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The incidence of adverse effects, particularly gastrointestinal complications, psychiatric disorders, and ocular problems, highlights the critical need for thorough patient assessment and continuous monitoring to ensure both the safety and effectiveness of treatment

However, these trials had relatively short follow-up periods and excluded patients at high risk for MTC, limiting the ability to detect rare events or long-term risks

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Japan's PMDA often requires Japan-specific clinical data, which could delay approval there

Ehara, M