Statistical analysis
RECRUITMENT
Given the exploratory nature of the study, no formal sample size calculation was performed. Twenty participants per arm was estimated to provide an adequate level of precision for treatment differences for the primary endpoints.Enrollment was terminated early due to recruitment issues and the unlikely unfeasibility of timely study completion. Consequently, all data were summarized, with no statistical analyses performed. Due to the small sample size at Week 12, there was inadequate estimation of the dispersion of the data, and the frequency distribution of the data was not normal. For this reason, the median and interquartile ranges are presented.