Please select the eligibility criteria that correspond to the clinical trial below.
Title: Alpha Omega Trial: A Randomised, Placebo Controlled, Double Blind Intervention Study of the Effect of Low Doses of Omega-3 Fatty Acids on Cardiovascular Diseases in Patients With a History of Myocardial Infarction
Brief Summary: The Alpha Omega Trial is a randomized, placebo-controlled, double-blind dietary intervention study in 4837 postmyocardial infarction patients in the Netherlands to examine whether incidence of cardiovascular diseases during 40 months of follow-up can be prevented by low doses of omega-3 polyunsaturated fatty acids. The key objectives are:

* to examine the effect of low-dose supplementation (400 mg/day) of eicosapentaenoic acid and docosahexaenoic acid on incidence of cardiovascular diseases; and
* to examine the effect of low-dose supplementation (2 g/day) of alpha-linolenic acid on incidence of cardiovascular diseases.


Options:
A: Inclusion criteria:

1. Steatohepatitis diagnosed on normal clinical grounds including in most cases liver biopsy and assessed by Kleiner scoring system to assess severity, with no known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B \& C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
2. Steatosis diagnosed by ultrasound, CT or magnetic resonance imaging who also have either diabetes and/or features of the metabolic syndrome, without evidence of known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B \& C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).

Liver biopsy or liver scan will be within 3 years of recruitment to the study. Age: men \& women \>18 years. Alcohol consumption \<35 units / week for women \<50 units / week for men).

Exclusion criteria:

* Decompensated acute or chronic liver disease, or harmful drinking (\> 35 u/week in women \> 50 u /week in men).
B: Inclusion criteria:

* Men and women
* Aged 60 through 80 y
* Verified clinically diagnosed myocardial infarction up to 10 y before randomization
* Written informed consent

Exclusion criteria:

* Living in a nursing home or other institution
* Participation in another scientific study
* Habitual margarine intake \< 10 g per day
* Habitual fish intake \> 150 g per day
* Habitual alcohol intake \> 6 drinks per day
* Use of fish oil capsules or other supplements containing omega-3 fatty acids
* Presence of cancer with \< 1 y of life expectancy
* Cognitive impairment, as indicated by the Mini Mental State Examination (score \<= 21)
* Unintended weight loss \> 5 kg in the past year
* Lack of facilities for cooled margarine storage at home
* Inability or unwillingness to comply with study procedures
C: Inclusion Criteria:

* Men and non-pregnant or sterile women ages 45 and older
* Hypertriglyceridemia
* On statin therapy for at least four weeks
* Either having established cardiovascular disease or at high risk for cardiovascular disease

Exclusion Criteria:

* Severe heart failure
* Any life-threatening disease other than cardiovascular disease
* Active severe liver disease
* Hemoglobin A1c \>10.0%
* Poorly controlled hypertension
* Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
* Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
* Known hypersensitivity to the study product, fish and/or shellfish, or placebo
* History of acute or chronic pancreatitis
* Patients are excluded if using the following medications:

  * PCSK9 inhibitors
  * niacin \>200 mg/day or fibrates;
  * any omega-3 fatty acid medications ;
  * dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
  * bile acid sequestrants
D: Inclusion Criteria:

1. NASH with NAS (NASH Activity Score) of \>4 evident on a biopsy performed within 6 months of enrollment.
2. Age 21 years or older.
3. BMI 25 or greater.
4. Ability to provide informed consent.

Exclusion Criteria:

1. Cirrhosis evident clinically or on biopsy.
2. Secondary forms of NASH such as that seen with bariatric surgery or medication induced from such medications as methotrexate, amiodarone, tamoxifen, corticosteroids.
3. Current or past history of diabetes or hyperlipidemia requiring specific drug therapy (see below).
4. Current use of a weight loss medicine, such as a 'fat-burner' or similar agent
5. Alcohol consumption \> 30 g/day, currently or for more than 3 consecutive months within 5 years.
6. Other liver disease (hepatitis C,B, Wilson's, autoimmune, ct-1-antitrypsin and hemochromatosis or HIV
7. Pregnancy or unwillingness to use an effective form of birth control for women of child bearing years.
8. Renal insufficiency (creatinine \> 2), symptomatic coronary, peripheral or neurovascular disease, symptomatic heart failure or advanced respiratory disease requiring oxygen therapy.
9. Inability to provide informed consent.
10. Any condition in the opinion of the primary investigator that would contraindicate the patient's participation.

Answer: B