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The investigation could result in a label change, additional warnings, or a determination that no label change is needed

Monitoring and follow-up should be arranged at 3 months initially to assess HbA1c response, tolerability, weight change, blood pressure, and renal function

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Debray TPA, Moons KGM, Riley RD (2018) Detecting small-study effects and funnel plot asymmetry in meta-analysis of survival data: a comparison of new and existing tests

These patents cover not just the molecule itself but manufacturing processes, delivery systems, and specific formulations that took years to develop

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