Statistical Considerations. Standard statistical methods will be employed to determine primary and secondary efficacy and safety outcomes. Depending on the final study design, BioForm may consult with appropriate statistical authorities to both determine the effectiveness of the surgery and accurately assess a change over time using a 95% confidence interval. BioForm expects to enroll up to [****] patients at up to [****] investigator sites. Standard screening and evaluation criteria may be employed to identify the appropriate patient population. [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 2 contracts
Sources: Exclusive Development, Distribution, and Supply Agreement (Bioform Medical Inc), Exclusive Development, Distribution, and Supply Agreement (Bioform Medical Inc)