Losso 2000.
Methods | Study design was a prospective open‐labelled RCT | |
Participants | There were a total of 73 participants Inclusion criteria
Exclusion criteria
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Interventions |
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Outcomes |
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Notes | This was a multi‐centred trial conducted in 6 clinical centres in Buenos Aires, Argentina. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The trial used a stratified block randomization method, using blocks of 24 stratified according to ART history (naive or experienced) and clinical centres. |
Allocation concealment (selection bias) | Low risk | The trial used a centralized method of randomization. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The trial was not blinded. However, the outcome measures are objective and unlikely to have been influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The trial was not blinded. However, the outcome measures are objective and unlikely to have been influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The trial excluded less than 15% (2 out of 73 participants) from the analysis. There was no differential loss to follow‐up. |
Selective reporting (reporting bias) | Low risk | There was no evidence of selective reporting. |
Other bias | High risk | There was more monitoring in the treatment group compared to the control group. |