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$399 Program Details Program length: 4 weeks Self-pay price: $399 Medical consultation required Prescription required when applicable Available only when approved by the evaluating provider Treatment plans may vary based on dosage, formulation, patient goals, health history, availability and provider recommendations

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A Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Study of PL 14736 Enema in the Treatment of Mild-To-Moderate Ulcerative Colitis

This indicates that the agency viewed the backdating not as an isolated incident but as a symptom of a system that allowed users to manipulate the "time" element of the data record