8 Number of Subjects and Statistical Plan
8.1 Number of Subjects
Indicate the maximum number of subjects to be accrued/enrolled. Distinguish between the number of subjects who are expected to be enrolled and screened, and the number of subjects needed to complete the research procedures if applicable (i.e., numbers of subjects excluding screen failures.)
The number of participants depends on the number of University-approved lists we are able to access, the number of subscribers to those lists, and the proportion of recipients who respond. We hope to have a sample of several hundred. We estimate that the maximum number of participants is about 2,000, assuming a very optimistic response rate of 10% and a total possible participant pool of ~20,000 (see Section 15.2).
8.2 Sample Size Determination
If applicable, provide a justification of the sample size outlined in section 8.1 to include reflections on, or calculations of, the power of the study.
This is an exploratory study that will use simple statistical techniques, and has no formal inferential goals. Hence power considerations are not directly applicable.