Ramsey 2010

Methods	Randomised, multicentre, double‐blind trial conducted in the USA 2 treatment arms: PHT and TPM
Participants	Participants 12–65 years (inclusive), weighed at least 50 kg and experienced 1–20 unprovoked, complex partial or primary/secondarily generalised tonic–clonic seizures within the past 3 months, either as newly diagnosed epilepsy or as epilepsy relapse from remission Number randomised: PHT = 128, TPM = 133 126 male participants (48%) 53 participants with partial epilepsy (20%) Mean age (range): 34 (12‐78 years)
Interventions	Monotherapy with PHT or TPM Short titration (1 day) to target dose of PHT = 300 mg/d and TPM = 100 mg/d Range of follow‐up: 0‐2.5 months
Outcomes	Time to first complex partial seizure or generalised tonic clonic seizure Participant retention (time to discontinuation of treatment) Incidence and summary of adverse events
Notes	IPD provided by trial sponsor Johnson & Johnson for time to withdrawal and time to first seizure, trial duration insufficient to measure remission outcomes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Trial described as randomised, no further information provided
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and personnel double‐blind
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded assessment of results and serum AED level
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	All outcomes reported or calculated with IPD provided (see footnote 2)
Other bias	Low risk	None identified