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:

* Men and women, ages \>18
* Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL
* Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant
* Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects
* History of pancreatitis
* History of bariatric surgery or currently on weight loss drugs
* Uncontrolled hypertension (BP \> 160/100)
* HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin
* Consumption of more than 2 alcoholic beverages per day
* History of cancers (except if been disease free for \>5 years OR history was basal or squamous cell skin cancer)
* Participation in another clinical trial involving an investigational agent in the last 30 days
* Other parameters will be assessed at the study center to ensure eligibility for this study.
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:

* 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
D: Inclusion Criteria:

* Clinical evidence of heart failure according to the European Society of Cardiology guidelines (New York Heart Association class II-IV) (32)
* Any left ventricular Ejection Fraction (EF) measured within 3 months from enrolment (if EF% \>40%, at least 1 hospital admission for Congestive Heart Failure(CHF) in the previous year)
* No age limits
* Any etiology
* Informed consent (obtained before any study specific procedure)

Exclusion Criteria:

COMMON EXCLUSION CRITERIA (R1=n-3 PUFA vs placebo and R2=rosuvastatin vs placebo):

* Acute Myocardial Infarction, unstable angina or revascularization procedure within 1 month;
* planned cardiac surgery, expected to be performed within 3 months;
* congenital or primary valvular etiology;
* known hypersensitivity to study treatments;
* significant liver disease;
* pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception;
* any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol;
* presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy;
* treatment with any investigational agent within 1 month before randomization;
* patients already on treatment with n-3 PUFA or statin for whom the prescription is confirmed.

EXCLUSION CRITERIA FOR R2 (statin hypothesis):

* current serum creatinine level \>2.5 mg/dL;
* current ALT, AST level \>1.5 times the upper normal limit;
* current CPK upper normal limits.

Answer: B