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Interim sample size re-estimation in the IIVOP trial
The IIVOP trial is a cross-over trial which examines the effect of the drug ivabridine in reducing pain in an enriched healthy volunteer pain model. The trial was designed based on very limited information, and as such an interim analysis was built into the design to allow the re-estimation of the sample size requirements based on updated trial parameters. The blinded data will be used to assess the assumptions regarding the variability of the primary endpoint. If appropriate and feasible thedoi:10.1186/1745-6215-16-s2-p128 fatcat:5c6zsmeasjfovhu5xee5itdriu