Statistical Analysis
The primary analyses were based on the intention-to-treat approach. The 3 symptom end points were considered coprimary outcomes by design. To address for multiple testing, we controlled for a false discovery rate (FDR) of 5% using the Benjamini-Hochberg correction.After assessing the model diagnostics, we included quadratic time, its interaction with the treatment group, and random time slopes. To improve precision, these models were adjusted for prespecified covariates (age, sex, site, and CCI) that were chosen based on prior literature demonstrating an association with symptom burden or response to treatment.Statistical analyses were conducted using R, version 4.2.1 (The R Foundation for Statistical Computing) with Ime4