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Table 2 Key practical aspects of the study with all the clinical visits and the requested exams
| Visits | Screening | Visit 1 | Visit 2 | Visit 3 |
|---|---|---|---|---|
| Weeks | −1 | 1 | 4 | 12 |
| Informed consent | X | |||
| Inclusion and exclusion criteria | X | X | ||
| Medical history | X | |||
| Medical evaluation/physical examination | X | X | X | X |
| Randomization | X | |||
| Pregnancy test | X | |||
| Creatinine | X | X | ||
| Fasting glucose | X | X | X | |
| Ultrasensitive C-reactive protein | X | X | ||
| Total cholesterol | X | X | ||
| High-density lipoprotein cholesterol | X | X | ||
| Triglycerides | X | X | ||
| Glycated hemoglobin | X | X | ||
| Alanine aminotransferase | X | X | ||
| Microalbuminuria | X | X | ||
| Ambulatory blood pressure monitoring | X | X | ||
| Treadmill test | X | |||
| Determination of the central aortic pressure and vascular stiffness markers | X | X | ||
| Endothelium function | X | X |
