Period | Inclusion | Treatment | Follow-up | ||||
---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Menstrual cycle | 0Â month | 1 | 2 | 3 | 4 | 5 | 6 |
Patients | √ |  |  |  |  |  |  |
Inclusion and exclusion criteria | √ |  |  |  |  |  |  |
Informed consent | √ |  |  |  |  |  |  |
Physical examination | √ |  |  | √ |  |  |  |
Medical history | √ |  |  |  |  |  |  |
Comorbidities | √ | √ | √ | √ | √ | √ | √ |
VAS | √ | √ | √ | √ | √ | √ | √ |
EHP-30 | √ |  |  | √ |  |  | √ |
MPI | √ |  |  | √ |  |  | √ |
BDI and POMS | √ |  |  | √ |  |  | √ |
PGIC | √ |  |  | √ |  |  | √ |
Pain diary | √ | √ | √ | √ | √ | √ | √ |
Patient compliance |  |  |  | √ |  |  | √ |
Reasons for dropout or withdrawal |  |  |  | √ |  |  | √ |
Adverse events |  |  |  | √ |  |  |  |
Safety evaluation |  |  |  |  |  |  | √ |