 - Use of statin therapy where doses are greater than those defined as low-dose within 4 weeks prior to screening; where low-dose is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg. 