<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT03021187</url>
  </required_header>
  <id_info>
    <org_study_id>NN9924-4280</org_study_id>
    <secondary_id>2016-000988-16</secondary_id>
    <secondary_id>U1111-1180-3637</secondary_id>
    <secondary_id>JapicCTI-173508</secondary_id>
    <nct_id>NCT03021187</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin</brief_title>
  <acronym>PIONEER 8</acronym>
  <official_title>Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)</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>
      This trial is conducted globally. The aim of the trial is to investigate the efficacy and&#xD;
      safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated&#xD;
      with insulin. All subjects should continue their pre-trial insulin therapy (basal,&#xD;
      basal-bolus or premixed regimen including combinations of soluble insulins) throughout the&#xD;
      trial. Subjects treated with metformin in addition to insulin treatment must continue their&#xD;
      metformin treatment throughout the entire trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">August 22, 2018</completion_date>
  <primary_completion_date type="Actual">January 18, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c (Week 26)</measure>
    <time_frame>Week 0, week 26</time_frame>
    <description>Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight (Week 26)</measure>
    <time_frame>Week 0, week 26</time_frame>
    <description>Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c (Week 52)</measure>
    <time_frame>Week 0, week 52</time_frame>
    <description>Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight (kg) (Week 52)</measure>
    <time_frame>Week 0, week 52</time_frame>
    <description>Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SMPG Mean Postprandial Increment Over All Meals</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight (Percentage)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Circumference</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Cholesterol - Ratio to Baseline</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LDL Cholesterol - Ratio to Baseline</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL Cholesterol - Ratio to Baseline</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Triglycerides - Ratio to Baseline</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Daily Insulin Dose</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve: HbA1c &lt; 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Number of particpants achieving HbA1c &lt; 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve Body Weight Loss ≥5% (Yes/no)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve Body Weight Loss ≥10% (Yes/no)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve HbA1c &lt;7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value &lt;3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)</measure>
    <time_frame>Week 26, week 52</time_frame>
    <description>Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Additional Anti-diabetic Medication</measure>
    <time_frame>Weeks 0-52</time_frame>
    <description>Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Rescue Medication</measure>
    <time_frame>Weeks 0-52</time_frame>
    <description>Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product</measure>
    <time_frame>Weeks 0-57</time_frame>
    <description>Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes</measure>
    <time_frame>Weeks 0-57</time_frame>
    <description>Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes</measure>
    <time_frame>Weeks 0-57</time_frame>
    <description>Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Amylase - Ratio to Baseline</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lipase - Ratio to Baseline</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulse Rate</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SBP and DBP</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ECG Evaluation</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Examination</measure>
    <time_frame>Week -2, week 52</time_frame>
    <description>Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Eye Examination Category</measure>
    <time_frame>Week -2, week 52</time_frame>
    <description>Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semaglutide Plasma Concentrations for Population PK Analyses</measure>
    <time_frame>Weeks 0-52</time_frame>
    <description>This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)</measure>
    <time_frame>Week 0, week 26, week 52</time_frame>
    <description>Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being &quot;none of the time&quot; unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">731</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Semaglutide 3 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide 3 mg + 7 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide 3 mg + 7 mg + 14 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</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>Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment</description>
    <arm_group_label>Semaglutide 3 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Oral semaglutide (3 mg followed by 7 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment</description>
    <arm_group_label>Semaglutide 3 mg + 7 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Oral semaglutide (3 mg followed by 7 mg and finally 14 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment</description>
    <arm_group_label>Semaglutide 3 mg + 7 mg + 14 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment</description>
    <arm_group_label>Placebo</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. - Male or female, age above or&#xD;
        equal to 18 years at the time of signing informed consent. For Japan only: Male or female,&#xD;
        age above or equal to 20 years at the time of signing informed consent. - Diagnosed with&#xD;
        type 2 diabetes mellitus 90 days or more prior to the day of screening. - HbA1c&#xD;
        (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive). - Stable&#xD;
        treatment with one of the following insulin regimens (minimum 10 IU/day) 90 or more days&#xD;
        prior to the day of screening. Maximum 20% change in total daily dose is acceptable: (1)&#xD;
        Basal insulin alone or (2) Basal and bolus insulin in any combination or (3) Premixed&#xD;
        insulin including combinations of soluble insulins Exclusion Criteria: - Female who is&#xD;
        pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and&#xD;
        not using an adequate contraceptive method (adequate contraceptive measure as required by&#xD;
        local regulation or practice). For Greece only: adequate contraceptive measures are defined&#xD;
        as combined hormonal contraception (containing oestrogen and progesterone), which suppress&#xD;
        ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception&#xD;
        which suppress ovulation (oral, injectable, implantable), intrauterine device,&#xD;
        hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy,&#xD;
        sexual abstinence. For Japan only: Adequate contraceptive measures are abstinence (not&#xD;
        having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or&#xD;
        oral contraceptives. For Canada only: adequate contraceptive measures are defined as&#xD;
        combined hormonal contraception (containing oestrogen and progesterone), which suppress&#xD;
        ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception&#xD;
        which suppress ovulation (oral, injectable, implantable), intrauterine device,&#xD;
        hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy,&#xD;
        sexual abstinence - Any disorder, which in the investigator's opinion might jeopardise&#xD;
        subject's safety or compliance with the protocol. - Family or personal history of Multiple&#xD;
        Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). - History of&#xD;
        pancreatitis (acute or chronic). - History of major surgical procedures involving the&#xD;
        stomach and potentially affecting absorption of trial product (e.g. subtotal and total&#xD;
        gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Any of the following:&#xD;
        myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient&#xD;
        ischaemic attack within the past 180 days prior to the day of screening and randomisation.&#xD;
        - Classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary,&#xD;
        carotid or peripheral artery revascularisation known on the day of screening. - Renal&#xD;
        impairment defined as estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73&#xD;
        m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). - Treatment&#xD;
        with any medication for the indication of diabetes or obesity other than stated in the&#xD;
        inclusion criteria in a period of 90 days before the day of screening. An exception is&#xD;
        short-term change of insulin treatment for acute illness for a total of 14 days or less. -&#xD;
        Known hypoglycaemic unawareness according to Clarke's questionnaire. - Proliferative&#xD;
        retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or&#xD;
        dilated fundoscopy performed within 90 days prior to randomisation. - History or presence&#xD;
        of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer&#xD;
        and carcinoma in situ). - Subjects with alanine aminotransferase (ALT) more than 2.5 x&#xD;
        upper normal limit (UNL).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fountain Hills</city>
        <state>Arizona</state>
        <zip>85268</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85723-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</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>90017</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>Riverside</city>
        <state>California</state>
        <zip>92506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Franklin</city>
        <state>Indiana</state>
        <zip>46131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Natchitoches</city>
        <state>Louisiana</state>
        <zip>71457-5881</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hyattsville</city>
        <state>Maryland</state>
        <zip>20782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052-2649</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>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>West Seneca</city>
        <state>New York</state>
        <zip>14224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Beaver</city>
        <state>Pennsylvania</state>
        <zip>15009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lansdale</city>
        <state>Pennsylvania</state>
        <zip>19446-1002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29485</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660-4652</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>75251</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>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75149</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Midland</city>
        <state>Texas</state>
        <zip>79707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1G 1A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6S 0C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Etobicoke</city>
        <state>Ontario</state>
        <zip>M9W 1P1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6G 2M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3L9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Besançon cedex</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bourgoin-jallieu</city>
        <zip>38302</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>LA ROCHE-sur-YON cedex 9</city>
        <zip>85295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>LA ROCHELLE cedex</city>
        <zip>17019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Le Coudray</city>
        <zip>28630</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Le Creusot</city>
        <zip>71200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Narbonne</city>
        <zip>11108</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Herblain</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>TOULOUSE cedex</city>
        <zip>31054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Venissieux</city>
        <zip>69200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Athens</city>
        <zip>GR-11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Athens</city>
        <zip>GR-17562</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ioannina</city>
        <zip>45500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Larissa</city>
        <zip>GR-41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Piraeus</city>
        <zip>GR-18536</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Thessaloniki</city>
        <zip>GR-54649</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560 017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kozhikode</city>
        <state>Kerala</state>
        <zip>673017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Indore</city>
        <state>Madhya Pradesh</state>
        <zip>452010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>New Dehli</city>
        <state>New Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600086</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kolkata</city>
        <zip>700020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Amagasaki-shi, Hyogo</city>
        <zip>661-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chuo-ku, Tokyo</city>
        <zip>103-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ebina-shi, Kanagawa</city>
        <zip>243-0432</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Iruma-shi, Saitama</city>
        <zip>358-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>247-0055</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kumamoto-shi, Kumamoto</city>
        <zip>860-0811</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>862-0976</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miyazaki</city>
        <zip>880-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Naka-shi</city>
        <zip>311 0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>569-1045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saga-shi, Saga</city>
        <zip>849-0937</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sapporo-shi</city>
        <zip>062 0007</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shimotsuke-shi, Tochigi</city>
        <zip>329-0433</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka-shi, Shizuoka</city>
        <zip>424-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Suita-shi, Osaka</city>
        <zip>565-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ube-shi, Yamaguchi</city>
        <zip>755-0046</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Durango</city>
        <zip>34000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78200</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-404</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-044</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-589</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pulawy</city>
        <zip>24-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Manati</city>
        <zip>00674</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kazan</city>
        <zip>420073</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Penza</city>
        <zip>440026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>191119</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Greece</country>
    <country>India</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Zinman B, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, Tarp-Johansen MJ, Araki E; PIONEER 8 Investigators. Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Diabetes Care. 2019 Dec;42(12):2262-2271. doi: 10.2337/dc19-0898. Epub 2019 Sep 17.</citation>
    <PMID>31530667</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>October 15, 2019</results_first_submitted>
  <results_first_submitted_qc>October 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 7, 2019</results_first_posted>
  <disposition_first_submitted>December 18, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>December 18, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 20, 2018</disposition_first_posted>
  <last_update_submitted>February 14, 2020</last_update_submitted>
  <last_update_submitted_qc>February 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2020</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.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>February 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03021187/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 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03021187/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 111 sites in 9 countries: Canada (7), France (10), Greece (6), India (9), Japan (18), Mexico (2), Poland (4), Russian Federation (5) and United States (48). Following sites were approved by the IRB/IEC but didn't randomise subjects: France (2), India (1), Japan (1) and United States (3).</recruitment_details>
      <pre_assignment_details>Data presented in &quot;participant flow&quot; is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Oral Semaglutide 3 mg</title>
          <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
        </group>
        <group group_id="P2">
          <title>Oral Semaglutide 7 mg</title>
          <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
        </group>
        <group group_id="P3">
          <title>Oral Semaglutide 14 mg</title>
          <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 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="184"/>
                <participants group_id="P2" count="182"/>
                <participants group_id="P3" count="181"/>
                <participants group_id="P4" count="184"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Exposed</title>
              <participants_list>
                <participants group_id="P1" count="184"/>
                <participants group_id="P2" count="181"/>
                <participants group_id="P3" count="181"/>
                <participants group_id="P4" count="184"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set (FAS)</title>
              <participants_list>
                <participants group_id="P1" count="184"/>
                <participants group_id="P2" count="182"/>
                <participants group_id="P3" count="181"/>
                <participants group_id="P4" count="184"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SAS)</title>
              <participants_list>
                <participants group_id="P1" count="184"/>
                <participants group_id="P2" count="181"/>
                <participants group_id="P3" count="181"/>
                <participants group_id="P4" count="184"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
                <participants group_id="P2" count="173"/>
                <participants group_id="P3" count="175"/>
                <participants group_id="P4" count="175"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="9"/>
              </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="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oral Semaglutide 3 mg</title>
          <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
        </group>
        <group group_id="B2">
          <title>Oral Semaglutide 7 mg</title>
          <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
        </group>
        <group group_id="B3">
          <title>Oral Semaglutide 14 mg</title>
          <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 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="184"/>
            <count group_id="B2" value="182"/>
            <count group_id="B3" value="181"/>
            <count group_id="B4" value="184"/>
            <count group_id="B5" value="731"/>
          </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="61" spread="9"/>
                    <measurement group_id="B2" value="60" spread="10"/>
                    <measurement group_id="B3" value="61" spread="10"/>
                    <measurement group_id="B4" value="60" spread="10"/>
                    <measurement group_id="B5" value="61" spread="10"/>
                  </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="82"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="79"/>
                    <measurement group_id="B5" value="336"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="85"/>
                    <measurement group_id="B4" value="105"/>
                    <measurement group_id="B5" value="395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race was recorded as 'Not Applicable' for France as per local regulation.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="94"/>
                    <measurement group_id="B4" value="98"/>
                    <measurement group_id="B5" value="376"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="65"/>
                    <measurement group_id="B5" value="263"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or other Pacific</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>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not applicable</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Ethnicity was recorded as 'Not Applicable' for France as per local regulation.</description>
          <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="18"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="154"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="143"/>
                    <measurement group_id="B4" value="150"/>
                    <measurement group_id="B5" value="595"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not applicable</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <description>Glycosylated haemoglobin</description>
          <units>Percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.2" spread="0.7"/>
                    <measurement group_id="B2" value="8.2" spread="0.7"/>
                    <measurement group_id="B3" value="8.2" spread="0.7"/>
                    <measurement group_id="B4" value="8.2" spread="0.7"/>
                    <measurement group_id="B5" value="8.2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in HbA1c (Week 26)</title>
        <description>Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any.</description>
        <time_frame>Week 0, week 26</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c (Week 26)</title>
          <description>Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Percentage 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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>In-trial</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="1.0"/>
                    <measurement group_id="O2" value="-1.0" spread="1.1"/>
                    <measurement group_id="O3" value="-1.3" spread="1.1"/>
                    <measurement group_id="O4" value="-0.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>On-treatment without rescue medication</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="157"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.1"/>
                    <measurement group_id="O2" value="-1.1" spread="1.0"/>
                    <measurement group_id="O3" value="-1.4" spread="0.9"/>
                    <measurement group_id="O4" value="-0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>Pattern mixture model</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
            <estimate_desc>Oral semaglutide 3mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>Pattern mixture model</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>-0.7</ci_upper_limit>
            <estimate_desc>Oral semaglutide 7 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>Pattern mixture model</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>-1.0</ci_upper_limit>
            <estimate_desc>Oral semaglutide 14 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>MMRM</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
            <estimate_desc>Oral semaglutide 3 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>MMRM</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
            <estimate_desc>Oral semaglutide 7 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>MMRM</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>-1.2</ci_upper_limit>
            <estimate_desc>Oral semaglutide 14 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight (Week 26)</title>
        <description>Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight (Week 26)</title>
          <description>Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>In trial</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="3.1"/>
                    <measurement group_id="O2" value="-2.6" spread="5.2"/>
                    <measurement group_id="O3" value="-3.7" spread="4.0"/>
                    <measurement group_id="O4" value="-0.5" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>On-treatment without rescue medication</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="157"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="3.1"/>
                    <measurement group_id="O2" value="-3.0" spread="3.7"/>
                    <measurement group_id="O3" value="-3.9" spread="3.6"/>
                    <measurement group_id="O4" value="-0.5" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).</non_inferiority_desc>
            <p_value>0.0392</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>Pattern mixture model</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>-0.0</ci_upper_limit>
            <estimate_desc>Oral semaglutide 3 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).</non_inferiority_desc>
            <p_value>0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>Pattern mixture model</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.0</ci_lower_limit>
            <ci_upper_limit>-1.0</ci_upper_limit>
            <estimate_desc>Oral semaglutide 7 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>Pattern mixture model</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-3.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.2</ci_lower_limit>
            <ci_upper_limit>-2.3</ci_upper_limit>
            <estimate_desc>Oral semaglutide 14 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).</non_inferiority_desc>
            <p_value>0.0111</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>MMRM</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
            <estimate_desc>Oral semaglutide 3 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>MMRM</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-2.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.2</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
            <estimate_desc>Oral semaglutide 7 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 0 (superiority).</p_value_desc>
            <method>MMRM</method>
            <param_type>Mean treatment difference</param_type>
            <param_value>-3.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.4</ci_lower_limit>
            <ci_upper_limit>-3.0</ci_upper_limit>
            <estimate_desc>Oral semaglutide 14 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c (Week 52)</title>
        <description>Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 52</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c (Week 52)</title>
          <description>Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Percentage 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="173"/>
                <count group_id="O2" value="169"/>
                <count group_id="O3" value="168"/>
                <count group_id="O4" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.0" lower_limit="1.0"/>
                    <measurement group_id="O2" value="-0.9" spread="1.1" lower_limit="1.1"/>
                    <measurement group_id="O3" value="-1.2" spread="1.0" lower_limit="1.0"/>
                    <measurement group_id="O4" value="-0.2" spread="0.8" lower_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight (kg) (Week 52)</title>
        <description>Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 52</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight (kg) (Week 52)</title>
          <description>Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
                <count group_id="O2" value="171"/>
                <count group_id="O3" value="170"/>
                <count group_id="O4" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="3.9" lower_limit="3.9"/>
                    <measurement group_id="O2" value="-2.2" spread="5.2" lower_limit="5.2"/>
                    <measurement group_id="O3" value="-3.8" spread="5.8" lower_limit="5.8"/>
                    <measurement group_id="O4" value="0.5" spread="3.2" lower_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose (FPG)</title>
        <description>Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose (FPG)</title>
          <description>Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.45" spread="3.35"/>
                    <measurement group_id="O2" value="-1.14" spread="3.08"/>
                    <measurement group_id="O3" value="-1.36" spread="2.72"/>
                    <measurement group_id="O4" value="0.51" spread="2.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="168"/>
                    <count group_id="O3" value="169"/>
                    <count group_id="O4" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.81" spread="3.21"/>
                    <measurement group_id="O2" value="-1.12" spread="2.91"/>
                    <measurement group_id="O3" value="-1.60" spread="2.65"/>
                    <measurement group_id="O4" value="-0.09" spread="2.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile</title>
        <description>Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile</title>
          <description>Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="164"/>
                    <count group_id="O3" value="159"/>
                    <count group_id="O4" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.3"/>
                    <measurement group_id="O2" value="-1.8" spread="2.4"/>
                    <measurement group_id="O3" value="-2.0" spread="2.2"/>
                    <measurement group_id="O4" value="-0.3" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="157"/>
                    <count group_id="O3" value="157"/>
                    <count group_id="O4" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="2.5"/>
                    <measurement group_id="O2" value="-1.7" spread="2.4"/>
                    <measurement group_id="O3" value="-2.0" spread="2.1"/>
                    <measurement group_id="O4" value="-0.9" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SMPG Mean Postprandial Increment Over All Meals</title>
        <description>Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SMPG Mean Postprandial Increment Over All Meals</title>
          <description>Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="158"/>
                    <count group_id="O4" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.3"/>
                    <measurement group_id="O2" value="-0.8" spread="2.6"/>
                    <measurement group_id="O3" value="-1.2" spread="2.5"/>
                    <measurement group_id="O4" value="-0.1" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                    <count group_id="O2" value="153"/>
                    <count group_id="O3" value="156"/>
                    <count group_id="O4" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.3"/>
                    <measurement group_id="O2" value="-0.7" spread="2.3"/>
                    <measurement group_id="O3" value="-0.7" spread="2.3"/>
                    <measurement group_id="O4" value="-0.3" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight (Percentage)</title>
        <description>Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight (Percentage)</title>
          <description>Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.73" spread="3.34"/>
                    <measurement group_id="O2" value="-3.11" spread="5.66"/>
                    <measurement group_id="O3" value="-4.30" spread="4.57"/>
                    <measurement group_id="O4" value="-0.47" spread="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.18" spread="4.17"/>
                    <measurement group_id="O2" value="-2.54" spread="5.77"/>
                    <measurement group_id="O3" value="-4.42" spread="6.07"/>
                    <measurement group_id="O4" value="0.65" spread="3.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Mass Index</title>
        <description>Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Mass Index</title>
          <description>Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="1.1"/>
                    <measurement group_id="O2" value="-1.0" spread="1.7"/>
                    <measurement group_id="O3" value="-1.4" spread="1.5"/>
                    <measurement group_id="O4" value="-0.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="1.4"/>
                    <measurement group_id="O2" value="-0.8" spread="1.8"/>
                    <measurement group_id="O3" value="-1.4" spread="2.1"/>
                    <measurement group_id="O4" value="0.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Waist Circumference</title>
        <description>Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Waist Circumference</title>
          <description>Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="4.1"/>
                    <measurement group_id="O2" value="-2.3" spread="5.1"/>
                    <measurement group_id="O3" value="-3.6" spread="4.9"/>
                    <measurement group_id="O4" value="-0.6" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="4.8"/>
                    <measurement group_id="O2" value="-2.3" spread="5.1"/>
                    <measurement group_id="O3" value="-4.0" spread="6.8"/>
                    <measurement group_id="O4" value="0.3" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Cholesterol - Ratio to Baseline</title>
        <description>Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Cholesterol - Ratio to Baseline</title>
          <description>Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="15.5"/>
                    <measurement group_id="O2" value="0.95" spread="18.7"/>
                    <measurement group_id="O3" value="0.95" spread="17.3"/>
                    <measurement group_id="O4" value="1.03" spread="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="167"/>
                    <count group_id="O3" value="167"/>
                    <count group_id="O4" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="18.2"/>
                    <measurement group_id="O2" value="0.97" spread="19.2"/>
                    <measurement group_id="O3" value="0.95" spread="18.1"/>
                    <measurement group_id="O4" value="1.00" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in LDL Cholesterol - Ratio to Baseline</title>
        <description>Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in LDL Cholesterol - Ratio to Baseline</title>
          <description>Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="27.1"/>
                    <measurement group_id="O2" value="0.93" spread="30.2"/>
                    <measurement group_id="O3" value="0.93" spread="24.5"/>
                    <measurement group_id="O4" value="1.03" spread="25.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="167"/>
                    <count group_id="O3" value="167"/>
                    <count group_id="O4" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="29.2"/>
                    <measurement group_id="O2" value="0.96" spread="29.4"/>
                    <measurement group_id="O3" value="0.95" spread="27.6"/>
                    <measurement group_id="O4" value="1.00" spread="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HDL Cholesterol - Ratio to Baseline</title>
        <description>Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HDL Cholesterol - Ratio to Baseline</title>
          <description>Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="13.5"/>
                    <measurement group_id="O2" value="0.98" spread="13.5"/>
                    <measurement group_id="O3" value="0.98" spread="16.7"/>
                    <measurement group_id="O4" value="1.01" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="167"/>
                    <count group_id="O3" value="167"/>
                    <count group_id="O4" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" spread="14.4"/>
                    <measurement group_id="O2" value="0.98" spread="13.4"/>
                    <measurement group_id="O3" value="1.01" spread="14.3"/>
                    <measurement group_id="O4" value="1.00" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Triglycerides - Ratio to Baseline</title>
        <description>Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Triglycerides - Ratio to Baseline</title>
          <description>Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="41.5"/>
                    <measurement group_id="O2" value="0.92" spread="33.0"/>
                    <measurement group_id="O3" value="0.91" spread="44.8"/>
                    <measurement group_id="O4" value="0.99" spread="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="167"/>
                    <count group_id="O3" value="167"/>
                    <count group_id="O4" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="48.7"/>
                    <measurement group_id="O2" value="0.94" spread="34.9"/>
                    <measurement group_id="O3" value="0.86" spread="43.7"/>
                    <measurement group_id="O4" value="0.97" spread="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Daily Insulin Dose</title>
        <description>Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Daily Insulin Dose</title>
          <description>Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Units/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" spread="22"/>
                    <measurement group_id="O2" value="-9" spread="21"/>
                    <measurement group_id="O3" value="-8" spread="19"/>
                    <measurement group_id="O4" value="-2" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="172"/>
                    <count group_id="O4" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="26"/>
                    <measurement group_id="O2" value="-8" spread="64"/>
                    <measurement group_id="O3" value="-5" spread="19"/>
                    <measurement group_id="O4" value="8" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve: HbA1c &lt; 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)</title>
        <description>Number of particpants achieving HbA1c &lt; 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve: HbA1c &lt; 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)</title>
          <description>Number of particpants achieving HbA1c &lt; 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="74"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="72"/>
                    <measurement group_id="O4" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="168"/>
                    <count group_id="O4" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="67"/>
                    <measurement group_id="O3" value="91"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="77"/>
                    <measurement group_id="O4" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no)</title>
        <description>Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no)</title>
          <description>Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="74"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="152"/>
                    <measurement group_id="O2" value="129"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="168"/>
                    <count group_id="O4" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="65"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="153"/>
                    <measurement group_id="O2" value="136"/>
                    <measurement group_id="O3" value="103"/>
                    <measurement group_id="O4" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve Body Weight Loss ≥5% (Yes/no)</title>
        <description>Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve Body Weight Loss ≥5% (Yes/no)</title>
          <description>Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="67"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                    <measurement group_id="O2" value="121"/>
                    <measurement group_id="O3" value="106"/>
                    <measurement group_id="O4" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="67"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="123"/>
                    <measurement group_id="O3" value="103"/>
                    <measurement group_id="O4" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve Body Weight Loss ≥10% (Yes/no)</title>
        <description>Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve Body Weight Loss ≥10% (Yes/no)</title>
          <description>Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="175"/>
                    <measurement group_id="O2" value="162"/>
                    <measurement group_id="O3" value="154"/>
                    <measurement group_id="O4" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="170"/>
                    <measurement group_id="O2" value="154"/>
                    <measurement group_id="O3" value="149"/>
                    <measurement group_id="O4" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve HbA1c &lt;7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)</title>
        <description>Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value &lt;3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve HbA1c &lt;7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)</title>
          <description>Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value &lt;3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="97"/>
                    <measurement group_id="O4" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="168"/>
                    <count group_id="O4" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="61"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="126"/>
                    <measurement group_id="O3" value="107"/>
                    <measurement group_id="O4" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)</title>
        <description>Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)</title>
          <description>Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                    <measurement group_id="O2" value="123"/>
                    <measurement group_id="O3" value="97"/>
                    <measurement group_id="O4" value="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="168"/>
                    <count group_id="O4" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="64"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="153"/>
                    <measurement group_id="O2" value="132"/>
                    <measurement group_id="O3" value="104"/>
                    <measurement group_id="O4" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Additional Anti-diabetic Medication</title>
        <description>Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Weeks 0-52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Additional Anti-diabetic Medication</title>
          <description>Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0-26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0-52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.0627</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.0083</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.0019</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Rescue Medication</title>
        <description>Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.</description>
        <time_frame>Weeks 0-52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Rescue Medication</title>
          <description>Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0-26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0-52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.1210</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>This hypothesis was not controlled for multiplicity.</non_inferiority_desc>
            <p_value>0.0007</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <p_value_desc>Unadjusted two-sided p-value for test of no difference from 1.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>0.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product</title>
        <description>Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Weeks 0-57</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product</title>
          <description>Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="626"/>
                    <measurement group_id="O2" value="555"/>
                    <measurement group_id="O3" value="586"/>
                    <measurement group_id="O4" value="464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes</title>
        <description>Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
        <time_frame>Weeks 0-57</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes</title>
          <description>Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196"/>
                    <measurement group_id="O2" value="180"/>
                    <measurement group_id="O3" value="147"/>
                    <measurement group_id="O4" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes</title>
        <description>Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
        <time_frame>Weeks 0-57</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes</title>
          <description>Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="48"/>
                    <measurement group_id="O4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Amylase - Ratio to Baseline</title>
        <description>Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Amylase - Ratio to Baseline</title>
          <description>Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="157"/>
                    <count group_id="O3" value="148"/>
                    <count group_id="O4" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="25.4"/>
                    <measurement group_id="O2" value="1.12" spread="24.7"/>
                    <measurement group_id="O3" value="1.14" spread="26.7"/>
                    <measurement group_id="O4" value="1.01" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="144"/>
                    <count group_id="O3" value="140"/>
                    <count group_id="O4" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread="24.6"/>
                    <measurement group_id="O2" value="1.11" spread="26.5"/>
                    <measurement group_id="O3" value="1.17" spread="21.6"/>
                    <measurement group_id="O4" value="0.99" spread="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Lipase - Ratio to Baseline</title>
        <description>Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipase - Ratio to Baseline</title>
          <description>Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="157"/>
                    <count group_id="O3" value="148"/>
                    <count group_id="O4" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" spread="56.7"/>
                    <measurement group_id="O2" value="1.34" spread="59.1"/>
                    <measurement group_id="O3" value="1.35" spread="65.1"/>
                    <measurement group_id="O4" value="0.99" spread="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="144"/>
                    <count group_id="O3" value="140"/>
                    <count group_id="O4" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.09" spread="57.5"/>
                    <measurement group_id="O2" value="1.25" spread="59.8"/>
                    <measurement group_id="O3" value="1.35" spread="49.6"/>
                    <measurement group_id="O4" value="0.99" spread="53.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulse Rate</title>
        <description>Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulse Rate</title>
          <description>Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</population>
          <units>Beats/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="159"/>
                    <count group_id="O3" value="150"/>
                    <count group_id="O4" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="9"/>
                    <measurement group_id="O2" value="2" spread="9"/>
                    <measurement group_id="O3" value="3" spread="10"/>
                    <measurement group_id="O4" value="-0" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="148"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0" spread="8"/>
                    <measurement group_id="O2" value="1" spread="9"/>
                    <measurement group_id="O3" value="2" spread="10"/>
                    <measurement group_id="O4" value="0" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SBP and DBP</title>
        <description>Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SBP and DBP</title>
          <description>Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP: Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="159"/>
                    <count group_id="O3" value="150"/>
                    <count group_id="O4" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" spread="12"/>
                    <measurement group_id="O2" value="-3" spread="17"/>
                    <measurement group_id="O3" value="-5" spread="14"/>
                    <measurement group_id="O4" value="1" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="148"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" spread="12"/>
                    <measurement group_id="O2" value="-3" spread="16"/>
                    <measurement group_id="O3" value="-6" spread="14"/>
                    <measurement group_id="O4" value="0" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="159"/>
                    <count group_id="O3" value="150"/>
                    <count group_id="O4" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0" spread="8"/>
                    <measurement group_id="O2" value="-1" spread="10"/>
                    <measurement group_id="O3" value="-1" spread="9"/>
                    <measurement group_id="O4" value="0" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="148"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" spread="8"/>
                    <measurement group_id="O2" value="-2" spread="9"/>
                    <measurement group_id="O3" value="-2" spread="9"/>
                    <measurement group_id="O4" value="-0" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in ECG Evaluation</title>
        <description>Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ECG Evaluation</title>
          <description>Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal (week 0) to Normal (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="110"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                    <measurement group_id="O2" value="98"/>
                    <measurement group_id="O3" value="90"/>
                    <measurement group_id="O4" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to Abnormal NCS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="110"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to Abnormal CS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="110"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal NCS (week 0) to Normal (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal NCS (week 0) to Abnormal NCS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal NCS (week 0) to Abnormal CS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal CS (week 0) to Normal (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal CS (week 0) to Abnormal NCS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal CS (week 0) to Abnormal CS (week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to Normal (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="106"/>
                    <count group_id="O4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="91"/>
                    <measurement group_id="O3" value="85"/>
                    <measurement group_id="O4" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to Abnormal NCS (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="106"/>
                    <count group_id="O4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal (week 0) to Abnormal CS (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="106"/>
                    <count group_id="O4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal NCS to Normal (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal NCS to Abnormal NCS (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="42"/>
                    <measurement group_id="O4" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal NCS to Abnormal CS (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal CS to Normal (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal CS to Abnormal NCS (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal CS to Abnormal CS (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Physical Examination</title>
        <description>Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.</description>
        <time_frame>Week -2, week 52</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Physical Examination</title>
          <description>Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1) Cardiovascular system (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                    <measurement group_id="O2" value="166"/>
                    <measurement group_id="O3" value="157"/>
                    <measurement group_id="O4" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1) Cardiovascular system (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="158"/>
                    <measurement group_id="O3" value="145"/>
                    <measurement group_id="O4" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Central and peripheral nervous system (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="157"/>
                    <measurement group_id="O3" value="158"/>
                    <measurement group_id="O4" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Central and peripheral nervous system (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                    <measurement group_id="O2" value="150"/>
                    <measurement group_id="O3" value="147"/>
                    <measurement group_id="O4" value="155"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Gastrointestinal system, incl. mouth (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                    <measurement group_id="O2" value="175"/>
                    <measurement group_id="O3" value="177"/>
                    <measurement group_id="O4" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Gastrointestinal system, incl. mouth (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="163"/>
                    <measurement group_id="O2" value="164"/>
                    <measurement group_id="O3" value="166"/>
                    <measurement group_id="O4" value="171"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4) General appearance (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="162"/>
                    <measurement group_id="O3" value="160"/>
                    <measurement group_id="O4" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4) General appearance (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="148"/>
                    <measurement group_id="O3" value="153"/>
                    <measurement group_id="O4" value="152"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5) Head, ears, eyes, nose, throat, neck (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="173"/>
                    <measurement group_id="O3" value="172"/>
                    <measurement group_id="O4" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5) Head, ears, eyes, nose, throat, neck (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="161"/>
                    <measurement group_id="O2" value="164"/>
                    <measurement group_id="O3" value="165"/>
                    <measurement group_id="O4" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6) Lymph node palpation (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="184"/>
                    <measurement group_id="O2" value="181"/>
                    <measurement group_id="O3" value="181"/>
                    <measurement group_id="O4" value="184"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6) Lymph node palpation (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="172"/>
                    <measurement group_id="O2" value="170"/>
                    <measurement group_id="O3" value="170"/>
                    <measurement group_id="O4" value="172"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7) Musculoskeletal system (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="171"/>
                    <measurement group_id="O2" value="170"/>
                    <measurement group_id="O3" value="169"/>
                    <measurement group_id="O4" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7) Musculoskeletal system (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="160"/>
                    <measurement group_id="O2" value="160"/>
                    <measurement group_id="O3" value="159"/>
                    <measurement group_id="O4" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) Respiratory system (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                    <measurement group_id="O2" value="177"/>
                    <measurement group_id="O3" value="180"/>
                    <measurement group_id="O4" value="184"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) Respiratory system (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                    <measurement group_id="O2" value="164"/>
                    <measurement group_id="O3" value="170"/>
                    <measurement group_id="O4" value="173"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9) Skin (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="156"/>
                    <measurement group_id="O2" value="153"/>
                    <measurement group_id="O3" value="159"/>
                    <measurement group_id="O4" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9) Skin (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="152"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="151"/>
                    <measurement group_id="O4" value="155"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10) Thyroid gland (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="176"/>
                    <measurement group_id="O3" value="176"/>
                    <measurement group_id="O4" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10) Thyroid gland (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                    <measurement group_id="O2" value="165"/>
                    <measurement group_id="O3" value="168"/>
                    <measurement group_id="O4" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Eye Examination Category</title>
        <description>Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
        <time_frame>Week -2, week 52</time_frame>
        <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Eye Examination Category</title>
          <description>Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</description>
          <population>Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Left eye (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="64"/>
                    <measurement group_id="O3" value="64"/>
                    <measurement group_id="O4" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left eye (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="167"/>
                    <count group_id="O3" value="162"/>
                    <count group_id="O4" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="92"/>
                    <measurement group_id="O4" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="52"/>
                    <measurement group_id="O4" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right eye (week -2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="104"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="64"/>
                    <measurement group_id="O4" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right eye (week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="169"/>
                    <count group_id="O2" value="167"/>
                    <count group_id="O3" value="163"/>
                    <count group_id="O4" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="99"/>
                    <measurement group_id="O3" value="97"/>
                    <measurement group_id="O4" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="51"/>
                    <measurement group_id="O4" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Semaglutide Plasma Concentrations for Population PK Analyses</title>
        <description>This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
        <time_frame>Weeks 0-52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Semaglutide Plasma Concentrations for Population PK Analyses</title>
          <description>This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>nmol/L</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="176"/>
                    <count group_id="O3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="111.2"/>
                    <measurement group_id="O2" value="2.9" spread="116.4"/>
                    <measurement group_id="O3" value="2.9" spread="98.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="106.9"/>
                    <measurement group_id="O2" value="7.5" spread="143.2"/>
                    <measurement group_id="O3" value="14.5" spread="172.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="167"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="124.7"/>
                    <measurement group_id="O2" value="7.2" spread="141.4"/>
                    <measurement group_id="O3" value="12.6" spread="203.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="123.8"/>
                    <measurement group_id="O2" value="6.9" spread="139.7"/>
                    <measurement group_id="O3" value="10.8" spread="238.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="148"/>
                    <count group_id="O3" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="126.0"/>
                    <measurement group_id="O2" value="5.8" spread="160.5"/>
                    <measurement group_id="O3" value="11.9" spread="210.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)</title>
        <description>SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)</title>
          <description>SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1) Physical functioning (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="7.58"/>
                    <measurement group_id="O2" value="0.52" spread="6.61"/>
                    <measurement group_id="O3" value="-0.07" spread="6.75"/>
                    <measurement group_id="O4" value="-0.82" spread="7.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1) Physical functioning (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51" spread="8.27"/>
                    <measurement group_id="O2" value="-0.40" spread="6.69"/>
                    <measurement group_id="O3" value="-0.32" spread="7.55"/>
                    <measurement group_id="O4" value="-0.77" spread="6.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Role Physical (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="8.64"/>
                    <measurement group_id="O2" value="-0.43" spread="8.45"/>
                    <measurement group_id="O3" value="0.04" spread="6.81"/>
                    <measurement group_id="O4" value="-0.39" spread="7.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Role Physical (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="8.46"/>
                    <measurement group_id="O2" value="-0.76" spread="7.88"/>
                    <measurement group_id="O3" value="-0.87" spread="7.97"/>
                    <measurement group_id="O4" value="-0.93" spread="8.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Bodily Pain (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="9.75"/>
                    <measurement group_id="O2" value="1.47" spread="8.98"/>
                    <measurement group_id="O3" value="-0.18" spread="7.76"/>
                    <measurement group_id="O4" value="-0.72" spread="9.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Bodily Pain (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" spread="9.78"/>
                    <measurement group_id="O2" value="0.56" spread="9.70"/>
                    <measurement group_id="O3" value="-0.21" spread="8.22"/>
                    <measurement group_id="O4" value="-0.64" spread="11.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4) General Health (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43" spread="6.75"/>
                    <measurement group_id="O2" value="0.70" spread="7.23"/>
                    <measurement group_id="O3" value="1.26" spread="6.11"/>
                    <measurement group_id="O4" value="-0.36" spread="6.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4) General Health (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="6.27"/>
                    <measurement group_id="O2" value="0.75" spread="7.00"/>
                    <measurement group_id="O3" value="1.38" spread="6.04"/>
                    <measurement group_id="O4" value="-1.43" spread="6.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5) Vitality (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="7.73"/>
                    <measurement group_id="O2" value="-1.27" spread="6.70"/>
                    <measurement group_id="O3" value="0.14" spread="8.01"/>
                    <measurement group_id="O4" value="-1.69" spread="7.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5) Vitality (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="8.24"/>
                    <measurement group_id="O2" value="-1.43" spread="7.68"/>
                    <measurement group_id="O3" value="0.70" spread="8.40"/>
                    <measurement group_id="O4" value="-1.09" spread="7.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6) Social functioning (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.31" spread="8.86"/>
                    <measurement group_id="O2" value="0.34" spread="8.65"/>
                    <measurement group_id="O3" value="-0.51" spread="9.25"/>
                    <measurement group_id="O4" value="-1.10" spread="8.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6) Social functioning (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="9.73"/>
                    <measurement group_id="O2" value="-0.61" spread="10.09"/>
                    <measurement group_id="O3" value="0.03" spread="8.73"/>
                    <measurement group_id="O4" value="-1.74" spread="8.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7) Role emotional (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.94" spread="11.20"/>
                    <measurement group_id="O2" value="0.62" spread="9.94"/>
                    <measurement group_id="O3" value="0.24" spread="9.78"/>
                    <measurement group_id="O4" value="-1.50" spread="9.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7) Role emotional (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" spread="10.61"/>
                    <measurement group_id="O2" value="-0.34" spread="10.58"/>
                    <measurement group_id="O3" value="0.09" spread="9.91"/>
                    <measurement group_id="O4" value="-2.78" spread="10.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) Mental health (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.41" spread="9.29"/>
                    <measurement group_id="O2" value="-0.82" spread="7.58"/>
                    <measurement group_id="O3" value="0.99" spread="8.50"/>
                    <measurement group_id="O4" value="-2.32" spread="7.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8) Mental health (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="8.69"/>
                    <measurement group_id="O2" value="-0.74" spread="9.91"/>
                    <measurement group_id="O3" value="0.89" spread="8.39"/>
                    <measurement group_id="O4" value="-1.30" spread="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9) Physical component summary (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="6.20"/>
                    <measurement group_id="O2" value="0.75" spread="6.27"/>
                    <measurement group_id="O3" value="-0.02" spread="4.81"/>
                    <measurement group_id="O4" value="-0.05" spread="6.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9) Physical component summary (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="6.78"/>
                    <measurement group_id="O2" value="0.12" spread="6.24"/>
                    <measurement group_id="O3" value="-0.36" spread="6.09"/>
                    <measurement group_id="O4" value="-0.41" spread="6.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10) Mental component summary (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.41" spread="9.50"/>
                    <measurement group_id="O2" value="-0.55" spread="7.91"/>
                    <measurement group_id="O3" value="0.49" spread="8.72"/>
                    <measurement group_id="O4" value="-2.16" spread="7.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10) Mental component summary (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="8.45"/>
                    <measurement group_id="O2" value="-0.89" spread="9.66"/>
                    <measurement group_id="O3" value="0.82" spread="8.57"/>
                    <measurement group_id="O4" value="-2.19" spread="8.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains</title>
        <description>The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains</title>
          <description>The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1) Psychosocial (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.45" spread="13.89"/>
                    <measurement group_id="O2" value="-0.32" spread="13.58"/>
                    <measurement group_id="O3" value="4.10" spread="14.24"/>
                    <measurement group_id="O4" value="-0.49" spread="11.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1) Psychosocial (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.96" spread="14.89"/>
                    <measurement group_id="O2" value="-0.92" spread="13.20"/>
                    <measurement group_id="O3" value="5.35" spread="15.89"/>
                    <measurement group_id="O4" value="-0.46" spread="14.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Physical (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" spread="17.30"/>
                    <measurement group_id="O2" value="-0.66" spread="15.20"/>
                    <measurement group_id="O3" value="2.15" spread="14.66"/>
                    <measurement group_id="O4" value="-1.75" spread="13.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2) Physical (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.10" spread="18.81"/>
                    <measurement group_id="O2" value="-0.53" spread="15.30"/>
                    <measurement group_id="O3" value="2.50" spread="15.33"/>
                    <measurement group_id="O4" value="-1.24" spread="16.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Physical function(Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.88" spread="18.64"/>
                    <measurement group_id="O2" value="-0.35" spread="16.28"/>
                    <measurement group_id="O3" value="2.51" spread="15.94"/>
                    <measurement group_id="O4" value="-1.70" spread="15.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3) Physical function(Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.45" spread="19.79"/>
                    <measurement group_id="O2" value="-0.59" spread="15.85"/>
                    <measurement group_id="O3" value="2.59" spread="16.02"/>
                    <measurement group_id="O4" value="-0.98" spread="17.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4) Pain/discomfort (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.30" spread="22.52"/>
                    <measurement group_id="O2" value="-1.45" spread="21.22"/>
                    <measurement group_id="O3" value="1.23" spread="22.86"/>
                    <measurement group_id="O4" value="-1.85" spread="21.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4) Pain/discomfort (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="24.48"/>
                    <measurement group_id="O2" value="-0.37" spread="20.88"/>
                    <measurement group_id="O3" value="2.28" spread="22.12"/>
                    <measurement group_id="O4" value="-1.88" spread="22.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5) IWQOL-Lite-CT Total (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.74" spread="13.37"/>
                    <measurement group_id="O2" value="-0.45" spread="12.47"/>
                    <measurement group_id="O3" value="3.41" spread="12.19"/>
                    <measurement group_id="O4" value="-0.94" spread="10.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5) IWQOL-Lite-CT Total (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.35" spread="14.50"/>
                    <measurement group_id="O2" value="-0.79" spread="12.47"/>
                    <measurement group_id="O3" value="4.35" spread="13.82"/>
                    <measurement group_id="O4" value="-0.73" spread="13.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)</title>
        <description>Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being &quot;none of the time&quot; unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.</description>
        <time_frame>Week 0, week 26, week 52</time_frame>
        <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Semaglutide 3 mg</title>
            <description>Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Oral Semaglutide 7 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52.</description>
          </group>
          <group group_id="O3">
            <title>Oral Semaglutide 14 mg</title>
            <description>Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)</title>
          <description>Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being &quot;none of the time&quot; unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.</description>
          <population>Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.</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="184"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfaction with treatment: wk 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.47" spread="1.27"/>
                    <measurement group_id="O2" value="0.59" spread="1.49"/>
                    <measurement group_id="O3" value="0.63" spread="1.50"/>
                    <measurement group_id="O4" value="0.18" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction with treatment: wk 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="169"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="1.42"/>
                    <measurement group_id="O2" value="0.51" spread="1.45"/>
                    <measurement group_id="O3" value="0.78" spread="1.53"/>
                    <measurement group_id="O4" value="0.20" spread="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feeling of unacceptably high blood sugars: wk 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.62" spread="1.89"/>
                    <measurement group_id="O2" value="-1.23" spread="1.98"/>
                    <measurement group_id="O3" value="-1.29" spread="1.96"/>
                    <measurement group_id="O4" value="-0.28" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feeling of unacceptably high blood sugars: wk 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="2.02"/>
                    <measurement group_id="O2" value="-1.15" spread="1.95"/>
                    <measurement group_id="O3" value="-1.34" spread="2.13"/>
                    <measurement group_id="O4" value="-0.41" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feeling of unacceptably low blood sugars: wk 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="1.97"/>
                    <measurement group_id="O2" value="-0.06" spread="1.70"/>
                    <measurement group_id="O3" value="0.13" spread="2.08"/>
                    <measurement group_id="O4" value="-0.15" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feeling of unacceptably low blood sugars: wk 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="168"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="1.90"/>
                    <measurement group_id="O2" value="-0.10" spread="1.74"/>
                    <measurement group_id="O3" value="-0.06" spread="2.04"/>
                    <measurement group_id="O4" value="-0.02" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Convenience of treatment: wk 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51" spread="1.25"/>
                    <measurement group_id="O2" value="0.50" spread="1.68"/>
                    <measurement group_id="O3" value="0.50" spread="1.43"/>
                    <measurement group_id="O4" value="0.20" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Convenience of treatment: wk 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="169"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="1.50"/>
                    <measurement group_id="O2" value="0.52" spread="1.54"/>
                    <measurement group_id="O3" value="0.44" spread="1.70"/>
                    <measurement group_id="O4" value="0.19" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flexibility of treatment: wk 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="1.43"/>
                    <measurement group_id="O2" value="0.37" spread="1.66"/>
                    <measurement group_id="O3" value="0.40" spread="1.43"/>
                    <measurement group_id="O4" value="0.23" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flexibility of treatment: wk 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="169"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="1.60"/>
                    <measurement group_id="O2" value="0.42" spread="1.58"/>
                    <measurement group_id="O3" value="0.46" spread="1.53"/>
                    <measurement group_id="O4" value="0.23" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction with understading of diabetes: wk 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="1.31"/>
                    <measurement group_id="O2" value="0.31" spread="1.40"/>
                    <measurement group_id="O3" value="0.27" spread="1.22"/>
                    <measurement group_id="O4" value="0.04" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction with understading of diabetes: wk 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="1.40"/>
                    <measurement group_id="O2" value="0.35" spread="1.45"/>
                    <measurement group_id="O3" value="0.34" spread="1.28"/>
                    <measurement group_id="O4" value="0.03" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recommending treatment to others: wk 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="1.50"/>
                    <measurement group_id="O2" value="0.66" spread="1.79"/>
                    <measurement group_id="O3" value="0.53" spread="1.53"/>
                    <measurement group_id="O4" value="0.02" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recommending treatment to others: wk 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="170"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" spread="1.47"/>
                    <measurement group_id="O2" value="0.63" spread="1.55"/>
                    <measurement group_id="O3" value="0.65" spread="1.62"/>
                    <measurement group_id="O4" value="-0.01" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction to continue present treatment: wk 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="1.30"/>
                    <measurement group_id="O2" value="0.57" spread="1.65"/>
                    <measurement group_id="O3" value="0.58" spread="1.39"/>
                    <measurement group_id="O4" value="0.09" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction to continue present treatment: wk 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="169"/>
                    <count group_id="O4" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="1.27"/>
                    <measurement group_id="O2" value="0.56" spread="1.58"/>
                    <measurement group_id="O3" value="0.65" spread="1.52"/>
                    <measurement group_id="O4" value="0.03" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total treatment satisfaction: wk 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="173"/>
                    <count group_id="O4" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.12" spread="5.38"/>
                    <measurement group_id="O2" value="3.00" spread="7.36"/>
                    <measurement group_id="O3" value="2.90" spread="5.95"/>
                    <measurement group_id="O4" value="0.76" spread="5.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total treatmemt satisfaction: wk 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="169"/>
                    <count group_id="O4" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="6.02"/>
                    <measurement group_id="O2" value="2.99" spread="6.80"/>
                    <measurement group_id="O3" value="3.32" spread="6.78"/>
                    <measurement group_id="O4" value="0.67" spread="5.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.</time_frame>
      <desc>Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.</desc>
      <group_list>
        <group group_id="E1">
          <title>Oral Semaglutide 3 mg</title>
          <description>Subjects were to take oral semaglutide 3 mg tablets once daily from week 1 to 52.</description>
        </group>
        <group group_id="E2">
          <title>Oral Semaglutide 7 mg</title>
          <description>Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 52: 3 mg from week 1 to 4 and 7 mg from week 5 to 52.</description>
        </group>
        <group group_id="E3">
          <title>Oral Semaglutide 14 mg</title>
          <description>Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 52: 3 mg from week 1 to 4, 7 mg from week 5 to 8 and 14 mg from week 9 to 52.</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20</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="184"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="184"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="181"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="184"/>
              </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="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Normocytic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Silent myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Carbuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Postoperative thoracic procedure complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Spinal myelogram</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </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="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Vulval cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain stem infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic unconsciousness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Mononeuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>White matter lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression suicidal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </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="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Vaginal prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Hysterectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Spinal operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Thyroidectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20</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="77" subjects_at_risk="184"/>
                <counts group_id="E2" subjects_affected="86" subjects_at_risk="181"/>
                <counts group_id="E3" subjects_affected="100" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="73" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="184"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="181"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="181"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="184"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="181"/>
                <counts group_id="E3" events="13" subjects_affected="12" subjects_at_risk="181"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="19" subjects_affected="16" subjects_at_risk="184"/>
                <counts group_id="E2" events="26" subjects_affected="22" subjects_at_risk="181"/>
                <counts group_id="E3" events="40" subjects_affected="26" subjects_at_risk="181"/>
                <counts group_id="E4" events="15" subjects_affected="11" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="23" subjects_affected="21" subjects_at_risk="184"/>
                <counts group_id="E2" events="34" subjects_affected="30" subjects_at_risk="181"/>
                <counts group_id="E3" events="60" subjects_affected="41" subjects_at_risk="181"/>
                <counts group_id="E4" events="19" subjects_affected="13" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="184"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="181"/>
                <counts group_id="E3" events="28" subjects_affected="17" subjects_at_risk="181"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="42" subjects_affected="27" subjects_at_risk="184"/>
                <counts group_id="E2" events="32" subjects_affected="21" subjects_at_risk="181"/>
                <counts group_id="E3" events="29" subjects_affected="18" subjects_at_risk="181"/>
                <counts group_id="E4" events="35" subjects_affected="27" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="184"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="181"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="181"/>
                <counts group_id="E4" events="17" subjects_affected="13" subjects_at_risk="184"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="184"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="181"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="181"/>
                <counts group_id="E4" events="12" subjects_affected="7" subjects_at_risk="184"/>
              </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="8" subjects_affected="8" subjects_at_risk="184"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="181"/>
                <counts group_id="E3" events="24" subjects_affected="23" subjects_at_risk="181"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="184"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="184"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" events="12" subjects_affected="11" subjects_at_risk="184"/>
              </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>
    </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/NCT03021187
org study id: NN9924-4280
secondary id: 2016-000988-16
secondary id: U1111-1180-3637
secondary id: JapicCTI-173508
nct id: NCT03021187
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This trial is conducted globally. The aim of the trial is to investigate the efficacy and
      safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated
      with insulin. All subjects should continue their pre-trial insulin therapy (basal,
      basal-bolus or premixed regimen including combinations of soluble insulins) throughout the
      trial. Subjects treated with metformin in addition to insulin treatment must continue their
      metformin treatment throughout the entire trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in HbA1c (Week 26)
time frame: Week 0, week 26
description: Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any.
measure: Change in Body Weight (Week 26)
time frame: Week 0, week 26
description: Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in HbA1c (Week 52)
time frame: Week 0, week 52
description: Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in Body Weight (kg) (Week 52)
time frame: Week 0, week 52
description: Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in Fasting Plasma Glucose (FPG)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in SMPG Mean Postprandial Increment Over All Meals
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in Body Weight (Percentage)
time frame: Week 0, week 26, week 52
description: Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in Body Mass Index
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in Waist Circumference
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in Total Cholesterol - Ratio to Baseline
time frame: Week 0, week 26, week 52
description: Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in LDL Cholesterol - Ratio to Baseline
time frame: Week 0, week 26, week 52
description: Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in HDL Cholesterol - Ratio to Baseline
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in Triglycerides - Ratio to Baseline
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in Total Daily Insulin Dose
time frame: Week 0, week 26, week 52
description: Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)
time frame: Week 26, week 52
description: Number of particpants achieving HbA1c < 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no)
time frame: Week 26, week 52
description: Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Participants Who Achieve Body Weight Loss ≥5% (Yes/no)
time frame: Week 26, week 52
description: Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Participants Who Achieve Body Weight Loss ≥10% (Yes/no)
time frame: Week 26, week 52
description: Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any.
measure: Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
time frame: Week 26, week 52
description: Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
time frame: Week 26, week 52
description: Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Time to Additional Anti-diabetic Medication
time frame: Weeks 0-52
description: Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Time to Rescue Medication
time frame: Weeks 0-52
description: Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
measure: Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product
time frame: Weeks 0-57
description: Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
time frame: Weeks 0-57
description: Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
measure: Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
time frame: Weeks 0-57
description: Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
measure: Change in Amylase - Ratio to Baseline
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Change in Lipase - Ratio to Baseline
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication
measure: Change in Pulse Rate
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Change in SBP and DBP
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Change in ECG Evaluation
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Change in Physical Examination
time frame: Week -2, week 52
description: Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.
measure: Change in Eye Examination Category
time frame: Week -2, week 52
description: Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
measure: Semaglutide Plasma Concentrations for Population PK Analyses
time frame: Weeks 0-52
description: This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
measure: Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)
time frame: Week 0, week 26, week 52
description: SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.
measure: Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains
time frame: Week 0, week 26, week 52
description: The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
measure: Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)
time frame: Week 0, week 26, week 52
description: Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.
arm group label: Semaglutide 3 mg
arm group type: Experimental
arm group label: Semaglutide 3 mg + 7 mg
arm group type: Experimental
arm group label: Semaglutide 3 mg + 7 mg + 14 mg
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: semaglutide
description: Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
arm group label: Semaglutide 3 mg
intervention type: Drug
intervention name: semaglutide
description: Oral semaglutide (3 mg followed by 7 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
arm group label: Semaglutide 3 mg + 7 mg
intervention type: Drug
intervention name: semaglutide
description: Oral semaglutide (3 mg followed by 7 mg and finally 14 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
arm group label: Semaglutide 3 mg + 7 mg + 14 mg
intervention type: Drug
intervention name: placebo
description: Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Canada
country: France
country: Greece
country: India
country: Japan
country: Mexico
country: Poland
country: Puerto Rico
country: Russian Federation
country: United States
citation: Zinman B, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, Tarp-Johansen MJ, Araki E; PIONEER 8 Investigators. Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Diabetes Care. 2019 Dec;42(12):2262-2271. doi: 10.2337/dc19-0898. Epub 2019 Sep 17.
PMID: 31530667
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
provided document: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 