Reunanen 1996

Methods	Randomised, double‐blind, parallel‐group trial conducted in 56 centres in Europe and Australia. 3 treatment arms: LTG (200 mg/d), LTG (100 mg/d) and CBZ
Participants	Adults and children > 12 years with newly diagnosed, currently untreated or recurrent epilepsy with ≥ two seizures in the previous 6 months and with at least 1 seizure in the last 3 months. Participants must not have taken AEDs in the previous 6 months Number randomised: LTG (200 mg) = 115, LTG (100 mg) = 115, CBZ = 121 188 male participants (54%) 237 participants with partial epilepsy (68%) Not stated how many participants had received previous AED treatment Mean age (range): 32 (12‐72) years
Interventions	Monotherapy with LTG or CBZ for 30 weeks 4‐week escalation phase leading to LTG = 100 mg/d, LTG = 200 mg/d, CBZ = 600 mg/d Range of follow‐up: 0‐378 days
Outcomes	Proportion completing seizure‐free after the first 6 weeks of treatment Time to first seizure Time to withdrawal Frequency of adverse events with at least 5% incidence in any treatment group
Notes	IPD provided by trial sponsor Glaxo Smith Kline for time to treatment withdrawal, time to first seizure and time to six‐month remission. Participants considered to complete the trial if they experienced a seizure after the first 6 weeks. In primary analysis, two arms of LTG pooled and compared to CBZ and separate doses of LTG compared to CBZ in sensitivity analysis (see Data extraction and management)
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)
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	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