Baseline/Inclusion | Telephone call 1 week ± 3 days | Telephone call 2 weeks ± 3 days | Visit 1 month ± 5 days | Visit 12 months ± 2 weeks | |
---|---|---|---|---|---|
Written informed consent | X | ||||
Inclusion /Exclusion criteria | X | ||||
Allocation of code number | X | ||||
Medical history | X | ||||
Demographics | X | ||||
Weight/length/BMI | X | ||||
Physical examination | X | ||||
NeBoP score | X | ||||
House-Brackmann grading scale (HBGS) | X | X | X | ||
Sunnybrook grading system (SFGS) | X | X | X | ||
Concomitant medication | X | X | X | ||
Initiation of study treatment | X | ||||
Compliance with study drug | X | X | |||
Reporting of Adverse Events (AE) | X | X | X | X | |
Return of bottles of study drug | X | ||||
Facial disability index (FDI) | X | X | |||
Facial Clinimetric Evaluation (FaCE) Scale | X | X | |||
Synkinesis Assessment Questionnaire (SAQ) | X |