapy. Exceptions: prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 IU s.c. per day) and prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy); b. Hemorrhagic CNS event, gross / frank haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers after completion of the parent trial; c. Coagulation parameters: International normalised ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of institutional ULN. 4. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery. 5. New major thrombo-embolic events developed after completion of the parent trial: a. Stroke; b.