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. 2017 Dec 15;2017(12):CD011412. doi: 10.1002/14651858.CD011412.pub3

Brodie 2007.

Methods Randomised, double‐blind, parallel‐group trial conducted at 85 centres in 12 European countries and in South Africa
2 treatment arms: CBZ (controlled release) and LEV
Participants Adults (> 16 years) with 2 partial or generalised tonic–clonic seizures separated by at least 48 h in the previous year with at least one seizure in the last 3 months
Number randomised: CBZ = 291, LEV = 288
319 male participants (55%)
466 participants with partial epilepsy (80%)
Mean age (range): 39 (15‐82 years)
Interventions Monotherapy with CBZ or LEV
Titration for 2 weeks to target dose of CBZ = 400 mg/d, LEV = 1000 mg/d
Range of follow‐up = 0‐28 months
Outcomes Proportion of per‐protocol (PP) participants achieving at least 6 months of seizure freedom at the last evaluated dose
One year seizure‐freedom rate
6‐month and 1‐year seizure‐freedom rate by dose level
Time to trial withdrawal
Incidence of adverse events
Notes IPD provided for all outcomes of this review by trial sponsor UCB
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised following a central 1:1 randomisation scheme with a statistical block size of 2 and stratified by seizure category
Allocation concealment (selection bias) Low risk Participants were randomised using an interactive voice‐response system
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk To ensure blinding, LEV and CBZ‐CR tablets were identically encapsulated.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Attrition rates reported, ITT approach, all randomised participants analysed from IPD provided (see footnote 2)
Selective reporting (reporting bias) Low risk All outcomes reported or calculated with IPD provided (see footnote 2)
Other bias Low risk None identified