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. 2015 Sep 3;2015(9):CD005399. doi: 10.1002/14651858.CD005399.pub3

Yamatogi 1997.

Methods RCT, parallel
Participants Total randomised: 80
 Age range = 10 months to 17 years. Number of patients with intellectual disabilities = 61/66
 Most patients were receiving 1 to 3 concomitant AEDs
 Baseline period = 4 weeks. Treatment period = 12 weeks
Interventions Clobazam versus clonazepam as comparator
Outcomes Primary efficacy = number of patients with a 50% or greater reduction in seizure frequency. Seizure frequency at the end of the treatment phase (12 weeks) was compared with the frequency at the end of the baseline period
Notes Numbers used in data analysis: 66 (CLB = 34, CZP = 32) used for efficacy data and 76 (CLB = 36, CZP = 40) used for safety data
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information about how randomisation achieved
Allocation concealment (selection bias) Low risk Sealed, opaque envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Single‐blinded study
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 80 patients were randomised but only 66 and 76 were included in the analyses. Reasons for dropouts unavailable
Selective reporting (reporting bias) Unclear risk Insufficient information
Other bias Unclear risk Insufficient information

ABC: Aberrant Behaviour Checklist
 AED: antiepileptic drug
 CLB: clobazam
 CZP: clonazepam
 EEG: electroencephalography
 ELDQOL: Epilepsy and Learning Disabilities Quality of Life
 EOS: Epilepsy Outcome Scale
 FBM: felbamate
 LMG: lamotrigine
 RCT: randomised controlled trial
 VPA: valproic acid