| PROCÉDURE |
D-7 |
D0 |
D28 |
D84 |
D168 |
| Informed Consent |
X |
|
|
|
|
| medical history |
X |
X |
|
|
|
| Pregnancy Test |
X |
|
|
X |
X |
| HIV test |
X |
|
|
|
|
| Randomization |
|
X |
|
|
|
| clinical examination |
X |
X |
X |
X |
X |
| Evaluation of Adverse Events |
|
|
X |
X |
X |
| Laboratory tests |
X |
X |
X |
X |
X |
D-7: seven days of the inclusion
D0: day of inclusion
D28: twenty eighth day of monitoring
D84: eighty-fourth day of monitoring (third month follow-up)
D168: eight hundred and sixty days of follow-up (sixth month of follow-up) |
