4. Evidence of pre-existing well-controlled blood glucose, blood pressure or LDL-cholesterol (as evidenced by HbA1c < 7.0%, SBP < 130 mmHg, LDL-cholesterol < 100 mg/dl [LDL-cholesterol < 70 mg/dl with history of CVD event]) obtained from screening within a period not exceeding 28 days (4 weeks) prior to randomization