Moore 2008.

Methods	Method of randomisation: randomisation done using a computer‐generated sequence. Randomisation stratified in blocks of 4 by unilateral or bilateral spasticity. Blinding: both participants and assessors blinded to the intervention Intention‐to‐treat analysis: yes Loss of follow‐up: 6 children lost to follow‐up and 19 children "withdrew from treatment during the study because they discerned no benefits from the injections" BoNT‐A group: Withdrew from treatment (n = 9) Lost to follow‐up (n = 2) Placebo group: Withdrew from treatment (n = 10) Lost to follow‐up (n = 4) Unit of analysis: child
Participants	Place: 1 centre in the UK Period of study: patients recruited from October 1997 to July 1999 Number assigned: 64 Number assessed: 58 30 BoNT‐A group 28 placebo group Inclusion criteria: Children with CP validated by a paediatric neurologist Spasticity of 1 or both legs Excessive involuntary muscle activity Age from 2 to 6 years (2 to 8 years if targeting hamstrings) Ability and willingness to attend for trial procedures Exclusion criteria: Other diseases, handicaps, or situations likely to prejudice treatment or assessment Unless there were other eligible muscles, patients with fixed contractures were excluded Previous treatments with BoNT‐A Contraindications to BoNT‐A Age: BoNT‐A group (mean/SD): 5.30/1.67 years Placebo group (mean/SD): 4.82/1.45 years Gender: BoNT‐A group: 17 males; 13 females Placebo group: 19 males; 9 females Motor distribution: BoNT‐A group: 20 diplegia; 5 hemiplegia; 5 quadriplegia Placebo group: 19 diplegia; 4 hemiplegia; 5 quadriplegia GMFCS: Not described
Interventions	BoNT‐A group: Multiple BoNT‐A (abobotulinumtoxinA) injections cycles into target muscles Maximum dose of 15 U/kg in the first cycle The maximum dose increased by 5 U/kg every 3‐month cycle, until a total maximum dose of 30 U/kg The injections were administered every 3 months, if clinically indicated, for 2 years Target muscles were selected according to an individualised clinical evaluation Children received usual care with physical therapy, orthosis, or orthopaedic surgery Placebo group: Injection of saline solution in the same conditions as above
Outcomes	Length of follow‐up: Follow‐up of 2 years Children were seen at baseline, weeks 2 and 6, and 3 months This basic pattern continued for up to 8 times over 2 years Outcomes had major assessments at 1 year and 2 years Primary outcomes: GMFM (changes in total and goal scores at 2 years) PEDI (at 2 years) Secondary outcomes: GMFM (at 1 year) PEDI (at 2 years) Weight change over 2 years Adverse events Note: range of motion was not considered an outcome by the study author, although it was described and was used for the purposes of this review.
Notes	Comments: none Source of funding: the charity Action Medical Research funded this study (grant AP0622) Conflicts of interest: APM has received payment from Ipsen, UK, and other companies promoting botulinum toxins for advice and for educational help. His unit has received funds from them to support other research with botulinum toxins. The remaining study authors report no conflicts.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: randomisation was done using a computer‐generated sequence
Allocation concealment (selection bias)	Low risk	Comment: central allocation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: participants and personnel were blinded to the intervention
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: outcome assessors were blinded to the intervention
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