Statistical Analysis
All statistical analyses were descriptive; no statistical hypothesis was tested. The planned total sample size for this study was 24 participants (8 per treatment arm), with a minimum of 18 individuals expected to complete the study. This sample size was considered adequate for assessing the tolerability and safety of fSCIG 20% based on clinical judgment. Statistical Analysis Software (SAS; SAS Institute, Cary, NC, USA) version 9.4 or higher was used to conduct all statistical analyses.