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Serious Adverse Events Potential Serious Risks (Based on Mechanism & Class Effects) 1

Modulating the microbiota as a therapeutic intervention for type 2 diabetes

This framework evaluates several key aspects: biological plausibility (i.e., whether the upstream and downstream events are mechanistically linked), the essentiality of key events (i.e., whether blocking an upstream KE prevents the occurrence of downstream events), empirical support (i.e., consistency with doseresponse, temporal, and incidence patterns), and overall coherence across studies (52)

Allow the lyophilized powder to reach room temperature before opening the vial