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Illustrative Example: When Medicare Covers B12 Consider Dorothy, a 74-year-old resident of Arizona, who begins to experience fatigue and tingling in her hands

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Phase 3 trials involve: Larger populations Longer duration Broader safety monitoring Rare adverse event detection It is possible that: Efficacy is confirmed Efficacy is slightly lower Safety signals emerge Dose adjustments are required This is why regulatory approval depends on Phase 3 outcomes

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