Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double Blind, Randomized, Placebo Controlled, Study for Assessment of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Brief Summary: This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.


Options:
A: Inclusion Criteria:

* persistent Atrial Fibrillation (AF) lasting \> one month
* history of at least one AF relapse after previous electrical or Pharmacological cardioversion

Exclusion Criteria:

* left atrium size \> 6 cm
* severe valvulopathy
* myocardial infarction during the previous 6 months
* unstable angina
* NYHA heart failure class IV or hemodynamic instability
* cardiac surgery during the previous 3 months
* significant pulmonary thyroid and hepatic disease
* contraindications to treatment with amiodarone or RASS inhibitors
* chronic renal dysfunction
* QT \> 480 msec in the absence of bundle-branch block
* bradycardia \< 50 b/min
* diagnosis of paroxysmal AF
* hyperkalemia
* pregnancy
* any disease or other medical treatment that, in the opinion of the investigators, could interfere with the study.
B: Inclusion Criteria:

1. coronary artery disease
2. previous myocardial infarction
3. angioplasty (\> 6 months ago)
4. previous coronary bypass surgery (\> 12 months ago)
5. stable angina
6. non-calcified plaque on prior CT
7. abnormal exercise tolerance test
8. aged 21- 80 years
9. BMI ≥ 27 kg/m2 and ≤ 35 kg/m2 if female and ≤ 40 kg/m2 if male (a BMI \> 24.5 for subjects from Asian origin)
10. stable dose of statin for 1 month at screening or unable to tolerate a statin
11. normal renal function - estimated creatinine clearance calculated using Cockcroft-Gault (CG) equation ≥60 at screening \[eCrCLCG (ml/min) = \[(140 - age) x weight (kg)\]/\[SCr(mg/dl) x 72\] x \[0.85 if female\] or serum Cr \< 1.3
12. ALT, AST) \< 3 times upper limits of normal)
13. normal thyroid function or on stable dose replacement therapy
14. an ETT performed within 12 months prior

Exclusion criteria

1. unstable angina (increase in frequency or severity of anginal episodes or development of chest pain at rest)
2. significant obstructive disease in left main coronary artery, ostial LAD or newly diagnosed three-vessel disease since prior cardiac catheterization by MDCTA
3. significant heart failure (NYHA class III and IV)
4. Current atrial fibrillation or Wolf-Parkinson-White (WPW) syndrome
5. allergy to beta-blocker in subjects with resting heart rate \> 65 bpm
6. systolic blood pressure \> 160 mm Hg
7. diastolic BP \> 100 mm Hg
8. persons with allergies to iodinated contrast material or shellfish
9. allergy to nitroglycerin
10. history of asthma only if unable to tolerate beta-blockers
11. BMI \> 35 kg/m2 if female and \> 40 kg/m2 if male
12. body weight \> 350 lbs
13. Use of drugs for weight loss \[eg Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanolamine) or similar over-the-counter medications\] within three months of screening
14. surgery within 30 days of screening
15. history of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)
16. poor mental function or history of dementia/Alzheimer's Disease or on medications used for treatment of dementia \[e.g. Tacrine (Cognex), Rivastigmine (Exelon), Galantamine (Razadyne, Reminyl), Donepezil (Aricept), Memantine (Namenda)\] or any other reason to except patient difficulty in complying with the requirements of the study
17. medicine for erectile dysfunction within 72 hours prior to MDCTA
18. Prior stroke with residual cognitive deficit or functional deficit preventing any type of exercise
19. Current chemotherapy or radiation for malignancy
20. Current weekly alcohol consumption \> 21 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)

Exclusions based on nuclear imaging:

1. Transient cavity dilation
2. More than one vascular territory involved with reversible defect (multiple defects)
3. Reversible defects involving the anterior wall, septum or apex (LAD territory)

Exclusions based on echocardiography imaging:

1. More than one vascular territory involved with inducible wall motion abnormalities (multiple defects) 2. Inducible wall motion abnormalities involving the anterior wall, septum or apex (LAD territory)

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C: Inclusion Criteria:

A patient may be included if he/she;

* Is aged between 18 and 55 years (both included).
* Has multiple sclerosis according to the McDonald criteria (McDonald 2001)
* Has a stable disease during the last month period prior to inclusion, and a disability equivalent to EDSS of 5.5 or less (Kurtzke 1983).
* Has shown disease activity defined as at least one relapse or at least one new MRI lesion (T1 enhancing or T2 lesion - ref. McDonald criteria) during the year prior to inclusion.
* Is prepared to and considered able to follow the protocol and to attend the planned visits during the whole study period.
* Is using adequate contraceptive methods and has negative pregnancy test results (female of childbearing potential must).
* Has given written informed consent.

Exclusion Criteria:

A patient has to be excluded if he/she;

* Has received continuous for more than one-week treatment with unsaturated fatty acids (omega-3) within 3 months prior to inclusion in the study.
* Has an active RRMS disease that would strongly be recommended for standard immunomodulatory treatment by the treating neurologist.
* Has received treatment with interferon-beta or glatiramer acetate within 6 months prior to inclusion in the study.
* Has received treatment with lymphoid irradiation, mitoxantrone, cyclophosphamide or long-term glucocorticoids.
* Has received treatment with azathioprine, cyclosporine or other immunosuppressive agents within the year prior to inclusion in the study.
* Has received treatment with glucocorticoids or ACTH within two month prior to inclusion in the study.
* Has experienced a relapse within one month prior to the inclusion in the study.
* Has converted to secondary progressive MS.
* Has suffered from major depression or any other psychiatric disorder that would preclude safe participation in the protocol.
* Has diabetes mellitus.
* Has alcohol or drug abuse.
* Has cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or malignant hypertension.
* Has renal insufficiency.
* Has ASAT or ALAT \> 2,5 x normal upper limit.
* Has leukopenia \< 2500 leukocytes per µl or thrombocytopenia \<100 000 thrombocytes per µl.
* Has any systemic disease, which can influence his/her safety and compliance, or the evaluation of the disability.
* Has thromboembolic disease that needs anticoagulative treatment.
* Have formerly shown severe reactions against study drug, interferon-beta or gadolinium (MRI contrast).
* Is breastfeeding or is pregnant.
D: Inclusion Criteria:

* Subjects with peripheral arterial disease for more than 6 months.
* Male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited IC but not incapacitated for walking on the level) confirmed with ankle/brachial pressures\< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease.
* Over 40 years old
* Able to comply with protocol requirements
* Able to provide informed consent
* Subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study.
* Subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study.

Exclusion Criteria:

* Patients with ischemic rest pain in limbs, ulceration, or gangrene.
* At baseline, any condition that prevents walking on a treadmill.
* History of major bleeding.
* Patients with bowel disease (including Crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis).
* Patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with EF\<40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures).
* Moderate to severe renal failure.
* Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study.
* Fish limitations (no more than 2 fish meals per week)
* Gluten allergy
* Subjects with allergies to any ingredient in the study product or placebo.
* Patients who plan to undergo surgery during the course of the trial.

Answer: D