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Adverse Event

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which may or may not have a causal relationship with this treatment.

Additional safety information includes (but is not limited to) the following report types:

• Unapproved or off-label use
• Use during pregnancy
• Exposure to a drug during breastfeeding/lactation
• Overdose (whether intentional, accidental, or prescribed)
• Drug abuse or misuse
• Medication errors
• Drug-drug interactions
• Drug-food interactions
• Lack of therapeutic effect