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EMEA guidelines for trials in osteoporosis: design implications
1Department of Clinical Epidemiology & Biostatistics, Free University Hospital, PO Box 7057, 1007 MB Amsterdam, The Netherlands.
The Netherlands Journal of Medicine
|December 17, 2002
Abstract:
The design, execution and interpretation of trials that do not contain a placebo arm are a challenge. These issues are briefly discussed in the context of the new European guidelines for the study of drugs for the indication prevention and treatment of postmenopausal osteoporosis.