Table 2 Key practical aspects of the study with all the clinical visits and the requested exams

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