| Falsaperla 2019 |
Some concerns |
No information on allocation concealment, but baseline characteristics do not show any differences between the two groups |
Low risk of bias |
Single blinded study with the personnel aware of the intervention allocation, but there seems to be no deviations that arouse outside the trial context. Also all patients analysed as randomised. |
Low risk of bias |
Data reasonably complete for all the included patients |
Low risk of bias |
Being an objective outcome, it is unlikely that assessment of the outcome would be influenced by knowledge of allocation group |
Some concerns |
A trial protocol is not available for assessment |
High risk of bias |
Some concerns in more than one domain |
