Table 1.
Calendar summary
| Period | Pre-selection | Inclusion | Follow-up | End of the study |
|---|---|---|---|---|
| Week (W) | W0 | W12 | W24 | |
| Pre-inclusion criteria | X | |||
| Inclusion/Non-inclusion criteria | X | |||
| Informed consent | X | |||
| Inclusion clinical examination | X | |||
| Analysis of posture and gait | X | X | X | |
| Assigning a 'Patient's kit'according to inclusion number in compliance with randomization lists | X | |||
| Serum 25OHD measurement | X | X | X | |
| Serum calcium measurement | X | X | X | |
| Serum parathyroid hormone measurement | X | X | X | |
| Treatment administration | X | |||
| Compliance (account of fully consumed vials) | X | X | ||
| Follow-up clinical examination | X | X | ||
| Cognitive scores (including ADAS-cog) | X | X | X | |
| Functional scores | X | X | X | |
| AEs and SAEs | X | X | X | |