•Ctrough after multiple dosing. •Incidence and titers of ADA and neutralizing antibodies against tremelimumab. •Incidence and titers of ADA and neutralizing antibodies against PF-06801591.CCI Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 13 6.7. Covariates Analyses of immune response and analyses of pharmacodynamic parameters may be adjusted (or stratified) by demographic and prognostics variables (eg, age, gleason score, baseline PSA, baseline PSADT etc).