Please select the eligibility criteria that correspond to the clinical trial below.
Title: LungVITamin D and OmegA-3 Trial
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.


Options:
A: 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.
B: 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
C: Inclusion Criteria:

* Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI)
* Ability to take Ω-3-FAE or olive oil without risk
* Informed consent

Exclusion Criteria:

* Premenopausal women who are not surgically sterile, who are pregnant or nursing, who are of child-bearing potential and are not practising acceptable means of birth control (pregnancy testing required before randomisation)
* Known hypersensitivity to study medication
* Dislike of fish oil
* Haemorrhagic diathesis
* Unwillingness to discontinue other medications containing fish oil
* Legal incapacity
* History of drug or alcohol abuse within 6 months
* Any investigational therapy within one month of signing informed consent form
D: * This study is open to all VITAL participants (NCT 01169259). Population includes men 50 years of age or older and women 55 years of age or older in the United States
* Participants who live in selected metropolitan areas of the U.S. (where we set up the infrastructure for clinic or home visits), are eligible for pulmonary function measurements.

Answer: D