The ADHD-RS-IV consists of 18 items with first 9 items assessing inattentive symptoms and the last 9 items assessing hyperactive-impulsive symptoms scored on a 4-point Likert-type severity scale with 0 (none), 1 (mild), 2 (moderate), and 3 (severe) with a total score ranging from 0 to 54. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR. A negative change from Baseline indicates improvement.

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations.

The ADHD-RS-IV consists of 18 items with first 9 items assessing inattentive symptoms and the last 9 items assessing hyperactive-impulsive symptoms scored on a 4-point Likert-type severity scale with 0 (none), 1 (mild), 2 (moderate), and 3 (severe) with a total score ranging from 0 to 54. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR. A negative change from Baseline indicates improvement.

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.

BRIEF-A is a standardized self-administered scale that captures an adult's executive functions or self-regulation in their everyday environment, composed of 75 items within 9 nonoverlapping derived clinical scales and measures various aspects of executive functioning, including the following: inhibit, self-monitor shift, emotional control, initiate, working memory, plan/organize, monitor, and organization of materials. Items are rated 1=never, 2=sometimes, and 3=often; total raw scale score ranges from 75-225, higher total scores=more problems with executive functioning. Raw scale scores are used to generate T-scores. Total T-scores range from 30 to 90, with broader composite indexes including Behavioral Regulation Index(BRI) and Metacognition Index(Ml). These indexes form overall summary score, the Global Executive Composite(GEC). Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR. A negative change from Baseline indicates improvement.

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations.

Responders are defined as participants with ≥30% improvement in ADHD symptoms compared with Baseline-2, as measured by the ADHD-RS-IV. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR.

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations.

High responders are defined as participants with ≥50% improvement in ADHD symptoms compared with Baseline-2, as measured by the ADHD-RS-IV. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR.

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations.

The ADHD-RS-IV consists of 18 items with first 9 items assessing inattentive symptoms and the last 9 items assessing hyperactive-impulsive symptoms scored on a 4-point Likert-type severity scale with 0=none, 1=mild, 2=moderate, and 3=severe, with a total score ranging from 0 to 54. Inattention and hyperactivity/impulsivity subscales consist of 9 items each, for total subscale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR. A negative change from Baseline indicates improvement.

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations.

CGI-S is an observer-rated scale that is used to assess the severity of the participants condition on a 7-point scale ranging from 1 to 7, where 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill. This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days with a minimum score of 1 and maximum score of 7. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR. A negative change from Baseline indicates improvement.

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations. Number analyzed is the number of participants with data available for analysis at the given timepoint.

CGl-I is an observer-rated scale to assess how much the participant's illness has improved or worsened relative to a Baseline state, with scores ranging from 1 to 7. It consists of a 7-point scale ranging from 1 to 7, where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from Baseline-2 (the initiation of treatment); 5=minimally worse; 6=much worse; and 7=very much worse since the initiation of treatment. Improvement is defined as a score of 1=very much improved or 2=much improved on the scale. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR.

Data for this outcome measure was not collected as Baseline-2 CGI-I values were not recorded.

CGl-I is an observer-rated scale to assess how much the participant's illness has improved or worsened relative to a Baseline state, with scores ranging from 1 to 7. It consists of a 7-point scale ranging from 1 to 7, where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from Baseline-2 (the initiation of treatment); 5=minimally worse; 6=much worse; and 7=very much worse since the initiation of treatment. Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Responders are defined as those who had CGI-I (ADHD version) scores of much or very much improved.

We have exhausted all efforts to locate this data and it has since been destroyed, therefore no data is available to report for this outcome measure.

C-SSRS is a brief method of assessing both behavior and ideation that tracks all suicidal events, and provides a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation, and deterrents), all of which are significantly predictive of completed suicide. Severity of suicidal ideation is rated on a 6-point scale from 0=no ideation present to 5=active ideation with plan and intent. Suicidal behavior was collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior.

We have exhausted all efforts to locate this data and it has since been destroyed, therefore no data is available to report for this outcome measure.

POMS 2-A Short version consists of a subset of 35 items from the full-length version of 72 mood adjectives assessing 7 mood domains namely, anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, and friendliness. High scores indicate better vigor-activity and friendliness, but more severe symptoms for the five other domains. In addition, the Total Mood Disturbance (TMD) score is calculated from anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, and vigor-activity. Participants rated each of the 35 items using 4-point Likert-type scale (0=much unlike this; 3=much like this). Items from each domain are summed T-score such that total scores were in the negative-mood direction (i.e., higher scores indicate greater experience of negative moods). Total scores range from 0 to 100. TMD is calculated based on a standard value (mean of 50 and standard deviation of 10).

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR. Change from Baseline-2 for the POMS 2-A Short version scale is calculated using summary T-scores.

WRAADDS is used to measure the severity of symptoms in adults with ADHD. This structured interview consists of 28 items in 7 psychopathologic domains, which were rated by a clinical expert on a 0 to 2-point Likert scale. The psychopathologic 7 domains are inattention, hyperactivity, affective lability, hot temper, stress intolerance, disorganization, and impulsivity. The scale rated individual items from 0 to 2 (0=not present, 1=mild, 2=clearly present) and summarized each of the 7 categories on a 0-to-4 scale (0=none, 1=mild, 2=moderate, 3=quite a bit, 4=very much). The WRAADDS total score is defined as sum of all 28 item sub scores (range 0 to 56), higher scores indicate worsening of symptoms. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR. A negative change from Baseline indicates improvement. Change from Baseline-2 for the WRAADDS scale is calculated using total scores.

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations.

The WFIRS-S is a validated rating scale used to capture functional difficulties in the lives of individuals with ADHD. It investigates emotional or behavioral problems and is comprised of 69 items grouped into six domains: family (8 items), work (11 items), school (10 items, includes learning [4 items] and behavior [6 items]), life skills (12 items), self-concept (5 items), social (9 items), and risky (14 items). It uses a 4-point Likert scale where 0=never or not at all, 1=sometimes or somewhat, 2=often or much, and 3=very often or very much. Any item rating of 2 or 3 was considered in the clinically impaired range. A total score was derived by summing all scores from every domain, ranging from 0 to 207 with higher scores=greater ADHD-related functional impairment.

Per-protocol Population included all participants who met inclusion/exclusion criteria and completed the trial (4 weeks of drug treatment with evaluable data after Week 4) without major protocol violations. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with EB-1020 SR. A negative change from Baseline indicates improvement. Change from Baseline-2 for the WFIRS-S scale is calculated using average total scores.

The change on the ADHD-RS-IV was used to assess relapse of symptoms after end of investigational product administration.

We have exhausted all efforts to locate this data and it has since been destroyed, therefore no data is available to report for this outcome measure.