Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors
Brief Summary: The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.

The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.


Options:
A: Inclusion Criteria:

* Ambulatory, male or female, 21-65 years of age
* A body mass index (BMI) of 23-34.9
* Generally healthy and having no significant difficulty with digestion of food
* Has been generally weight stable for the past six months
* Willing to discontinue use of any (non-study) multivitamin or Vitamin D supplements during the study
* Willing and able to give written informed consent
* Clearly understands the procedures and study requirements
* Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
* Able to communicate, including reading, in English

Primary Exclusion Criteria:

* Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug in the past 30 days
* History of allergy or sensitivity to any component of the study products including milk, soy and almonds
* Donation of blood with 30 days prior to screening/baseline
* Inability to provide a venous blood sample
* Participation in another study within 30 days prior to baseline/screening
* Being pregnant or planning on becoming pregnant during study participation; or breast feeding
* Having been diagnosed, received medical treatment or taking medication daily for the following medical condition(s):
* Diabetes mellitus
* Eating disorder
* Acute or chronic inflammatory disease or autoimmune disease
* Cardiovascular disease
* Gastrointestinal disease including gallbladder problems, gallstones or biliary tract obstruction
* Thyroid disease (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study)
* Hypertension (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study)
* Psychiatric disorder
* Neurologic condition/disease
* Cancer (unless skin cancer other than melanoma which has been treated \> 3 years prior to Baseline/screening)
* Active or chronic liver, pancreatic and kidney disease
* Blood coagulation disorder
* Other condition or medication use that would preclude participation in the study in the judgment of the investigator/sub-investigator (Sub-I)
* Currently taking or having taken within the 30 days prior to screening/baseline any hormone replacement therapy (including DHEA (dehydroepiandrosterone), estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for \> 3 months, with no anticipated change for the duration of the study)
* Currently taking any of the nutritional supplements used in the study and unwilling to discontinue use at least 14 days prior to screening.
* Currently taking a medication or nutritional supplement specifically for weight loss and unwilling to discontinue use 14 days prior to the first dosing of study supplements
* Currently participating in a weight loss program and unwilling to discontinue participation prior to enrollment into the study
* Currently taking an anti-coagulant, anti-platelet medication or a glucose lowering medication
* Having had a surgical procedure or having an internal medical device which, in the judgment of the PI/Sub-I, would preclude participation in the study
* Having abnormal screening laboratory test values including bilirubin \> 2.5 x ULN (upper limit of normal), AST/SGOT(aspartate aminotransferase/serum glutamin oxaloacetic transaminase) and ALT/SGPT (alanine aminotransferase/serum glutamic pyruvic transaminase) \> 2.5 x ULN, serum creatinine \> 1.5 mg/dL, blood glucose \< 85 mg/dL or \> 125 mg/dL, and TSH(thyroid stimulating hormone) \> 4.12 µIU/mL, or other lab test result(s) that would preclude study participation in the judgement of the PI/Sub-I
* Having blood pressure readings at Baseline/screening \> 140 systolic or \> 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the PI/Sub-I
* Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
* Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos
* Having any other circumstance that precludes study participation in the judgment of the PI/Sub-I including use of other nutritional supplements which will be evaluated on a case-by-case basis.
B: Inclusion Criteria:

* Have elevated ALT or AST level (ALT \>41 or AST\>34 IU/L)
* No evidence of other forms of liver diseases
* For those with diabetes mellitus and dyslipidaemia, they must be on a stable therapy for at least 6 months prior to study enrolment

Exclusion Criteria:

* Significant alcohol consumption (\> 1 standard drink per day)
* Pregnancy
* Involvement in an active weight loss program or taking weight loss medications
* Substance abuse and significant psychiatric problems.
C: Inclusion Criteria:

1. - The participants in this study will be 50 men and women in the 30 to 65 year age range, who have a BMI in the high-normal to moderately overweight range (i.e. 22 to 28 kg/m2),
2. - Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).
3. - Participants have at least one of these metabolic abnormalities: pre-hypertension or hypertension (i.e. systolic blood pressure \> 120 mmHg or diastolic blood pressure \> 80 mmHg or specific treatment of previously diagnosed hypertension)10, sub-optimal lipid levels (i.e. LDL-cholesterol \> 100 mg/dl or HDL-cholesterol \< 59 mg/dl or specific treatment for this lipid abnormality)11, impaired fasting glucose or glucose intolerance (i.e. fasting glucose \> 100 mg/dl or 2 hr-glucose during OGTT with a glucose load of 75 g \> 140 mg/dl or specific treatment for previously diagnosed type 2 diabetes)12, or high-risk waist circumference (≥ 94 cm in men and ≥ 80 cm in women)13.

Exclusion Criteria:

- 1 - History of any chronic disease process that could interfere with interpretation of results 2 - Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.

3 - Currently eating diet similar to Mediterranean diet based on dietary and food frequency questionnaires and 4-day food diary.
D: Inclusion Criteria:

Waist circumference \>102 cm (40 inches) males, \>88 cm (35 inches) females, with one coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular disease.

* CHD equivalents:

  * Recent (within 3 years)documented heart attack
  * Documented symptomatic coronary artery disease
  * Recent (within 3 years) ischemic cerebrovascular episode (stroke or TIA)
  * Documented symptomatic peripheral arterial disease
* Major risk factors:

  * Documented type 2 diabetes mellitus
  * Metabolic syndrome (NCEP criteria)
  * Asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair
  * Elevated high-sensitivity C-reactive protein
  * Age \> or = 65 years for males, age \> or = 70 years for females

Exclusion Criteria:

* Obesity of known endocrine origin
* Pregnant or breastfeeding women
* Very low calorie diet or weight loss surgery within past 6 months
* Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness
* Likely cardiovascular intervention within next 1 month
* Allergy to rimonabant or excipients, or prior participation in a rimonabant trial
* Receipt of investigational product within past 30 days

Answer: D