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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Prospective, open‐label randomised trial conducted in Serbia and Montenegro
2 treatment arms: LTG and VPS
Participants Participants with newly diagnosed, previously untreated epilepsy
Number randomised: LTG = 35, VPS = 38
51 (70%) with partial epilepsy
Median age (range): 34 (18‐76) years
No information on gender
Interventions Monotherapy with LTG or VPS
All participants to be followed up for at least 6 months
Outcomes Seizure freedom
Retention on treatment
Notes Abstract of interim results only available. Contact was made with trial author who was unable to provide IPD
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 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 Unclear risk Interim report, proportion of participants completing the trial period presented. Unclear if an ITT approach was taken to analysis
Selective reporting (reporting bias) Unclear risk Abstract only, insufficient information to make a judgement
Other bias Low risk None identified