Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Brief Summary: The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.


Options:
A: Inclusion Criteria:

* aged ≥18 years
* able to provide informed consent
* had confirmed HIV infection
* on ART including atazanavir 300 mg and ritonavir 100 mg each day in the regimens that were not changed within 12 weeks before the randomization
* patients who had cholesterol level between 200 and 500 and LDL between 130 and 400 mg/dL without any lipid-lowering agent or discontinued the lipid-lowering agent at least 1 month prior to randomization

Exclusion Criteria:

* had the history of pitavastatin and/or the constituent of the drugs allergy
* known history of myocardial infarction and/or ischemic stroke within 1 month prior to the randomization that would be endangered if we stopped the previous lipid-lowering agent before the enrollment
* abnormal AST and ALT with level ≥5 times in asymptomatic patients or ≥3 times of upper normal limit (UNL) in symptomatic patients
* pregnancy or breastfeeding
* on cyclosporine which had major drug interactions with pitavastatin
* patients who denied to join the study
B: Inclusion Criteria:

* Males and postmenopausal females (aged 65 years and older
* Eligible, able to participate, have given informed consent
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia
* Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
* Agree to be available

Exclusion Criteria

* Homozygous familial hypercholesterolemia
* Conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus (HbA1c \>8%).
* Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
* History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
* Liver injury
* Impaired renal function
* Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
* Serum CK \>5 x ULRR without clinical explanation
* Uncontrolled hypothyroidism defined as TSH \>ULRR
* Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
* Major surgery, 3 months prior to Visit 1
* Significant CVD prior to randomization
* Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of \> 100 beats per minute at rest.
* Left ventricular ejection fraction \<0.25;
* History of symptomatic cerebrovascular disease
* Any other conditions at the discretion of the investigator
* Known HIV infection
* Poorly controlled or uncontrolled hypertension
* Prior or current known muscular or neuromuscular disease of any type;
* Neoplastic disease
* Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
* Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
* Current or recent use of supplements known to alter lipid metabolism
* History of hypersensitivity to other HMG-CoA reductase inhibitors;
* Concomitant medication not permitted
* Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
* Excessive obesity
* Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.
C: Inclusion Criteria:

* Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.
* Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age \>40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception
* Documented HIV infection.

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Any conditions that may cause secondary dyslipidemia
* History of coronary artery disease (CAD) or CAD equivalent
D: 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

Answer: D