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The 503A evaluation uses a balancing test, not the new-drug approval standard
We conducted a phase 1 study to verify the feasibility and safety of A-dopamine titration in patients with PD and LDRCs, followed by a randomized, controlled, open-label, crossover, phase 2 study of 1 month of A-dopamine versus 1 month of optimized oral antiparkinsonian therapy (Extended Data Fig
[18] Glatter & Shah, Does Direct-to-Consumer Advertising Directly Harm Patients
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