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