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The label states that the dosage escalation schedule exists to reduce the risk of gastrointestinal adverse reactions, and that severe gastrointestinal adverse reactions have been associated with use

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However, pharmacovigilance reporting in public databases is subject to many major limitations, such as heterogeneous reporting, including notoriety and ripple bias, double reporting, the lack of a population denominator or enough clinical detail to enable comparison between agents and over time [20, 22], therefore no causal association link can be inferred from such studies

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Ghoshal S, Witta J, Zhong J, et al