Table 1.

Analysis of key secondary efficacy endpoints

Number	Endpoint	Primary analysis method
1	Hb change from BL to the average Hb in Weeks 28–36, without having received rescue therapy within 6 weeks prior to and during this 8-week evaluation period	Analysis method: MMRM Categorical variables: region, history of CV, visits and visits by treatment Continuous covariates: BL Hb, BL eGFR and BL Hb by visit
2	Change from BL in LDL cholesterol to the average LDL cholesterol of Weeks 12–28	Analysis method: MMRM Categorical variables: region, history of CV, visits and visits by treatment Continuous covariates: BL LDL, BL Hb and BL eGFR
3	Occurrence and time to first use of rescue therapy (composite of RBC transfusions, IV iron supplementation and rescue ESA)	Analysis method: Cox regression + Kaplan–Meier Categorical variables: stratified by region, history of CV and adjusted for BL Hb and BL eGFR as continuous covariates
4	Change from BL in SF-36 VT subscore to the average VT subscore of Weeks 12–28	Analysis method: MMRM Categorical variables: region, history of CV, visits and visits by treatment Continuous covariates: BL Hb, BL SF-36 VT subscore and BL eGFR
5	Change from BL in SF-36 PF subscore to the average PF subscore of Weeks 12–28	Analysis method: MMRM Categorical variables: region, history of CV, visits and visits by treatment Continuous covariates: BL Hb, BL SF-36 PF subscore and BL eGFR

MMRM, mixed model of repeated measures. Superiority was tested using a fixed sequence testing procedure.