Please select the eligibility criteria that correspond to the clinical trial below.
Title: Vitamin D and Omega-3 Trial (VITAL)
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL) is a 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. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.


Options:
A: To be eligible for the study, respondents had to, at study entry,:

1. be men aged 50 or older or women aged 55 or older;
2. have no history of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, coronary-artery bypass grafting, or percutaneous coronary intervention;
3. have none of the following safety exclusions: history of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or granulomatosis with polyangiitis (Wegener's);
4. have no allergy to fish or soy;
5. have no other serious illness that would preclude participation;
6. be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D \[e.g., Fosamax Plus D\], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
7. be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
8. not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
B: Inclusion Criteria:

* Greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline visits (Same signs must be present at Screening and Baseline visits): Conjunctival staining present greater than or equal to 1 (out of possible score of 6 per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7 seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes.
* Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.
* Symptoms of DED for greater than or equal to 6 months.
* Use of or desire to use artificial tears at least 2 times per day in preceding 2 weeks.
* Ability to swallow large, soft gelcaps

Exclusion Criteria:

* Allergic to ingredients in supplements or placebo
* Contact lens wear
* Pregnant, nursing, or lactating
* Current ocular infection, inflammation, or acute allergic conjunctivitis
* History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery, use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation, hemophilia or bleeding tendencies
* Currently on anticoagulation therapy
* Eyelid abnormalities or extensive ocular scarring
* Use of EPA/DHA supplements in excess of 1200 mg per dayi
* Current use, insufficient washout period, or intent to change specific treatments for dry eye disease
C: Inclusion Criteria:

* Men and women age \>70 years
* Self-reported difficulty walking ¼ of a mile or climbing a flight of stairs
* Walking speed \<1 meters per second and \>0.44 meters per second on the 4 meter walk at usual pace. A walking speed of \<0.44 meters per second would not be compatible with completing the 400 meter walk in 15 minutes. (In the pilot phase we explore the feasibility of recruiting at least 50% of participants who have a baseline walking speed of \<0.80 meters per second and \>0.44 meters per second)
* Able to complete the 400 meter walk test within 15 minutes without sitting or the help of another person and without a walker, a cane is allowed
* Blood level IL-6 \>2.5 pg/ml and \<30 pg/ml.
* Willingness to be randomized to the intervention groups

Exclusion Criteria:

* Failure or inability to provide informed consent
* Lives in a nursing home; persons living in assisted or independent housing are not excluded
* Self-reported inability to walk one block
* Significant cognitive impairment, defined as a known diagnosis of dementia, or a Mini-Mental State Exam (MMSE) score \<24 (\<23 for racial/ethnic minorities or participants with less than 9 years of education)
* Unable to communicate because of severe hearing loss or speech disorder
* Neurological conditions that are causing impaired muscle function or mobility (may include stroke with residual paresis, paralysis, neuropathy, Parkinson disease, or multiple sclerosis)
* Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, known active inflammatory or autoimmune disease (e.g. rheumatoid arthritis, lupus, Crohn's disease, HIV)
* Terminal illness with life expectancy less than 12 months
* Severe pulmonary disease, requiring either steroid pills or injections
* Other significant co-morbid disease that in the opinion of the field center PI would impair ability to participate in the trial, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia), excessive alcohol use (\>14 drinks per week); drug addiction; treatment for cancer (radiation or chemotherapy) within the past 1 year; or other conditions
* Lives outside of the study site or is planning to move out of the area in next 1 year or leave the area for \>3 months during the next year
* Exclusion criteria that apply only to those who receive losartan:

  * Intolerance or allergy to Angiotensin II Receptor Blockers (ARBs)
  * Known bilateral renal artery stenosis or liver cirrhosis
  * Hypotension Systolic Blood Pressure\<110 or Diastolic Blood Pressure\<60 mmHg
  * Serum potassium ≥5.0 mEq/L
  * Use of lithium salts
  * eGFR \<15
  * Congestive heart failure with ejection fraction \< 40%
* Exclusion criteria that apply only to those who receive ω-3:

  * Intolerance or allergy to ω-3 or fish/shellfish
  * Fatty fish intake \>2 servings per week on average
  * History of paroxysmal or persistent atrial fibrillation
* To maintain blinding, those who are not eligible to receive any active treatment (ω-3 or losartan) are excluded

Temporary exclusion criteria

* Myocardial infarction, coronary artery bypass grafting (CABG), or valve replacement within past 6 months;
* Pulmonary embolism or deep venous thrombosis within past 6 months;
* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
* Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
* Physical therapy for gait, balance, or other lower extremity training within the past 2 months;
* Severe hypertension, e.g., Systolic Blood Pressure \> 200, or Diastolic Blood Pressure\> 110 mmHg;
* Hemoglobin \<10 g/dL
* Participation in another intervention trial within 3 months; participation in an observational study may be permitted;
* Current smoking (within 6 months),
* Acute infection (urinary, respiratory, other) or hospitalization within 1 month
* Exclusion criteria that apply only to those who receive losartan:

  * Use of Angiotensin-Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) within 2 months
  * Use of aliskiren within 2 months in patients with type 2 diabetes or renal impairment with Estimated Glomerular Filtration Rate (eGFR)\<60
  * Use of potassium sparing diuretics, other medications with potassium sparing properties (such as but not limited to spironolactone or eplerenone) potassium supplements, and salt substitutes containing potassium within 1 week
  * Transaminases \>twice upper limit of normal to exclude participants with impaired liver function
* Exclusion criteria that apply only to those who receive ω-3:

  * Use of ω-3 within 2 months
D: 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

Answer: A