SPACE Study 2000.
Methods |
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Participants | Inclusion criteria
Exclusion criteria
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Interventions |
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Outcomes |
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Notes | Mean duration of follow‐up: 1.4 years | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated coin toss, each participating centre randomised separately |
Allocation concealment (selection bias) | Unclear risk | No information regarding methods to prevent allocation concealment |
Blinding (performance bias and detection bias) All outcomes | Low risk | Study reported the used of double blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes of all initially randomised patients were reported (although the use of intention‐to‐treat analyses was not explicitly stated in the methods) |
Selective reporting (reporting bias) | Low risk | Study protocol is not separately available, however, it appears all expected outcomes, including those that were pre‐specified, have been reported |
Other bias | Low risk | Funding: This research was funded by grant 4204 from the Chief Scientist’s Office, Ministry of Health, Israel Vitamin E provided by Solgar, Inc, New York, USA, during the first year and Henkel Corp, La Grange, IL, USA, during the second year. |