The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan-Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) <2 mg/dL were included.

Iron isomaltoside/ferric derisomaltose will be compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.

Day 1

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 7

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 8

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 14

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 21

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 35

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 1

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 7

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 8

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 14

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 21

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 35

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 1

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 7

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 8

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 14

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 21

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 35

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 1

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 7

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 8

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 14

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 21

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 35

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 1

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 7

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 8

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 14

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 21

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 35

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 1

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 7

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.

Day 8

Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.

The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction.