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Most spontaneous reports of fatal gastrointestinal events are in this population
The pharmaceutical product, Bacteriostatic Water for Injection, USP, is an FDA-approved drug diluent, though it is technically a prescription item and is not for use in newborns
While human clinical trials remain limited, the depth of animal research, consistency of positive findings across multiple study designs, and extensive community experience create a reasonable basis for therapeutic use
Reporting attributes the stall to commercial and organizational factors rather than a specific safety problem
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