| Methods |
Randomised, parallel group unblinded study. Follow‐up for 12 months. |
| Participants |
38 drug‐naive participants, all with typical AS, age 3 to 13 years. |
| Interventions |
Monotherapy with VPS or LTG. |
| Outcomes |
Total seizures freedom defined by clinical reports, 24 hours EEG and hyperventilation test. |
| Notes |
This study was not sponsored by any commercial organisation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random sequence was generated using a randomisation code. |
| Allocation concealment (selection bias) |
Low risk |
Central allocation. |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
No blinding. It is not stated whether tables of VPA and LTG were indistinguishable. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No blinding. It is not stated whether tables of VPA and LTG were indistinguishable. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
No blinding. It is not stated whether tables of VPA and LTG were indistinguishable. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing outcome data. |
| Selective reporting (reporting bias) |
Low risk |
The study protocol is not available but it is clear that the published reports include all expected outcomes. |
