| COMET‐ICE |
Low risk of bias |
Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation. |
Low risk of bias |
Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate. |
Low risk of bias |
Data for this outcome was available for 868 out of 868 participants randomised. |
Low risk of bias |
The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received. |
Some concerns |
The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary and the time point measured was not entirely clear. |
Some concerns |
For this outcome, there is a low risk of bias from the randomization process, due to deviations from intended interventions, due to missing outcomes and due to measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. |
