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Withholding is generally only necessary in selected high-risk cases or for patients with significant gastrointestinal symptoms
Results Baseline characteristics A flowchart of patient enrollment was shown in Fig
Should Phase 3 trials demonstrate a favourable benefit-risk profile, Eli Lilly would be expected to submit a Marketing Authorisation Application (MAA) to the MHRA (and separately to the EMA for European markets) for regulatory review
Metabolic monitoring is required
1 Given the longitudinal nature of this process, the focusing stage of MI becomes more relevant as the patient ages
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