Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.
Brief Summary: The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787).


Options:
A: * Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
* BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia
B: Inclusion Criteria:

1. Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee
2. Male or female patients \> 18 years with type 2 diabetes (WHO criteria).
3. Patients must be on treatment with metformin. Any form of treatment with SU compounds will be discontinued and washed out for two weeks prior to the start of study drug.
4. eGFR ≥ 60 ml/min/1.73 m2 (estimated by MDRD formula)
5. Fertile female patients must use chemical, hormonal and mechanical contraceptives or be in menopause (i.e. must not have had regular menstrual bleeding for at least one year) or have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least six months prior to screening
6. Patients must be on antihypertensive treatment or having elevated blood pressure (SBP ≥130 mm Hg and DBP ≥80 mmHg), lower than 170/105 mm Hg at baseline and the patients must be stable antihypertensive medication for at least 4 weeks prior to baseline
7. Patients must be on stable hypoglycemic medication for at least two weeks before the first visit.
8. Must be able to communicate with the investigator

Exclusion Criteria:

1. Ongoing insulin therapy
2. BP \> 170/105 mm Hg at baseline
3. Type 1 diabetes mellitus
4. Chronic pancreatitis / previous acute pancreatitis
5. Known or suspected hypersensitivity to trial product(s) or related products.
6. Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
7. Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial
8. Inflammatory bowel disease
9. Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
10. Previous bowel resection
11. Body mass index \<18.5 kg/m2
12. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
13. Clinical signs of diabetic gastroparesis
14. Impaired liver function (transaminases \> two times upper reference levels)
C: Inclusion Criteria:

To be eligible for enrollment into this study, subjects must meet all of the following criteria:

* Completion of study OB-303 (NCT00553787) on treatment and compliance with all protocol requirements
* Written informed consent
* Female subjects of childbearing potential must be using adequate contraception, defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. Female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 IU/L
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Subjects will not be included in the study if they meet any of the following:

* Body mass index ≤22 kg/m2 at the completion of study OB-303
* Off study medication at completion of study OB-303 (NCT00553787) for longer than 4 weeks continuously due to an event-driven holiday, or off study medication with no plans to restart
* Development of any condition during study OB-303 (NCT00553787) that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results
* Participation in a formal weight loss program (including: Weight Watchers and related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).
D: Inclusion Criteria:

* Written and signed informed consent
* Age greater than or equal to 55 years
* Abdominal obesity defined by waist circumference \> 88 cm (35 inches) in women and \> 102 cm (40 inches) in men
* Metabolic syndrome diagnosed on the basis of at least two of the following additional risk factors:

  1. Triglyceride level equal to or greater than 150 mg/dL
  2. HDL cholesterol less than 40 mg/dL in men or 50 mg/dL in women
  3. Fasting glucose of equal to or greater than 110 mg/dL
  4. High blood pressure defined as equal to or greater than 140 mmHg systolic and/or equal to or greater than 90 mmHg diastolic at screening visit or current treatment by antihypertensive medication.
* Ultrasonographic evidence at Screening quantitative B-mode ultrasound imaging of a minimal CIMT measurement of greater than or equal to 0.7 mm in either of the far walls of the common carotid artery, and maximal CIMT measurement less than 3 mm in any carotid artery segment.
* All 6 carotid artery segments must have ultrasound images for all CIMT measurements
* Screening CIMT recording deemed to be of acceptable CIMT image quality, and demonstrating adherence to the CIMT interrogation protocol, as determined by the Imaging Core Laboratory's assessment.

Exclusion Criteria:

* History of very low calorie diet or surgical procedures for weight loss within 6 months prior to screening visit
* Obesity of known endocrine origin
* Uncontrolled diabetes, i.e. with HbA1c \> 10%
* Anticipated survival less than 27 months
* Presence of any severe medical or psychological condition, that in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study
* Presence of any other condition (e.g. geographic, social, or other), actual or anticipated, that the Investigator feels would restrict or limit the subject's participation for the duration of the study
* Receipt of any investigational treatment (drug or device) within 30 days prior to Screening
* Previous participation in a rimonabant study
* Total occlusion of any carotid artery segment
* Previous history of carotid intervention
* Patient considered at high risk of carotid intervention during the next 27 months

Answer: C