| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "Patients were randomized in two groups using a computerized random number generator."
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: "Masking: None (open label)"
Comment: Unblinded study. No participant cross-over. No information on cointerventions of interest were reported: antivirals, corticosteroids and biologics. Appropriate method of analysis used; participants analyzed according to allocated intervention. |
| Missing outcome data |
Low |
Comment: 194 patients randomized; 194 patients analyzed.
Risk assessed to be low for the outcome: Mortality. |
| Measurement of the outcome |
Low |
Comment: Unblinded study
Mortality is an observer-reported outcomes not involving judgement. Risk assessed to be low for the outcome: Mortality. |
| Selection of the reported results |
Low |
Comment: No protocol or statistical plan available. The registry was available and utilized.
Outcome reported as pre-specified in the trial registry. Risk assessed to be low for the outcome: Mortality. |
| Overall risk of bias |
Some concerns |