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

Brodie 1995a.

Methods Randomised, double‐blind, parallel‐group trial conducted in 8 centres in the UK.
2 treatment arms: LTG and CBZ
Participants Adults and children > 13 years with newly diagnosed epilepsy. None had received previous AED treatment.
Number randomised: LTG = 70, CBZ = 66
56 male participants (41%)
82 with partial epilepsy (60%);
Mean age (range): 34 (14‐71) years
Interventions Monotherapy with LTG or CBZ
4‐week escalation phase leading to LTG = 150 mg/d, CBZ = 600 mg/d
Range of follow‐up = 0‐14 months
Outcomes Time to first seizure after 6 weeks of treatment
Time to withdrawal
Proportion of randomised participants remaining seizure‐free during the last 40 and 24 weeks of trial
Percentages of participants who reported adverse events
Notes IPD provided by trial sponsor Glaxo Smith Kline for time to treatment withdrawal, time to first seizure and time to six‐month remission
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random sequence (information provided by drug manufacturer). Stratification by seizure type
Allocation concealment (selection bias) Low risk Allocation concealed by individual sealed, opaque envelopes (information provided by drug manufacturer)
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind achieved using LTG tablets formulated to be identical in appearance to CBZ tablets
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Trial investigator blinded, not stated if other outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Attrition rates reported, all randomised participants analysed from IPD provided (see footnote 2)
Selective reporting (reporting bias) Low risk Protocol provided. All outcomes reported or calculated with IPD provided (see footnote 2)
Other bias Low risk None identified