STATISTICAL METHODS 5.1. Sample Size Justification Up to 60 subjects in total could be enrolled, based on the original planned cohort of 16 subjects and the study was then expanded to enroll up to an additional 44 subj ects. A total of 32 subjects were planned for Cohort 1 (CRS- 207 in combination with chemotherapy ) (Cohort 1), and up to 28 subjects were planned for Cohort 2 (Cy 1 day prior to each CRS -207 administration combined with chemotherapy ). Ultimately, a total of 38 subjects were in Cohort 1, and 22 subjects were in Cohort 2 (for a total of 60 subjects). The originally planned sample size calculation was based on the primary endpoint of mesothelin -specific T cell responses as measured by ELISPOT (enzyme- linked immunosorbent spot) assay . With one primary parameter (ELISPOT) to be measured with respect to a change from baseline at three post -baseline time points, the sample size was selected to allow each test to be performed using a 0.017 two- tailed significance level, in order to allow the overall set of three tests to be very conservatively performed as if at an overall 0.05 level using a Bonferroni adjustment. Assuming 14 subjects with complete measurements of the main parameter at baseline and the three subsequent time points, there would be 80% power to detect a change from baseline to each time point equal to 1.0 standard deviations of the change (1.0 effect size) using a two -tailed 0.017 level paired t -test. This stringent multiplicity adjustment is for power computation only. In practice, for analysis purposes, instead of requiring that each test achieve a 0.017 level in order to be declared significant, a less overly stringent Hochberg adjustment will be used. In order to allow for a small number of non- evaluable subjects, up to 16 subjects could be e nrolled. The planned expanded cohort of up to 44 additional subjects (Cohort 2) was intended to obtain additional safety, immune, and efficacy data for future study planning. The sample size was based on practical rather than statistical considerations.