| Bias | Rapid review authors’ judgment | Reason for judgment |
|---|---|---|
| Random sequence generation | High risk | Non-randomised trial |
| Allocation concealment | High risk | Open-label |
| Blinding | High risk | Open-label |
| Incomplete outcome data | High risk | Intention-to-treat analysis not performed |
| Selective reporting | Unclear risk | No adverse event data reported, although the authors state that this will be reported separately at the end of the trial |
| Other bias | High risk | Under-powered according to the authors’ own power calculation |