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FCP generally presents in young CF patients within 12 months of starting high-dose pancreatic enzyme replacement therapy. Data were collected through the hospital-based clinic approximately six months apart, before and after implementation of the Australian Pancreatic Enzyme Replacement Therapy Guidelines. Altus expects to recruit approximately 300 patients from more than 50 sites worldwide for the two trials, making this Phase III program the largest ever conducted to evaluate the efficacy and safety of pancreatic enzyme replacement therapy in cystic fibrosis patients. |
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