Study week | Screening | Baseline | 1–11 wks | 12 wks | 13–23 wks | 24 wks |
---|---|---|---|---|---|---|
Informed consent | ● | |||||
Inclusion/exclusion criteria | ● | |||||
Demographics | ● | |||||
Concomitant disorders | ● | |||||
Medical history | ● | |||||
Medication | ● | |||||
Adverse events/vital signs | ● | ● | ● | ● | ● | |
Assessment | ||||||
Blood and urine test | ● | ● | ||||
Height/weight | ● | ● | ● | |||
GMFCS | ● | ● | ● | |||
GMFM-88 | ● | ● | ● | |||
K-BSID III | ● | ● | ● | |||
GAS | ● | ● | ● | |||
PedsQL | ● | ● | ● |