Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia
Brief Summary: This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.


Options:
A: Inclusion Criteria:

* Primary prevention patient with ischemic or non-ischemic heart disease who meets current guidelines for dual-chamber ICD or CRT-D device therapy
* Patient in sinus rhythm
* Patient on stable optimal pharmacologic therapy for the cardiac condition or who has developed a recent ICD indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy
* Patient ≥ 21 years of age, or legal representative, willing and capable of giving informed consent

Exclusion Criteria:

* Patient with an implanted pacemaker or CRT-P
* Patient with existing ICD or CRT-D device components
* Patient with a history of VT or VF
* Patient with permanent or chronic AF, or cardioversion for AF, within the past three calendar months before enrollment
* Patient with coronary artery bypass graft surgery or percutaneous coronary intervention within the past three calendar months prior to enrollment
* Patient with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
* Patient with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
* Patient with second or third degree heart block
* Patient in NYHA Class IV
* Patient who is pregnant or plans to become pregnant during the course of the trial
* Patient with irreversible brain damage from preexisting cerebral disease
* Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
* Patient with chronic renal disease with BUN ≥ 50mg/dl or creatinine ≥ 2.5 mg/dl
* Patient participating in any other clinical trial
* Patient unwilling or unable to cooperate with the protocol
* Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
* Patient who does not anticipate being a resident of the area for the scheduled duration of the trial
* Patient unwilling to sign the consent for participation
* Patient whose physician does not allow participation
B: Inclusion Criteria:

* Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
* Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Exclusion Criteria:

* Persons with moderate or severe liver disease
* Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
* Persons who are being treated with blood clotting agents that cannot be stopped
C: Inclusion Criteria:

* Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
* Glycated haemoglobin (HbA1c) \>7.0 % to = 9.0 % at visit 1.
* Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
* Body mass index \>25.0 kg/m2.

Exclusion Criteria:

* Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
* Patients with systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg.
* Patients who have required the use of insulin for glycaemic control at any time in the past.
* Hospitalisation for any major cardiovascular event in the last 3 months.
D: Inclusion Criteria:

* Scheduled to undergo nonemergent CABG and/or valve repair or replacement surgery through a full median sternotomy. This includes the following eligible procedures: isolated CABG surgery, isolated valve surgery, and combined CABG + valve surgery.
* Be at higher risk for SWI, defined as the presence of diabetes mellitus (treated with either oral agent or insulin) and/or obesity, defined as BMI \> 30.
* Have the capacity to understand and sign an informed consent form.
* Are male or female and \> 18 years of age.
* If female, be postmenopausal (no menstrual period for a minimum of 1 year), be surgically sterilized and have a negative serum or urine pregnancy test on entry in the study, or agree to use adequate birth control during the study and for 3 months after the administration of study agent. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD).
* Agree to be available for evaluation from baseline until final evaluation at 90 days postsurgery.

Exclusion Criteria:

* Known history of hypersensitivity to gentamicin or bovine collagen.
* Undergoing emergency cardiac surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed).
* Undergoing a significant concomitant surgical procedure (eg, carotid endarterectomy, aortic root repair or replacement, DHCA, or pulmonary resection).
* Undergoing a minimally invasive or a thoracic surgical approach.
* Using a preoperative mechanical assist device or IABP if inserted for shock/low output syndrome (an IABP is allowed if it is inserted for unstable angina).
* Active and significant systemic infection, eg active endocarditis, or a history of significant recurrent systemic infection.
* Receiving antibiotic therapy within the 2 weeks before the date of surgery.
* Preoperative serum creatinine \> 3 mg/dL or renal failure requiring dialysis.
* History of malignancy within the past year (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
* History of major organ transplantation, including bone marrow transplantation.
* Recent history of significant drug or alcohol abuse.
* Taking systemic immunosuppressive drugs, including steroids (at a dose \> 10 mg oral prednisone daily) or a history of a current immunosuppressive condition (eg, symptomatic HIV infection), defined as a CD4 count \< 200.
* Scheduled to receive "stress doses" of glucocorticoids (ie, doses \> 2 mg/kg/day of methylprednisolone or equivalent).
* Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).
* Postsurgical life expectancy ≤ 90 days, in the investigator's or sponsor's opinion.
* Refusal to accept medically indicated blood products.
* Current participation or participation within 30 days before the start of this study in another experimental drug or device study, or is currently participating in a study during which the administration of investigational drugs within 90 days is anticipated.
* Has a moderate or severe pectus deformity.

Answer: C