Hindsén 2006 (P).
Methods | DESIGN Between‐patient Participant delivery ALLOCATION Random Method of randomisation: not stated Concealment: unclear BLINDING Double‐blind (participant/investigator) WITHDRAWAL/DROPOUT Not described | |
Participants | N: 360
Treatment duration: 2 or 6 wks; FU: 6 or 10 wks
LF: NR
BC: not demonstrated
Age: NR
Gender (per cent men): NR
Severity: NR
INCLUSION CRITERIA
EXCLUSION CRITERIA
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Interventions |
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Outcomes |
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Notes | Leo Pharma, Ballerup, sponsored the trial. It was unclear how participants were blinded to treatment options where 2/3 involved occlusion. The sponsor supplied unpublished data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | The trial reported insufficient details. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | The trial was reported to be double‐blind (participant/investigator), but it was unclear how they blinded participants to treatment options where 2/3 involved occlusion. |
Randomisation method reported | Unclear risk | The trial did not report this. |
Loss to follow up | Unclear risk | The trial did not report this. |
Baseline assessments | Unclear risk | The trial did not report these. |
Baseline comparability demonstrated | Unclear risk | This was not demonstrated. |