<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/NCT02970942</url>
  </required_header>
  <id_info>
    <org_study_id>NN9931-4296</org_study_id>
    <secondary_id>2016-000685-39</secondary_id>
    <secondary_id>U1111-1179-7464</secondary_id>
    <nct_id>NCT02970942</nct_id>
  </id_info>
  <brief_title>Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.</brief_title>
  <official_title>This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once&#xD;
      daily versus placebo in subjects with non-alcoholic steatohepatitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2016</start_date>
  <completion_date type="Actual">March 19, 2020</completion_date>
  <primary_completion_date type="Actual">February 13, 2020</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)</measure>
    <time_frame>After 72 weeks</time_frame>
    <description>NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)</measure>
    <time_frame>After 72 weeks</time_frame>
    <description>NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Steatosis</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Lobular Inflammation</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Hepatocyte Ballooning</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fibrosis-4 Score</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A Fibrosis-4 index of &lt; 1.45 indicated no or moderate fibrosis and an index of &gt; 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NAFLD Fibrosis Score (NFS)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * body mass index (BMI) (kg/m^2) + 1.13 * hyperglycaemia (yes/no) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (*10^9/L) - 0.66 * albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) &lt; -1.5 indicates a low probability, b) &gt; -1.5 to &lt; 0.67 indicates intermediate probability, and a score of c) &gt; 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Alanine Aminotransferase (ALT)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Aspartate Aminotransferase (AST)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gamma Glutamyl Transferase (GGT)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Albumin</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in International Normalized Ratio (INR)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Enhanced Liver Fibrosis (ELF)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) &lt; 7.7: no to mild fibrosis; b) ≥ 7.7 - &lt; 9.8: Moderate fibrosis; c) ≥ 9.8 - &lt; 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cytokeratin 18 (CK-18) Fragments</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microRNA 122 (miR-122)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin-1 Receptor (IL-1R) Antagonist</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Monocyte Chemoattractant Protein 1 (MCP-1)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fibroblast Growth Factor 21 (FGF-21)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Liver Stiffness Assessed by FibroScan®</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Liver Steatosis Assessed by FibroScan®</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)</measure>
    <time_frame>Week 72</time_frame>
    <description>Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)</measure>
    <time_frame>Week 72</time_frame>
    <description>Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Circumference</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Glycosylated Haemoglobin (HbA1c) (%-Point)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c (Millimoles Per Mole)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Glucagon</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure (SBP)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Cholesterol</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Low Density Lipoprotein (LDL) Cholesterol</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High Density Lipoprotein (HDL) Cholesterol</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Very Low Density Lipoprotein (VLDL) Cholesterol</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Triglycerides</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Free Fatty Acids</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High Sensitivity C-reactive Protein (hsCRP)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Short Form 36 (SF-36) Score</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From week 0 to week 79</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-emergent Hypoglycaemic Episodes</measure>
    <time_frame>From week 0 to week 79</time_frame>
    <description>Hypoglycaemic episode (blood glucose less than or equal to (&lt;=) 3.9 mmol/L (70 mg/dL) Or greater than (&gt;) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes</measure>
    <time_frame>From week 0 to week 79</time_frame>
    <description>Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value &lt; 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-emergent Severe Hypoglycaemic Episodes</measure>
    <time_frame>From week 0 to week 79</time_frame>
    <description>Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events</measure>
    <time_frame>From week 0 to week 79</time_frame>
    <description>Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)</measure>
    <time_frame>From week 0 to week 79</time_frame>
    <description>Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)</measure>
    <time_frame>From week 0 to week 79</time_frame>
    <description>Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)</measure>
    <time_frame>From week 0 to week 79</time_frame>
    <description>Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)</measure>
    <time_frame>From week 0 to week 79</time_frame>
    <description>Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulse From Baseline to Week 72</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Electrocardiogram (ECG)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: Cardiovascular System</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: General Appearance</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: Lymph Node Palpation</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: Musculoskeletal System</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: Respiratory System</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: Skin</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Physical Examination: Thyroid Gland</measure>
    <time_frame>Week -6, week 72</time_frame>
    <description>Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Haematocrit</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Haemoglobin (g/dL)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Haemoglobin (mmol/L)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Leukocytes</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Thrombocytes</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Erythrocytes</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Creatinine (mg/dL)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Creatinine (Umol/L)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Estimated Glomerular Filtration Rate (eGFR)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Creatine Kinase</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Urea</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Bilirubin (mg/dL)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Bilirubin (Umol/L)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Alkaline Phosphatase</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ferritin</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sodium (mEq/L)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sodium (mmol/L)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Potassium (mEq/L)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Potassium (mmol/L)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Calcium (mg/dL)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Calcium (mmol/L)</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Amylase</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lipase</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Calcitonin</measure>
    <time_frame>Baseline (week 0), Week 72</time_frame>
    <description>Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Hepatobiliary Disorders</condition>
  <condition>Non-alcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>Semaglutide 0,1 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide 0,2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide 0,4 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Semaglutide</intervention_name>
    <description>Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)</description>
    <arm_group_label>Semaglutide 0,1 mg</arm_group_label>
    <arm_group_label>Semaglutide 0,2 mg</arm_group_label>
    <arm_group_label>Semaglutide 0,4 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Once daily administration subcutaneously ( s.c., under the skin)</description>
    <arm_group_label>Placebo 1</arm_group_label>
    <arm_group_label>Placebo 2</arm_group_label>
    <arm_group_label>Placebo 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: - Informed consent obtained before any trial-related activities.&#xD;
        Trial-related activities are any procedures that are carried out as part of the trial,&#xD;
        including activities to determine suitability for the trial except for protocol described&#xD;
        pre-screening activities which require a separate informed consent. - Male or female, aged&#xD;
        18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive))&#xD;
        at the time of signing informed consent - Local histological diagnosis of NASH followed by&#xD;
        histological confirmation of NASH based on central pathologist evaluation of a liver biopsy&#xD;
        obtained up to 21 weeks before screening - Histologic evidence of NASH based on central&#xD;
        pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH&#xD;
        fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central&#xD;
        pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20&#xD;
        g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed&#xD;
        by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type&#xD;
        1 diabetes according to medical records - HbA1c above 10% at screening - History or&#xD;
        presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at&#xD;
        screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary&#xD;
        thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤&#xD;
        25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or&#xD;
        intends to become pregnant or is of childbearing potential and not using an adequate&#xD;
        contraceptive method (adequate contraceptive measures as required by local regulation or&#xD;
        practice)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Coronado</city>
        <state>California</state>
        <zip>92118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92627</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <zip>91402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rialto</city>
        <state>California</state>
        <zip>92377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33434</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lakewood Ranch</city>
        <state>Florida</state>
        <zip>34211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822-2111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hermitage</city>
        <state>Tennessee</state>
        <zip>37076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rollingwood</city>
        <state>Texas</state>
        <zip>78746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kingswood</city>
        <state>New South Wales</state>
        <zip>2747</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wien</city>
        <zip>1030</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>1407</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <country>Canada</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6T 0G1</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hamilton</city>
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        <zip>L8S 4K1</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>London</city>
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        <zip>N6A 5A5</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toronto</city>
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        <zip>M5G 2C4</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6H 3M1</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <city>Montreal</city>
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        <zip>H4A 3J1</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>8200</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>2650</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>00290</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lyon Cedex 4</city>
        <zip>69317</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>MARSEILLE cedex 08</city>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Montpellier</city>
        <zip>34090</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>NICE cedex 3</city>
        <zip>06202</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>31059</zip>
        <country>France</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Venissieux</city>
        <zip>69200</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <country>Greece</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <country>Greece</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <country>Greece</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>078-8510</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fukui-shi, Fukui</city>
        <zip>918-8503</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kamigyo-ku, Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kumamoto-shi, Kumamoto</city>
        <zip>862-8655</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nagakute-shi, Aichi</city>
        <zip>480-1195</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nara-shi, Nara</city>
        <zip>630-8305</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nishinomiya-shi, Hyogo</city>
        <zip>663-8501</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osaka-shi, Osaka</city>
        <zip>545-8586</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Otsu-shi, Shiga</city>
        <zip>520-0804</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saga-shi, Saga</city>
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        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <city>Shimonoseki-shi, Yamaguchi</city>
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        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>564-0013</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>565-0862</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <country>Japan</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>470-1192</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <zip>1815 JD</zip>
        <country>Netherlands</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <zip>1186 AM</zip>
        <country>Netherlands</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <country>Netherlands</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <zip>2625 AD</zip>
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    <facility>
      <name>Novo Nordisk Investigational Site</name>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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  <location>
    <facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>650066</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <zip>660022</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>111123</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>121170</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>121293</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>123423</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>125367</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <zip>630005</zip>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <zip>630099</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <zip>440026</zip>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>190013</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194356</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>194358</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>195067</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197342</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>199226</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>410039</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saratov</city>
        <zip>410053</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>355017</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>355035</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>634028</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ulianovsk</city>
        <zip>432063</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>424004</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>28034</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Majadahonda</city>
        <zip>28222</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Göteborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Malmö</city>
        <zip>205 02</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stockholm</city>
        <zip>112 81</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bolton</city>
        <zip>BL4 0JR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 2QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Derby</city>
        <zip>DE22 3NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Glasgow</city>
        <zip>G31 2ER</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hull</city>
        <zip>HU3 2GZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Swansea</city>
        <zip>SA2 8PP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Greece</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.</citation>
    <PMID>33185364</PMID>
  </results_reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <results_first_submitted>February 11, 2021</results_first_submitted>
  <results_first_submitted_qc>March 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2021</results_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to Novo Nordisk disclosure commitment on novonordisk.com</ipd_description>
  </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>January 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02970942/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>February 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02970942/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 114 sites in 16 countries as follows (number of sites that screened participants/ number of sites that randomised participants): Australia (4/ 3); Austria (3/ 3); Belgium (4/ 4); Bulgaria (2/ 2); Canada (9/ 7); Denmark (2/ 2); Finland (1/ 1); France (8/ 6); Greece (5/ 5); Japan (13/ 12); Netherlands (7/ 5); Russian Federation (25/ 17); Spain (6/ 5); Sweden (3/ 2); United Kingdom (15/ 11); United States (36/ 29).</recruitment_details>
      <pre_assignment_details>Participants were randomised in a 3:3:3:1:1:1 ratio to receive once-daily semaglutide or placebo subcutaneously. After randomisation, the participants entered a dose-escalation period, with increase in dose every 4 weeks until the target dose was reached.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Semaglutide 0.1 mg</title>
          <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
        </group>
        <group group_id="P2">
          <title>Semaglutide 0.2 mg</title>
          <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
        </group>
        <group group_id="P3">
          <title>Semaglutide 0.4 mg</title>
          <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="82"/>
                <participants group_id="P4" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="82"/>
                <participants group_id="P4" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="81"/>
                <participants group_id="P4" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Exposed</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="81"/>
                <participants group_id="P4" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="72"/>
                <participants group_id="P3" count="77"/>
                <participants group_id="P4" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" 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 group_id="P3" count="2"/>
                <participants group_id="P4" 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="5"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The full analysis set included all randomised participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Semaglutide 0.1 mg</title>
          <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
        </group>
        <group group_id="B2">
          <title>Semaglutide 0.2 mg</title>
          <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
        </group>
        <group group_id="B3">
          <title>Semaglutide 0.4 mg</title>
          <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
        </group>
        <group group_id="B5">
          <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="80"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="82"/>
            <count group_id="B4" value="80"/>
            <count group_id="B5" value="320"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="55.2" spread="10.9"/>
                    <measurement group_id="B2" value="58.1" spread="9.9"/>
                    <measurement group_id="B3" value="54.3" spread="10.2"/>
                    <measurement group_id="B4" value="52.4" spread="10.8"/>
                    <measurement group_id="B5" value="55.0" spread="10.6"/>
                  </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="51"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="126"/>
                  </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="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="66"/>
                    <measurement group_id="B5" value="263"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="17"/>
                  </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>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="62"/>
                    <measurement group_id="B5" value="248"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not applicable</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)</title>
        <description>NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>After 72 weeks</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved NASH resolution without worsening of fibrosis and 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)</title>
          <description>NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved NASH resolution without worsening of fibrosis and 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.4"/>
                    <measurement group_id="O2" value="35.6"/>
                    <measurement group_id="O3" value="58.9"/>
                    <measurement group_id="O4" value="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.4"/>
                    <measurement group_id="O2" value="47.5"/>
                    <measurement group_id="O3" value="30.4"/>
                    <measurement group_id="O4" value="74.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3"/>
                    <measurement group_id="O2" value="16.9"/>
                    <measurement group_id="O3" value="10.7"/>
                    <measurement group_id="O4" value="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)</title>
        <description>NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.</description>
        <time_frame>After 72 weeks</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved at least one stage of fibrosis improvement with no worsening of NASH; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)</title>
          <description>NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved at least one stage of fibrosis improvement with no worsening of NASH; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.1"/>
                    <measurement group_id="O2" value="32.2"/>
                    <measurement group_id="O3" value="42.9"/>
                    <measurement group_id="O4" value="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6"/>
                    <measurement group_id="O2" value="50.8"/>
                    <measurement group_id="O3" value="46.4"/>
                    <measurement group_id="O4" value="58.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3"/>
                    <measurement group_id="O2" value="16.9"/>
                    <measurement group_id="O3" value="10.7"/>
                    <measurement group_id="O4" value="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)</title>
        <description>Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)</title>
          <description>Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.3"/>
                    <measurement group_id="O2" value="79.5"/>
                    <measurement group_id="O3" value="82.9"/>
                    <measurement group_id="O4" value="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worsening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="2.6"/>
                    <measurement group_id="O3" value="3.7"/>
                    <measurement group_id="O4" value="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8"/>
                    <measurement group_id="O2" value="5.1"/>
                    <measurement group_id="O3" value="1.2"/>
                    <measurement group_id="O4" value="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="12.8"/>
                    <measurement group_id="O3" value="12.2"/>
                    <measurement group_id="O4" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Steatosis</title>
        <description>Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Steatosis</title>
          <description>Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.5"/>
                    <measurement group_id="O2" value="60.3"/>
                    <measurement group_id="O3" value="63.4"/>
                    <measurement group_id="O4" value="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worsening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3"/>
                    <measurement group_id="O2" value="2.6"/>
                    <measurement group_id="O3" value="3.7"/>
                    <measurement group_id="O4" value="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.8"/>
                    <measurement group_id="O2" value="24.4"/>
                    <measurement group_id="O3" value="20.7"/>
                    <measurement group_id="O4" value="46.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="12.8"/>
                    <measurement group_id="O3" value="12.2"/>
                    <measurement group_id="O4" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Lobular Inflammation</title>
        <description>Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Lobular Inflammation</title>
          <description>Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3"/>
                    <measurement group_id="O2" value="47.4"/>
                    <measurement group_id="O3" value="37.8"/>
                    <measurement group_id="O4" value="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worsening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="7.7"/>
                    <measurement group_id="O3" value="6.1"/>
                    <measurement group_id="O4" value="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8"/>
                    <measurement group_id="O2" value="32.1"/>
                    <measurement group_id="O3" value="43.9"/>
                    <measurement group_id="O4" value="45.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="12.8"/>
                    <measurement group_id="O3" value="12.2"/>
                    <measurement group_id="O4" value="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Hepatocyte Ballooning</title>
        <description>Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Hepatocyte Ballooning</title>
          <description>Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.3"/>
                    <measurement group_id="O2" value="70.5"/>
                    <measurement group_id="O3" value="74.4"/>
                    <measurement group_id="O4" value="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worsening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="2.6"/>
                    <measurement group_id="O3" value="1.2"/>
                    <measurement group_id="O4" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.8"/>
                    <measurement group_id="O2" value="14.1"/>
                    <measurement group_id="O3" value="12.2"/>
                    <measurement group_id="O4" value="46.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="12.8"/>
                    <measurement group_id="O3" value="12.2"/>
                    <measurement group_id="O4" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification</title>
        <description>Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification</title>
          <description>Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.3"/>
                    <measurement group_id="O2" value="32.1"/>
                    <measurement group_id="O3" value="42.7"/>
                    <measurement group_id="O4" value="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worsening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0"/>
                    <measurement group_id="O2" value="7.7"/>
                    <measurement group_id="O3" value="4.9"/>
                    <measurement group_id="O4" value="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.3"/>
                    <measurement group_id="O2" value="42.3"/>
                    <measurement group_id="O3" value="36.6"/>
                    <measurement group_id="O4" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="17.9"/>
                    <measurement group_id="O3" value="15.9"/>
                    <measurement group_id="O4" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score</title>
        <description>Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score</title>
          <description>Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5"/>
                    <measurement group_id="O2" value="71.8"/>
                    <measurement group_id="O3" value="72.0"/>
                    <measurement group_id="O4" value="42.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worsening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="3.8"/>
                    <measurement group_id="O3" value="1.2"/>
                    <measurement group_id="O4" value="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5"/>
                    <measurement group_id="O2" value="11.5"/>
                    <measurement group_id="O3" value="14.6"/>
                    <measurement group_id="O4" value="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="12.8"/>
                    <measurement group_id="O3" value="12.2"/>
                    <measurement group_id="O4" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fibrosis-4 Score</title>
        <description>Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A Fibrosis-4 index of &lt; 1.45 indicated no or moderate fibrosis and an index of &gt; 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fibrosis-4 Score</title>
          <description>Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A Fibrosis-4 index of &lt; 1.45 indicated no or moderate fibrosis and an index of &gt; 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis</population>
          <units>Ratio of fibrosis-4 score</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" spread="36.8"/>
                    <measurement group_id="O2" value="0.77" spread="32.4"/>
                    <measurement group_id="O3" value="0.77" spread="31.3"/>
                    <measurement group_id="O4" value="0.95" spread="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in NAFLD Fibrosis Score (NFS)</title>
        <description>Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * body mass index (BMI) (kg/m^2) + 1.13 * hyperglycaemia (yes/no) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (*10^9/L) - 0.66 * albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) &lt; -1.5 indicates a low probability, b) &gt; -1.5 to &lt; 0.67 indicates intermediate probability, and a score of c) &gt; 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in NAFLD Fibrosis Score (NFS)</title>
          <description>Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * body mass index (BMI) (kg/m^2) + 1.13 * hyperglycaemia (yes/no) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (*10^9/L) - 0.66 * albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) &lt; -1.5 indicates a low probability, b) &gt; -1.5 to &lt; 0.67 indicates intermediate probability, and a score of c) &gt; 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.322" spread="0.819"/>
                    <measurement group_id="O2" value="-0.617" spread="0.691"/>
                    <measurement group_id="O3" value="-0.475" spread="0.770"/>
                    <measurement group_id="O4" value="-0.040" spread="0.844"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Alanine Aminotransferase (ALT)</title>
        <description>Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Alanine Aminotransferase (ALT)</title>
          <description>Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of ALT</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="62.7"/>
                    <measurement group_id="O2" value="0.57" spread="62.1"/>
                    <measurement group_id="O3" value="0.40" spread="68.2"/>
                    <measurement group_id="O4" value="0.80" spread="60.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Aspartate Aminotransferase (AST)</title>
        <description>Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Aspartate Aminotransferase (AST)</title>
          <description>Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of AST</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="55.1"/>
                    <measurement group_id="O2" value="0.63" spread="46.6"/>
                    <measurement group_id="O3" value="0.50" spread="45.8"/>
                    <measurement group_id="O4" value="0.84" spread="62.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gamma Glutamyl Transferase (GGT)</title>
        <description>Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gamma Glutamyl Transferase (GGT)</title>
          <description>Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of GGT</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="52.0"/>
                    <measurement group_id="O2" value="0.64" spread="51.6"/>
                    <measurement group_id="O3" value="0.48" spread="60.2"/>
                    <measurement group_id="O4" value="0.92" spread="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Albumin</title>
        <description>Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Albumin</title>
          <description>Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of albumin</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" spread="5.6"/>
                    <measurement group_id="O2" value="1.01" spread="6.0"/>
                    <measurement group_id="O3" value="1.01" spread="5.4"/>
                    <measurement group_id="O4" value="1.02" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in International Normalized Ratio (INR)</title>
        <description>Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in International Normalized Ratio (INR)</title>
          <description>Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of INR</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="18.8"/>
                    <measurement group_id="O2" value="0.96" spread="11.8"/>
                    <measurement group_id="O3" value="0.93" spread="22.3"/>
                    <measurement group_id="O4" value="0.99" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Enhanced Liver Fibrosis (ELF)</title>
        <description>Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) &lt; 7.7: no to mild fibrosis; b) ≥ 7.7 - &lt; 9.8: Moderate fibrosis; c) ≥ 9.8 - &lt; 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Enhanced Liver Fibrosis (ELF)</title>
          <description>Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) &lt; 7.7: no to mild fibrosis; b) ≥ 7.7 - &lt; 9.8: Moderate fibrosis; c) ≥ 9.8 - &lt; 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="0.7"/>
                    <measurement group_id="O2" value="-0.4" spread="0.8"/>
                    <measurement group_id="O3" value="-0.6" spread="0.8"/>
                    <measurement group_id="O4" value="0.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cytokeratin 18 (CK-18) Fragments</title>
        <description>Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cytokeratin 18 (CK-18) Fragments</title>
          <description>Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of CK-18 fragments</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>M30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" spread="84.2"/>
                    <measurement group_id="O2" value="0.50" spread="76.4"/>
                    <measurement group_id="O3" value="0.40" spread="74.5"/>
                    <measurement group_id="O4" value="0.78" spread="106.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51" spread="73.1"/>
                    <measurement group_id="O2" value="0.52" spread="62.5"/>
                    <measurement group_id="O3" value="0.38" spread="65.6"/>
                    <measurement group_id="O4" value="0.71" spread="83.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in microRNA 122 (miR-122)</title>
        <description>Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in microRNA 122 (miR-122)</title>
          <description>Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of miR-122</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.86" spread="151.8"/>
                    <measurement group_id="O2" value="0.74" spread="203.1"/>
                    <measurement group_id="O3" value="0.58" spread="161.3"/>
                    <measurement group_id="O4" value="1.28" spread="194.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Interleukin-1 Receptor (IL-1R) Antagonist</title>
        <description>Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Interleukin-1 Receptor (IL-1R) Antagonist</title>
          <description>Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of IL-1R antagonist</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" spread="49.3"/>
                    <measurement group_id="O2" value="0.85" spread="37.5"/>
                    <measurement group_id="O3" value="0.73" spread="47.9"/>
                    <measurement group_id="O4" value="0.94" spread="41.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Monocyte Chemoattractant Protein 1 (MCP-1)</title>
        <description>Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Monocyte Chemoattractant Protein 1 (MCP-1)</title>
          <description>Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of MCP-1</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread="23.3"/>
                    <measurement group_id="O2" value="1.08" spread="29.8"/>
                    <measurement group_id="O3" value="0.99" spread="30.7"/>
                    <measurement group_id="O4" value="1.04" spread="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fibroblast Growth Factor 21 (FGF-21)</title>
        <description>Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fibroblast Growth Factor 21 (FGF-21)</title>
          <description>Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of FGF-21</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread="86.1"/>
                    <measurement group_id="O2" value="0.61" spread="104.1"/>
                    <measurement group_id="O3" value="0.55" spread="91.3"/>
                    <measurement group_id="O4" value="0.76" spread="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Liver Stiffness Assessed by FibroScan®</title>
        <description>Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Liver Stiffness Assessed by FibroScan®</title>
          <description>Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of liver stiffness</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="46"/>
                <count group_id="O4" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread="49.3"/>
                    <measurement group_id="O2" value="0.64" spread="52.2"/>
                    <measurement group_id="O3" value="0.66" spread="58.4"/>
                    <measurement group_id="O4" value="1.18" spread="71.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Liver Steatosis Assessed by FibroScan®</title>
        <description>Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Liver Steatosis Assessed by FibroScan®</title>
          <description>Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Decibels per meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="41.1"/>
                    <measurement group_id="O2" value="-50.9" spread="64.3"/>
                    <measurement group_id="O3" value="-42.1" spread="73.3"/>
                    <measurement group_id="O4" value="-18.7" spread="43.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)</title>
        <description>Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</description>
        <time_frame>Week 72</time_frame>
        <population>Full analysis set included all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)</title>
          <description>Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</description>
          <population>Full analysis set included all randomised participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8"/>
                    <measurement group_id="O2" value="62.8"/>
                    <measurement group_id="O3" value="76.8"/>
                    <measurement group_id="O4" value="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3"/>
                    <measurement group_id="O2" value="28.2"/>
                    <measurement group_id="O3" value="17.1"/>
                    <measurement group_id="O4" value="78.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="9.0"/>
                    <measurement group_id="O3" value="6.1"/>
                    <measurement group_id="O4" value="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)</title>
        <description>Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</description>
        <time_frame>Week 72</time_frame>
        <population>Full analysis set included all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)</title>
          <description>Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).</description>
          <population>Full analysis set included all randomised participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5"/>
                    <measurement group_id="O2" value="38.5"/>
                    <measurement group_id="O3" value="59.8"/>
                    <measurement group_id="O4" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.5"/>
                    <measurement group_id="O2" value="52.6"/>
                    <measurement group_id="O3" value="34.1"/>
                    <measurement group_id="O4" value="92.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="9.0"/>
                    <measurement group_id="O3" value="6.1"/>
                    <measurement group_id="O4" value="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight</title>
        <description>Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight</title>
          <description>Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="6.0"/>
                    <measurement group_id="O2" value="-9.4" spread="9.2"/>
                    <measurement group_id="O3" value="-12.3" spread="8.6"/>
                    <measurement group_id="O4" value="-1.0" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Waist Circumference</title>
        <description>Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Waist Circumference</title>
          <description>Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" spread="6.3"/>
                    <measurement group_id="O2" value="-7.1" spread="8.9"/>
                    <measurement group_id="O3" value="-11.4" spread="9.3"/>
                    <measurement group_id="O4" value="-1.7" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Mass Index (BMI)</title>
        <description>Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Mass Index (BMI)</title>
          <description>Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Kilograms per square meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="2.2"/>
                    <measurement group_id="O2" value="-3.5" spread="3.4"/>
                    <measurement group_id="O3" value="-4.6" spread="3.3"/>
                    <measurement group_id="O4" value="-0.3" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Glycosylated Haemoglobin (HbA1c) (%-Point)</title>
        <description>Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Glycosylated Haemoglobin (HbA1c) (%-Point)</title>
          <description>Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
          <units>Percentage point of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.1"/>
                    <measurement group_id="O2" value="-1.2" spread="0.9"/>
                    <measurement group_id="O3" value="-1.2" spread="1.0"/>
                    <measurement group_id="O4" value="-0.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c (Millimoles Per Mole)</title>
        <description>Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c (Millimoles Per Mole)</title>
          <description>Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
          <units>millimoles per mole</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.9" spread="12.2"/>
                    <measurement group_id="O2" value="-12.8" spread="9.5"/>
                    <measurement group_id="O3" value="-12.8" spread="11.3"/>
                    <measurement group_id="O4" value="-0.3" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose (FPG)</title>
        <description>Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose (FPG)</title>
          <description>Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
          <units>Millimoles per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.39" spread="2.53"/>
                    <measurement group_id="O2" value="-2.17" spread="1.82"/>
                    <measurement group_id="O3" value="-2.09" spread="2.68"/>
                    <measurement group_id="O4" value="-0.34" spread="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Glucagon</title>
        <description>Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Glucagon</title>
          <description>Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
          <units>Ratio of glucagon</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" spread="76.8"/>
                    <measurement group_id="O2" value="0.65" spread="94.8"/>
                    <measurement group_id="O3" value="0.63" spread="100.4"/>
                    <measurement group_id="O4" value="1.04" spread="80.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)</title>
        <description>Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)</title>
          <description>Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
          <units>Ratio of HOMA-IR</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" spread="62.2"/>
                    <measurement group_id="O2" value="0.60" spread="77.6"/>
                    <measurement group_id="O3" value="0.58" spread="94.6"/>
                    <measurement group_id="O4" value="0.81" spread="127.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diastolic Blood Pressure (DBP)</title>
        <description>Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diastolic Blood Pressure (DBP)</title>
          <description>Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="10"/>
                    <measurement group_id="O2" value="-2" spread="11"/>
                    <measurement group_id="O3" value="-2" spread="9"/>
                    <measurement group_id="O4" value="-1" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Systolic Blood Pressure (SBP)</title>
        <description>Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure (SBP)</title>
          <description>Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2" spread="16"/>
                    <measurement group_id="O2" value="-7" spread="18"/>
                    <measurement group_id="O3" value="-6" spread="16"/>
                    <measurement group_id="O4" value="-2" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Cholesterol</title>
        <description>Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Cholesterol</title>
          <description>Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of total cholesterol</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="17.1"/>
                    <measurement group_id="O2" value="1.00" spread="20.3"/>
                    <measurement group_id="O3" value="0.93" spread="15.7"/>
                    <measurement group_id="O4" value="0.93" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Low Density Lipoprotein (LDL) Cholesterol</title>
        <description>Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Low Density Lipoprotein (LDL) Cholesterol</title>
          <description>Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of LDL cholesterol</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="22.9"/>
                    <measurement group_id="O2" value="1.01" spread="34.9"/>
                    <measurement group_id="O3" value="0.92" spread="25.5"/>
                    <measurement group_id="O4" value="0.90" spread="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in High Density Lipoprotein (HDL) Cholesterol</title>
        <description>Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in High Density Lipoprotein (HDL) Cholesterol</title>
          <description>Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of HDL cholesterol</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" spread="16.1"/>
                    <measurement group_id="O2" value="1.05" spread="12.9"/>
                    <measurement group_id="O3" value="1.09" spread="16.4"/>
                    <measurement group_id="O4" value="1.01" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Very Low Density Lipoprotein (VLDL) Cholesterol</title>
        <description>Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Very Low Density Lipoprotein (VLDL) Cholesterol</title>
          <description>Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of VLDL cholesterol</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="31.9"/>
                    <measurement group_id="O2" value="0.90" spread="36.1"/>
                    <measurement group_id="O3" value="0.74" spread="38.2"/>
                    <measurement group_id="O4" value="0.93" spread="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Triglycerides</title>
        <description>Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Triglycerides</title>
          <description>Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of triglycerides</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.88" spread="34.1"/>
                    <measurement group_id="O2" value="0.89" spread="37.6"/>
                    <measurement group_id="O3" value="0.73" spread="41.4"/>
                    <measurement group_id="O4" value="0.95" spread="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Free Fatty Acids</title>
        <description>Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Free Fatty Acids</title>
          <description>Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of free fatty acids</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.83" spread="54.8"/>
                    <measurement group_id="O2" value="0.92" spread="73.2"/>
                    <measurement group_id="O3" value="0.72" spread="80.8"/>
                    <measurement group_id="O4" value="1.05" spread="75.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in High Sensitivity C-reactive Protein (hsCRP)</title>
        <description>Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in High Sensitivity C-reactive Protein (hsCRP)</title>
          <description>Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of hsCRP</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" spread="114.6"/>
                    <measurement group_id="O2" value="0.50" spread="124.1"/>
                    <measurement group_id="O3" value="0.41" spread="114.6"/>
                    <measurement group_id="O4" value="0.91" spread="85.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Short Form 36 (SF-36) Score</title>
        <description>Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Short Form 36 (SF-36) Score</title>
          <description>Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mental component sum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="8.5"/>
                    <measurement group_id="O2" value="0.6" spread="9.2"/>
                    <measurement group_id="O3" value="1.2" spread="9.5"/>
                    <measurement group_id="O4" value="-0.4" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical component sum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="7.0"/>
                    <measurement group_id="O2" value="1.1" spread="7.3"/>
                    <measurement group_id="O3" value="3.9" spread="7.1"/>
                    <measurement group_id="O4" value="-0.1" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="7.8"/>
                    <measurement group_id="O2" value="2.0" spread="7.3"/>
                    <measurement group_id="O3" value="2.8" spread="7.8"/>
                    <measurement group_id="O4" value="-0.4" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="6.9"/>
                    <measurement group_id="O2" value="0.5" spread="9.3"/>
                    <measurement group_id="O3" value="2.2" spread="8.1"/>
                    <measurement group_id="O4" value="-0.3" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="10.9"/>
                    <measurement group_id="O2" value="1.2" spread="10.1"/>
                    <measurement group_id="O3" value="3.4" spread="7.9"/>
                    <measurement group_id="O4" value="-1.3" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="14.8"/>
                    <measurement group_id="O2" value="2.3" spread="17.8"/>
                    <measurement group_id="O3" value="9.0" spread="17.4"/>
                    <measurement group_id="O4" value="4.3" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="8.6"/>
                    <measurement group_id="O2" value="0.6" spread="9.4"/>
                    <measurement group_id="O3" value="4.6" spread="9.8"/>
                    <measurement group_id="O4" value="-0.2" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="9.0"/>
                    <measurement group_id="O2" value="-0.1" spread="9.9"/>
                    <measurement group_id="O3" value="2.2" spread="9.4"/>
                    <measurement group_id="O4" value="-1.6" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role emotional</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="8.9"/>
                    <measurement group_id="O2" value="0.6" spread="9.1"/>
                    <measurement group_id="O3" value="0.5" spread="9.5"/>
                    <measurement group_id="O4" value="-0.3" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="8.9"/>
                    <measurement group_id="O2" value="1.5" spread="8.2"/>
                    <measurement group_id="O3" value="1.3" spread="9.5"/>
                    <measurement group_id="O4" value="-0.2" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>From week 0 to week 79</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="525"/>
                    <measurement group_id="O2" value="577"/>
                    <measurement group_id="O3" value="511"/>
                    <measurement group_id="O4" value="445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-emergent Hypoglycaemic Episodes</title>
        <description>Hypoglycaemic episode (blood glucose less than or equal to (&lt;=) 3.9 mmol/L (70 mg/dL) Or greater than (&gt;) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>From week 0 to week 79</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent Hypoglycaemic Episodes</title>
          <description>Hypoglycaemic episode (blood glucose less than or equal to (&lt;=) 3.9 mmol/L (70 mg/dL) Or greater than (&gt;) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
          <units>episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="66"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes</title>
        <description>Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value &lt; 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.</description>
        <time_frame>From week 0 to week 79</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes</title>
          <description>Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value &lt; 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
          <units>episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-emergent Severe Hypoglycaemic Episodes</title>
        <description>Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>From week 0 to week 79</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent Severe Hypoglycaemic Episodes</title>
          <description>Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.</population>
          <units>episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events</title>
        <description>Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>From week 0 to week 79</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events</title>
          <description>Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</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="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)</title>
        <description>Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>From week 0 to week 79</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)</title>
          <description>Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</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="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="77"/>
                    <measurement group_id="O3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)</title>
        <description>Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>From week 0 to week 79</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)</title>
          <description>Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</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="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)</title>
        <description>Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>From week 0 to week 79</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)</title>
          <description>Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</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="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)</title>
        <description>Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
        <time_frame>From week 0 to week 79</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)</title>
          <description>Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment.</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="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulse From Baseline to Week 72</title>
        <description>Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulse From Baseline to Week 72</title>
          <description>Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>beats per minute (bpm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="10.9"/>
                    <measurement group_id="O2" value="2.1" spread="9.0"/>
                    <measurement group_id="O3" value="0.9" spread="9.6"/>
                    <measurement group_id="O4" value="-0.3" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Electrocardiogram (ECG)</title>
        <description>A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Electrocardiogram (ECG)</title>
          <description>A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.8"/>
                    <measurement group_id="O2" value="60.3"/>
                    <measurement group_id="O3" value="66.7"/>
                    <measurement group_id="O4" value="63.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3"/>
                    <measurement group_id="O2" value="39.7"/>
                    <measurement group_id="O3" value="32.1"/>
                    <measurement group_id="O4" value="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="1.2"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.9"/>
                    <measurement group_id="O2" value="65.1"/>
                    <measurement group_id="O3" value="74.6"/>
                    <measurement group_id="O4" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.1"/>
                    <measurement group_id="O2" value="34.9"/>
                    <measurement group_id="O3" value="23.9"/>
                    <measurement group_id="O4" value="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="1.4"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: Cardiovascular System</title>
        <description>Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: Cardiovascular System</title>
          <description>Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5"/>
                    <measurement group_id="O2" value="93.6"/>
                    <measurement group_id="O3" value="92.6"/>
                    <measurement group_id="O4" value="92.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3"/>
                    <measurement group_id="O2" value="5.1"/>
                    <measurement group_id="O3" value="7.4"/>
                    <measurement group_id="O4" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.8"/>
                    <measurement group_id="O2" value="96.9"/>
                    <measurement group_id="O3" value="94.4"/>
                    <measurement group_id="O4" value="90.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2"/>
                    <measurement group_id="O2" value="3.1"/>
                    <measurement group_id="O3" value="5.6"/>
                    <measurement group_id="O4" value="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System</title>
        <description>Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System</title>
          <description>Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="79"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.5"/>
                    <measurement group_id="O2" value="94.8"/>
                    <measurement group_id="O3" value="98.7"/>
                    <measurement group_id="O4" value="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="5.2"/>
                    <measurement group_id="O3" value="1.3"/>
                    <measurement group_id="O4" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="69"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.6"/>
                    <measurement group_id="O2" value="93.7"/>
                    <measurement group_id="O3" value="98.6"/>
                    <measurement group_id="O4" value="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="69"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4"/>
                    <measurement group_id="O2" value="4.8"/>
                    <measurement group_id="O3" value="1.4"/>
                    <measurement group_id="O4" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="69"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth</title>
        <description>Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth</title>
          <description>Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5"/>
                    <measurement group_id="O2" value="83.1"/>
                    <measurement group_id="O3" value="84.0"/>
                    <measurement group_id="O4" value="86.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8"/>
                    <measurement group_id="O2" value="15.6"/>
                    <measurement group_id="O3" value="16.0"/>
                    <measurement group_id="O4" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.2"/>
                    <measurement group_id="O2" value="81.0"/>
                    <measurement group_id="O3" value="87.5"/>
                    <measurement group_id="O4" value="84.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8"/>
                    <measurement group_id="O2" value="19.0"/>
                    <measurement group_id="O3" value="12.5"/>
                    <measurement group_id="O4" value="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: General Appearance</title>
        <description>Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: General Appearance</title>
          <description>Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.8"/>
                    <measurement group_id="O2" value="85.9"/>
                    <measurement group_id="O3" value="79.0"/>
                    <measurement group_id="O4" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3"/>
                    <measurement group_id="O2" value="12.8"/>
                    <measurement group_id="O3" value="21.0"/>
                    <measurement group_id="O4" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.8"/>
                    <measurement group_id="O2" value="90.6"/>
                    <measurement group_id="O3" value="90.3"/>
                    <measurement group_id="O4" value="76.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2"/>
                    <measurement group_id="O2" value="6.3"/>
                    <measurement group_id="O3" value="9.7"/>
                    <measurement group_id="O4" value="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="3.1"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck</title>
        <description>Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck</title>
          <description>Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="80"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.5"/>
                    <measurement group_id="O2" value="94.8"/>
                    <measurement group_id="O3" value="98.8"/>
                    <measurement group_id="O4" value="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="5.2"/>
                    <measurement group_id="O3" value="1.3"/>
                    <measurement group_id="O4" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.5"/>
                    <measurement group_id="O2" value="96.8"/>
                    <measurement group_id="O3" value="98.6"/>
                    <measurement group_id="O4" value="98.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                    <measurement group_id="O2" value="3.2"/>
                    <measurement group_id="O3" value="1.4"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: Lymph Node Palpation</title>
        <description>Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: Lymph Node Palpation</title>
          <description>Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="98.7"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: Musculoskeletal System</title>
        <description>Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: Musculoskeletal System</title>
          <description>Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="79"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.0"/>
                    <measurement group_id="O2" value="96.1"/>
                    <measurement group_id="O3" value="94.9"/>
                    <measurement group_id="O4" value="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="3.9"/>
                    <measurement group_id="O3" value="5.1"/>
                    <measurement group_id="O4" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.6"/>
                    <measurement group_id="O2" value="96.8"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="95.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4"/>
                    <measurement group_id="O2" value="3.2"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: Respiratory System</title>
        <description>Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: Respiratory System</title>
          <description>Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6"/>
                    <measurement group_id="O2" value="96.9"/>
                    <measurement group_id="O3" value="98.6"/>
                    <measurement group_id="O4" value="98.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="3.1"/>
                    <measurement group_id="O3" value="1.4"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: Skin</title>
        <description>Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: Skin</title>
          <description>Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.3"/>
                    <measurement group_id="O2" value="92.3"/>
                    <measurement group_id="O3" value="85.2"/>
                    <measurement group_id="O4" value="90.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="6.4"/>
                    <measurement group_id="O3" value="13.6"/>
                    <measurement group_id="O4" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="1.2"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.6"/>
                    <measurement group_id="O2" value="87.5"/>
                    <measurement group_id="O3" value="90.0"/>
                    <measurement group_id="O4" value="88.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                    <measurement group_id="O2" value="10.9"/>
                    <measurement group_id="O3" value="8.6"/>
                    <measurement group_id="O4" value="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="1.4"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Physical Examination: Thyroid Gland</title>
        <description>Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Week -6, week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Physical Examination: Thyroid Gland</title>
          <description>Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="80"/>
                <count group_id="O4" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week -6: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.8"/>
                    <measurement group_id="O2" value="97.4"/>
                    <measurement group_id="O3" value="97.5"/>
                    <measurement group_id="O4" value="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0"/>
                    <measurement group_id="O2" value="2.6"/>
                    <measurement group_id="O3" value="2.5"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week -6: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.6"/>
                    <measurement group_id="O2" value="98.4"/>
                    <measurement group_id="O3" value="97.1"/>
                    <measurement group_id="O4" value="98.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal NCS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="2.9"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72: Abnormal CS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="70"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Haematocrit</title>
        <description>Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Haematocrit</title>
          <description>Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Percentage of haematocrit in blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.79" spread="3.14"/>
                    <measurement group_id="O2" value="-0.71" spread="2.77"/>
                    <measurement group_id="O3" value="-1.43" spread="3.50"/>
                    <measurement group_id="O4" value="-0.41" spread="3.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Haemoglobin (g/dL)</title>
        <description>Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Haemoglobin (g/dL)</title>
          <description>Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Grams per deciliter (g/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="71"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="1.05"/>
                    <measurement group_id="O2" value="0.08" spread="0.89"/>
                    <measurement group_id="O3" value="-0.07" spread="0.98"/>
                    <measurement group_id="O4" value="0.21" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Haemoglobin (mmol/L)</title>
        <description>Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Haemoglobin (mmol/L)</title>
          <description>Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>millimoles per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.65"/>
                    <measurement group_id="O2" value="0.05" spread="0.55"/>
                    <measurement group_id="O3" value="-0.05" spread="0.61"/>
                    <measurement group_id="O4" value="0.13" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Leukocytes</title>
        <description>Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Leukocytes</title>
          <description>Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>10^9 cells per liter (10^9/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.489" spread="1.564"/>
                    <measurement group_id="O2" value="0.260" spread="1.343"/>
                    <measurement group_id="O3" value="-0.047" spread="1.532"/>
                    <measurement group_id="O4" value="0.075" spread="1.733"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Thrombocytes</title>
        <description>Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Thrombocytes</title>
          <description>Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>10^9 cells per liter (10^9/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="69"/>
                <count group_id="O4" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" spread="46.9"/>
                    <measurement group_id="O2" value="14.6" spread="34.8"/>
                    <measurement group_id="O3" value="9.0" spread="44.9"/>
                    <measurement group_id="O4" value="0.3" spread="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Erythrocytes</title>
        <description>Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Erythrocytes</title>
          <description>Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>10^12 cells per liter (10^12/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.038" spread="0.292"/>
                    <measurement group_id="O2" value="0.004" spread="0.220"/>
                    <measurement group_id="O3" value="-0.034" spread="0.334"/>
                    <measurement group_id="O4" value="0.054" spread="0.314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Creatinine (mg/dL)</title>
        <description>Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Creatinine (mg/dL)</title>
          <description>Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of creatinine</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.018" spread="30.70"/>
                    <measurement group_id="O2" value="1.069" spread="42.19"/>
                    <measurement group_id="O3" value="1.026" spread="35.17"/>
                    <measurement group_id="O4" value="1.021" spread="33.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Creatinine (Umol/L)</title>
        <description>Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Creatinine (Umol/L)</title>
          <description>Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of creatinine</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.018" spread="30.70"/>
                    <measurement group_id="O2" value="1.069" spread="42.19"/>
                    <measurement group_id="O3" value="1.026" spread="35.17"/>
                    <measurement group_id="O4" value="1.021" spread="33.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Estimated Glomerular Filtration Rate (eGFR)</title>
        <description>Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Estimated Glomerular Filtration Rate (eGFR)</title>
          <description>Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of eGFR</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.976" spread="28.04"/>
                    <measurement group_id="O2" value="0.940" spread="40.47"/>
                    <measurement group_id="O3" value="0.973" spread="31.42"/>
                    <measurement group_id="O4" value="0.969" spread="31.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Creatine Kinase</title>
        <description>Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Creatine Kinase</title>
          <description>Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of creatine kinase</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.975" spread="73.02"/>
                    <measurement group_id="O2" value="0.798" spread="77.96"/>
                    <measurement group_id="O3" value="0.825" spread="74.17"/>
                    <measurement group_id="O4" value="0.904" spread="76.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Urea</title>
        <description>Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Urea</title>
          <description>Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of urea</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.018" spread="51.01"/>
                    <measurement group_id="O2" value="0.973" spread="52.30"/>
                    <measurement group_id="O3" value="1.042" spread="51.14"/>
                    <measurement group_id="O4" value="1.043" spread="52.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Bilirubin (mg/dL)</title>
        <description>Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Bilirubin (mg/dL)</title>
          <description>Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of total bilirubin</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.978" spread="66.72"/>
                    <measurement group_id="O2" value="1.011" spread="70.66"/>
                    <measurement group_id="O3" value="0.949" spread="65.89"/>
                    <measurement group_id="O4" value="1.040" spread="67.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Bilirubin (Umol/L)</title>
        <description>Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Bilirubin (Umol/L)</title>
          <description>Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of total bilirubin</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.978" spread="66.72"/>
                    <measurement group_id="O2" value="1.011" spread="70.66"/>
                    <measurement group_id="O3" value="0.949" spread="65.89"/>
                    <measurement group_id="O4" value="1.040" spread="67.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Alkaline Phosphatase</title>
        <description>Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Alkaline Phosphatase</title>
          <description>Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of alkaline phosphatase</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.980" spread="45.68"/>
                    <measurement group_id="O2" value="0.931" spread="43.59"/>
                    <measurement group_id="O3" value="0.884" spread="54.90"/>
                    <measurement group_id="O4" value="0.992" spread="42.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Ferritin</title>
        <description>Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Ferritin</title>
          <description>Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of ferritin</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.660" spread="99.95"/>
                    <measurement group_id="O2" value="0.617" spread="88.70"/>
                    <measurement group_id="O3" value="0.603" spread="88.83"/>
                    <measurement group_id="O4" value="0.713" spread="96.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sodium (mEq/L)</title>
        <description>Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sodium (mEq/L)</title>
          <description>Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of sodium</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.999" spread="12.23"/>
                    <measurement group_id="O2" value="1.000" spread="12.13"/>
                    <measurement group_id="O3" value="1.002" spread="11.68"/>
                    <measurement group_id="O4" value="1.002" spread="12.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sodium (mmol/L)</title>
        <description>Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sodium (mmol/L)</title>
          <description>Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of sodium</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.999" spread="12.23"/>
                    <measurement group_id="O2" value="1.000" spread="12.13"/>
                    <measurement group_id="O3" value="1.002" spread="11.68"/>
                    <measurement group_id="O4" value="1.002" spread="12.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Potassium (mEq/L)</title>
        <description>Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Potassium (mEq/L)</title>
          <description>Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of potassium</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.004" spread="27.00"/>
                    <measurement group_id="O2" value="0.979" spread="29.36"/>
                    <measurement group_id="O3" value="0.998" spread="27.81"/>
                    <measurement group_id="O4" value="0.998" spread="27.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Potassium (mmol/L)</title>
        <description>Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Potassium (mmol/L)</title>
          <description>Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of potassium</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.004" spread="27.00"/>
                    <measurement group_id="O2" value="0.979" spread="29.36"/>
                    <measurement group_id="O3" value="0.998" spread="27.81"/>
                    <measurement group_id="O4" value="0.998" spread="27.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Calcium (mg/dL)</title>
        <description>Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Calcium (mg/dL)</title>
          <description>Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of calcium</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.017" spread="20.37"/>
                    <measurement group_id="O2" value="1.018" spread="20.49"/>
                    <measurement group_id="O3" value="1.008" spread="20.88"/>
                    <measurement group_id="O4" value="1.010" spread="22.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Calcium (mmol/L)</title>
        <description>Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Calcium (mmol/L)</title>
          <description>Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of calcium</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.017" spread="20.37"/>
                    <measurement group_id="O2" value="1.018" spread="20.49"/>
                    <measurement group_id="O3" value="1.008" spread="20.88"/>
                    <measurement group_id="O4" value="1.010" spread="22.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Amylase</title>
        <description>Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Amylase</title>
          <description>Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of amylase</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.155" spread="49.85"/>
                    <measurement group_id="O2" value="1.120" spread="65.01"/>
                    <measurement group_id="O3" value="1.170" spread="47.88"/>
                    <measurement group_id="O4" value="1.051" spread="45.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Lipase</title>
        <description>Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipase</title>
          <description>Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of lipase</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.305" spread="77.43"/>
                    <measurement group_id="O2" value="1.245" spread="87.68"/>
                    <measurement group_id="O3" value="1.375" spread="73.88"/>
                    <measurement group_id="O4" value="1.003" spread="66.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Calcitonin</title>
        <description>Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
        <time_frame>Baseline (week 0), Week 72</time_frame>
        <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.1 mg</title>
            <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 0.2 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
          </group>
          <group group_id="O3">
            <title>Semaglutide 0.4 mg</title>
            <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Calcitonin</title>
          <description>Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.</description>
          <population>Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.</population>
          <units>Ratio of Calcitonin</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.040" spread="62.98"/>
                    <measurement group_id="O2" value="0.937" spread="65.42"/>
                    <measurement group_id="O3" value="1.000" spread="66.24"/>
                    <measurement group_id="O4" value="0.950" spread="62.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From week 0 to week 79 Results are based on the safety analysis set which included all participants who received at least one dose of randomised treatment.</time_frame>
      <desc>All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Semaglutide 0.1 mg</title>
          <description>Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).</description>
        </group>
        <group group_id="E2">
          <title>Semaglutide 0.2 mg</title>
          <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).</description>
        </group>
        <group group_id="E3">
          <title>Semaglutide 0.4 mg</title>
          <description>Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22</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="80"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="81"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Basedow's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal adhesions</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal polyp haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Megacolon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cystitis escherichia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatitis E</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cholesteatoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Endometrial adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neurilemmoma benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral T-cell lymphoma unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lumbosacral radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Transient epileptic amnesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysfunctional uterine bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22</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="61" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="63" subjects_at_risk="81"/>
                <counts group_id="E4" subjects_affected="55" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="80"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="81"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="80"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="81"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="80"/>
                <counts group_id="E2" events="22" subjects_affected="17" subjects_at_risk="78"/>
                <counts group_id="E3" events="20" subjects_affected="18" subjects_at_risk="81"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="31" subjects_affected="23" subjects_at_risk="80"/>
                <counts group_id="E2" events="30" subjects_affected="22" subjects_at_risk="78"/>
                <counts group_id="E3" events="21" subjects_affected="16" subjects_at_risk="81"/>
                <counts group_id="E4" events="16" subjects_affected="11" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="80"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="78"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="80"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="80"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="80"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="32" subjects_affected="24" subjects_at_risk="80"/>
                <counts group_id="E2" events="39" subjects_affected="29" subjects_at_risk="78"/>
                <counts group_id="E3" events="49" subjects_affected="33" subjects_at_risk="81"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="21" subjects_affected="14" subjects_at_risk="80"/>
                <counts group_id="E2" events="26" subjects_affected="17" subjects_at_risk="78"/>
                <counts group_id="E3" events="29" subjects_affected="12" subjects_at_risk="81"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="81"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="10" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="80"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="80"/>
                <counts group_id="E2" events="21" subjects_affected="15" subjects_at_risk="78"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="81"/>
                <counts group_id="E4" events="22" subjects_affected="12" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="80"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="78"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="80"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="80"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="80"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="80"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="78"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="18" subjects_affected="16" subjects_at_risk="80"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="78"/>
                <counts group_id="E3" events="22" subjects_affected="18" subjects_at_risk="81"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" events="6" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="81"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="81"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="80"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="81"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="78"/>
                <counts group_id="E3" events="13" subjects_affected="10" subjects_at_risk="81"/>
                <counts group_id="E4" events="10" subjects_affected="8" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="80"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </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>At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Reporting Anchor and Disclosure (1452)</name_or_title>
      <organization>Novo Nordisk A/S</organization>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.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/NCT02970942
org study id: NN9931-4296
secondary id: 2016-000685-39
secondary id: U1111-1179-7464
nct id: NCT02970942
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once
      daily versus placebo in subjects with non-alcoholic steatohepatitis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)
time frame: After 72 weeks
description: NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)
time frame: After 72 weeks
description: NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.
measure: Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)
time frame: Baseline (week 0), Week 72
description: Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Percentage of Participants With Change in Steatosis
time frame: Baseline (week 0), Week 72
description: Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Percentage of Participants With Change in Lobular Inflammation
time frame: Baseline (week 0), Week 72
description: Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Percentage of Participants With Change in Hepatocyte Ballooning
time frame: Baseline (week 0), Week 72
description: Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification
time frame: Baseline (week 0), Week 72
description: Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score
time frame: Baseline (week 0), Week 72
description: Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Fibrosis-4 Score
time frame: Baseline (week 0), Week 72
description: Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A Fibrosis-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in NAFLD Fibrosis Score (NFS)
time frame: Baseline (week 0), Week 72
description: Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * body mass index (BMI) (kg/m^2) + 1.13 * hyperglycaemia (yes/no) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (*10^9/L) - 0.66 * albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) < -1.5 indicates a low probability, b) > -1.5 to < 0.67 indicates intermediate probability, and a score of c) > 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Alanine Aminotransferase (ALT)
time frame: Baseline (week 0), Week 72
description: Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Aspartate Aminotransferase (AST)
time frame: Baseline (week 0), Week 72
description: Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Gamma Glutamyl Transferase (GGT)
time frame: Baseline (week 0), Week 72
description: Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Albumin
time frame: Baseline (week 0), Week 72
description: Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in International Normalized Ratio (INR)
time frame: Baseline (week 0), Week 72
description: Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Enhanced Liver Fibrosis (ELF)
time frame: Baseline (week 0), Week 72
description: Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) < 7.7: no to mild fibrosis; b) ≥ 7.7 - < 9.8: Moderate fibrosis; c) ≥ 9.8 - < 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Cytokeratin 18 (CK-18) Fragments
time frame: Baseline (week 0), Week 72
description: Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in microRNA 122 (miR-122)
time frame: Baseline (week 0), Week 72
description: Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Interleukin-1 Receptor (IL-1R) Antagonist
time frame: Baseline (week 0), Week 72
description: Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Monocyte Chemoattractant Protein 1 (MCP-1)
time frame: Baseline (week 0), Week 72
description: Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Fibroblast Growth Factor 21 (FGF-21)
time frame: Baseline (week 0), Week 72
description: Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Liver Stiffness Assessed by FibroScan®
time frame: Baseline (week 0), Week 72
description: Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Liver Steatosis Assessed by FibroScan®
time frame: Baseline (week 0), Week 72
description: Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)
time frame: Week 72
description: Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
measure: Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)
time frame: Week 72
description: Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
measure: Change in Body Weight
time frame: Baseline (week 0), Week 72
description: Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Waist Circumference
time frame: Baseline (week 0), Week 72
description: Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Body Mass Index (BMI)
time frame: Baseline (week 0), Week 72
description: Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
time frame: Baseline (week 0), Week 72
description: Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in HbA1c (Millimoles Per Mole)
time frame: Baseline (week 0), Week 72
description: Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Fasting Plasma Glucose (FPG)
time frame: Baseline (week 0), Week 72
description: Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Fasting Glucagon
time frame: Baseline (week 0), Week 72
description: Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
time frame: Baseline (week 0), Week 72
description: Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Diastolic Blood Pressure (DBP)
time frame: Baseline (week 0), Week 72
description: Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Systolic Blood Pressure (SBP)
time frame: Baseline (week 0), Week 72
description: Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Total Cholesterol
time frame: Baseline (week 0), Week 72
description: Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Low Density Lipoprotein (LDL) Cholesterol
time frame: Baseline (week 0), Week 72
description: Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in High Density Lipoprotein (HDL) Cholesterol
time frame: Baseline (week 0), Week 72
description: Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Very Low Density Lipoprotein (VLDL) Cholesterol
time frame: Baseline (week 0), Week 72
description: Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Triglycerides
time frame: Baseline (week 0), Week 72
description: Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Free Fatty Acids
time frame: Baseline (week 0), Week 72
description: Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in High Sensitivity C-reactive Protein (hsCRP)
time frame: Baseline (week 0), Week 72
description: Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Short Form 36 (SF-36) Score
time frame: Baseline (week 0), Week 72
description: Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Number of Treatment-emergent Adverse Events (TEAEs)
time frame: From week 0 to week 79
description: An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.
measure: Number of Treatment-emergent Hypoglycaemic Episodes
time frame: From week 0 to week 79
description: Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes
time frame: From week 0 to week 79
description: Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value < 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.
measure: Number of Treatment-emergent Severe Hypoglycaemic Episodes
time frame: From week 0 to week 79
description: Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events
time frame: From week 0 to week 79
description: Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)
time frame: From week 0 to week 79
description: Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)
time frame: From week 0 to week 79
description: Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
time frame: From week 0 to week 79
description: Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
time frame: From week 0 to week 79
description: Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
measure: Change in Pulse From Baseline to Week 72
time frame: Baseline (week 0), Week 72
description: Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Electrocardiogram (ECG)
time frame: Baseline (week 0), Week 72
description: A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: Cardiovascular System
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: General Appearance
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: Lymph Node Palpation
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: Musculoskeletal System
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: Respiratory System
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: Skin
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Percentage of Participants With Change in Physical Examination: Thyroid Gland
time frame: Week -6, week 72
description: Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Haematocrit
time frame: Baseline (week 0), Week 72
description: Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Haemoglobin (g/dL)
time frame: Baseline (week 0), Week 72
description: Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Haemoglobin (mmol/L)
time frame: Baseline (week 0), Week 72
description: Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Leukocytes
time frame: Baseline (week 0), Week 72
description: Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Thrombocytes
time frame: Baseline (week 0), Week 72
description: Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Erythrocytes
time frame: Baseline (week 0), Week 72
description: Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Creatinine (mg/dL)
time frame: Baseline (week 0), Week 72
description: Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Creatinine (Umol/L)
time frame: Baseline (week 0), Week 72
description: Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
time frame: Baseline (week 0), Week 72
description: Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Creatine Kinase
time frame: Baseline (week 0), Week 72
description: Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Urea
time frame: Baseline (week 0), Week 72
description: Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Total Bilirubin (mg/dL)
time frame: Baseline (week 0), Week 72
description: Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Total Bilirubin (Umol/L)
time frame: Baseline (week 0), Week 72
description: Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Alkaline Phosphatase
time frame: Baseline (week 0), Week 72
description: Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Ferritin
time frame: Baseline (week 0), Week 72
description: Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Sodium (mEq/L)
time frame: Baseline (week 0), Week 72
description: Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Sodium (mmol/L)
time frame: Baseline (week 0), Week 72
description: Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Potassium (mEq/L)
time frame: Baseline (week 0), Week 72
description: Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Potassium (mmol/L)
time frame: Baseline (week 0), Week 72
description: Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Calcium (mg/dL)
time frame: Baseline (week 0), Week 72
description: Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Calcium (mmol/L)
time frame: Baseline (week 0), Week 72
description: Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Amylase
time frame: Baseline (week 0), Week 72
description: Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Lipase
time frame: Baseline (week 0), Week 72
description: Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
measure: Change in Calcitonin
time frame: Baseline (week 0), Week 72
description: Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
arm group label: Semaglutide 0,1 mg
arm group type: Experimental
arm group label: Semaglutide 0,2 mg
arm group type: Experimental
arm group label: Semaglutide 0,4 mg
arm group type: Experimental
arm group label: Placebo 1
arm group type: Placebo Comparator
arm group label: Placebo 2
arm group type: Placebo Comparator
arm group label: Placebo 3
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Semaglutide
description: Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
arm group label: Semaglutide 0,1 mg
arm group label: Semaglutide 0,2 mg
arm group label: Semaglutide 0,4 mg
intervention type: Drug
intervention name: Placebo
description: Once daily administration subcutaneously ( s.c., under the skin)
arm group label: Placebo 1
arm group label: Placebo 2
arm group label: Placebo 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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country: Australia
country: Austria
country: Belgium
country: Bulgaria
country: Canada
country: Denmark
country: Finland
country: France
country: Greece
country: Japan
country: Netherlands
country: Puerto Rico
country: Russian Federation
country: Spain
country: Sweden
country: United Kingdom
country: United States
citation: Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.
PMID: 33185364
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Digestive System Diseases
mesh term: Liver Diseases
sharing ipd: Yes
ipd description: According to Novo Nordisk disclosure commitment on novonordisk.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
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