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Table 1 Entry and exclusion criteria
| Entry criteria | |
|---|---|
| Japanesess | |
| Type 2 diabetes mellitus | |
| Age ≥ 20 years | |
| Using atorvastatin 10 mg/day or pitavastatin 1 mg/day for > 1 month | |
| LDL-C ≥ 120 mg/dL for patients without CAD , LDL-C ≥ 100 mg/dL for patients with CAD | |
| Exclusion criteria | |
| Pregnant, possible to become pregnant, or brest-feeding to baby(s) | |
| Hypersensitive to the medicines concerned | |
| Liver dysfunction | |
| HbA1C ≥ 9.4% | |
| Serum creatinine ≥ 2.0 mg/dL | |
| Triglyceride ≥ 400 mg/dL | |
| Secondary dyslipidemia, drug-induced dyslipidemia | |
| Homozygotic familial hypercholesterolemia | |
| Other non-specific reason, such as poor adherence |
