Visit | Baseline 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 |
---|---|---|---|---|---|
Month | 0 | 3 | 6 | 9 | 12 |
Informed Consent | x | Â | Â | Â | Â |
Demographic data | x | Â | Â | Â | Â |
Medical history | x | Â | Â | Â | Â |
In- and exclusion criteria | x | Â | Â | Â | Â |
Randomization | x | Â | Â | Â | Â |
Endpoints | Â | x | x | x | x |
Weight | x | x | x | x | x |
Waist-hip ratio | x | Â | Â | Â | x |
Ankle-Brachial Index | x | Â | Â | Â | x |
RR and HR in sitting position | x | x | x | x | x |
RR 30 minutes Dynamap | x | Â | x | Â | x |
Smoking habit | x | x | x | x | x |
Medication use | x | x | x | x | x |
Three monthly Laboratory evaluationa | x | x | x | x | x |
Annual Laboratory evaluation b | x | Â | Â | Â | x |
ECG | x | Â | Â | Â | x |
PWV (Proportion of patients) | x | Â | Â | Â | x |
Carotid-IMT (Proportion of patients) | x | Â | Â | Â | x |
Questionnaires c | x | Â | Â | Â | x |