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 with newly diagnosed or currently untreated partial epilepsy with 2 or more seizures in the previous 6 months and with at least 1 seizure in the last 3 months Number randomised: LTG = 420, CBZ = 202 329 males (53%) 619 with partial seizures (99.5%) Not stated how many participants had received previous AED treatment Mean age (range): 27 (2 to 84) years
Interventions	Monotherapy with LTG or CBZ for 24 weeks 6‐week escalation phase leading to minimum of LTG 2 mg/kg/day age range 2 to 12 years, 200 mg/day age range 13 to 64 years and 100 mg/day age > 65 years. CBZ aged 2 to 12 years 5 to 40 mg/kg, age > 12 years 100 to 1500 mg/day Range of follow‐up: 0 to 245 days
Outcomes	Proportion of patients seizure‐free during the last 16 weeks of treatment Efficacy success: proportion of patients 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 patients completing the trial) Proportion of patients experiencing adverse events Withdrawals due to adverse events
Notes	IPD provided by trial sponsor GlaxoSmithKline 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 individual participant data
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
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	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