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To assess the impact on entities in the pharmaceutical-manufacturing sector (NAICS 325412), ERG adjusted SBA data on firm size and revenues to estimate average receipts per firm for the affected sector.

If subpopulations of chronic alcoholics are sensitive to lower doses of acetaminophen, this type of study would be inadequate to make any assessment of risk.

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FDA did a new literature search, selecting new articles describing the relationship between alcohol use and the risk of GI bleeding in OTC IAAA users.

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FDA reviewed the cases for common risk factors for GI bleeding that are recognized in the medical literature, including previous GI bleed or history of an ulcer, social history (alcohol or tobacco use), concomitant use of other drugs (NSAIDs, aspirin, anticoagulants, corticosteroids), use of doses higher than recommended, and advanced age (65 years and older).

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