Potential bias	Review authors' judgementa
Random sequence generation (selection bias)	High: not randomized or quasi‐randomized Unclear: states 'randomized', but does not report method Low: describes method of randomization
Allocation concealment (selection bias)	High: not concealed, open‐label trial for individually randomized, method of concealment not adequate Unclear: details of method not reported or insufficient detail Low: central allocation; sequentially numbered, opaque, sealed envelopes
Blinding (performance bias and detection bias)	High: personnel, participants, or outcome assessors not blinded Unclear: no details reported, insufficient details reported Low: personnel, participants, and outcome assessors blinded
Incomplete outcome data (attrition bias)	High: losses to follow‐up not evenly distributed across intervention and control group Unclear: no details reported, insufficient details reported Low: losses to follow‐up evenly distributed across groups, reasons for loss to follow‐up and exclusions clearly stated
Selective reporting (reporting bias)	High: did not fully report measured or relevant outcomes Unclear: insufficient information to permit judgement Low: all stated outcomes reported
Other bias	High: other source of bias identified by review authors Low: no obvious other source of bias of concern to review authors
Adverse event monitoring (detection bias)	High: passive methods relying on spontaneous patient report only, undefined adverse events Unclear: insufficient information to permit judgement Low: key adverse events defined, prespecified active detection method
Incomplete adverse event reporting (reporting bias)	High: adverse event severity undefined, combination of treatment groups, post hoc cut‐offs for reporting adopted Unclear: insufficient information to permit judgement Low: clear reporting on important adverse events with numerical data by intervention group