Koman 2000.

Methods	Method of randomisation: not described Blinding: double‐blind study Intention‐to‐treat analysis: not described, but apparently yes Loss of follow‐up: BoNT‐A group (3 discontinued) and placebo group (3 discontinued). Reasons not stated Unit of analysis: child
Participants	Place: multiple centres in the USA, Canada, Italy, and Spain Period of study: not described Number assigned: 114 Number assessed: 108 53 BoNT‐A group 55 placebo group Inclusion criteria: Ambulatory patients with CP Age 2 to 16 years Spasticity of 1 or both legs with stance‐phase equinus of the foot Exclusion criteria: Fixed contractures Severe athetoid movements Leg length discrepancy > 5 cm Atrophy of the calf muscles Current need for surgery Previous surgery of the foot Previous injections of phenol or alcohol Current or previous treatment with BoNT‐A Age: Both groups (range): 4 to 11 years Gender: Both groups: 68 males; 46 females Motor distribution: BoNT‐A group: 15 hemiplegia; 41 diplegia Placebo group: 17 hemiplegia; 41 diplegia GMFCS: Not described, but since all children were walkers, likely GMFCS I, II, and III
Interventions	BoNT‐A group: First BoNT‐A injection into the gastrocnemius muscles (onabotulinumtoxinA) 4 U/kg. The maximal dose was 200 U. All children received a second injection of the same dose 4 weeks after the initial intervention Placebo group: Placebo (human serum albumin and sodium chloride) injections in a similar fashion to the BoNT‐A group
Outcomes	Length of follow‐up: Follow‐up of 12 weeks Assessments at baseline, 2, 4, 8, and 12 weeks Primary outcomes: Physician Rating Scale Passive ankle range of motion Active ankle range of motion Electrophysiologic measurements Adverse events Blood serum antibodies
Notes	Comments: A total of 145 patients were initially enrolled and included in the evaluation of safety. Data from 1 centre (n = 15) were excluded from the efficacy analysis because regulations in that country prohibited the use of placebo in children; consequently, data from this centre were not blinded. Data from 16 children were excluded from efficacy evaluation because of failure to meet entry criteria. Since both injections were given 4 weeks apart and at a low dose each, we considered this as a single‐injection study for the purposes of our review. Source of funding: this study was supported by a grant from Allergan Inc. The research at Bowman Gray School of Medicine of Wake Forest University was supported by the General Clinical Research Center of the Bowman Gray School of Medicine, grant number M01RR07122. Conflict of interest: not reported, but the grant mentioned above could be considered as a possible conflict of interest
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not described
Allocation concealment (selection bias)	Low risk	Comment: multicentre study, likely central allocation by the description
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: double‐blinded study
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: the outcome assessors were blind to group allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no missing data
Selective reporting (reporting bias)	Unclear risk	Comment: study protocol not available. It appears that the relevant outcomes were addressed.
Other bias	Unclear risk	Comment: Data from 1 centre (n = 15) were excluded from the efficacy analysis because regulations in that country prohibited the use of placebo in children.