Study design considerations for evaluating the efficacy and safety of pancreatic enzyme replacement therapy in patients with cystic fibrosis

Affiliations

• ¹ Case Western Reserve University School of Medicine, Cleveland, OH, USA.
• ² State University of New York at Buffalo, Buffalo, NY, USA ; Cystic Fibrosis Foundation Data Safety Monitoring Board, Tucson, AZ, USA.
• ³ University of Washington, Seattle, WA, USA ; CF Therapeutics Development Network Coordinating Center, Seattle, WA, USA.
• ⁴ Stanford University, Palo Alto, CA, USA.
• ⁵ University of Florida, Gainesville, FL, USA.
• ⁶ Cystic Fibrosis Foundation Data Safety Monitoring Board, Tucson, AZ, USA ; University of Michigan, Ann Arbor, MI, USA.
• ⁷ Seattle Children's Hospital , Seattle, WA, USA.
• ⁸ Cystic Fibrosis Foundation Data Safety Monitoring Board, Tucson, AZ, USA ; University of Arizona, Tucson, AZ, USA.