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Extractables are compounds that can be extracted from packaging materials under worst-case laboratory conditions (elevated temperature, aggressive solvents)

Standard practice limits cycles to 4 to 6 weeks, followed by equal or longer time off

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Serious Side Effects Less common but more serious side effects can include acute pancreatitis (severe abdominal pain that does not resolve), acute gallbladder disease (upper stomach pain, jaundice, fever), acute kidney injury (often related to dehydration from GI side effects), serious allergic reactions, hypoglycemia (especially if taking other diabetes medications), and mental health changes including suicidal thoughts

Disproportion analysis were based on the 2 2 four-grid table (Supplementary Table S2), wherein the ratio of suspected AEs associated with the target drug to AEs caused by other drugs in the database was calculated

Quantification was determined by the comparative Ct (Ct) method