| Random sequence generation and allocation concealment (selection bias) |
Unclear |
A random sequence was generated in SPSS; the allocation concealment method was not described |
| Blinding of participants and personnel (performance bias) |
High |
The study design was an open-label randomised controlled trial |
| Blinding of outcome assessment (detection bias) |
Low |
Severe adverse events are an objective outcome and their detection is unlikely to have been affected by no blinding |
| Incomplete outcome data (attrition bias) |
Low |
Loss to follow-up was similar across the different study groups, ranging from 26% to 33% |
| Selective outcome reporting (reporting bias) |
Unclear |
A study protocol was not found in any of the clinical trial registries; the study was not registered in any clinical trial repository |
| Other bias |
Low |
The authors took measures to prevent baseline imbalances between study groups |
