Random sequence generation (selection bias)
|
Unclear risk |
Method of randomization not mentioned in detail. Randomization was stratified by encephalopathy grade with a blocking factor of 4. |
Allocation concealment (selection bias)
|
High risk |
Not mentioned |
Blinding of participants and personnel (performance bias)
|
Low risk |
Double‐blind. Participants and all study personnel, except biostatisticians and site pharmacist were blinded. |
Blinding of outcome assessment (detection bias)
|
Low risk |
Double‐blind. All study personnel except biostatisticians and site pharmacist were blinded. |
Incomplete outcome data (attrition bias)
|
Low risk |
Intention‐to‐treat analysis. All participants analyzed in the group they were randomized to. No missing data. |
Selective reporting (reporting bias)
|
Low risk |
No |
Other bias
|
Low risk |
No |