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No substantial protocol amendments affecting eligibility criteria, outcomes, or analyses were made after trial initiation

However, if the primary insurer pays less than policy limits via a Gasquet , where typical primary policy language provides that exhaustion of the policy limit terminates the duty to defend, could the primary carrier be forced to continue to provide a defense

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For the efficacy estimand, the LSM change in HbA1c from baseline at week 52 as the primary endpoint was 2.24%, 2.43%, and 2.58% with tirzepatide 5, 10, and 15 mg, respectively, versus 1.44% with insulin glargine

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PTs classified under nervous system disorders meeting these thresholds were identified as GLP-1 RA-related NAEs for subsequent analysis