Signorelli 2006.
Study characteristics | ||
Methods | Study characteristics
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Participants | Baseline characteristics
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Interventions | Intervention group
Control group
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Outcomes | Outcomes relevant to this review
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Notes | Funding source: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study was described as randomised; method of randomisation was not reported |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) | Low risk | Quote: "double‐blind placebo‐controlled" study |
Blinding of outcome assessment (detection bias) Adverse events | Low risk | Quote: "double‐blind placebo‐controlled" study |
Blinding of outcome assessment (detection bias) Death | Low risk | Quote: "double‐blind placebo‐controlled" study |
Incomplete outcome data (attrition bias) Adverse events | Low risk | All patient outcome data reported |
Incomplete outcome data (attrition bias) Death | Low risk | All patient outcome data reported |
Selective reporting (reporting bias) | Unclear risk | The study protocol is not available |
Other bias | Unclear risk | Funding source: the authors have provided no information on sources of funding |