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Even though all CV events were prospectively adjudicated, the study was a registration trial neither designed nor powered to assess CV outcomes, and the overall number of CV events was low (n = 38).
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If there was any disagreement between ratings (e.g., ADE/No ADE) or uncertainty (e.g., ADE/Uncertain), an independent committee consisting of a clinical pharmacist and a medical toxicologist (who was also a physician), both of whom were otherwise not involved in the study, adjudicated the cases (See Algorithm for adjudication committee, Additional file 1).
Cancer events were also monitored and adjudicated throughout the study.
A physician external to the study team, blinded to study medications, adjudicated the presence of asthma and COPD using the Global Initiative for Chronic Obstructive Lung Disease GOLDD) criteria for COPD [ 10] and the third Expert Panel Report of Guidelines on Asthma [ 11].
-- and adjudicated the "winner" accordingly.
A blinded, independent committee adjudicated the secondary clinical outcomes.
An independent endpoint committee adjudicated the events.
DJH adjudicated the radiograph, and supervised data analysis.
A third reviewer adjudicated the findings when necessary.
A third investigator adjudicated the result where discrepancies were found.
An independent end point committee adjudicated the mode of death.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com