| Methods |
RCT |
| Participants |
120, 2 ‐ 72 months, first FS |
| Interventions |
Phenobarbitone 3 ‐ 5 per kilo, or intermittent phenobarbitone same dose, or intermittent diazepam 0.6 per kilo, or no treatment |
| Outcomes |
RS @ 60 ‐ 72 months |
| Notes |
No attrition reported, unblinded study |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
Not used, “Randomly divided in 4 groups of 30 each” |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
No blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Apparently no withdrawal |
| Selective reporting (reporting bias) |
Low risk |
Stated outcome objective met |
| Other bias |
Low risk |
No bias identified |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No blinding |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
No blinding |
