<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04507204</url>
  </required_header>
  <id_info>
    <org_study_id>ADA4003</org_study_id>
    <nct_id>NCT04507204</nct_id>
  </id_info>
  <brief_title>Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)</brief_title>
  <acronym>RE-DAX</acronym>
  <official_title>Real-world Evidence of Duration of Adhansia XR for Treatment of ADHD (RE-DAX): An Open-label Pragmatic Study to Assess the Real-world Effectiveness of Adhansia XR in Treatment of Adult and Adolescent Patients With ADHD in the United States</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue Pharma LP</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Purdue Pharma LP</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>
      The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at&#xD;
      month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with&#xD;
      the active comparator group (Concerta) over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase IV study is a prospective, open-label, randomized, pragmatic study to investigate&#xD;
      the treatment effectiveness of Adhansia XR at Month-2 after initiation, and the effectiveness&#xD;
      of Adhansia XR overall and when compared with the active comparator group (OROS MPH or&#xD;
      Concerta) over time. Additional outcome assessments for both treatment arms include&#xD;
      Health-Related Quality of Life (HRQoL) during the 6-month follow-up period. The burden of&#xD;
      illness (BOI) will be investigated by collecting additional measures such as healthcare&#xD;
      resource utilization (HCRU), broader treatment patterns, and comorbidities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    (due to administrative reasons not related to efficacy or safety.)&#xD;
  </why_stopped>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 22, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR</measure>
    <time_frame>Baseline to Month-2</time_frame>
    <description>The ADHD-RS-5 assesses the frequency and severity of each of the 18 ADHD symptoms among adults based on DSM-5 criteria. Each of the 18 DSM-5 symptoms are rated on a 4 point scale from 0 (never or rarely) to 3 (very often), yielding a total score of 0 to 54. A higher score corresponds to worse ADHD severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority</measure>
    <time_frame>Month-2</time_frame>
    <description>TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Clinical Global Impression-Severity (CGI-S)</measure>
    <time_frame>Baseline, Month-2, Month-4, and Month-6</time_frame>
    <description>The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Clinical Global Impression-Improvement (CGI-I)</measure>
    <time_frame>Month-2, Month-4, and Month-6</time_frame>
    <description>The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Treatment Satisfaction</measure>
    <time_frame>Month-1, Month-2, and Month-6</time_frame>
    <description>The Treatment Satisfaction Questionnaire for Medications (TSQM) measures a patient's level of satisfaction or dissatisfaction with the study medication. It assesses perceptions of effectiveness, side effects and convenience of the medication and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100.&#xD;
A lower score indicates a lower satisfaction with treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Resource Utilization (HCRU)</measure>
    <time_frame>Baseline (past 6 months) Months -2, -4, and -6</time_frame>
    <description>A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult ADHD Quality of Life Scale - Revised (AAQoL-R)</measure>
    <time_frame>Baseline, Months -1, -2, -3, -4, -5 and -6</time_frame>
    <description>Used to assess health-related quality of life for adult patients. The AAQoL yields a total score based on 29 items. The raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Productivity and Activity Impairment (WPAI) Questionnaire</measure>
    <time_frame>Baseline, Months -2, -3, -4, -5, and -6</time_frame>
    <description>The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains [absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Baseline and Months -2, -4, and -6</time_frame>
    <description>The PSQI is an instrument used to measure the quality and patterns of sleep; It differentiates &quot;poor&quot; from &quot;good&quot; sleep. It is filled out by the caregiver or the patient and the global sum score ranges from 0 to 21, with higher scores indicating worse sleep quality.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">267</enrollment>
  <condition>Attention-Deficit/Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>Adhansia XR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adhansia XR capsules taken orally once daily with or without food.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Concerta</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adhansia XR</intervention_name>
    <description>Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)</description>
    <arm_group_label>Adhansia XR</arm_group_label>
    <other_name>Methylphenidate hydrochloride (HCl) extended release</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Concerta</intervention_name>
    <description>An osmotic-controlled oral release delivery system (OROS) of methylphenidate HCl (MPH) extended-release tablets taken once daily (18 mg, 27 mg, 36 mg, and 54 mg)</description>
    <arm_group_label>Concerta</arm_group_label>
    <other_name>Methylphenidate hydrochloride (HCl)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a physician-confirmed diagnosis of ADHD per Diagnostic and Statistical&#xD;
             Manual of Mental Disorders (DSM-5) criteria and the health care practitioner (HCP) has&#xD;
             made the decision to prescribe an extended-release methylphenidate (ER MPH) product to&#xD;
             the patient for potential improvement of symptoms throughout and later in the day,&#xD;
             independent of this study.&#xD;
&#xD;
          -  Patient must be 12 years of age or older.&#xD;
&#xD;
          -  Patient must be eligible to receive Adhansia XR or osmotic- release oral delivery&#xD;
             system methylphenidate ([OROS MPH] or Concerta) according to the US product labels; a&#xD;
             patient must be eligible and willing to receive either drug, as randomization will&#xD;
             assign them to a specific treatment group. Patient may be treatment-experienced or&#xD;
             naïve to pharmacological therapy for ADHD, so long as all inclusion and no exclusion&#xD;
             criteria are met.&#xD;
&#xD;
          -  Patient must be willing to take only the assigned study medication per HCP&#xD;
             instructions based on FDA label guidance for treatment of their ADHD for the first 2&#xD;
             months of the study (i.e. full titration period). Patients should not be on any other&#xD;
             medication, or starting any new non-medication treatment, proven to have effect on&#xD;
             ADHD in the first two months of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent participation in an investigational study in which patient assessment&#xD;
             and/or treatment may be dictated by a protocol.&#xD;
&#xD;
          -  Patients with a true allergy to methylphenidate (MPH), amphetamine (AMP), or&#xD;
             sympathomimetic amines, history of serious adverse reactions to MPH or AMP or be known&#xD;
             to be non-responsive to MPH or AMP treatment.&#xD;
&#xD;
          -  Patient is currently stable on their ADHD treatment regimen.&#xD;
&#xD;
          -  Female patients of child bearing potential who are pregnant, planning on becoming&#xD;
             pregnant or breastfeeding.&#xD;
&#xD;
          -  Patient with any known conditions that are contraindicated for either Adhansia XR or&#xD;
             OROS MPH (or Concerta) use, as documented in the US Full Prescribing Information,&#xD;
             including patients with any known serious structural cardiac abnormalities,&#xD;
             cardiomyopathy, serious heart arrhythmias, or coronary artery disease.&#xD;
&#xD;
          -  Patients with a known sensitivity to the food dye tartrazine (Federal Food, Drug, and&#xD;
             Cosmetic Yellow No. 5).&#xD;
&#xD;
          -  Suicidal Ideation&#xD;
&#xD;
               -  The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered at&#xD;
                  screening and at Month-2, Month-4, and Month-6, but also depends on the judgment&#xD;
                  of the HCP.&#xD;
&#xD;
          -  Inability or unwillingness of the patient (or parent/guardian if patient is a minor)&#xD;
             to complete the study-required electronic questionnaires and provide required&#xD;
             information through electronic means.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Harmonex, Inc.</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Research LLC</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CT Clinical Research</name>
      <address>
        <city>Cromwell</city>
        <state>Connecticut</state>
        <zip>06416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulfcoast Clinical Research Center</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reliable Clinical Research, LLC</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Research. Inc.</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellness Research Center Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Medical Group Pediatrics at Orange City</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>32763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Epilepsy &amp; Neurology Specialists</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Integrative Research Center of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revive Research Institute</name>
      <address>
        <city>Elgin</city>
        <state>Illinois</state>
        <zip>60123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMR-Baber Research Inc.</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BTC of New Bedford, LLC</name>
      <address>
        <city>New Bedford</city>
        <state>Massachusetts</state>
        <zip>02740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurobehavioral Medicine Group</name>
      <address>
        <city>Bloomfield Hills</city>
        <state>Michigan</state>
        <zip>48302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Center for Behavioral Medicine</name>
      <address>
        <city>Rochester Hills</city>
        <state>Michigan</state>
        <zip>48307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatric Care and Research Center</name>
      <address>
        <city>O'Fallon</city>
        <state>Missouri</state>
        <zip>63368</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Charles Psychiatric Associates - Midwest Research Group</name>
      <address>
        <city>Saint Charles</city>
        <state>Missouri</state>
        <zip>63304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Southern Nevada, LLC</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Emotional Fitness</name>
      <address>
        <city>Cherry Hill</city>
        <state>New Jersey</state>
        <zip>08002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioscience Research, LLC</name>
      <address>
        <city>Mount Kisco</city>
        <state>New York</state>
        <zip>10549</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richmond Behavioral Associates</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Ohio Behavioral Health</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SFM Clinical Trials</name>
      <address>
        <city>Scotland</city>
        <state>Pennsylvania</state>
        <zip>17254</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainbow Research</name>
      <address>
        <city>Barnwell</city>
        <state>South Carolina</state>
        <zip>29812</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Dallas, LP</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>InSite Clinical Research, LLC</name>
      <address>
        <city>DeSoto</city>
        <state>Texas</state>
        <zip>75115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Red Oak Psychiatry Associates, PA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Road Runner Research, Ltd.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Psychiatry of the Woodlands</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dixie Pediatrics</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Partners, LLC</name>
      <address>
        <city>Petersburg</city>
        <state>Virginia</state>
        <zip>23805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastside Therapeutic Resource Inc dba Core Clinical Research</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Health System - Rockwood Clinic</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <results_first_submitted>January 30, 2023</results_first_submitted>
  <results_first_submitted_qc>July 7, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2023</results_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>Methylphenidate</keyword>
  <keyword>Adhansia XR</keyword>
  <keyword>MPH</keyword>
  <keyword>OROS</keyword>
  <keyword>Phase IV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylphenidate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT04507204/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First patient first visit was 30-Jul-2020; primary completion date was 22-Dec-2021 (i.e., the adult portion was completed). This study was statistically powered to conduct a separate analysis for adult and adolescent patients. However, enrollment of adolescents was unexpectedly slow as a result of the Coronavirus Disease 2019 (COVID-19) pandemic and a business decision was made on 31-Jan-2022 to discontinue enrollment of adolescents, thus terminating this branch of the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Adhansia XR</title>
          <description>Methylphenidate extended-release capsules taken once daily.</description>
        </group>
        <group group_id="P2">
          <title>Concerta</title>
          <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="133"/>
                <participants group_id="P2" count="134"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <participants group_id="P2" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor Compliance with Protocol</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other (e.g., PI judgment, moved out of state. etc.)</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of Patient Consent</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Adhansia XR</title>
          <description>Methylphenidate extended-release capsules taken once daily.</description>
        </group>
        <group group_id="B2">
          <title>Concerta</title>
          <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="133"/>
            <count group_id="B2" value="134"/>
            <count group_id="B3" value="267"/>
          </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="36.9" spread="11.7"/>
                    <measurement group_id="B2" value="38.6" spread="12.5"/>
                    <measurement group_id="B3" value="37.7" spread="12.1"/>
                  </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="71"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR</title>
        <description>The ADHD-RS-5 assesses the frequency and severity of each of the 18 ADHD symptoms among adults based on DSM-5 criteria. Each of the 18 DSM-5 symptoms are rated on a 4 point scale from 0 (never or rarely) to 3 (very often), yielding a total score of 0 to 54. A higher score corresponds to worse ADHD severity.</description>
        <time_frame>Baseline to Month-2</time_frame>
        <population>Full Analysis Set (FAS) Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Adhansia XR</title>
            <description>Methylphenidate extended-release capsules taken once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR</title>
          <description>The ADHD-RS-5 assesses the frequency and severity of each of the 18 ADHD symptoms among adults based on DSM-5 criteria. Each of the 18 DSM-5 symptoms are rated on a 4 point scale from 0 (never or rarely) to 3 (very often), yielding a total score of 0 to 54. A higher score corresponds to worse ADHD severity.</description>
          <population>Full Analysis Set (FAS) Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</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="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Score at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6" spread="8.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score at Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.7" spread="9.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority</title>
        <description>TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity.</description>
        <time_frame>Month-2</time_frame>
        <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Adhansia XR</title>
            <description>Methylphenidate extended-release capsules taken once daily.</description>
          </group>
          <group group_id="O2">
            <title>Concerta</title>
            <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority</title>
          <description>TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity.</description>
          <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" spread="0.93"/>
                    <measurement group_id="O2" value="22.1" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Clinical Global Impression-Severity (CGI-S)</title>
        <description>The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.</description>
        <time_frame>Baseline, Month-2, Month-4, and Month-6</time_frame>
        <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Adhansia XR</title>
            <description>Methylphenidate extended-release capsules taken once daily.</description>
          </group>
          <group group_id="O2">
            <title>Concerta</title>
            <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Clinical Global Impression-Severity (CGI-S)</title>
          <description>The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.</description>
          <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="0.08"/>
                    <measurement group_id="O2" value="4.6" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="0.09"/>
                    <measurement group_id="O2" value="3.2" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="0.09"/>
                    <measurement group_id="O2" value="3.0" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="0.09"/>
                    <measurement group_id="O2" value="3.1" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Clinical Global Impression-Improvement (CGI-I)</title>
        <description>The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity.</description>
        <time_frame>Month-2, Month-4, and Month-6</time_frame>
        <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Adhansia XR</title>
            <description>Methylphenidate extended-release capsules taken once daily.</description>
          </group>
          <group group_id="O2">
            <title>Concerta</title>
            <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Clinical Global Impression-Improvement (CGI-I)</title>
          <description>The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity.</description>
          <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="0.10"/>
                    <measurement group_id="O2" value="2.3" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.09"/>
                    <measurement group_id="O2" value="2.2" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.11"/>
                    <measurement group_id="O2" value="2.3" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Treatment Satisfaction</title>
        <description>The Treatment Satisfaction Questionnaire for Medications (TSQM) measures a patient's level of satisfaction or dissatisfaction with the study medication. It assesses perceptions of effectiveness, side effects and convenience of the medication and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100.&#xD;
A lower score indicates a lower satisfaction with treatment.</description>
        <time_frame>Month-1, Month-2, and Month-6</time_frame>
        <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Adhansia XR</title>
            <description>Methylphenidate extended-release capsules taken once daily.</description>
          </group>
          <group group_id="O2">
            <title>Concerta</title>
            <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Treatment Satisfaction</title>
          <description>The Treatment Satisfaction Questionnaire for Medications (TSQM) measures a patient's level of satisfaction or dissatisfaction with the study medication. It assesses perceptions of effectiveness, side effects and convenience of the medication and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100.&#xD;
A lower score indicates a lower satisfaction with treatment.</description>
          <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Global Satisfaction at Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8" spread="1.60"/>
                    <measurement group_id="O2" value="84.3" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Satisfaction at Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.2" spread="1.83"/>
                    <measurement group_id="O2" value="82.8" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Satisfaction at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2" spread="1.98"/>
                    <measurement group_id="O2" value="84.3" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Effectiveness at Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3" spread="1.91"/>
                    <measurement group_id="O2" value="52.4" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Effectiveness at Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.1" spread="1.94"/>
                    <measurement group_id="O2" value="58.8" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Effectiveness at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.9" spread="2.69"/>
                    <measurement group_id="O2" value="61.9" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Side Effects at Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0" spread="2.93"/>
                    <measurement group_id="O2" value="69.6" spread="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Side Effects at Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.0" spread="3.26"/>
                    <measurement group_id="O2" value="67.6" spread="3.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Side Effects at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.7" spread="3.48"/>
                    <measurement group_id="O2" value="74.1" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Convenience at Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.9" spread="1.81"/>
                    <measurement group_id="O2" value="59.2" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Convenience at Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.0" spread="1.90"/>
                    <measurement group_id="O2" value="58.7" spread="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Convenience at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.7" spread="2.10"/>
                    <measurement group_id="O2" value="57.0" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Resource Utilization (HCRU)</title>
        <description>A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups.</description>
        <time_frame>Baseline (past 6 months) Months -2, -4, and -6</time_frame>
        <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Adhansia XR</title>
            <description>Methylphenidate extended-release capsules taken once daily.</description>
          </group>
          <group group_id="O2">
            <title>Concerta</title>
            <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Resource Utilization (HCRU)</title>
          <description>A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups.</description>
          <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
          <units>Visits or Inpatient Admissions</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (past 6 months) Overall Total Visits or Inpatient Admissions</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="0.314"/>
                    <measurement group_id="O2" value="2.93" spread="0.314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2 - Overall Total Visits or Inpatient Admissions</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.26" spread="0.542"/>
                    <measurement group_id="O2" value="2.43" spread="0.481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 - Overall Total Visits or Inpatient Admissions</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.67" spread="0.474"/>
                    <measurement group_id="O2" value="1.73" spread="0.504"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 - Overall Total Visits or Inpatient Admissions</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" spread="0.515"/>
                    <measurement group_id="O2" value="1.85" spread="0.480"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adult ADHD Quality of Life Scale - Revised (AAQoL-R)</title>
        <description>Used to assess health-related quality of life for adult patients. The AAQoL yields a total score based on 29 items. The raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life.</description>
        <time_frame>Baseline, Months -1, -2, -3, -4, -5 and -6</time_frame>
        <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Adhansia XR</title>
            <description>Methylphenidate extended-release capsules taken once daily.</description>
          </group>
          <group group_id="O2">
            <title>Concerta</title>
            <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
          </group>
        </group_list>
        <measure>
          <title>Adult ADHD Quality of Life Scale - Revised (AAQoL-R)</title>
          <description>Used to assess health-related quality of life for adult patients. The AAQoL yields a total score based on 29 items. The raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life.</description>
          <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Score at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.1" spread="1.19"/>
                    <measurement group_id="O2" value="41.1" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score at Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5" spread="1.24"/>
                    <measurement group_id="O2" value="55.0" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score at Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.0" spread="1.31"/>
                    <measurement group_id="O2" value="59.1" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score at Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.4" spread="1.38"/>
                    <measurement group_id="O2" value="60.9" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score at Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.7" spread="1.43"/>
                    <measurement group_id="O2" value="61.8" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score at Month 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.3" spread="1.44"/>
                    <measurement group_id="O2" value="60.2" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.4" spread="1.52"/>
                    <measurement group_id="O2" value="63.6" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Productivity and Activity Impairment (WPAI) Questionnaire</title>
        <description>The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains [absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.</description>
        <time_frame>Baseline, Months -2, -3, -4, -5, and -6</time_frame>
        <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Adhansia XR</title>
            <description>Methylphenidate extended-release capsules taken once daily.</description>
          </group>
          <group group_id="O2">
            <title>Concerta</title>
            <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
          </group>
        </group_list>
        <measure>
          <title>Work Productivity and Activity Impairment (WPAI) Questionnaire</title>
          <description>The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains [absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.</description>
          <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
          <units>percentage of impairment</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent work time missed due to health (Absenteeism) - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="1.26"/>
                    <measurement group_id="O2" value="5.6" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent work time missed due to health (Absenteeism) - Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="1.48"/>
                    <measurement group_id="O2" value="3.7" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent work time missed due to health (Absenteeism) - Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="1.57"/>
                    <measurement group_id="O2" value="3.2" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent work time missed due to health (Absenteeism) - Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.61"/>
                    <measurement group_id="O2" value="4.7" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent work time missed due to health (Absenteeism) - Month 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="1.62"/>
                    <measurement group_id="O2" value="4.9" spread="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent work time missed due to health (Absenteeism) - Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.72"/>
                    <measurement group_id="O2" value="4.1" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent impairment while working due to health (Presenteeism) - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0" spread="2.16"/>
                    <measurement group_id="O2" value="33.3" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent impairment while working due to health (Presenteeism) - Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" spread="2.52"/>
                    <measurement group_id="O2" value="24.2" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent impairment while working due to health (Presenteeism) - Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1" spread="2.73"/>
                    <measurement group_id="O2" value="25.0" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent impairment while working due to health (Presenteeism) - Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" spread="2.75"/>
                    <measurement group_id="O2" value="24.6" spread="2.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent impairment while working due to health (Presenteeism) - Month 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8" spread="2.76"/>
                    <measurement group_id="O2" value="18.3" spread="2.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent impairment while working due to health (Presenteeism) - Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="2.91"/>
                    <measurement group_id="O2" value="17.6" spread="3.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent overall work impairment due to health - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.1" spread="2.31"/>
                    <measurement group_id="O2" value="35.5" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent overall work impairment due to health - Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.4" spread="2.71"/>
                    <measurement group_id="O2" value="27.2" spread="2.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent overall work impairment due to health - Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" spread="2.94"/>
                    <measurement group_id="O2" value="26.4" spread="2.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent overall work impairment due to health - Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" spread="2.94"/>
                    <measurement group_id="O2" value="25.3" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent overall work impairment due to health - Month 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" spread="2.98"/>
                    <measurement group_id="O2" value="19.5" spread="3.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent overall work impairment due to health - Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" spread="3.15"/>
                    <measurement group_id="O2" value="18.9" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent activity impairment due to health - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.7" spread="2.05"/>
                    <measurement group_id="O2" value="40.9" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent activity impairment due to health - Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1" spread="2.33"/>
                    <measurement group_id="O2" value="30.1" spread="2.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent activity impairment due to health - Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1" spread="2.44"/>
                    <measurement group_id="O2" value="27.1" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent activity impairment due to health - Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5" spread="2.52"/>
                    <measurement group_id="O2" value="28.6" spread="2.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent activity impairment due to health - Month 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6" spread="2.54"/>
                    <measurement group_id="O2" value="26.3" spread="2.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent activity impairment due to health - Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9" spread="2.72"/>
                    <measurement group_id="O2" value="23.5" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)</title>
        <description>The PSQI is an instrument used to measure the quality and patterns of sleep; It differentiates &quot;poor&quot; from &quot;good&quot; sleep. It is filled out by the caregiver or the patient and the global sum score ranges from 0 to 21, with higher scores indicating worse sleep quality.</description>
        <time_frame>Baseline and Months -2, -4, and -6</time_frame>
        <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Adhansia XR</title>
            <description>Methylphenidate extended-release capsules taken once daily.</description>
          </group>
          <group group_id="O2">
            <title>Concerta</title>
            <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)</title>
          <description>The PSQI is an instrument used to measure the quality and patterns of sleep; It differentiates &quot;poor&quot; from &quot;good&quot; sleep. It is filled out by the caregiver or the patient and the global sum score ranges from 0 to 21, with higher scores indicating worse sleep quality.</description>
          <population>FAS Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Global PSQI - Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.68" spread="0.219"/>
                    <measurement group_id="O2" value="9.59" spread="0.209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global PSQI - Month 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.92" spread="0.251"/>
                    <measurement group_id="O2" value="9.59" spread="0.209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global PSQI - Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.11" spread="0.268"/>
                    <measurement group_id="O2" value="7.76" spread="0.252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global PSQI - Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.92" spread="0.284"/>
                    <measurement group_id="O2" value="7.80" spread="0.273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events were reported starting from the time informed consent for study participation up to 6 months.</time_frame>
      <desc>Since participants may have received multiple dose levels during the study and a participant may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.</desc>
      <group_list>
        <group group_id="E1">
          <title>Adhansia XR</title>
          <description>Methylphenidate extended-release capsules taken once daily.</description>
        </group>
        <group group_id="E2">
          <title>Concerta</title>
          <description>Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Non-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="133"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Hallucination, auditory</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Non-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="28" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jaromir Mikl, PhD MSPH</name_or_title>
      <organization>Purdue Pharma L.P.</organization>
      <phone>800-745-7445 ext 7277</phone>
      <email>jaromir.mikl@pharma.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/NCT04507204
org study id: ADA4003
nct id: NCT04507204
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at
      month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with
      the active comparator group (Concerta) over time.
This phase IV study is a prospective, open-label, randomized, pragmatic study to investigate
      the treatment effectiveness of Adhansia XR at Month-2 after initiation, and the effectiveness
      of Adhansia XR overall and when compared with the active comparator group (OROS MPH or
      Concerta) over time. Additional outcome assessments for both treatment arms include
      Health-Related Quality of Life (HRQoL) during the 6-month follow-up period. The burden of
      illness (BOI) will be investigated by collecting additional measures such as healthcare
      resource utilization (HCRU), broader treatment patterns, and comorbidities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR
time frame: Baseline to Month-2
description: The ADHD-RS-5 assesses the frequency and severity of each of the 18 ADHD symptoms among adults based on DSM-5 criteria. Each of the 18 DSM-5 symptoms are rated on a 4 point scale from 0 (never or rarely) to 3 (very often), yielding a total score of 0 to 54. A higher score corresponds to worse ADHD severity.
measure: Difference in Time Sensitive ADHD Symptom Scale (TASS) Between Treatment Groups to Establish Non-inferiority
time frame: Month-2
description: TASS was completed at the end of waking hours (14 - 16 hours post-dosing) at Month-2 after baseline visit. TASS was developed to capture the change in ADHD symptoms over the course of a day and consists of 18 items that directly correspond to the 18 ADHD symptom domains listed in the DSM-5. Each item is scored on a 4-point scale as follows: 0 (none), 1 (mild), 2 (moderate), and 3 (severe); the maximum total score is 54. A higher total score corresponds to worse ADHD severity.
measure: Assessment of Clinical Global Impression-Severity (CGI-S)
time frame: Baseline, Month-2, Month-4, and Month-6
description: The CGI-S rates symptoms from 1 (not ill) to 7 (extremely ill). A higher score corresponds to higher ADHD severity.
measure: Assessment of Clinical Global Impression-Improvement (CGI-I)
time frame: Month-2, Month-4, and Month-6
description: The CGI-I measures global improvement prior to and after initiating the study medication. The CGI-I scale is 1 question, and rates improvement compared with the baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A higher score corresponds to higher ADHD severity.
measure: Assessment of Treatment Satisfaction
time frame: Month-1, Month-2, and Month-6
description: The Treatment Satisfaction Questionnaire for Medications (TSQM) measures a patient's level of satisfaction or dissatisfaction with the study medication. It assesses perceptions of effectiveness, side effects and convenience of the medication and consists of 14 items that evaluate these three domains and one global scale item (ie, global satisfaction). Scores for each domain are computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100.
A lower score indicates a lower satisfaction with treatment.
measure: Healthcare Resource Utilization (HCRU)
time frame: Baseline (past 6 months) Months -2, -4, and -6
description: A comparison of the frequency of health care encounters between the 2 treatment groups. Healthcare resource utilization were evaluated monthly by comparing the frequency of clinic visits (outpatient), inpatient/hospitalizations (and length of stay), and emergency department visits between the 2 treatment groups.
measure: Adult ADHD Quality of Life Scale - Revised (AAQoL-R)
time frame: Baseline, Months -1, -2, -3, -4, -5 and -6
description: Used to assess health-related quality of life for adult patients. The AAQoL yields a total score based on 29 items. The raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life.
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire
time frame: Baseline, Months -2, -3, -4, -5, and -6
description: The WPAI questionnaire is designed to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It consists of 4 domains [absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment)]. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
measure: Patient Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
time frame: Baseline and Months -2, -4, and -6
description: The PSQI is an instrument used to measure the quality and patterns of sleep; It differentiates "poor" from "good" sleep. It is filled out by the caregiver or the patient and the global sum score ranges from 0 to 21, with higher scores indicating worse sleep quality.
arm group label: Adhansia XR
arm group type: Experimental
description: Adhansia XR capsules taken orally once daily with or without food.
arm group label: Concerta
arm group type: Active Comparator
description: Concerta tablets taken orally once daily in the morning and swallowed whole with the aid of liquids, with or without food.
intervention type: Drug
intervention name: Adhansia XR
description: Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)
arm group label: Adhansia XR
other name: Methylphenidate hydrochloride (HCl) extended release
intervention type: Drug
intervention name: Concerta
description: An osmotic-controlled oral release delivery system (OROS) of methylphenidate HCl (MPH) extended-release tablets taken once daily (18 mg, 27 mg, 36 mg, and 54 mg)
arm group label: Concerta
other name: Methylphenidate hydrochloride (HCl)
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Methylphenidate
sharing ipd: No
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