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Hospitalization due to heart failure or death occurred in 23.2% of people taking ALA and 28.8% of those receiving placebo

Fratelli, M

Examples of manufacturer misreporting could include instances in which the manufacturer has made a correction to previously submitted data as well as instances in which the reporting individual or entity reporting data or information to CMS on behalf of the manufacturer knows or should know is inaccurate or misleading (for example, inaccurate manufacturer pricing or product data under section 1927(b)(3) of the Act)