A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease

Inclusion Criteria:

1. Either gender (tentatively 50 percent females to be included and if of childbearingpotential she must agree to use medically acceptable methods of contraception from thetime of signing the informed consent until 7 days following administration of the lasttreatment or dose of study medication). Accepted contraceptive methods are implants,injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.

2. between 18 (inclusive) and 80 years

3. With mixed dyslipidemia with fasting lipid results of a blood sample taken atinclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):

• TG higher than/equal to 1.71 mmol/L (higher than/equal to 150 mg/dL) and

• LDL-C higher or equal to 1.81 mmol/L (higher or equal 70 mg/dL) but smallerthan/equal to 3.36 mmol/L (smaller than/equal to 130 mg/dL)

4. High risk or very high risk based on known CardioVascular Disease (CVD) or type 2diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary RiskEstimation (SCORE) chart risk ≥ 5percent

5. Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2times the Upper Normal of Limit (UNL)

Exclusion Criteria:

1. Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxicreactions under treatment with fibrates or ketoprofen or known allergic reactionscaused by peanuts, peanuts or arachis oil or soy lecithin, or related products,

2. Pregnant or lactating women,

3. Unable or unwilling to comply with the protocol and the recommended diet,

4. Likely to withdraw from the study before its completion,

5. Having received an investigational drug or vaccine in the last 30 days before date ofinclusion, or still participating in such a trial at Visit 1