Table 1.
Visit schedule
| V0 | V1 | V2 | V2 | V4 | V5 | V6 | |
|---|---|---|---|---|---|---|---|
| 0 m | 1.5 m | 3 m | 6 m | 9 m | 12 m | 13 m | |
| Inclusion/exclusion criteria | X | ||||||
| Informed consent | X | ||||||
| Clinical history | X | X | X | X | X | ||
| Concomitant medication | X | X | X | ||||
| Physical exam | X | X | X | ||||
| Heart rate and blood pressure | X | X | X | ||||
| Haemogram and biochemistry | X | X | X | ||||
| Chest roentgenogram | X | X | |||||
| ECG | X | X | X | ||||
| Calcidiol and calcium determination | X | ||||||
| Biological samples | X | X | X | ||||
| Cardiac MRI | X | X | |||||
| Echocardiogram | X | X | |||||
| Endothelial function* | X | X | |||||
| Dispense study medication/collect empty blisters | X | X | X | ||||
| Compliance check | X | X | X | X | X | ||
| Adverse events | X | X | X | X | X | X |
,.
*Only in Fundación Jiménez Díaz (FJD).