Biton 2001

Methods	Randomised, double‐blind, parallel group, multicentre trial conducted in the USA. 2 treatment arms: LTG and VPS
Participants	Participants > 12 years with newly diagnosed or previously diagnosed epilepsy of any seizure type, not currently using an AED Number randomised: LTG = 66, VPS = 69, ITT population: LTG = 65, VPS = 68 (2 participants withdrew before drug escalation phase) 60 male participants (44%) 82 participants with partial epilepsy (60%) Proportion newly diagnosed not stated Mean age (range): 32 (12‐76) years
Interventions	Monotherapy with LTG or VPS Dose‐escalation phase of 8 weeks to target doses of LTG = 200 mg/d and VPS = 20 mg/kg/d Trial duration: 32 weeks
Outcomes	Weight change The proportion of participants seizure‐free during the entire trial Incidence of the most common drug‐related adverse events Time to withdrawal from the trial
Notes	IPD provided for remote analysis by trial sponsor Glaxo Smith Kline for time to treatment withdrawal, time to first seizure and time to six‐month remission. IPD had to be treated as aggregate data in network meta‐analysis due to remote access to data.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐ generated randomisation scheme was used
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and personnel double‐ blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Results presented to investigator in a " blinded " fashion
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates reported, ITT approach, 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