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All MACE data were adjudicated by an experienced cardiovascular physician blinded to clinical details and outcomes.
Endpoint data are adjudicated by an independent endpoint committee blinded to randomised treatment.
24 Endpoint data are adjudicated by two independent endpoint committees, one for cardiovascular endpoints (also adjudicated in heart failure, renal and death endpoints) and one for gastrointestinal endpoints.
Further, all information was adjudicated by trained physicians.
Any disagreement in study selection and data collection was adjudicated by a third reviewer.
Also, the current analysis relied on central radiographic readings of the OA Initiative imaging data, which was adjudicated in case of discrepancy between two independent readers, and has been shown to deviate in a substantial number of cases from the site readings used for the purpose of recruiting participants for the OA Initiative [ 11].
Major protocol violations were defined as any unapproved changes in the treatment protocol or procedures that could affect the completeness, accuracy, reliability and integrity of the study data; this was adjudicated by an independent committee of two rheumatologists not involved in the execution of the study.
The discharge diagnosis was adjudicated by two independent experts on the basis of all available data.
Any discrepancy was adjudicated with the original patient record.
The final diagnosis was adjudicated by two independent cardiologists who were blinded to BNP results.
The final diagnosis was adjudicated by a study-independent physician.
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