Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects

Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is
outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this
posting.

For LOV111818/OM6X - Subjects were included in the study if they had met all relevant
inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6
and completed Study LOV111858/OM6 to Week 8.

FYI - entry criteria for LOV111818/OM6 (double-blind study)

Inclusion Criteria:

- Men and women ages 18-79 years, inclusive

- Current therapy with a statin drug

- Triglyceride levels between 200 and 499 mg/dL

- Normally active and in good health on the basis of medical history, brief physical
examination, electrocardiogram, and routine laboratory tests

- Provide written informed consent and authorization for protected health information
disclosure

Exclusion Criteria:

- Sensitivity to statin drugs or omega-3 fatty acids

- Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia

- Unexplained muscle pain or weakness

- History of pancreatitis

- Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or
cancer (except non-melanoma skin cancer)

- Poorly controlled diabetes, or receiving insulin therapy

- Pregnant or lactating females. Women of childbearing potential who are not using a
medically approved method of contraception.

- Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic,
antifungal and antiviral drugs, and cardiac drugs

- Use of warfarin (Coumadin)