Pre-specified Principal and Sensitivity Analyses of the Primary Endpoint.
REGRESSION
Local and central lab CD34+ HSPC assessments of the apheresis product from each patient were analyzed for the primary endpoint using Cochran-Mantel-Haenszel (CMH) weights on an intent-to-treat (ITT) basis using N = 122 biologically independent samples examined over 1 experiment/sample. In addition, a pre-specified sensitivity analysis was performed on a modified intent-to-treat (mITT) basis using N = 120 biologically independent samples examined over 1 experiment/sample and on a per protocol (PP) basis using N = 76 biologically independent samples examined over 1 experiment/sample. The data are presented as CMH common proportions differences for each analysis with 2-sided 95% confidence intervals (CI) indicated by the error bars. Mixed* analyses accounted for missing central lab values by replacing them with non-missing local lab values. Logistic regression (LR**), multiple imputation missing not at random (MI MNAR) and missing at random (MI MAR) analyses were also performed.
