Feniman De Stefano 2015.
Study characteristics | ||
Methods |
|
|
Participants |
|
|
Interventions | Treatment group
Control group
|
|
Outcomes |
|
|
Identification |
|
|
Notes |
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Only states the study was randomised, does not ensure how sequence generation was done |
Allocation concealment (selection bias) | Unclear risk | Only states the study was randomised, does not ensure how allocation concealment was done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind", "placebo‐controlled" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double‐blind", "placebo‐controlled" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced across intervention groups |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes have been reported in ClinicalTrials.gov identifier NCT01128101 |
Other bias | Low risk | Funded by FUNDUNESP (Foundation for the Development of UNESP, Process 0090910) and FAPESP (Foundation for Research Support of São Paulo, Process 2010/10439‐1) |