Baker 2002.

Methods	Method of randomisation: computer‐generated sequence with block randomisation, stratified by centre and baseline spasticity component Blinding: all participants and personnel blinded to the intervention Intention‐to‐treat analysis: yes Loss of follow‐up: 2 BoNT‐A 30 U/kg group: 1 withdrew before treatment BoNT‐A 20 U/kg group: 1 lost to follow‐up in week 8 Unit of analysis: lower limb for local measures and child for global measures
Participants	Place: 6 centres in the UK, 1 in Ireland, and 5 in Poland Period of study: not described Number assigned: 126 Number assessed: 124 29 BoNT‐A 30 U/kg group 27 BoNT‐A 20 U/kg group 36 BoNT‐A 10 U/kg group 31 placebo group Inclusion criteria: Spastic diplegic CP Aged 2 to 9 years Weight 10 to 25 kg Ambulatory with or without walking aids Dynamic component Indication of BoNT‐A treatment Exclusion criteria: Previous BoNT‐A treatment within 9 months Previous phenol treatment Previous muscle or ligament surgery in the lower limbs Age: BoNT‐A 20 U/kg group (mean (SD)): 4.9 (1.9) Placebo group (mean (SD)): 5.5 (2.2) Gender: BoNT‐A 20 U/kg group: 46% males; 54% females Placebo group: 55% males; 45% females Motor distribution: Only spastic diplegia GMFCS: BoNT‐A group: 11 level I; 1 level II Placebo group: 14 level l; 0 level II
Interventions	BoNT‐A groups: Single BoNT‐A (abobotulinumtoxinA) injection into the gastrocnemius in 3 different doses (10, 20, and 30 U/kg) Oral antispasticity medication, regular physiotherapy, walking aids and/or orthoses were all maintained in the course of the study Placebo group: Single placebo injections into the gastrocnemius Oral antispasticity medication, regular physiotherapy, walking aids and/or orthoses were all maintained in the course of the study
Outcomes	Length of follow‐up: Follow‐up of 16 weeks Assessments at baseline, 4, 8, and 16 weeks Primary outcomes: Change in the dynamic component of gastrocnemius shortening at 4 weeks (assessed by flexible electrogoniometers) Adverse events Secondary outcomes: Ankle range of motion Gross Motor Function Measure
Notes	Comments: This was a dose‐range study. For the purposes of this review, we analysed the main outcomes only for the intermediate‐dose group (20 U/kg) versus placebo. For the analysis of adverse events, we pooled data from all the BoNT‐A groups in the study. Source of funding: Ipsen Limited Conflicts 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)	Low risk	Comment: computer‐generated sequence
Allocation concealment (selection bias)	Low risk	Comment: allocation concealed
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: blinding of participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: group assignments were not released until the final assessment and completion of data analysis
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no missing outcome data
Selective reporting (reporting bias)	Unclear risk	Comment: study protocol not available. The relevant outcomes seem to have been reported.
Other bias	Low risk	Comment: no other sources of bias identified