Table 1 Comparison of adult and pediatric trial

Design

phase III, randomized, placebo-controlled

phase III, randomized, placebo-controlled

Trial Duration

1–2 years

4.5 years

Sample Size

Botox group (233)

Ctrl. (235)

Botox 8 U/kg group (128)

Botox 4 U/kg group (126)

Ctrl. (130)

Primary Efficacy Endpoint

Posterior mean (SD)

Botox group vs Ctrl.: 0.20 (0.10)

Botox 8 U/kg group vs Ctrl.: 0.27 (0.10)

Botox 4 U/kg group vs Ctrl.: 0.10 (0.10)