Please select the eligibility criteria that correspond to the clinical trial below.
Title: Risk and Prevention Study: Optimisation of the Preventive Strategies and Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk
Brief Summary: In the everyday practice cardiovascular prevention in people at high risk is still unsatisfactory and treatments with documented efficacy are generally under-used.

Polyunsaturated fatty acids of marine origin (n-3 PUFA) are the latest more promising strategy to improve prognosis in these patients.

The Risk and Prevention study combines an epidemiological and an experimental approach in order to:

1. Verify the possibility to optimise cardiovascular prevention in subjects at high risk by planning the intervention with patients and setting individual goals (outcome study)
2. Evaluate the efficacy of a long term n-3 PUFA treatment in reducing the incidence of cardiovascular events, through a controlled, randomised, double blind clinical trial.


Options:
A: Inclusion Criteria:

* 65-79 years old.
* Free of clinically diagnosed overt disease for at least 2 years.
* Free-living, independent.

Exclusion Criteria:

* \<65 or \> 79 years old.
* Overt disease such as aggressive cancer or dementia.
* Unstable organ failure or organ failure necessitating a special diet.
* Heart failure.
* Renal failure.
* Respiratory failure.
* Liver failure.
* Type 1 diabetes mellitus.
* Chronic use of corticosteroids.
* Recent (previous 2 months) use of antibiotics.
* Recent (previous 3 months) change to habitual medication (e.g statins and thyroxine) use
* Presence of food allergy/intolerance or disease necessitating a special diet.
* Malnutrition, as diagnosed by body mass index \< 18.5 kg/m2.
* Body weight loss of \>10% BW within 6 months.
* Presence of frailty (as assessed by the presence of at least three out of five criteria according to Fried et al., 2001: unintentional weight loss, self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity).
* Individual unable to give informed consent.
* Volunteers showing previously unrecognized illness will also be excluded.
B: Inclusion Criteria:

* Multiple risk factors:

  * diabetes,
  * age =\> 65 years,
  * male sex,
  * hypertension,
  * hypercholesterolemia,
  * smoking,
  * obesity,
  * family history of premature cardiovascular disease;
* Previous manifestations of atherosclerotic disease (ischemic stoke, transient ischemic attack \[TIA\], peripheral artery disease, previous arterial revascularisation procedures, angina pectoris)

Exclusion Criteria:

* Contraindications (known allergies to n-3 PUFA) or indications (previous myocardial infarction) for the treatment with n-3 PUFA
* Serious comorbidity with an unfavourable prognosis over the short term
* Expected non compliance over a long period of time
* Pregnancy
C: Inclusion Criteria:

* Diagnosis of definite NASH
* Patients with diabetes taking stable doses of anti-diabetic agents are eligible
* No significant concomitant medical illness

Exclusion Criteria:

* Diagnosis of cirrhosis.
* Serum ALT \> 300 U/L
* Use of drugs associated with steatohepatitis
* Use of the following anit-NASH agents:

  1. Vitamin E \> 60 IU per day
  2. Omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements \> 200 mg per day
  3. Thiazolidinediones (e.g. pioglitazone)
* Use of non-stable doses of the following anti-NASH agents: HMGCoA reductase inhibitors (statins), fibrates, probucol, ezetimibe, ursodiol (UDCA), taurine, betaine, N-acetylcysteine, s-adenosylmethionine (SAM-E), milk thistle, anti-TNF therapies, or probiotics.
* Other liver disease
D: Inclusion Criteria:

* 63 to 79 years old
* healthy men and women
* able to attend clinic at a study sites

Exclusion Criteria:

* illiteracy or inability to understand the protocol
* unable to undergo neurophysiological tests
* morbid obesity (BMI greater than or equal to ≥ 40 kg/m2)
* uncontrolled diabetes (HbA1c\>85)
* uncontrolled hypertension
* prior cerebrovascular accident
* any relevant psychiatric illness, including major depression
* advanced cognitive deterioration, dementia
* other neurodegenerative diseases (i.e. Parkinson's disease)
* any chronic illness expected to shorten survival (heart, liver, cancer, etc)
* bereavement in the first year of loss
* bad dentures unless fixable dental prostheses are used
* allergy to walnuts
* customary us of fish oil or flaxseed oil supplements
* eye related exclusion criteria

Answer: B