Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Test the Safety and Efficacy of Lipitor (Atorvastatin) in Reducing the Progression of Carotid IMT in Early Childhood SLE
Brief Summary: The purpose of this study is:

1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood.
2. To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvastatin.
3. To further characterize the course of SLE in children and young adults, by establishing a cohort of pediatric SLE patients to be followed prospectively.
4. To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).


Options:
A: Inclusion Criteria:

* Statin-naive (i.e., has never taken statins before)

Exclusion Criteria:

* Previous use of statins
* Current treatment with cholesterol- or triglyceride-lowering drugs
* Impaired liver or kidney function
* Untreated hypothyroidism or hyperthyroidism
* Treatment with other medications known to increase risk of myopathy in atorvastatin-treated patients (e.g., cyclosporine, azithromycin, erythromycin, azole antifungals, fusidic acid)
* Existing infection requiring treatment with antibiotic therapy
* Consumption of greater that 1 quart of grapefruit juice per day
* Documented history of neuroleptic malignant syndrome
* Inherited muscle disorders or myopathy
* Known sickle cell trait
* Cancer within the 5 years prior to study entry
* Diabetes
* Currently being treated for high blood pressure
* Coronary artery disease
* Peripheral vascular disease
* Physical disability or previous injury that prevents safe exercise testing
* Pregnant or breastfeeding
B: Inclusion Criteria:

* Patients with a clinical diagnosis of SLE, confirmed by a faculty rheumatologist at Johns Hopkins.
* Patients must be 18 years of age or older
* Give informed consent.

Exclusion Criteria:

* SLE patients with a known atherosclerotic event, such as angina, myocardial infarction, or stroke, with an abnormal lipid profile for which a statin would be standard of care, are excluded.
* Pregnant patients (or patients planning to become pregnant in the next two years) are excluded.
* Patients who have known chronic liver disease, have unexplained elevation of their liver enzymes greater than 2 times the upper limit of normal , or an elevated CPK greater than 1.5 times the upper limit of the normal value for the patient's racial group, are excluded.
* Patients with triglycerides greater than 500 mg/dl or LDL greater than 190 in the absence of 2 risk factors (and who are unwilling to participate in a formal nutritional/lifestyle modification program that we recommend for them) are excluded.
C: Inclusion Criteria:

* Male or female 18 to 65 years of age.
* Weight\> 50 kg and \<95 kg inclusive
* For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day 1.
* For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant during the full duration of the study.
* Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
* Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria:

* Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
* Pregnant or breast-feeding females.
* Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
* Hospitalization for any reason within 60 days of screening.
* Known history of Human Immunodeficiency Virus (HIV) antibody; and/or positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit.
* Previous exposure to any therapeutic or investigational biological agent.
* History of alcohol or substance abuse within previous 5 years.
D: Inclusion Criteria:

* Meets American College of Rheumatology (ACR) revised diagnostic guidelines for SLE
* Weight of 25 kg (55 lbs) or more
* Outpatient
* Ability to complete self-report questionnaires in either English or Spanish
* Willingness to comply with recommended diet
* Acceptable methods of contraception

Exclusion Criteria:

* Drug-induced lupus
* Liver disease (ALT or aspartate aminotransferase greater than 2 X normal value)
* Myositis (CK greater than 3 X normal value)
* Inability to obtain adequate-quality IMT images
* Current use of oral or parenteral tacrolimus or cyclosporine
* Dialysis or serum creatinine reater than 2.5 mg/dL
* Active nephrotic syndrome (urinary protein greater than 3 g/24 h and serum albumin less than 2.3 g/dl)
* Total cholesterol greater than 350 mg/dL
* Xanthoma
* Familial hypercholesterolemia
* Pregnant or breastfeeding
* Use of estrogen-containing contraceptives (e.g., Lo-Ovral)
* Unable to adhere to study regimen
* Life-threatening non-SLE illness that would interfere with ability to complete the study
* Current drug or alcohol abuse
* Anticipated poor compliance
* Participation in another drug intervention study within 30 days of study enrollment

Answer: D