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Treatment typically begins with 3 mg once daily for 30 days, which serves as a dose escalation step to improve gastrointestinal tolerability rather than a therapeutic dose

As a retrospective case series, there may be additional limiting and confounding factors, including the lack of a control group

These may include: Nausea Vomiting Diarrhea Constipation Bloating Mild fatigue Symptoms are most common when starting therapy or increasing the dose

Moreover, differences in reporting practices and regulatory requirements between FAERS and JADER may partially account for discrepancies in signal strength observed between the two databases

Acknowledgements This work was supported by the National Natural Science Foundation of China (21102182), the Natural Science Foundation of Jiangsu Province (BK2012760, China), Fundamental Research Funds for the Central Universities (2632018ZD09, China), and Excellent Science and Technology Innovation Team of Jiangsu Province Universities in 2015 (China)

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