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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.
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I fully intended never to write anything until Scooter Libby's legal plight was adjudicated.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com