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While serious adverse events (SAEs) or other problems are not anticipated, serious and unanticipated and related adverse events or unanticipated problems involving risks to participants or others will be reported within 48 h to the Yale IRB and within 72 h to the relevant Serious Adverse Event Tracking and Reporting System at NIDA/NIH

Some studies suggest that people with IBD may have stool with different or stronger odors than people without the condition

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A study in Brazil discovered that removing flavor imagery and descriptors through plain packaging significantly reduced the taste ratings of flavored brands [61]

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