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New JP, Bakerly ND, Leather D, Woodcock A. Obtaining real-world evidence: the Salford Lung Study. Thorax 2014;69:1152-4.
The following text on page 1153,
To ensure accuracy, all of the possible adverse events or study endpoints are verified blind by the study clinicians. Thus, we can accurately evaluate composite endpoints of primary and secondary care events while closely monitoring patient safety.
has been revised by authors. The correct text is as follows:
All possible serious adverse events are reviewed and verified by the study safety physicians and the investigators. Thus, we can accurately evaluate composite endpoints of primary and secondary care events while closely monitoring patient safety. The statistical reporting team and others involved in the analysis plan are blinded to the patients' individual therapies. Only those directly involved in clinical study conduct are not blinded to individual patient therapies. An independent statistical house not involved in the conduct of the study performed all safety analyses for the Independent Data Monitoring Committee. No analysis by randomised treatment is performed by the sponsor until after the analysis plan is finalised and the database has been locked.
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