Clinical Outcomes and Statistical Analysis

The investigational regimen is hypothesized to improve 1-year recurrence-free survival from 55% to 70%. The tailor-made approach is considered superior only if it does not increase advanced therapy use and lowers mean disease activity. Secondary analyses test whether intervention effects differ by rural or urban residence. The original sample size required 1232 infants, with 616 infants in each arm from 17 sites. Assessments occur at baseline, 3 months, 6 months, and 12 months after randomisation. The primary endpoint is physician-reported acute CTCAE v5 grade 2 or higher genitourinary adverse events within 12 weeks after radiotherapy completion. The trial plans a pooled sample of 700 participants, with 350 in each arm. The target sample size is 36 participants and the study is exploratory and non-confirmatory. The primary endpoint was percent maintenance of body weight reduction achieved in SURMOUNT-5 among participants who had reached a body weight plateau. The sample size was powered to detect a 35% relative reduction in late-onset sepsis incidence from 25% to 16.25%. The primary quantitative analysis uses intention to treat. The 12-month assessment is the primary endpoint for…