Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
Brief Summary: This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).


Options:
A: 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
B: Inclusion Criteria:

1. Patients must have an age range between 18 to 65 years (inclusive).
2. Patients with fatty liver confirmed by ultrasound.
3. Patients must meet the criteria for impaired glucose regulation or type 2 diabetes mellitus (FPG ≥ 5.6 mmol/L and/or a two hour glucose value ≥ 7.8 mmol/L).
4. Course of diabetic mellitus no more than 1 years
5. Diabetic patients have not received anti-diabetic drugs, including insulin, biguanides, sulfonylureas, thiazolidinediones, Alpha-glucosidase inhibitors, or glinides for 4 weeks before the time of enrollment
6. Patients have not received lipid-regulating drugs (statins, fibrates)for 4 weeks before the time of enrollment
7. Blood pressure \< 160/100 mmHg,after receiving lifestyle therapy and effective anti-hypertensive drugs.
8. Patients must stopped other drugs medications for four weeks prior to entering the treatment period, such as: silybin, ursodeoxycholic acid, Polyene Phosphatidylcholine, vitamin E, some herbs with effect of regulating lipid and protecting liver function, etc.
9. Liver fat content(LFC) assessed by 1H MRS ≥ 13%(LFC was calculated by dividing the integral of the methylene groups in fatty acid chains of the hepatic triglycerides by the sum of methylene groups and water).

Exclusion Criteria:

1. Any causes of chronic liver disease other than NAFLD (such as - but not restricted to - alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, etc.);
2. Patients with significantly impaired liver function: ALT or AST ≥ 2 times upper limit of normal;
3. HBsAg (+) and/or HCV-Ab (+);
4. Patients with type 1 diabetes mellitus or gestational diabetes or special type diabetes, and patients with BMI \< 22 Kg/m2;
5. Course of diabetes more than 1 years;
6. Diabetics patients who have taken or are taking oral glucose-lowering drugs or insulin;
7. Diabetics patients with a HbA1c \> 7.5% on initial visit;
8. Patients with severe diabetes complications (diabetes ketoacidosis, diabetes coma or with symptomatic of diabetes coma; dysfunction of nerve, retinopathy, dysfunction of kidney）;
9. Patients with serum creatinine ≥ 1.5 mg/dL (133 umol/L);
10. Patients with a history of clinically significant heart disease (myocardial infarct, heart failure, and or severe cardiac rhythm);
11. Complicating severe infection, within 6 months after operation, severe trauma;
12. Patients with excess alcohol consumption≥140g/week(male); ≥ 70g/week(female);
13. Patients have participated other clinical trials within 24 weeks;
14. Patients with a history of drug allergy to TZDs and berberine;
15. Patients wth gestation or possible gestation or lactation, or males or females who expecting gestation during clinical trial;
16. Mental diseases patients;
17. Those who refuse to sign informed consent;
18. Any other conditions, which, in the opinion of the investigators would impede competence or compliance or possibility of hindering completion of the study;
19. Patients with serum triglyceride ≥ 5.0 mmol/L;
20. Patients with thyroid disease, including hyperthyroidism or hypothyroidism.
C: Inclusion Criteria:

* age 6-12
* parents or tutors able to give the written consent and follow the study procedures Value of BMI\>90°

Exclusion Criteria:

* - Any severe or concomitant clinical or psychiatric condition that, in the investigator's opinion, could affect the treatment, the evaluations and the inclusion in the protocol;
* Evidence of active liver disease due to other causes;
* Steroid treatment; immuno suppressive therapies, chemotherapy agents within 2 month from screening;
* Pregnancy or breastfeeding;
* Abuse of alcohol and drugs clinically relevant;
* Diabetes.
D: Inclusion Criteria:

* Patient diagnosed with type 2 diabetes based on American Diabetes Association (ADA) definition or who only take oral antidiabetic drug.
* CAPscore \>263

Exclusion Criteria:

* Criteria:

  * Taking any kind of antibiotics two weeks before recruitment;
  * History of alcohol consumption ;
  * pregnancy or lactation;
  * Professional athletes;
  * Other liver disease (viral/etc);
  * High dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs;
  * A history of Cardiovascular disease;
  * Renal disease, Celiac disease, Cirrhosis;
  * History of Upper Gastrointestinal surgery ;
  * A history of hypothyroidism or Cushing's syndrome;
  * History of drug dependence;
  * Body mass index (BMI) ≥35 kg/m2;
  * A restrictive diet or weight change ≥ 5 kg during the 3 months prior to study;
  * Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
  * Use of weight loss medications

Answer: A