Please select the eligibility criteria that correspond to the clinical trial below.
Title: A RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, PARALLEL GROUP STUDY OF PITAVASTATIN 4 MG VS. PRAVASTATIN 40 MG IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
Brief Summary: Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.


Options:
A: Inclusion Criteria:

* Males and females (18-75 years)
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

* Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
* Conditions which may cause secondary dyslipidemia.
* Uncontrolled diabetes mellitus (by hemoglobin A1c \[HbA1c\] \> 8%)
* Abnormal serum creatine kinase (CK) above the pre-specified level
* Abnormal pancreatic, liver or renal function
* Significant heart disease
B: Inclusion Criteria:

* Patient aged ≥ 20 years old and \< 75 years old.
* Patient who was eligible and able to participate in the study and accepts to enter the study by signing written informed consent.
* Patient with fasting LDL-C \> 100 mg/dL. The concentration of LDL-C is obtained from laboratory examination.
* Patient with at least one of the following description (NCEP ATP III guideline).
* Female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.

Exclusion Criteria:

* Patient who has participated in other investigational studies within 3 months.
* Patient took medication and natural health foods known to alter blood lipid profiles within 4 weeks.
* Patient is taking any medication or food that is prohibited by the study.
* Patient taking Amiodarone will be excluded from this study (due to long half life of this medication).
* Patient is diagnosed with type 1 DM or has been using insulin/insulin analog medication.
* Patient with a history of multiple drug allergies or with a known allergy to HMG-CoA reductase inhibitors.
* Patient with TG \> 400 mg/dL.
* Excessive obesity defined as BMI above 35 kg/m2.
* Cerebral vascular disease (including cerebrovascular hemorrhage or ischemia, transient ischemic attack) diagnosed within 3 months.
* Myocardial infarction, heart failure (NYHA class III or IV), gross cardiac enlargement (cardiothoracic ratio \> 0.5), significant heart block or cardiac arrhythmias within 3 months; history of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardia, pacemaker or implantable cardiac device were not eligible for this study.
* Patient with advanced renal disorder (Serum creatinine levels ≥ 2 mg/dL and BUN ≥ 25 mg/dL).
* Patient with advanced hepatic disorder (AST or ALT level ≥ 100 IU/L)
* Patient with CK level \> 5 × ULRR at any time point between Visit 1 and Visit 2.
* Patient with poorly controlled diabetes mellitus (HbA1c \> 9.0%) or patient with severe hypertension (\> 180 mmHg for systolic or \> 120 mmHg in diastolic blood pressure).
* Patient with hypothyroidism, hereditary muscular disorders, family history of the above or history of drug-induced myopathy.
* Patient has significant alcohol consumption (\> 65 mL pure alcohol) within 48 hours before Visit 2.
* Any major surgery within 3 months prior to Visit 2.
* Female patient who is lactating, being pregnant or plans to become pregnant.
* Patient with conditions judged by the investigator as unsuitable for the study.
C: Inclusion Criteria:

* Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent
* Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Any conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus
D: Inclusion Criteria:

* Hypercholesterolemic patients

Exclusion Criteria:

* Patients receiving lipid-lowering agents
* Familial hypercholesterolemia
* Renal disease
* Diseases of liver, gallbladder and bile ducts
* Pregnant women

Answer: C