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*Adjusted for baseline values and stratification variables (lesion size and presence of underlying disease).
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Primary and continuous secondary efficacy endpoints were assessed using an analysis of covariance (ancova) model with treatment and stratification factors as fixed effects and corresponding baseline values and baseline eGFR as covariates.
Changes from baseline in SF-36, FACIT-Fatigue, and EQ-5D scores were analysed using a covariance model, with covariates for baseline value and the three stratification factors, including baseline SELENA-SLEDAI score (≤9 vs ≥10), baseline proteinuria level (<2 g/24 h vs ≥2 g/24 h equivalent), and race (African descent or indigenous American descent vs other).
We repeated the analysis with the baseline value and included the prespecified stratification variables as covariates.
We repeated this analysis with the baseline value and included the three prespecified stratification variables as covariates.
*Adjusted for baseline value and site.
†Adjusted by stratification variables and baseline values.
Regression analyses adjusted for baseline values of the dependent variable and sex (the stratification variable) will be used to compare changes between baseline and follow-up for each independent variable.
Change in CD4% and other continuous laboratory outcomes from baseline to 48 weeks were analyzed using normal regression, adjusting for the baseline measurement and stratification factors.
The primary outcome (change in HbA1c from baseline to endpoint) was analysed using the analysis of covariance (ancova) model with treatment, baseline HbA1c and stratification variables [SU use and baseline HbA1c strata (≤8.5% and >8.5%)].
The model included treatment group and visit as fixed factors, as well as their interaction, together with covariates representing the randomisation stratification factors (gender, fracture aetiology, use of bisphosphonates at the time of enrolment and use of systemic steroids during the last 12 months before enrolment) and baseline values.
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