| Gonzalez 2021 |
Some concerns |
Computer‐generated randomization. There was no information on allocation concealment. Baseline details differed between groups. Due to small group sizes and stratification according to QT prolongation the deviations may be caused by chance. |
Some concerns |
Participants were not aware of the intervention received. No information on those delivering the intervention. No information reported whether there were deviations from the intended interventions or not. The analysis was appropriate (mITT). |
Low risk of bias |
Most people were followed up > 95%. 2/108 participants were excluded from analysis due to transfer to another hospital. |
Low risk of bias |
There was insufficient information on whether the outcome assessors were aware of the intervention received. By following a clinical protocol, knowledge of the intervention received could only minimally affect the outcome measurement. |
Some concerns |
The protocol was prospectively registered. The outcome was not prespecified in the study protocol. |
Some concerns |
Due to insufficient information on allocation concealment and blinding of healthcare providers. Due to lack of registering the outcome in the protocol. |
