Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg/Day When Added to Ongoing Therapy With a Statin Versus Statin Therapy Alone, in Patients With Hypercholesterolemia Who Have Not Reached National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Target LDL-Cholesterol Level
Brief Summary: The purpose of this 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.


Options:
A: Inclusion Criteria:

* Genotype-confirmed heterozygous familial hypercholesterolemia with written documentation of the genetic diagnosis at the time of screening and LDL-C \>=210 mg/dL (5.43 mmol/L), or clinical diagnosis of heterozygous familial hypercholesterolemia, defined as LDL-C \>=210 mg/dL (5.43 mmol/L) and at least one of the following:

  * tendinous xanthoma
  * child \<18 years of age with hypercholesterolemia (LDL-C \>159 mg/dL (4.11 mmol/L)
  * has a sibling with hypercholesterolemia (LDL-C \>190 mg/dL \[4.91 mmol/L\]) and tendinous xanthoma
  * family history with an LDL-C value distribution pattern compatible with dominant autosomal transmission and at least one relative presenting fasting total cholesterol values \>348 mg/dL (9.0 mmol/L) after exclusion of secondary causes of dyslipidemia
* LDL-C \>=210 mg/dL (5.43 mmol/L) 1 week before randomization
* plasma triglyceride level \<=400 mg/dL (4.52 mmol/L)

Exclusion Criteria:

* pregnancy or any other situation, condition, or illness that, in the opinion of the investigator, may interfere with optimal participation in the study
* presence of an apolipoprotein B gene mutation with confirmed absence of an LDL receptor mutation in either allele
* undergoing LDL-apheresis or plasma apheresis
* unsuitable plaque or artery morphology
* use of certain drugs, foods, or other agents known to alter cholesterol levels or to cause pharmacokinetic interactions with either ezetimibe or simvastatin
B: Inclusion Criteria:

* Male and female subjects, ≥ 30 years old with either known atherosclerotic coronary or vascular disease OR coronary risk equivalents defined as either:

  * diabetes mellitus,
  * multiple coronary risk factors with a Framingham Risk Score \> 2% per year, or
  * an elevated coronary calcium score (\> 400 for men, \> 200 for women)
* Currently being treated with a statin (Simvastatin 20 mg/d or its equivalent) as monotherapy for treatment of hyperlipidemia
* Recent lipids (within the past 3 months without interval change in the statin regimen) showing both: LDL-C \< 100 mg/dL and HDL-C \< 50 mg/dL (men) or \< 55 mg/dL (women)

Exclusion Criteria:

* Current use of or known intolerance to niacin or ezetimibe
* Known history of liver disease (cirrhosis, chronic hepatitis) or abnormal liver associated enzymes, \> 3x the upper laboratory reference value
* Enrollment in another drug or device research protocol
* Females who are pregnant, expect to get pregnant during the course of the study, or are breastfeeding
C: Inclusion Criteria:

* Male or female ≥ 18 to ≤ 80 years of age
* National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less
* Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and \<190 mg/dL
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

* History of coronary heart disease
* New York Heart Association (NYHA) III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
* Uncontrolled hypothyroidism or hyperthyroidism
D: Inclusion Criteria:

* High cholesterol levels that are identified by specific laboratory values

Exclusion Criteria:

* Active liver disease
* Any condition or situation which would interfere with participation

Answer: D