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

Nieto‐Barrera 2001.

Methods Randomised, multicentre, open‐label, parallel‐group trial conducted in Europe and Mexico
2 treatment arms: LTG and CBZ randomised in a 2:1 ratio
Participants Adults and children over the age of 2 years with newly diagnosed or currently untreated partial epilepsy with ≥ two seizures in the previous 6 months and with at least 1 seizure in the last 3 months
Number randomised: LTG = 420, CBZ = 202
329 male participants (53%)
619 participants with partial epilepsy (99.5%)
Not stated how many participants had received previous AED treatment
Mean age (range): 27 (2‐84) years
Interventions Monotherapy with LTG or CBZ
6‐week escalation phase leading to minimum of LTG 2 mg/kg/d age range 2‐12 years, 200 mg/d age range 13‐64 years and 100 mg/d age > 65 years. CBZ aged 2‐12 years 5 mg/kg‐40 mg/kg, age > 12 years 100 mg/d‐1500 mg/d
Range of follow‐up: 0‐245 days
Outcomes Proportion of participants seizure‐free during the last 16 weeks of treatment
Efficacy success: proportion of participants who did not withdraw before the end of week 18 and were seizure‐free in the last 16 weeks of the trial
Time to withdrawal from the trial (proportion of participants completing the trial)
Proportion of participants experiencing adverse events
Withdrawals due to adverse events
Notes IPD provided by trial sponsor Glaxo Smith Kline for time to treatment withdrawal and time to first seizure (plus seizure‐freedom rates at 24 weeks)
Dates of seizures during the first 4 weeks not provided with IPD
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random sequence. Participants randomised in a 2:1 ratio (LTG:CBZ), stratified by age group and country
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 High risk Open‐label trial
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open‐label trial
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Protocol provided. Attrition rates reported, 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