Please select the eligibility criteria that correspond to the clinical trial below.
Title: Sertindole Versus Risperidone Safety Outcome Study: a Randomised, Partially-blinded, Parallel-group, Active-controlled, Post-marketing Study
Brief Summary: The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.


Options:
A: Inclusion Criteria:

* The patient has signed the Informed Consent Form or, if he/she is not able to sign it (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's legal representative has signed the Informed Consent Form
* The patient has been diagnosed with schizophrenia
* Based on the patient's clinical status, new or change of antipsychotic treatment is indicated
* The patient is at least 18 years of age
* The patient meets the criteria set out in the national SPCs for sertindole and risperidone. For those countries in which sertindole was not marketed, the EU SPC applied

Exclusion Criteria:

* The last treatment taken by the patient was sertindole or risperidone
* The patient has never previously received any antipsychotic drug therapy
* The patient has contraindications to treatment with either sertindole or risperidone
* In addition to sertindole/risperidone, treatment with another antipsychotic is indicated
* The patient is homeless
* The patient has previously been included in one of the two H. Lundbeck A/S post-marketing studies, 99823 or 99824
* The patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason
B: Inclusion Criteria:

* Subjects who presented or were admitted to hospital with:

  1. Signs and symptoms of AMI
  2. Were able to randomize within 12 hours of symptom onset; and-
  3. Had definite ECG changes indicating STEMI: persistent ST-elevation (≥0.2mV in two contiguous precordial leads, or ≥0.1mV in at least two limb leads), or new left bundle branch block, or ECG changes indicating true posterior MI.
* Written informed consent
* Able to be randomized within 24 hours of symptom onset

Exclusion Criteria:

* Age \<21 years.
* Was currently receiving an oral anticoagulant agent with an INR \>1.8.
* Had any contraindication to anticoagulation therapy such as high risk of bleeding or active bleeding.
* Had hemorrhagic stroke within the last 12 months.
* Had an indication for anticoagulation other than ACS.
* Pregnant women or women of child-bearing potential who were not using an effective method of contraception.
* Had a co-morbid condition with a life-expectancy \<6 months.
* Previous enrollment in one of the fondaparinux ACS trials.
* Participation in another pharmacotherapeutic study within the prior 30 days or was currently receiving an experimental pharmacological agent.
* Had a known allergy to heparin or fondaparinux.
* Had severe renal insufficiency (i.e. serum creatinine ≥3mg/dL or ≥265μmol/L).
* Had \>5000IU UFH administered prior to randomization.
* Had LMWH administered prior to randomization.
* Subject had pre-randomization revascularization (PCI) for the index event.
* Subject had pre-randomization rescue PCI.
C: Inclusion Criteria:

* Women and men 55 years of age or over with established CVD and at high risk for future fatal and nonfatal CV events, defined as:

  1. Documented coronary artery disease (CAD);
  2. Documented peripheral vascular disease (PVD);
  3. Documented cerebrovascular disease;
  4. Diabetes with one of the following; additional cardiovascular risk factors:

  i) hypertension (BP \>160 mmHg systolic or \>90 mmHg diastolic or on treatment); ii) total cholesterol \>5.2 mmol/L (\>200 mg/dl); iii) HDL cholesterol \<0.9 mmol/L (3.5 mg/dl); iv) current cigarette smoker; v) any evidence of previous vascular disease
* Provision of informed consent

Exclusion Criteria:

* Current use of any vitamin supplements containing folic acid \>200 micrograms/day. The patients taking such vitamin supplements can be asked if they agree to discontinue these supplements. If they agree, they can be randomized to the study following a one month wash-out period.
* Known previous adverse reactions to folic acid and/or vitamin B6 and/or B12.
* Planned cardiac, peripheral or cerebrovascular revascularization, defined as a decision taken by the patient and his or her physician(s) to perform surgical or percutaneous transluminal revascularization within the next 6 months.
* Hemodynamically significant primary valvular outflow tract obstruction (e.g. mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve).
* Constrictive pericarditis.
* Complex congenital heart disease.
* Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic arrhythmias including ventricular tachycardia are not exclusion criteria.
* Uncontrolled hypertension.
* Cor pulmonale.
* Heart transplant recipient.
* Other important non-cardiovascular disease(s) expected to limit compliance and/or impact on patient's ability to complete the study, such as: \*history of alcohol or drug abuse, \*psychiatric disorders, \*senility, \*severe physical disability, \*illnesses including terminal stage of cancer and other major systemic illnesses expected to limit the patient's ability to comply with the study protocol and to complete the study.
D: 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

Answer: A