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Risk of bias: all four RCTs were rated low risk by RoB2 (with some concerns for open-label outcome ascertainment in three trials, a domain-specific issue that does not alter the overall RoB2 category from low)

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Data Integrity Is a Leadership Problem, Not a Regional One: Lessons from 2025 FDA Warning Letters Executive Summary This report provides an evaluation of US FDA Warning Letters issued in calendar year 2025 that cite 21 CFR 211.68(b), focusing on automated and computerized systems used to generate, p

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