We consider a clinical trial with a primary and a secondary endpoint where the secondary endpoint is tested only if the primary endpoint is significant. The trial uses a group sequential procedure with two stages. The familywise error rate (FWER) of falsely concluding significance on either endpoint is to be controlled at a nominal level α. The type I error rate for the primary endpoint is cont...

This report provides a review of the multiple imputation methodology used by the Sponsor (Acorn Cardiovascular, Inc.) to handle missing data in the analysis of the primary endpoint of its pivotal clinical trial of the CorCap Cardiac Support Device (CorCap), as well as an evaluation of the impact of multiple imputation on the results of that analysis. This included a completely blinded imputatio...

Recent studies reveal that publicly available SPARQL endpoints exhibit significant limitations in supporting real-world applications. In order for this querying infrastructure to reach its full potential, more flexible client-server architectures capable of deciding appropriate shipping plans are needed. Shipping plans indicate how the execution of query operators is distributed between the cli...