The primary efficacy population excluded the exploratory participant aged 3 to 5 years. Primary-endpoint missing data were handled by multiple imputation. The reported confirmatory endpoints were evaluated through a prespecified testing hierarchy.
SELVA lacked a concurrent placebo or active-treatment comparator. The primary assessment was performed by a clinician in an open-label study; blinded photographic assessment was a separate secondary endpoint. The 24-week efficacy population comprised 49 participants aged at least 6 years, while the exploratory younger cohort contributed only one treated participant. Six of 50 treated participants did not complete the efficacy evaluation period. Baseline-control and imputation methods do not eliminate all risks of expectation bias, confounding, or informative missingness. Treatment satisfaction among completers does not establish an effect on a generic health-utility measure.