Kanovsky 2004.

Methods	Method of randomisation: children were randomly allocated "using a computer system" Blinding: participants and study personnel blinded to the intervention Intention‐to‐treat analysis: no Loss of follow‐up: no losses to follow‐up Unit of analysis: lower limb for local measures and child for global measures
Participants	Place: 3 centres in the Czech Republic and 2 in Slovakia Period of study: not described Number assigned: 52 Number assessed: 52 26 BoNT‐A group 26 placebo group Inclusion criteria: Ambulatory children with diplegic CP Age 2 to 7 years Potential to benefit from the injection of BoNT‐A to the gastrocnemius muscle Exclusion criteria: Fixed contractures Need for multilevel BoNT‐A injections Previous surgery to the affected limbs or perceived need for surgery within the next 6 months Previous BoNT‐A injections within the previous 9 months Previous phenol treatment for lower limb spasticity Age: BoNT‐A group (mean/SD): 5.1/1.3 years Placebo group (mean/SD): 4.2/1.5 years Gender: BoNT‐A group: 16 males; 10 females Placebo group: 13 males; 13 females Motor distribution: All children were diplegic GMFCS: Not described, but according to inclusion criteria presumably all were GMFCS I, II, or III
Interventions	BoNT‐A group: Single BoNT‐A injection into the gastrocnemius muscles (abobotulinumtoxinA) 30 U/kg Children continued to receive regular physiotherapy and to use walking aids and orthoses, as appropriate Placebo group: Single placebo injection into the gastrocnemius muscles Children continued to receive regular physiotherapy and to use walking aids and orthoses, as appropriate
Outcomes	Length of follow‐up: Follow‐up of 16 weeks Assessments at baseline and weeks 4, 8, and 16 post‐treatment Primary outcomes: Videographic gait assessment Gross Motor Function Measure Subjective functional assessment Adverse events
Notes	Comment: none Source of funding: sponsored by Ipsen Limited Conflicts of interest: not reported, but the funding 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: randomisation was done "using a computer system"
Allocation concealment (selection bias)	Low risk	Comment: central allocation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: both participants and personnel were blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: outcome assessors were blinded
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. It appears that the relevant outcomes were addressed.
Other bias	Low risk	Comment: no other sources of bias identified