<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/NCT03260205</url>
  </required_header>
  <id_info>
    <org_study_id>SPD489-347</org_study_id>
    <nct_id>NCT03260205</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)</brief_title>
  <official_title>A Phase 3, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-Dose Safety and Efficacy Study of SPD489 Compared With Placebo in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>Yes</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 determine if an investigational treatment is effective in&#xD;
      improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old&#xD;
      diagnosed with ADHD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">October 23, 2018</completion_date>
  <primary_completion_date type="Actual">October 23, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions Global Improvement (CGI-I) at Week 6</measure>
    <time_frame>Week 6</time_frame>
    <description>CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From start of study drug administration up to follow-up (Week 7)</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Potentially Clinically Significant Changes in Vital Signs</measure>
    <time_frame>Week 6</time_frame>
    <description>Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Height at Week 6</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at Week 6</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (&lt;) 5th, 5th to &lt; 95th, and greater than or equal to (&gt;=) 95th percentiles. Change from baseline in body weight at Week 6 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Mass Index (BMI) at Week 6</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>BMI was derived from height and weight. BMI percentile was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI &lt; 5th percentile); Healthy weight (BMI 5th percentile up to &lt; 85th percentile); Overweight (BMI 85th percentile &lt; 95th percentile); Obese (BMI &gt;= 95th percentile). Change from baseline in body mass index at Week 6 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values</measure>
    <time_frame>Week 6</time_frame>
    <description>Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, &gt; = represents greater than or equal to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters</measure>
    <time_frame>Week 6</time_frame>
    <description>Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Sleep Habits Questionnaire (CSHQ) at Week 6</measure>
    <time_frame>Week 6</time_frame>
    <description>Children's Sleep Habits Questionnaire was a tool designed to screen the most common sleep problems in children, and consisted of 33 items for scoring. The instrument evaluated the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Up to Week 6</time_frame>
    <description>C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">199</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder (ADHD)</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participant will receive placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPD489 (Lisdexamfetamine dimesylate)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized to receive SPD489 capsule in a 5:5:5:5:6 ratio to SPD489 5, 10, 20, 30 milligram (mg) orally once daily for 6 weeks. Dosing will begin with the lowest strength of SPD489 (5 mg), and will be titrated until the randomly assigned fixed-dose is reached.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPD489 (Lisdexamfetamine dimesylate)</intervention_name>
    <description>SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.</description>
    <arm_group_label>SPD489 (Lisdexamfetamine dimesylate)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPD489</intervention_name>
    <description>SPD489</description>
    <arm_group_label>SPD489 (Lisdexamfetamine dimesylate)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is a male or female aged 4-5 years inclusive at the time of consent&#xD;
&#xD;
          -  Participant's parent(s) or legally authorized representative (LAR) must provide&#xD;
             signature of informed consent, and there must be documentation of assent (if&#xD;
             applicable) by the participant before completing any study related procedures.&#xD;
&#xD;
          -  Participant and parent(s)/LAR are willing and able to comply with all of the testing&#xD;
             and requirements defined in the protocol, including oversight of morning dosing.&#xD;
&#xD;
          -  Participant must meet DSM-IV-TR criteria for a primary diagnosis of ADHD (any&#xD;
             sub-type).&#xD;
&#xD;
          -  Participant has an ADHD-RS-IV Preschool Version Total Score at the baseline visit&#xD;
             (Visit 0) greater than or equal to 28 for boys, and greater than or equal to 24 for&#xD;
             girls.&#xD;
&#xD;
          -  Participant has a Clinical Global Impressions - Severity of Illness (CGI-S) score&#xD;
             greater than or equal to 4 at the baseline visit (Visit 0).&#xD;
&#xD;
          -  Participant has a Peabody Picture Vocabulary Test standard score of greater than or&#xD;
             equal to 70 at the screening visit (Visit -1).&#xD;
&#xD;
          -  Participant has undergone an adequate course of non-pharmacological treatment or has a&#xD;
             severe enough condition to consider enrollment without undergoing prior&#xD;
             non-pharmacological treatment.&#xD;
&#xD;
          -  Participant has participated in a structured group activity (e.g, preschool, sports,&#xD;
             Sunday school) so as to assess symptoms and impairment in a setting outside the home.&#xD;
&#xD;
          -  Participant has lived with the same parent(s) or guardian for greater than or equal to&#xD;
             6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant is required to or anticipates the need to take any prohibited medications&#xD;
             or medications that have central nervous system (CNS) effects or have an effect on&#xD;
             performance. Stable use of bronchodilator inhalers is not exclusionary.&#xD;
&#xD;
          -  Participant has taken another investigational product or has taken part in a clinical&#xD;
             study within 30 days prior to the screening visit (Visit -1).&#xD;
&#xD;
          -  Participant is well-controlled on his/her current ADHD medication with acceptable&#xD;
             tolerability.&#xD;
&#xD;
          -  Participant has a concurrent chronic or acute illness, disability, or other condition&#xD;
             that might confound the results of safety assessments or may increase risk to the&#xD;
             participant..&#xD;
&#xD;
          -  Participant has glaucoma.&#xD;
&#xD;
          -  Participant has failed to fully respond to an adequate course of amphetamine therapy.&#xD;
&#xD;
          -  Participant has a documented allergy, hypersensitivity, or intolerance to amphetamine&#xD;
             or to any excipients in the investigational product.&#xD;
&#xD;
          -  Participant has a known family history of sudden cardiac death or ventricular&#xD;
             arrhythmia.&#xD;
&#xD;
          -  Participant has a blood pressure measurement greater than or equal to 95th percentile&#xD;
             for age, sex, and height at the screening visit (Visit -1) or the baseline visit&#xD;
             (Visit 0) or history of moderate or severe hypertension.&#xD;
&#xD;
          -  Participant has a known history of symptomatic cardiovascular disease, unexplained&#xD;
             syncope, exertional chest pain,advanced arteriosclerosis, structural cardiac&#xD;
             abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery&#xD;
             disease, or other serious cardiac problems.&#xD;
&#xD;
          -  Participant has any clinically significant clinical laboratory abnormalities at the&#xD;
             screening visit (Visit -1) or electrocardiogram (ECG) at screening visit (Visit-1) or&#xD;
             baseline visit (Visit 0) based on investigator judgment.&#xD;
&#xD;
          -  Participant has current abnormal thyroid function, defined as abnormal thyroid&#xD;
             stimulating hormone (TSH) and thyroxine (T4) at the screening visit (Visit -1).&#xD;
             Treatment with a stable dose of thyroid medication for at least 3 months is permitted.&#xD;
&#xD;
          -  Participant has a current, controlled (requiring medication or therapy) or&#xD;
             uncontrolled, co-morbid psychiatric disorder including but not limited to any of the&#xD;
             below co-morbid Axis I disorders and Axis II disorders:&#xD;
&#xD;
             i. post-traumatic stress disorder or adjustment disorder ii. bipolar illness,&#xD;
             psychosis, or a family history of these disorders iii. pervasive developmental&#xD;
             disorder iv. obsessive-compulsive disorder (OCD) v. psychosis/schizophrenia vi. a&#xD;
             serious tic disorder, or a family history of Tourette's disorder vii. Participant is&#xD;
             currently considered a suicide risk in the opinion of the investigator, has previously&#xD;
             made a suicide attempt, or has a prior history of, or is currently demonstrating&#xD;
             active suicidal ideation.&#xD;
&#xD;
        viii. a history of physical, sexual, or emotional abuse ix. any other disorder or agitated&#xD;
        state that in the opinion of the investigator, contraindicates SPD489 or lisdexamfetamine&#xD;
        dimesylate treatment or confound efficacy or safety assessments.&#xD;
&#xD;
          -  Participant has initiated behavioral therapy within 1 month of the baseline visit&#xD;
             (Visit 0). Participant may not initiate behavioral therapy during the study.&#xD;
&#xD;
          -  Participant has a height less than equal to (&lt;=) 5th percentile for age and sex at the&#xD;
             screening visit (Visit -1).&#xD;
&#xD;
          -  Participant has a weight &lt;= 5th percentile for age and sex at the screening visit&#xD;
             (Visit -1).&#xD;
&#xD;
          -  Participant lives with anyone who currently abuses stimulants or cocaine.&#xD;
&#xD;
          -  Participant has a history of seizures (other than infantile febrile seizures).&#xD;
&#xD;
          -  Participant is taking any medication that is excluded per the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <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>Preferred Research Partners, Inc</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMB Clinical Trials</name>
      <address>
        <city>Colton</city>
        <state>California</state>
        <zip>92324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Valley Research Center</name>
      <address>
        <city>Imperial</city>
        <state>California</state>
        <zip>92251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Wellness d/b/a Alliance for Research</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asclepes Research</name>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <zip>91402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatric Centers at San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Dept of Psychiatry</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Trials, Inc</name>
      <address>
        <city>Wildomar</city>
        <state>California</state>
        <zip>92595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research, LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarkis Clinical Trials</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions, Inc.</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Group of Central Florida</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>32763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APG Research, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida Department Of Psychiatry</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch Atlanta LLC</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Charles Clinical Trials</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kennedy Krieger Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</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>48306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neurophysiology Services</name>
      <address>
        <city>Sterling Heights</city>
        <state>Michigan</state>
        <zip>48314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Psychiatric Reseach Institute, LLC</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jersey Shore University Medical Center (JSUMC)</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Behavioral Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Associates of Fairfield, Inc</name>
      <address>
        <city>Fairfield</city>
        <state>Ohio</state>
        <zip>45014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Research Company</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Clinical Research Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paradigm Research Professionals</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cutting Edge Research Group</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cyn3rgy Research Center</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainbow Research Inc</name>
      <address>
        <city>Barnwell</city>
        <state>South Carolina</state>
        <zip>29812</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Clinical Trials, Inc.</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions, Inc</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioBehavioral Research of Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayou City Research Limited</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BI Research Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Red Oak Psychiatry Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Road Runner Research</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>Ericksen Research and Development</name>
      <address>
        <city>Clinton</city>
        <state>Utah</state>
        <zip>84015</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>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Childrens Hospital, Pearl Clinic</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <results_first_submitted>October 22, 2019</results_first_submitted>
  <results_first_submitted_qc>January 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2020</results_first_posted>
  <last_update_submitted>May 16, 2021</last_update_submitted>
  <last_update_submitted_qc>May 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SPD489</keyword>
  <keyword>Lisdexamfetamine dimesylate</keyword>
  <keyword>ADHD</keyword>
  <keyword>hyperactivity</keyword>
  <keyword>Neurobehavioral disorder</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>Lisdexamfetamine Dimesylate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03260205/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03260205/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 49 sites in United States between 06 September 2017 (first participant enrolled) and 23 October 2018 (last participant completed).</recruitment_details>
      <pre_assignment_details>A total of 284 participants were screened of them 85 participants were screen failures and did not receive any treatment. 199 participants (153 participants for SPD489 treatment and 46 participants for placebo treatment) were randomized, out of them 150 participants completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="P2">
          <title>SPD489 5 mg</title>
          <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="P3">
          <title>SPD489 10 mg</title>
          <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="P4">
          <title>SPD489 20 mg</title>
          <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="P5">
          <title>SPD489 30 mg</title>
          <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="37"/>
                <participants group_id="P4" count="37"/>
                <participants group_id="P5" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="35"/>
                <participants group_id="P4" count="34"/>
                <participants group_id="P5" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="30"/>
                <participants group_id="P5" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Participant or Parent/LAR</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other: Unspecified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Who Did Not Received AnyDose</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="B2">
          <title>SPD489 5 mg</title>
          <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="B3">
          <title>SPD489 10 mg</title>
          <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="B4">
          <title>SPD489 20 mg</title>
          <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="B5">
          <title>SPD489 30 mg</title>
          <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="B6">
          <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="45"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="35"/>
            <count group_id="B4" value="34"/>
            <count group_id="B5" value="38"/>
            <count group_id="B6" value="191"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.9" spread="6.32"/>
                    <measurement group_id="B2" value="60.7" spread="6.32"/>
                    <measurement group_id="B3" value="60.9" spread="7.18"/>
                    <measurement group_id="B4" value="61.1" spread="5.88"/>
                    <measurement group_id="B5" value="61.2" spread="7.23"/>
                    <measurement group_id="B6" value="61.2" spread="6.54"/>
                  </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="16"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="27"/>
                    <measurement group_id="B6" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="33"/>
                    <measurement group_id="B6" value="159"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </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>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other: Not specified</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6</title>
        <description>ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <population>Full analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. This outcome was pre-specified to collect and analyze pooled groups of SPD489 doses. The data were planned, analyzed, and reported only for the placebo and the pooled 10, 20, 30 mg doses of SPD489 arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pooled SPD489 Doses (10, 20, and 30 mg)</title>
            <description>Participants received SPD489 10, 20, and 30 mg capsule orally once daily for 6 weeks were pooled.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6</title>
          <description>ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.</description>
          <population>Full analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. This outcome was pre-specified to collect and analyze pooled groups of SPD489 doses. The data were planned, analyzed, and reported only for the placebo and the pooled 10, 20, 30 mg doses of SPD489 arms.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.1" spread="2.36"/>
                    <measurement group_id="O2" value="-14.2" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline visits, with the change from baseline in ADHD-RS-IV preschool version total score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline ADHD-RS-IV and baseline ADHD-RS-IV score-by-visit interaction as covariates.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0242</p_value>
            <method>MMRM</method>
            <param_type>Difference in Least Square Mean</param_type>
            <param_value>-5.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.01</ci_lower_limit>
            <ci_upper_limit>-0.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impressions Global Improvement (CGI-I) at Week 6</title>
        <description>CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.</description>
        <time_frame>Week 6</time_frame>
        <population>Full analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. This outcome was pre-specified to collect and analyze pooled groups of SPD489 doses. The data were planned, analyzed, and reported only for the placebo and the pooled 10, 20, 30 mg doses of SPD489 arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Pooled SPD489 Doses (10, 20, and 30 mg)</title>
            <description>Participants received SPD489 10, 20, and 30 mg capsule orally once daily for 6 weeks were pooled.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impressions Global Improvement (CGI-I) at Week 6</title>
          <description>CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.</description>
          <population>Full analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. This outcome was pre-specified to collect and analyze pooled groups of SPD489 doses. The data were planned, analyzed, and reported only for the placebo and the pooled 10, 20, 30 mg doses of SPD489 arms.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.18"/>
                    <measurement group_id="O2" value="2.8" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline Visits, with the CGI-I score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline CGI-S as covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0074</p_value>
            <method>MMRM</method>
            <param_type>Difference in Least Mean Square</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.03</ci_lower_limit>
            <ci_upper_limit>-0.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6</title>
        <description>Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <population>Dose response analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Each SPD489 arm is compared with placebo sequentially, with the highest dose level first.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 30 mg</title>
            <description>Participants received fixed dose of SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 20 mg</title>
            <description>Participants received fixed dose of SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 10 mg</title>
            <description>Participants received fixed dose of SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 5 mg</title>
            <description>Participants received fixed dose of SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6</title>
          <description>Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product.</description>
          <population>Dose response analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Each SPD489 arm is compared with placebo sequentially, with the highest dose level first.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.1" spread="2.36"/>
                    <measurement group_id="O2" value="-15.3" spread="2.62"/>
                    <measurement group_id="O3" value="-17.0" spread="2.90"/>
                    <measurement group_id="O4" value="-10.8" spread="2.63"/>
                    <measurement group_id="O5" value="-13.5" spread="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP.</description>
        <time_frame>From start of study drug administration up to follow-up (Week 7)</time_frame>
        <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 5 mg</title>
            <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 10 mg</title>
            <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 20 mg</title>
            <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 30 mg</title>
            <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP.</description>
          <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="34"/>
                <count group_id="O5" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Potentially Clinically Significant Changes in Vital Signs</title>
        <description>Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data.</description>
        <time_frame>Week 6</time_frame>
        <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 5 mg</title>
            <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 10 mg</title>
            <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 20 mg</title>
            <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 30 mg</title>
            <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Potentially Clinically Significant Changes in Vital Signs</title>
          <description>Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data.</description>
          <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="33"/>
                <count group_id="O5" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pulse: &gt;=130 beats per minute (bpm), Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse: &lt;=55 bpm, Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure (BP): &gt;=120 mmHg, Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic BP: &lt;75 mmHg, Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic BP: &gt;=85 mmHg, Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic BP: &lt;40 mmHg, Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Height at Week 6</title>
        <description>Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 5 mg</title>
            <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 10 mg</title>
            <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 20 mg</title>
            <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 30 mg</title>
            <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height at Week 6</title>
          <description>Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor.</description>
          <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Centimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="33"/>
                <count group_id="O5" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.21"/>
                    <measurement group_id="O2" value="0.7" spread="1.50"/>
                    <measurement group_id="O3" value="0.7" spread="1.08"/>
                    <measurement group_id="O4" value="1.0" spread="1.29"/>
                    <measurement group_id="O5" value="0.5" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight at Week 6</title>
        <description>Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (&lt;) 5th, 5th to &lt; 95th, and greater than or equal to (&gt;=) 95th percentiles. Change from baseline in body weight at Week 6 was reported.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 5 mg</title>
            <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 10 mg</title>
            <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 20 mg</title>
            <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 30 mg</title>
            <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Week 6</title>
          <description>Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (&lt;) 5th, 5th to &lt; 95th, and greater than or equal to (&gt;=) 95th percentiles. Change from baseline in body weight at Week 6 was reported.</description>
          <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Weight percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="33"/>
                <count group_id="O5" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="5.94"/>
                    <measurement group_id="O2" value="-1.0" spread="8.00"/>
                    <measurement group_id="O3" value="-2.8" spread="6.37"/>
                    <measurement group_id="O4" value="-4.8" spread="9.59"/>
                    <measurement group_id="O5" value="-5.8" spread="8.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Mass Index (BMI) at Week 6</title>
        <description>BMI was derived from height and weight. BMI percentile was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI &lt; 5th percentile); Healthy weight (BMI 5th percentile up to &lt; 85th percentile); Overweight (BMI 85th percentile &lt; 95th percentile); Obese (BMI &gt;= 95th percentile). Change from baseline in body mass index at Week 6 was reported.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 5 mg</title>
            <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 10 mg</title>
            <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 20 mg</title>
            <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 30 mg</title>
            <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Mass Index (BMI) at Week 6</title>
          <description>BMI was derived from height and weight. BMI percentile was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI &lt; 5th percentile); Healthy weight (BMI 5th percentile up to &lt; 85th percentile); Overweight (BMI 85th percentile &lt; 95th percentile); Obese (BMI &gt;= 95th percentile). Change from baseline in body mass index at Week 6 was reported.</description>
          <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>BMI percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="33"/>
                <count group_id="O5" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="11.17"/>
                    <measurement group_id="O2" value="-0.9" spread="14.06"/>
                    <measurement group_id="O3" value="-5.1" spread="10.49"/>
                    <measurement group_id="O4" value="-6.7" spread="14.28"/>
                    <measurement group_id="O5" value="-7.4" spread="11.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values</title>
        <description>Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, &gt; = represents greater than or equal to.</description>
        <time_frame>Week 6</time_frame>
        <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and at the specific categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 5 mg</title>
            <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 10 mg</title>
            <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 20 mg</title>
            <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 30 mg</title>
            <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values</title>
          <description>Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, &gt; = represents greater than or equal to.</description>
          <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and at the specific categories.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Eosinophils/Leukocytes: Greater than (&gt;)10%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="27"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes: Greater than (&gt;) 70%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="27"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes: Less than (&lt;) 30%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="27"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets: &gt;600x10^9/Litre (L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="25"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase: &gt;= 3x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase: &gt;=3x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine: &gt;176.8 mcmol/L or &gt;1.5x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: &lt;3.05 Millimole per liter (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: &gt;8.88 Millimole per liter (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: &gt;5.5 Millimole per liter (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones: Positive value (excluding trace)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="30"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Occult blood: Positive value (excluding trace)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="30"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein: Positive value (excluding trace)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="30"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters</title>
        <description>Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data.</description>
        <time_frame>Week 6</time_frame>
        <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and at the specific categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 5 mg</title>
            <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 10 mg</title>
            <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 20 mg</title>
            <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 30 mg</title>
            <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters</title>
          <description>Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data.</description>
          <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and at the specific categories.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Heart Rate (&lt; 55 Beats per minute)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart Rate (&gt; 130 Beats per minute)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Interval (&gt; = 90 millisecond [msec])</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval (&gt; = 440 msec)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB Interval (&gt; =440 msec and &lt;480 msec)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB Interval (&gt;=480 msec and &lt;500 msec)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB Interval (&gt;=500 msec)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval (&gt; =440 msec and &lt;480 msec)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval (&gt;=480 msec and &lt;500 msec)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval (&gt;=500 msec)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECG Abnormality - Rhythm</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Children's Sleep Habits Questionnaire (CSHQ) at Week 6</title>
        <description>Children's Sleep Habits Questionnaire was a tool designed to screen the most common sleep problems in children, and consisted of 33 items for scoring. The instrument evaluated the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.</description>
        <time_frame>Week 6</time_frame>
        <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 5 mg</title>
            <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 10 mg</title>
            <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 20 mg</title>
            <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 30 mg</title>
            <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Children's Sleep Habits Questionnaire (CSHQ) at Week 6</title>
          <description>Children's Sleep Habits Questionnaire was a tool designed to screen the most common sleep problems in children, and consisted of 33 items for scoring. The instrument evaluated the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.</description>
          <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories.</population>
          <units>Score on 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="45"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="34"/>
                <count group_id="O5" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bedtime resistance: Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" spread="3.22"/>
                    <measurement group_id="O2" value="9.4" spread="3.30"/>
                    <measurement group_id="O3" value="10.3" spread="3.36"/>
                    <measurement group_id="O4" value="10.2" spread="3.60"/>
                    <measurement group_id="O5" value="10.3" spread="3.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep-onset delay: Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="0.74"/>
                    <measurement group_id="O2" value="1.7" spread="0.80"/>
                    <measurement group_id="O3" value="1.8" spread="0.75"/>
                    <measurement group_id="O4" value="1.8" spread="0.75"/>
                    <measurement group_id="O5" value="1.8" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep duration: Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="1.20"/>
                    <measurement group_id="O2" value="3.9" spread="1.20"/>
                    <measurement group_id="O3" value="3.9" spread="1.35"/>
                    <measurement group_id="O4" value="4.1" spread="1.70"/>
                    <measurement group_id="O5" value="4.1" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep anxiety: Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="31"/>
                    <count group_id="O5" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.37"/>
                    <measurement group_id="O2" value="5.8" spread="2.17"/>
                    <measurement group_id="O3" value="6.5" spread="2.36"/>
                    <measurement group_id="O4" value="6.5" spread="2.75"/>
                    <measurement group_id="O5" value="6.4" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Night wakings: Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="1.78"/>
                    <measurement group_id="O2" value="4.2" spread="1.23"/>
                    <measurement group_id="O3" value="4.6" spread="1.58"/>
                    <measurement group_id="O4" value="4.3" spread="1.36"/>
                    <measurement group_id="O5" value="4.1" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parasomnias: Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="1.97"/>
                    <measurement group_id="O2" value="8.9" spread="1.70"/>
                    <measurement group_id="O3" value="8.8" spread="1.50"/>
                    <measurement group_id="O4" value="8.2" spread="1.54"/>
                    <measurement group_id="O5" value="8.4" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep-disordered breathing: Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="1.00"/>
                    <measurement group_id="O2" value="3.6" spread="1.02"/>
                    <measurement group_id="O3" value="3.3" spread="0.68"/>
                    <measurement group_id="O4" value="3.4" spread="0.70"/>
                    <measurement group_id="O5" value="3.5" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daytime sleepiness: Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="3.58"/>
                    <measurement group_id="O2" value="10.9" spread="3.33"/>
                    <measurement group_id="O3" value="10.3" spread="3.33"/>
                    <measurement group_id="O4" value="9.8" spread="3.57"/>
                    <measurement group_id="O5" value="12.4" spread="4.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS)</title>
        <description>C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported.</description>
        <time_frame>Up to Week 6</time_frame>
        <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489 5 mg</title>
            <description>Participants received SPD489 5 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O3">
            <title>SPD489 10 mg</title>
            <description>Participants received SPD489 10 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O4">
            <title>SPD489 20 mg</title>
            <description>Participants received SPD489 20 mg capsule orally once daily for 6 weeks.</description>
          </group>
          <group group_id="O5">
            <title>SPD489 30 mg</title>
            <description>Participants received SPD489 30 mg capsule orally once daily for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS)</title>
          <description>C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported.</description>
          <population>Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="34"/>
                <count group_id="O4" value="34"/>
                <count group_id="O5" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of the study drug administration up to follow up (Week 7)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks.</description>
        </group>
        <group group_id="E2">
          <title>SPD489 5 mg</title>
          <description>Participants received SPD489 capsule orally at a dose of 5 milligram (mg) once daily for 6 weeks.</description>
        </group>
        <group group_id="E3">
          <title>SPD489 10 mg</title>
          <description>Participants received SPD489 capsule orally at a dose of 10 mg once daily for 6 weeks.</description>
        </group>
        <group group_id="E4">
          <title>SPD489 20 mg</title>
          <description>Participants received SPD489 capsule orally at a dose of 20 mg once daily for 6 weeks.</description>
        </group>
        <group group_id="E5">
          <title>SPD489 30 mg</title>
          <description>Participants received SPD489 capsule orally at a dose of 30 mg once daily for 6 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.0</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="4" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="35"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="18" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="34"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Affect lability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Initial insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Middle insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </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>If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Shire</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@shire.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/NCT03260205
org study id: SPD489-347
nct id: NCT03260205
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine if an investigational treatment is effective in
      improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old
      diagnosed with ADHD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6
time frame: Baseline, Week 6
description: ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.
measure: Clinical Global Impressions Global Improvement (CGI-I) at Week 6
time frame: Week 6
description: CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.
measure: Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6
time frame: Baseline, Week 6
description: Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: From start of study drug administration up to follow-up (Week 7)
description: An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP.
measure: Number of Participants With Potentially Clinically Significant Changes in Vital Signs
time frame: Week 6
description: Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data.
measure: Change From Baseline in Height at Week 6
time frame: Baseline, Week 6
description: Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor.
measure: Change From Baseline in Body Weight at Week 6
time frame: Baseline, Week 6
description: Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (<) 5th, 5th to < 95th, and greater than or equal to (>=) 95th percentiles. Change from baseline in body weight at Week 6 was reported.
measure: Change From Baseline in Body Mass Index (BMI) at Week 6
time frame: Baseline, Week 6
description: BMI was derived from height and weight. BMI percentile was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI < 5th percentile); Healthy weight (BMI 5th percentile up to < 85th percentile); Overweight (BMI 85th percentile < 95th percentile); Obese (BMI >= 95th percentile). Change from baseline in body mass index at Week 6 was reported.
measure: Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values
time frame: Week 6
description: Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, > = represents greater than or equal to.
measure: Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters
time frame: Week 6
description: Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data.
measure: Children's Sleep Habits Questionnaire (CSHQ) at Week 6
time frame: Week 6
description: Children's Sleep Habits Questionnaire was a tool designed to screen the most common sleep problems in children, and consisted of 33 items for scoring. The instrument evaluated the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.
measure: Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Up to Week 6
description: C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participant will receive placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.
arm group label: SPD489 (Lisdexamfetamine dimesylate)
arm group type: Experimental
description: Participants will be randomized to receive SPD489 capsule in a 5:5:5:5:6 ratio to SPD489 5, 10, 20, 30 milligram (mg) orally once daily for 6 weeks. Dosing will begin with the lowest strength of SPD489 (5 mg), and will be titrated until the randomly assigned fixed-dose is reached.
intervention type: Drug
intervention name: Placebo
description: Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.
arm group label: Placebo
intervention type: Drug
intervention name: SPD489 (Lisdexamfetamine dimesylate)
description: SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.
arm group label: SPD489 (Lisdexamfetamine dimesylate)
intervention type: Drug
intervention name: SPD489
description: SPD489
arm group label: SPD489 (Lisdexamfetamine dimesylate)
criteria: 
gender: All
minimum age: 4 Years
maximum age: 5 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
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country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Lisdexamfetamine Dimesylate
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
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reported events: 
certain agreements: 
point of contact: 