<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03237065</url>
  </required_header>
  <id_info>
    <org_study_id>P-Monofer-IDA-05</org_study_id>
    <nct_id>NCT03237065</nct_id>
  </id_info>
  <brief_title>Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia</brief_title>
  <official_title>A Randomized, Open-label, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside/Ferric Derisomaltose and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (Phosphare-IDA-05)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmacosmos A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pharmacosmos A/S</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of&#xD;
      phosphate in the blood) in subjects with iron deficiency anaemia (IDA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial was designed to evaluate the effect of IV iron isomaltoside/ferric derisomaltose&#xD;
      compared with IV ferric carboxymaltose on s-phosphate in subjects with IDA caused by&#xD;
      different etiologies.&#xD;
&#xD;
      The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric&#xD;
      derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg&#xD;
      at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects&#xD;
      were monitored for up to 35 days from baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">May 29, 2018</completion_date>
  <primary_completion_date type="Actual">May 29, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Hypophosphatemia (S-phosphate Level &lt;2 mg/dL)</measure>
    <time_frame>Baseline to day 35</time_frame>
    <description>Safety&#xD;
The incidence of hypophosphatemia (defined as s-phosphate &lt;2 mg/dL) at any time from baseline up to day 35.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time With Hypophosphatemia ( S-phosphate Level &lt;2.0 mg/dL)</measure>
    <time_frame>Baseline to day 35</time_frame>
    <description>Safety&#xD;
Time with hypophosphatemia (i.e. time with s-phosphate level &lt; 2.0 mg/dL) from baseline up to day 35.&#xD;
The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was &lt;2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level &lt;2.0 mg/dL)</measure>
    <time_frame>Baseline to day 35</time_frame>
    <description>Safety&#xD;
Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level &lt;2.0 mg/dL) on day 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Absolute [∆] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Relative [%] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fractional Phosphate Urinary Excretion</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35.&#xD;
Fractional excretion of phosphate (FEPi) is calculated as ([phosphate in urine X creatinine in serum]/[phosphate in serum X creatinine in urine]) X 100, and the unit is %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Safety&#xD;
Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions</measure>
    <time_frame>Baseline to day 35</time_frame>
    <description>Safety&#xD;
For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Efficacy&#xD;
Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Efficacy&#xD;
Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35</measure>
    <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
    <description>Efficacy&#xD;
Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35.&#xD;
TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Iron Deficiency Anaemia</condition>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Iron isomaltoside/ferric derisomaltose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferric carboxymaltose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron isomaltoside/ferric derisomaltose</intervention_name>
    <description>Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.&#xD;
The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).</description>
    <arm_group_label>Iron isomaltoside/ferric derisomaltose</arm_group_label>
    <other_name>Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferric carboxymaltose</intervention_name>
    <description>Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).</description>
    <arm_group_label>Ferric carboxymaltose</arm_group_label>
    <other_name>Injectafer®, Ferinject®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria include:&#xD;
&#xD;
          -  Subjects having IDA caused by different aetiologies&#xD;
&#xD;
          -  Haemoglobin (Hb) ≤ 11 g/dL&#xD;
&#xD;
          -  Body weight &gt; 50 kg&#xD;
&#xD;
          -  Serum ferritin (S-ferritin) &lt; 100 ng/mL&#xD;
&#xD;
          -  Estimated Glomerular Filtration Rate (eGFR) ≥ 65 mL/min/1.73 m2&#xD;
&#xD;
          -  Serum phosphate (S-phosphate) &gt; 2.5 mg/dL&#xD;
&#xD;
          -  Intolerance or unresponsiveness to oral iron&#xD;
&#xD;
          -  Willingness to participate and signing the Informed Consent Form (ICF)&#xD;
&#xD;
        Exclusion criteria include:&#xD;
&#xD;
          -  Acute bleeding &gt; 500 mL within 72 hours&#xD;
&#xD;
          -  Anaemia predominantly caused by factors other than IDA&#xD;
&#xD;
          -  Hemochromatosis or other iron storage disorders&#xD;
&#xD;
          -  Previous serious hypersensitivity reactions to any IV iron compounds&#xD;
&#xD;
          -  Treatment with IV iron within the last 30 days prior to screening&#xD;
&#xD;
          -  Treatment with erythropoietin or erythropoietin-stimulation agents&#xD;
&#xD;
          -  Red blood cell transfusion, radiotherapy, and/or chemotherapy&#xD;
&#xD;
          -  Received an investigational drug within the last 30 days prior to screening&#xD;
&#xD;
          -  Planned surgical procedure within the trial period&#xD;
&#xD;
          -  Hepatic enzymes &gt; 3 times upper limit of normal&#xD;
&#xD;
          -  Surgery under anaesthetic within the last 30 days prior to screening&#xD;
&#xD;
          -  Any non-viral infection within the last 30 days prior to screening&#xD;
&#xD;
          -  Alcohol or drug abuse within the past 6 months&#xD;
&#xD;
          -  Vitamin D deficiency&#xD;
&#xD;
          -  Untreated hyperparathyroidism&#xD;
&#xD;
          -  Kidney transplantation&#xD;
&#xD;
          -  Active malignant disease, disease-free for less than 5 years&#xD;
&#xD;
          -  History of a psychological illness or seizures&#xD;
&#xD;
          -  Pregnant or nursing women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pharmacosmos A/S Clinical and Non-clinical Research</last_name>
    <role>Study Director</role>
    <affiliation>Pharmacosmos A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Muscle Shoals</city>
        <state>Alabama</state>
        <zip>35661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Oak Brook</city>
        <state>Illinois</state>
        <zip>60523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos investigational Site</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacosmos Investigational Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.1210/js.2019-OR13-3</url>
    <description>Effects of iron isomaltoside/ferric derisomaltose versus ferric carboxymaltose on hormonal control of phosphate homeostasis</description>
  </link>
  <results_reference>
    <citation>Wolf M, Rubin J, Achebe M, Econs M, Peacock M, Imel E, Thomsen L, Carpenter T, Weber T, Zoller H. Effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: The PHOSPHARE-IDA04/05 randomized controlled trials. Journal of the Endocrine Society, Volume 3, Issue Supplement_1, April-May 2019, OR13-3, https://doi.org/10.1210/js.2019-OR13-3</citation>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <results_first_submitted>February 5, 2020</results_first_submitted>
  <results_first_submitted_qc>February 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 25, 2020</results_first_posted>
  <disposition_first_submitted>May 7, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>February 24, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 25, 2020</disposition_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Iron Deficiency Anaemia</keyword>
  <keyword>Iron Deficiency Anemia</keyword>
  <keyword>IDA</keyword>
  <keyword>Iron deficiency</keyword>
  <keyword>Intravenous iron replacement therapy</keyword>
  <keyword>Iron isomaltoside</keyword>
  <keyword>Ferric derisomaltose</keyword>
  <keyword>Hypophosphatemia</keyword>
  <keyword>Ferric carboxymaltose</keyword>
  <keyword>Monofer</keyword>
  <keyword>Monoferric</keyword>
  <keyword>Monover</keyword>
  <keyword>Monofar</keyword>
  <keyword>Monoferro</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Deficiency Diseases</mesh_term>
    <mesh_term>Hypophosphatemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron isomaltoside 1000</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03237065/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03237065/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 244 subjects were screened and 122 subjects were randomised into the trial.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Iron Isomaltoside/Ferric Derisomaltose</title>
          <description>Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.&#xD;
Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg iron isomaltoside/ferric derisomaltose at the baseline visit.</description>
        </group>
        <group group_id="P2">
          <title>Ferric Carboxymaltose</title>
          <description>Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator product in this trial.&#xD;
The dose of ferric carboxymaltose for the individual subject was 750 mg, infused IV at baseline and on day 7 (cumulative dose: 1500 mg).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="62">1 subject from ferric carboxymaltose group received iron isomaltoside/ferric derisomaltose in error.</participants>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to obtain venous access</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Iron Isomaltoside/Ferric Derisomaltose</title>
          <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
        </group>
        <group group_id="B2">
          <title>Ferric Carboxymaltose</title>
          <description>Ferric carboxymaltose, administered IV</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="62"/>
            <count group_id="B2" value="57"/>
            <count group_id="B3" value="119"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.2" spread="12.9"/>
                    <measurement group_id="B2" value="43.1" spread="11.5"/>
                    <measurement group_id="B3" value="42.6" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mayan Indian/Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irish/Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current smoker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Iron Deficiency Anaemia (IDA) due to gynaecological blood loss</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>S-phosphate level at screening</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;3.5 mg/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥3.5 mg/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Hypophosphatemia (S-phosphate Level &lt;2 mg/dL)</title>
        <description>Safety&#xD;
The incidence of hypophosphatemia (defined as s-phosphate &lt;2 mg/dL) at any time from baseline up to day 35.</description>
        <time_frame>Baseline to day 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Hypophosphatemia (S-phosphate Level &lt;2 mg/dL)</title>
          <description>Safety&#xD;
The incidence of hypophosphatemia (defined as s-phosphate &lt;2 mg/dL) at any time from baseline up to day 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Power:&#xD;
The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Rate difference with 95% Newcombe confidence intervals (CI) adjusted for stratum, using the Cochran-Mantel-Haenszel method.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-65.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-76.6</ci_lower_limit>
            <ci_upper_limit>-49.8</ci_upper_limit>
            <estimate_desc>Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time With Hypophosphatemia ( S-phosphate Level &lt;2.0 mg/dL)</title>
        <description>Safety&#xD;
Time with hypophosphatemia (i.e. time with s-phosphate level &lt; 2.0 mg/dL) from baseline up to day 35.&#xD;
The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was &lt;2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.</description>
        <time_frame>Baseline to day 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Time With Hypophosphatemia ( S-phosphate Level &lt;2.0 mg/dL)</title>
          <description>Safety&#xD;
Time with hypophosphatemia (i.e. time with s-phosphate level &lt; 2.0 mg/dL) from baseline up to day 35.&#xD;
The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was &lt;2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="6" upper_limit="28"/>
                    <measurement group_id="O2" value="28" lower_limit="15" upper_limit="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>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) &lt;2 mg/dL were included.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0511</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level &lt;2.0 mg/dL)</title>
        <description>Safety&#xD;
Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level &lt;2.0 mg/dL) on day 35.</description>
        <time_frame>Baseline to day 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level &lt;2.0 mg/dL)</title>
          <description>Safety&#xD;
Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level &lt;2.0 mg/dL) on day 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Iron isomaltoside/ferric derisomaltose was 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 (&lt; or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-44.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-57.7</ci_lower_limit>
            <ci_upper_limit>-31.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35</title>
        <description>Safety&#xD;
Absolute [∆] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35</title>
          <description>Safety&#xD;
Absolute [∆] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.57"/>
                    <measurement group_id="O2" value="-0.18" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" spread="0.57"/>
                    <measurement group_id="O2" value="-0.89" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" spread="0.64"/>
                    <measurement group_id="O2" value="-1.14" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="0.60"/>
                    <measurement group_id="O2" value="-1.47" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.66"/>
                    <measurement group_id="O2" value="-1.27" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.49"/>
                    <measurement group_id="O2" value="-0.99" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.30</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>1.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35</title>
        <description>Safety&#xD;
Relative [%] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35</title>
          <description>Safety&#xD;
Relative [%] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>Percentage change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.89" spread="16.02"/>
                    <measurement group_id="O2" value="-4.34" spread="15.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.99" spread="15.38"/>
                    <measurement group_id="O2" value="-25.83" spread="20.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.32" spread="18.50"/>
                    <measurement group_id="O2" value="-33.36" spread="19.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.66" spread="16.27"/>
                    <measurement group_id="O2" value="-43.54" spread="22.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.23" spread="19.15"/>
                    <measurement group_id="O2" value="-37.71" spread="24.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.88" spread="14.19"/>
                    <measurement group_id="O2" value="-28.63" spread="28.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>13.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.38</ci_lower_limit>
            <ci_upper_limit>18.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>15.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.45</ci_lower_limit>
            <ci_upper_limit>22.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>21.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.72</ci_lower_limit>
            <ci_upper_limit>28.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>36.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.28</ci_lower_limit>
            <ci_upper_limit>43.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>37.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.99</ci_lower_limit>
            <ci_upper_limit>45.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>34.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.80</ci_lower_limit>
            <ci_upper_limit>42.26</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fractional Phosphate Urinary Excretion</title>
        <description>Safety&#xD;
Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35.&#xD;
Fractional excretion of phosphate (FEPi) is calculated as ([phosphate in urine X creatinine in serum]/[phosphate in serum X creatinine in urine]) X 100, and the unit is %.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fractional Phosphate Urinary Excretion</title>
          <description>Safety&#xD;
Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35.&#xD;
Fractional excretion of phosphate (FEPi) is calculated as ([phosphate in urine X creatinine in serum]/[phosphate in serum X creatinine in urine]) X 100, and the unit is %.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>percentage excreted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="4.26"/>
                    <measurement group_id="O2" value="1.77" spread="5.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="5.04"/>
                    <measurement group_id="O2" value="4.90" spread="6.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" spread="5.18"/>
                    <measurement group_id="O2" value="6.05" spread="5.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="4.59"/>
                    <measurement group_id="O2" value="8.50" spread="8.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="4.18"/>
                    <measurement group_id="O2" value="6.42" spread="6.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread="4.96"/>
                    <measurement group_id="O2" value="5.21" spread="7.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35</title>
        <description>Safety&#xD;
Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35</title>
          <description>Safety&#xD;
Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.18" spread="18.20"/>
                    <measurement group_id="O2" value="93.38" spread="88.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.97" spread="45.44"/>
                    <measurement group_id="O2" value="33.60" spread="57.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.09" spread="36.06"/>
                    <measurement group_id="O2" value="259.16" spread="210.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.35" spread="24.09"/>
                    <measurement group_id="O2" value="74.07" spread="90.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.13" spread="28.95"/>
                    <measurement group_id="O2" value="54.49" spread="74.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.17" spread="23.87"/>
                    <measurement group_id="O2" value="10.52" spread="39.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-96.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-119.8</ci_lower_limit>
            <ci_upper_limit>-73.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1064</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-15.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.9</ci_lower_limit>
            <ci_upper_limit>3.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-251.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-307.2</ci_lower_limit>
            <ci_upper_limit>-196.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-79.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-103.7</ci_lower_limit>
            <ci_upper_limit>-54.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-61.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-83.0</ci_lower_limit>
            <ci_upper_limit>-40.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0039</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-18.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.1</ci_lower_limit>
            <ci_upper_limit>-5.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
        <description>Safety&#xD;
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
          <description>Safety&#xD;
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>RU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-677.38" spread="758.35"/>
                    <measurement group_id="O2" value="-843.21" spread="1756.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-692.44" spread="800.04"/>
                    <measurement group_id="O2" value="-924.44" spread="1748.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-753.40" spread="803.63"/>
                    <measurement group_id="O2" value="-853.50" spread="1877.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-740.37" spread="822.35"/>
                    <measurement group_id="O2" value="-925.02" spread="1783.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-743.99" spread="805.24"/>
                    <measurement group_id="O2" value="-986.30" spread="1815.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-737.46" spread="791.86"/>
                    <measurement group_id="O2" value="-943.91" spread="1741.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1243</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-57.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-131.1</ci_lower_limit>
            <ci_upper_limit>16.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5547</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>20.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-49.7</ci_lower_limit>
            <ci_upper_limit>91.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-155.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-234.7</ci_lower_limit>
            <ci_upper_limit>-76.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3516</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-27.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-86.0</ci_lower_limit>
            <ci_upper_limit>31.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1988</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-24.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-62.3</ci_lower_limit>
            <ci_upper_limit>13.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4379</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>11.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.6</ci_lower_limit>
            <ci_upper_limit>41.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
        <description>Safety&#xD;
Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
          <description>Safety&#xD;
Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.39" spread="1.86"/>
                    <measurement group_id="O2" value="-0.25" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.39" spread="3.17"/>
                    <measurement group_id="O2" value="0.61" spread="3.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.92" spread="3.51"/>
                    <measurement group_id="O2" value="0.83" spread="3.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.46" spread="4.11"/>
                    <measurement group_id="O2" value="0.67" spread="3.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.23" spread="4.65"/>
                    <measurement group_id="O2" value="0.13" spread="4.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="6.10"/>
                    <measurement group_id="O2" value="-0.66" spread="4.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6869</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.06</ci_lower_limit>
            <ci_upper_limit>0.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1037</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.29</ci_lower_limit>
            <ci_upper_limit>0.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0213</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.99</ci_lower_limit>
            <ci_upper_limit>-0.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0176</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.47</ci_lower_limit>
            <ci_upper_limit>-0.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0999</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.01</ci_lower_limit>
            <ci_upper_limit>0.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8878</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.77</ci_lower_limit>
            <ci_upper_limit>2.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
        <description>Safety&#xD;
Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
          <description>Safety&#xD;
Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.89" spread="10.60"/>
                    <measurement group_id="O2" value="-16.97" spread="13.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.78" spread="17.81"/>
                    <measurement group_id="O2" value="-23.92" spread="30.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.93" spread="17.81"/>
                    <measurement group_id="O2" value="-35.59" spread="26.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" spread="16.54"/>
                    <measurement group_id="O2" value="-36.14" spread="26.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="16.11"/>
                    <measurement group_id="O2" value="-24.02" spread="29.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="15.33"/>
                    <measurement group_id="O2" value="-12.67" spread="25.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>21.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.66</ci_lower_limit>
            <ci_upper_limit>25.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2923</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.05</ci_lower_limit>
            <ci_upper_limit>13.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>19.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.37</ci_lower_limit>
            <ci_upper_limit>26.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>33.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.96</ci_lower_limit>
            <ci_upper_limit>40.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>21.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.20</ci_lower_limit>
            <ci_upper_limit>29.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0250</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>9.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.16</ci_lower_limit>
            <ci_upper_limit>16.90</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
        <description>Safety&#xD;
Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
          <description>Safety&#xD;
Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.45"/>
                    <measurement group_id="O2" value="0.07" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.84"/>
                    <measurement group_id="O2" value="0.26" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="0.84"/>
                    <measurement group_id="O2" value="0.38" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.75"/>
                    <measurement group_id="O2" value="0.55" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.55"/>
                    <measurement group_id="O2" value="0.50" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.77"/>
                    <measurement group_id="O2" value="0.23" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5134</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.22</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7579</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>0.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3169</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.41</ci_lower_limit>
            <ci_upper_limit>0.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0018</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.76</ci_lower_limit>
            <ci_upper_limit>-0.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.77</ci_lower_limit>
            <ci_upper_limit>-0.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1063</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.50</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
        <description>Safety&#xD;
Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
          <description>Safety&#xD;
Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="18.93"/>
                    <measurement group_id="O2" value="-7.02" spread="25.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.72" spread="24.41"/>
                    <measurement group_id="O2" value="0.73" spread="29.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="21.03"/>
                    <measurement group_id="O2" value="-3.26" spread="27.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.39" spread="24.17"/>
                    <measurement group_id="O2" value="22.22" spread="31.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" spread="19.36"/>
                    <measurement group_id="O2" value="22.80" spread="38.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.58" spread="22.86"/>
                    <measurement group_id="O2" value="22.19" spread="33.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2166</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.72</ci_lower_limit>
            <ci_upper_limit>11.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2997</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.47</ci_lower_limit>
            <ci_upper_limit>4.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9221</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.75</ci_lower_limit>
            <ci_upper_limit>8.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0034</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-15.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.07</ci_lower_limit>
            <ci_upper_limit>-5.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-22.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.93</ci_lower_limit>
            <ci_upper_limit>-11.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-24.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.42</ci_lower_limit>
            <ci_upper_limit>-14.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
        <description>Safety&#xD;
Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
          <description>Safety&#xD;
Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.002" spread="0.198"/>
                    <measurement group_id="O2" value="0.047" spread="0.168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.020" spread="0.206"/>
                    <measurement group_id="O2" value="-0.003" spread="0.219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.016" spread="0.206"/>
                    <measurement group_id="O2" value="-0.016" spread="0.186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.090" spread="0.500"/>
                    <measurement group_id="O2" value="-0.054" spread="0.251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.030" spread="0.204"/>
                    <measurement group_id="O2" value="-0.016" spread="0.194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.012" spread="0.212"/>
                    <measurement group_id="O2" value="-0.015" spread="0.211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3048</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1641</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1333</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9385</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0408</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2376</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.12</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions</title>
        <description>Safety&#xD;
For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.</description>
        <time_frame>Baseline to day 35</time_frame>
        <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions</title>
          <description>Safety&#xD;
For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.</description>
          <population>Safety analysis set: included all subjects who received at least one dose of the investigational product.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
        <description>Efficacy&#xD;
Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Intention-To-Treat (ITT) analysis set: included all randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
          <description>Efficacy&#xD;
Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35.</description>
          <population>Intention-To-Treat (ITT) analysis set: included all randomised subjects.</population>
          <units>g/dL per g of iron</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="0.80"/>
                    <measurement group_id="O2" value="0.46" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="1.13"/>
                    <measurement group_id="O2" value="1.41" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="1.21"/>
                    <measurement group_id="O2" value="0.84" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.68" spread="1.13"/>
                    <measurement group_id="O2" value="1.30" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" spread="0.97"/>
                    <measurement group_id="O2" value="1.63" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" spread="1.21"/>
                    <measurement group_id="O2" value="2.00" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0882</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.67</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0941</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.74</ci_lower_limit>
            <ci_upper_limit>0.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0628</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0056</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.14</ci_lower_limit>
            <ci_upper_limit>0.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0492</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0882</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>0.64</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
        <description>Efficacy&#xD;
Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Intention-To-Treat (ITT) analysis set: included all randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
          <description>Efficacy&#xD;
Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.</description>
          <population>Intention-To-Treat (ITT) analysis set: included all randomised subjects.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.47" spread="81.88"/>
                    <measurement group_id="O2" value="76.96" spread="79.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="252.39" spread="163.85"/>
                    <measurement group_id="O2" value="279.15" spread="215.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="219.36" spread="148.84"/>
                    <measurement group_id="O2" value="313.44" spread="229.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.39" spread="100.06"/>
                    <measurement group_id="O2" value="379.42" spread="282.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.81" spread="92.42"/>
                    <measurement group_id="O2" value="232.59" spread="212.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.27" spread="70.64"/>
                    <measurement group_id="O2" value="126.20" spread="157.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6568</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.3</ci_lower_limit>
            <ci_upper_limit>22.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4929</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-24.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-94.0</ci_lower_limit>
            <ci_upper_limit>45.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0113</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-91.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-162.3</ci_lower_limit>
            <ci_upper_limit>-21.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-240.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-318.4</ci_lower_limit>
            <ci_upper_limit>-162.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-135.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-196.1</ci_lower_limit>
            <ci_upper_limit>-74.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0039</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-67.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-113.2</ci_lower_limit>
            <ci_upper_limit>-22.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
        <description>Efficacy&#xD;
Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35.&#xD;
TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.</description>
        <time_frame>Baseline, days 1, 7, 8, 14, 21, and 35</time_frame>
        <population>Intention-To-Treat (ITT) analysis set: included all randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35</title>
          <description>Efficacy&#xD;
Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35.&#xD;
TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.</description>
          <population>Intention-To-Treat (ITT) analysis set: included all randomised subjects.</population>
          <units>percentage of saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.77" spread="53.11"/>
                    <measurement group_id="O2" value="83.78" spread="42.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.05" spread="10.00"/>
                    <measurement group_id="O2" value="12.92" spread="28.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.27" spread="9.59"/>
                    <measurement group_id="O2" value="73.44" spread="34.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.34" spread="7.68"/>
                    <measurement group_id="O2" value="16.74" spread="12.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.61" spread="9.81"/>
                    <measurement group_id="O2" value="16.19" spread="10.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.87" spread="8.49"/>
                    <measurement group_id="O2" value="14.43" spread="9.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 1&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0503</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>24.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0</ci_lower_limit>
            <ci_upper_limit>48.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5794</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.5</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-62.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-70.1</ci_lower_limit>
            <ci_upper_limit>-54.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.4</ci_lower_limit>
            <ci_upper_limit>-3.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 21&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.1</ci_lower_limit>
            <ci_upper_limit>-2.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 35&#xD;
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.&#xD;
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.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0040</p_value>
            <method>Mixed model for repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.1</ci_lower_limit>
            <ci_upper_limit>-1.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Incidence of S-phosphate Level ≤1.0 mg/dL at Any Time From Baseline to Day 35</title>
        <description>Safety&#xD;
Incidence of s-phosphate level ≤1.0 mg/dL at any time from baseline to day 35.</description>
        <time_frame>Baseline to day 35</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iron Isomaltoside/Ferric Derisomaltose</title>
            <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
          </group>
          <group group_id="O2">
            <title>Ferric Carboxymaltose</title>
            <description>Ferric carboxymaltose, administered IV</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of S-phosphate Level ≤1.0 mg/dL at Any Time From Baseline to Day 35</title>
          <description>Safety&#xD;
Incidence of s-phosphate level ≤1.0 mg/dL at any time from baseline to day 35.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0090</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-10.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.8</ci_lower_limit>
            <ci_upper_limit>-2.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).</time_frame>
      <desc>AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome.&#xD;
1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.</desc>
      <group_list>
        <group group_id="E1">
          <title>Iron Isomaltoside/Ferric Derisomaltose</title>
          <description>Iron isomaltoside/ferric derisomaltose, administered IV</description>
        </group>
        <group group_id="E2">
          <title>Ferric Carboxymaltose</title>
          <description>Ferric carboxymaltose, administered IV</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood parathyroid hormone increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Serum ferritin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" events="9" subjects_affected="4" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Before 1 year after completion of the Study report the Investigator must not publish details regarding the Protocol and the conduct or results of the Trial. However, if a joint publication is submitted for publication the individual Investigator has no right to publish results from his/her centre until such the joint publication is actually issued.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical trial disclosure desk</name_or_title>
      <organization>Pharmacosmos A/S</organization>
      <phone>+45 5948 5935</phone>
      <email>trial@pharmacosmos.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03237065
org study id: P-Monofer-IDA-05
nct id: NCT03237065
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of
      phosphate in the blood) in subjects with iron deficiency anaemia (IDA).
This trial was designed to evaluate the effect of IV iron isomaltoside/ferric derisomaltose
      compared with IV ferric carboxymaltose on s-phosphate in subjects with IDA caused by
      different etiologies.

      The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric
      derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg
      at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects
      were monitored for up to 35 days from baseline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)
time frame: Baseline to day 35
description: Safety
The incidence of hypophosphatemia (defined as s-phosphate <2 mg/dL) at any time from baseline up to day 35.
measure: Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)
time frame: Baseline to day 35
description: Safety
Time with hypophosphatemia (i.e. time with s-phosphate level < 2.0 mg/dL) from baseline up to day 35.
The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was <2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.
measure: Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)
time frame: Baseline to day 35
description: Safety
Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level <2.0 mg/dL) on day 35.
measure: Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Absolute [∆] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
measure: Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Relative [%] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
measure: Change From Baseline in Fractional Phosphate Urinary Excretion
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35.
Fractional excretion of phosphate (FEPi) is calculated as ([phosphate in urine X creatinine in serum]/[phosphate in serum X creatinine in urine]) X 100, and the unit is %.
measure: Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.
measure: Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.
measure: Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.
measure: Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.
measure: Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35.
measure: Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.
measure: Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Safety
Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.
measure: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
time frame: Baseline to day 35
description: Safety
For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.
measure: Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Efficacy
Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35.
measure: Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Efficacy
Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.
measure: Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
time frame: Baseline, days 1, 7, 8, 14, 21, and 35
description: Efficacy
Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35.
TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.
arm group label: Iron isomaltoside/ferric derisomaltose
arm group type: Experimental
description: Administered IV
arm group label: Ferric carboxymaltose
arm group type: Active Comparator
description: Administered IV
intervention type: Drug
intervention name: Iron isomaltoside/ferric derisomaltose
description: Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).
arm group label: Iron isomaltoside/ferric derisomaltose
other name: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®
intervention type: Drug
intervention name: Ferric carboxymaltose
description: Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).
arm group label: Ferric carboxymaltose
other name: Injectafer®, Ferinject®
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pharmacosmos A/S Clinical and Non-clinical Research
role: Study Director
affiliation: Pharmacosmos A/S
facility: 
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country: United States
url: https://doi.org/10.1210/js.2019-OR13-3
description: Effects of iron isomaltoside/ferric derisomaltose versus ferric carboxymaltose on hormonal control of phosphate homeostasis
citation: Wolf M, Rubin J, Achebe M, Econs M, Peacock M, Imel E, Thomsen L, Carpenter T, Weber T, Zoller H. Effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: The PHOSPHARE-IDA04/05 randomized controlled trials. Journal of the Endocrine Society, Volume 3, Issue Supplement_1, April-May 2019, OR13-3, https://doi.org/10.1210/js.2019-OR13-3
responsible party type: Sponsor
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Deficiency Diseases
mesh term: Hypophosphatemia
mesh term: Iron isomaltoside 1000
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 