Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00716274
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 94
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16 years old with ADHD and comorbid dyslexia

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder; Dyslexia	Drug: Atomoxetine; Drug: Placebo	Phase 4

Detailed Description

This is a randomized, placebo-controlled, double-blind, single site study that uses an fMRI measurement to assess brain activation during attention and reading tasks and the effects of atomoxetine in reducing symptoms of ADHD in participants with ADHD and comorbid dyslexia. Similar assessments are performed in two additional groups of participants with ADHD only and dyslexia only to determine to what extent symptomatic change in the comorbid ADHD & dyslexia is achieved independently by atomoxetine effects on either condition. A healthy control group of non-ADHD, non-dyslexia subjects (20) will be included to monitor practice effects & effects of treatment that may be interpreted as normal maturation. The healthy control group will not be treated with any study medications.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Neurophysiology of Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Dyslexia: Functional Magnetic Resonance Imaging (fMRI) Measures of Brain Activation During Attention and Reading Tasks Pre- and Post-Atomoxetine Treatment
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atomoxetine Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks (study period II). Participants who complete the study period II will be re-randomized in the study period III of 16-week duration to assess maintenance of benefit following discontinuation of treatment with atomoxetine. Participants assigned to atomoxetine during the study period II will be re-randomized to either atomoxetine or placebo whereas participants previously assigned to placebo will receive atomoxetine.	Drug: Atomoxetine; Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks; Other Names: LY139603
Placebo Comparator: Placebo Placebo will be packaged in the same way as active comparator to enforce double-blind study design	Drug: Placebo; oral, daily, for 16 weeks

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks) [Baseline, 16 Weeks]

   For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.

2. Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) [Baseline, 16 Weeks]

   For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.

3. Change From Baseline to Endpoint in fMRI Activation in Participants With Attention Deficit Hyperactivity Disorder (ADHD) or ADHD + Dyslexia (Stroop Attention Tasks) [Baseline, 16 Weeks]

   For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.

4. Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) [Baseline, 16 Weeks]

   For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.

5. Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone [Baseline, 16 Weeks]

   WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline.

6. Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia [Baseline, 16 weeks]

   The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

Secondary Outcome Measures

1. Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone [Baseline, 16 Weeks]

   WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant's word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

2. Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia [Baseline, 16 Weeks]

   The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, "ADD possible but not likely". 40-54 equate to, "ADD probable but not certain". 55-120 equate to, "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

3. Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone [Baseline, 16 Weeks]

   WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

4. Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia [Baseline, 16 Weeks]

   WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

5. Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone [Baseline, 16 Weeks]

   WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

6. Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone [Baseline, 16 weeks]

   The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

7. Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia [Baseline, 16 weeks]

   The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

8. Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone [Baseline, 16 weeks]

   The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

9. Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone [Baseline, 16 weeks]

   The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline.

10. Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia [Baseline, 16 weeks]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.

11. Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone [Baseline, 16 weeks]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.

12. Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone [Baseline, 16 Weeks]

    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

13. Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia [Baseline, 16 Weeks]

    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

14. Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone [Baseline, 16 Weeks]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

15. Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia [Baseline, 16 Weeks]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

16. Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone [Baseline, 16 Weeks]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

17. Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone [Baseline, 16 Weeks]

    The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

18. Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone [Baseline, 16 Weeks]

    The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

19. Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone [Baseline, 32 Weeks]

    WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age.

20. Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia [Baseline, 32 Weeks]

    WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.

21. Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone [Baseline, 32 Weeks]

    WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.

22. Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone [Baseline, 32 Weeks]

    The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

23. Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia [Baseline, 32 Weeks]

    The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

24. Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone [Baseline, 32 Weeks]

    The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

25. Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone [Baseline, 32 Weeks]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

26. Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia [Baseline, 32 Weeks]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

27. Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone [Baseline, 32 Weeks]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

28. Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone [Baseline, 32 Weeks]

    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

29. Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia [Baseline, 32 Weeks]

    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

30. Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone [Baseline, 32 Weeks]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

31. Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia [Baseline, 32 Weeks]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

32. Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone [Baseline, 32 Weeks]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

33. Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone [Baseline, 32 Weeks]

    The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.

34. Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia [Baseline, 32 Weeks]

    The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.

35. Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone [Baseline, 32 Weeks]

    The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.

36. Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia [Baseline, 32 Weeks]

    The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.

37. Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks) [From Week 16, Up to Week 32]

    For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.

38. Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Attention Tasks) [From Week 16, Up to 32 Weeks]

    For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.

39. Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) [From Week 16, Up to Week 32]

    For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.

40. Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic Tasks) [From Week 16, Up to Week 32]

    For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.

41. Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone [From Week 16, Up to 32 Weeks]

    WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.

42. Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia [From Week 16, Up to Week 32]

    WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.

43. Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone [From Week 16, Up to Week 32]

    WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.

44. Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone [From Week 16, Up to Week 32]

    The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

45. Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia [From Week 16, Up to Week 32]

    The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

46. Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone [From Week 16, Up to Week 32]

    The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

47. Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone [From Week 16, Up to Week 32]

    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

48. Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia [From Week 16, Up to Week 32]

    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

49. Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone [From Week 16, Up to Week 32]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

50. Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia [From Week 16, Up to Week 32]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

51. Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone [From Week 16, Up to Week 32]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

52. Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone [From Week 16, Up to Week 32]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

53. Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia [From Week 16, Up to Week 32]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

54. Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone [From Week 16, Up to Week 32]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.

55. Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone [From Week 16, Up to Week 32]

    The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

56. Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia [From Week 16, Up to Week 32]

    The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

57. Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone [From Week 16, Up to Week 32]

    The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

58. Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia [From Week 16, Up to Week 32]

    The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

59. The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia [16 Weeks]

    The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

60. The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. [16 Weeks]

    The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

61. The Number of Participants With TEAE in Participants With Dyslexia [From 16 Weeks Up to Week 32]

    The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

62. The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. [From Week 16 Up to Week 32]

    The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

63. Number of Participants With Adverse Events [32 Weeks]

    Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

64. Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants [Baseline, 16 Weeks]

    WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.

65. Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants [Baseline, 16 Weeks]

    The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.

66. Change From Baseline to Endpoint in GORT-4 in Healthy Participants [Baseline, 16 weeks]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.

67. Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants [Baseline, 16 Weeks]

    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction.

68. Change From Baseline to Endpoint in WMTB-C in Healthy Participants [Baseline, 16 Weeks]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).

69. Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants [Baseline, 16 Weeks]

    The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction.

70. Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants [Baseline, 16 Weeks]

    The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.

71. Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants [Baseline, 32 Weeks]

    WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.

72. Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants [Baseline, 32 weeks]

    The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.

73. Change From Baseline to Endpoint in GORT-4 in Healthy Participants [Baseline, 32 Weeks]

    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.

74. Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants [Baseline, 32 Weeks]

    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.

75. Change From Baseline to Endpoint in WMTB-C in Healthy Participants [Baseline, 32 Weeks]

    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).

76. Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants [Baseline, 32 Weeks]

    The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.

77. Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants [Baseline, 32 Weeks]

    The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants in the ADHD-only or ADHD+dyslexia groups must meet DSM-IV-TR criteria for ADHD

• Participants in the dyslexia-alone group or ADHD+dyslexia groups must meet criteria for dyslexia

• Participants must achieve a score of 80 or more on the Full Scale Intelligence Quotient

• Child or adolescent participants must be 10 to 16 years old

• Must be able to communicate in English

• Must be able to swallow capsules

• Be reliable to keep appointments for clinic visits & all related tests

• Participants for healthy control group do not meet DSM-IV-TR criteria for ADHD and/or dyslexia

• Participants for healthy control group must achieve a score of at least 80 but not

120 on the Full Scale Intelligence Quotient

Exclusion Criteria:

• Participants who weigh less than 25.1 kilogram (kg) or greater than 70 kg.

• Participants with severe allergies to more than 1 class of medications or who have had multiple adverse drug reactions

• Participants with prior diagnosis of bipolar I or bipolar II disorder or psychosis

• Participants with documented history of autism, Asperger's syndrome, or pervasive developmental disorder

• Females who are pregnant or breastfeeding

• Participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine	New Haven	Connecticut	United States	06520

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Lilly Clinical Trial Registry

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT00716274
• Other Study ID Numbers: 12212; B4Z-US-LYEI
• First Posted: Jul 16, 2008
• Last Update Posted: Feb 20, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Hyperkinesis; Dyslexia; Attention Deficit Disorder with Hyperactivity; Atomoxetine Hydrochloride

Study Results

Participant Flow

Pre-assignment Detail	Participants were randomized to either atomoxetine or placebo during study period II. Placebo participants were then assigned to atomoxetine in study period III. Atomoxetine participants were re-randomized to atomoxetine or placebo in study period III. Participants assigned to the healthy control group did not receive any study drug.

Arm/Group Title	Atomoxetine	Placebo	ATX/ATX	ATX/PLA	PLA/ATX	Healthy Participants
Arm/Group Description	Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III).	Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study.
Period Title: Study Period II (16-Weeks)
STARTED	45	44	0	0	0	21
COMPLETED	36	35	0	0	0	19
NOT COMPLETED	9	9	0	0	0	2
Period Title: Study Period II (16-Weeks)
STARTED	0	0	18	18	35	19
COMPLETED	0	0	16	17	32	19
NOT COMPLETED	0	0	2	1	3	0

Baseline Characteristics

Arm/Group Title	Atomoxetine	Placebo	Healthy Participants	Total
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.	Total of all reporting groups
Overall Participants	45	44	21	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.2 (1.89)	12.1 (1.90)	12.4 (2.05)	12.20 (1.92)
Sex: Female, Male (Count of Participants)
Female	18 40%	17 38.6%	13 61.9%	48 43.6%
Male	27 60%	27 61.4%	8 38.1%	62 56.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 13.3%	2 4.5%	4 19%	12 10.9%
Not Hispanic or Latino	39 86.7%	42 95.5%	17 81%	98 89.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	2 4.4%	0 0%	0 0%	2 1.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	4 8.9%	13 29.5%	5 23.8%	22 20%
White	33 73.3%	29 65.9%	12 57.1%	74 67.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	6 13.3%	2 4.5%	4 19%	12 10.9%
Region of Enrollment (Count of Participants)
United States	45 100%	44 100%	21 100%	110 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)
Description	For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Primary Outcome

Title	Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)
Description	For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

Title	Change From Baseline to Endpoint in fMRI Activation in Participants With Attention Deficit Hyperactivity Disorder (ADHD) or ADHD + Dyslexia (Stroop Attention Tasks)
Description	For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Primary Outcome

Title	Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
Description	For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Primary Outcome

Title	Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	13	13
Least Squares Mean (Standard Error) [units on a scale]	-3.57 (4.84)	2.92 (4.75)

6. Primary Outcome

Title	Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia
Description	The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	23	23
ADHD + Dyslexia	-11.04 (2.518)	-7.53 (2.155)
ADHD Alone	-13.85 (2.323)	-1.63 (2.588)

7. Secondary Outcome

Title	Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant's word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	13	13
Least Squares Mean (Standard Error) [units on a scale]	-2.81 (3.87)	2.25 (3.85)

8. Secondary Outcome

Title	Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
Description	The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, "ADD possible but not likely". 40-54 equate to, "ADD probable but not certain". 55-120 equate to, "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	23	22
ADHD + Dyslexia	-6.91 (4.689)	-4.29 (4.128)
ADHD Alone	-9.05 (5.515)	-1.85 (6.695)

9. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who had a WJ III baseline and post-baseline measurement.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	13	13
Letter Word Identification	0.88 (1.12)	2.77 (1.10)
Word Attack Score	0.48 (1.71)	2.53 (1.68)
Reading Vocabulary Score	1.04 (1.81)	-1.73 (1.75)
Reading Fluency Score	0.13 (1.59)	-1.06 (1.53)
Reading Comprehension Score	2.38 (1.81)	-1.03 (1.74)
Spelling Score	0.89 (1.50)	-0.36 (1.48)
Spelling of Sounds Score	3.11 (1.48)	3.59 (1.43)
Basic Reading Skills Score	0.99 (1.15)	2.13 (1.15)
Passage Comprehension	2.80 (2.03)	-0.20 (1.96)

10. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who had a baseline and post-baseline WJ III measurement.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	13	13
Reading Fluency	-3.41 (2.16)	2.61 (2.06)
Reading Comprehension	2.02 (1.63)	0.80 (1.56)
Letter Word Identification	1.71 (1.75)	-0.90 (1.69)
Word Attack Score	2.65 (1.13)	0.71 (1.07)
Reading Vocabulary	0.69 (1.89)	2.80 (1.77)
Spelling	-1.36 (2.25)	-2.59 (2.19)
Spelling of Sounds	8.42 (1.76)	5.02 (1.67)
Basic Reading Skills	2.53 (1.05)	-0.21 (1.01)
Passage Comprehension Score	2.65 (1.71)	-1.01 (1.65)

11. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who had a baseline and post-baseline WJ III measurement.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	13	13
Reading Fluency	-2.70 (1.58)	-4.98 (1.81)
Reading Comprehension	-2.92 (2.39)	-1.40 (2.77)
Letter Word Identification	2.60 (1.77)	0.46 (2.08)
Word Attack Score	-1.60 (1.56)	0.08 (1.78)
Reading Vocabulary	-1.15 (2.65)	-1.48 (3.23)
Spelling	4.30 (1.20)	3.62 (1.39)
Spelling of Sounds	5.90 (3.51)	0.57 (4.04)
Basic Reading Skills	0.86 (1.42)	0.48 (1.65)
Passage Comprehension Score	-4.10 (2.36)	-1.80 (2.70)

12. Secondary Outcome

Title	Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	13	13
Phonological Awareness	4.01 (4.81)	2.69 (1.91)
Phonological Memory	5.62 (1.82)	0.62 (1.75)
Rapid Naming Score	0.19 (2.31)	-1.00 (2.23)

13. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	12	15
Phonological Awareness	4.60 (1.74)	1.35 (1.66)
Phonological Memory	2.33 (2.49)	3.43 (2.39)
Rapid Naming Score	-0.71 (2.46)	0.21 (2.29)

14. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	12	9
Phonological Awareness	3.66 (2.10)	7.00 (2.57)
Phonological Memory	3.70 (2.61)	3.48 (2.98)
Rapid Naming Score	2.36 (3.01)	1.63 (3.47)

15. Secondary Outcome

Title	Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	13	12
Oral Reading Rate	0.24 (0.27)	-0.44 (0.27)
Accuracy	-0.10 (0.46)	-0.72 (0.47)
Fluency	-0.17 (0.42)	-0.65 (0.42)
Reading Comprehension	0.89 (0.77)	-0.29 (0.77)
Oral Reading Quotient	2.30 (2.69)	-2.66 (2.72)

16. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	12	15
Oral Reading Rate	-0.59 (0.40)	-0.45 (0.37)
Accuracy	-1.77 (0.53)	-1.02 (0.47)
Fluency	-1.66 (0.34)	-0.81 (0.31)
Reading Comprehension	-2.46 (0.67)	-1.55 (0.62)
Oral Reading Quotient	-14.01 (4.10)	-12.23 (3.40)

17. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	12	9
Oral Reading Rate	0.80 (0.42)	0.97 (0.48)
Accuracy	0.46 (0.35)	-0.17 (0.40)
Fluency	0.72 (0.35)	0.94 (0.40)
Reading Comprehension	-0.96 (0.59)	0.79 (0.70)
Oral Reading Quotient	-0.74 (2.12)	5.63 (2.46)

18. Secondary Outcome

Title	Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone
Description	The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	14	12
Least Squares Mean (Standard Error) [units on a scale]	2.21 (1.345)	-0.17 (1.471)

19. Secondary Outcome

Title	Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
Description	The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	26	28
ADHD + Dyslexia	0.59 (1.435)	1.18 (1.231)
ADHD Alone	4.98 (1.611)	4.69 (1.844)

20. Secondary Outcome

Title	Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	14	13
Digit Recall Score	0.74 (1.25)	0.94 (1.26)
Word List Matching Score	0.34 (2.15)	0.97 (2.12)
Word List Recall Score	0.61 (0.81)	0.50 (0.83)
Nonword List Recall Score	-0.10 (0.68)	0.17 (0.69)
Block Recall Score	0.59 (1.23)	0.82 (1.25)
Mazes Memory Score	-1.05 (1.87)	-2.96 (1.91)
Listening Recall Score	1.41 (0.82)	-0.52 (0.84)
Counting Recall Score	1.83 (0.85)	0.18 (0.88)
Backward Digit Recall Score	-0.28 (1.52)	0.65 (1.55)

21. Secondary Outcome

Title	Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	12	16
Digit Recall	-0.64 (1.04)	1.03 (0.93)
Word List Matching	-0.02 (1.90)	-0.78 (1.72)
Word List Recall	-0.78 (0.77)	0.80 (0.70)
NonWord	0.12 (0.32)	1.12 (0.29)
Block Recall	-1.71 (0.83)	0.75 (0.77)
Mazes Memory Score	3.08 (1.34)	-1.01 (1.22)
Listening Recall	-0.48 (0.75)	2.16 (0.68)
Counting Recall	-2.26 (1.36)	-1.61 (1.21)
Backward Digit Recall	-0.31 (0.82)	1.76 (0.74)

22. Secondary Outcome

Title	Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	13	10
Digit Recall	2.70 (1.76)	0.94 (1.93)
Word List Matching	-0.79 (1.61)	2.03 (1.84)
Word List Recall	1.50 (1.06)	1.17 (1.18)
NonWord	1.41 (0.82)	-0.13 (0.90)
Block Recall	1.03 (1.36)	0.44 (1.67)
Mazes Memory Score	2.70 (1.61)	0.16 (1.73)
Listening Recall	1.53 (1.06)	1.57 (1.18)
Counting Recall	0.31 (1.02)	-1.02 (1.14)
Backward Digit Recall	1.82 (1.23)	2.15 (1.32)

23. Secondary Outcome

Title	Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
Description	The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	14	13
Least Squares Mean (Standard Error) [units on a scale]	-7.22 (4.756)	-2.82 (5.022)

24. Secondary Outcome

Title	Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
Description	The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	13	12
Least Squares Mean (Standard Error) [units on a scale]	-1.88 (1.441)	-2.51 (1.492)

25. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	6
Reading Fluency	8.96 (3.63)
Reading Comprehension	0.24 (1.56)
Letter Word Identification	2.12 (1.67)
Spelling	-1.81 (2.87)
Spelling of Sounds	4.67 (4.82)
Basic Reading Skills	3.41 (1.72)
Passage Comprehension Score	2.17 (5.68)
Word Attack Score	5.37 (4.71)
Reading Vocabulary Score	-2.28 (2.18)

26. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	5
Letter Word Identification	2.40 (3.30)
Word Attack Score	-0.78 (0.21)
Reading Vocabulary	0.71 (1.16)
Reading Fluency	2.24 (0.27)
Reading Comprehension	2.61 (1.31)
Spelling	1.29 (3.68)
Spelling of Sounds	-1.79 (1.03)
Basic Reading Skills	0.70 (0.04)
Passage Comprehension Score	3.58 (2.01)

27. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	6
Letter Word Identification	-1.89 (0.39)
Word Attack Score	-1.87 (1.73)
Reading Vocabulary	5.88 (3.40)
Reading Fluency	2.93 (3.82)
Reading Comprehension	4.77 (2.39)
Spelling	4.04 (2.79)
Spelling of Sounds	6.80 (2.79)
Basic Reading Skills	-2.44 (0.77)
Passage Comprehension Score	-3.16 (1.09)

28. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	6
Phonological Awareness	-0.41 (0.67)
Phonological Memory	-4.63 (2.41)
Rapid Naming Score	3.99 (4.49)

29. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	5
Phonological Awareness	12.69 (1.89)
Phonological Memory	3.40 (2.27)
Rapid Naming Score	4.72 (3.47)

30. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	6
Phonological Awareness	5.90 (6.17)
Phonological Memory	5.61 (2.30)
Rapid Naming Score	2.67 (0.32)

31. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	6
Oral Reading Rate	0.63 (0.79)
Accuracy	-1.93 (0.47)
Fluency	-0.66 (0.45)
Reading Comprehension	-0.23 (2.86)
Oral Reading Quotient	-9.53 (14.45)

32. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	5
Oral Reading Rate	0.22 (0.25)
Accuracy	0.17 (0.02)
Fluency	-0.28 (0.34)
Reading Comprehension	-0.61 (0.31)
Oral Reading Quotient	-2.23 (1.89)

33. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	6
Oral Reading Rate	0.05 (0.63)
Accuracy	-1.44 (0.45)
Fluency	-0.20 (0.22)
Reading Comprehension	-0.02 (1.07)
Oral Reading Quotient	-1.37 (4.86)

34. Secondary Outcome

Title	Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone
Description	The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	15
Least Squares Mean (Standard Error) [units on a scale]	3.20 (3.04)

35. Secondary Outcome

Title	Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia
Description	The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	10
ADHD + Dyslexia	2.77 (1.99)
ADHD Alone	6.75 (0.04)

36. Secondary Outcome

Title	Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WMTB-C measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	6
Digit Recall Score	0.47 (1.00)
Word List Matching Score	1.29 (2.62)
Word List Recall Score	0.75 (1.65)
Nonword List Recall Score	-0.96 (2.45)
Block Recall Score	1.25 (2.51)
Mazes Memory Score	1.91 (3.74)
Listening Recall Score	4.15 (2.14)
Counting Recall Score	-0.88 (1.39)
Backwards Digit Recall Score	-0.64 (2.95)

37. Secondary Outcome

Title	Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	5
Digit Recall Score	0.06 (0.07)
Word List Matching Score	-4.12 (1.25)
Word List Recall Score	3.05 (1.51)
Nonword List Recall Score	1.78 (0.42)
Block Recall Score	0.56 (1.13)
Mazes Memory Score	-0.22 (2.73)
Listening Recall Score	0.73 (3.37)
Counting Recall Score	-0.55 (2.47)
Backward Digit Recall Score	0.05 (2.95)

38. Secondary Outcome

Title	Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	5
Digit Recall Score	3.75 (0.93)
Word List Matching Score	-3.37 (0.37)
Word List Recall Score	1.25 (0.49)
Nonword List Recall Score	1.12 (0.60)
Block Recall Score	3.65 (3.48)
Mazes Memory Score	-1.09 (1.43)
Listening Recall Score	4.24 (1.96)
Counting Recall Score	-3.05 (1.67)
Backward Digit Recall Score	-0.45 (0.00)

39. Secondary Outcome

Title	Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
Description	The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	6
Least Squares Mean (Standard Error) [units on a scale]	-10.07 (6.70)

40. Secondary Outcome

Title	Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
Description	The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	11
ADHD + Dyslexia	-9.44 (7.43)
ADHD Alone	-9.33 (5.04)

41. Secondary Outcome

Title	Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone
Description	The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	6
Least Squares Mean (Standard Error) [units on a scale]	12.60 (8.17)

42. Secondary Outcome

Title	Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia
Description	The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Measure Participants	11
ADHD + Dyslexia	-12.96 (2.44)
ADHD Alone	-18.76 (5.89)

43. Secondary Outcome

Title	Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)
Description	For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

44. Secondary Outcome

Title	Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Attention Tasks)
Description	For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame	From Week 16, Up to 32 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

45. Secondary Outcome

Title	Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)
Description	For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

46. Secondary Outcome

Title	Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic Tasks)
Description	For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

47. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Time Frame	From Week 16, Up to 32 Weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	6
Word Attack Score	2.79 (2.68)	-1.01 (2.10)
Letter Word Identification	2.92 (2.45)	-4.08 (2.02)
Reading Fluency	11.03 (3.14)	-1.53 (2.61)
Reading Comprehension	4.52 (2.60)	-6.86 (2.16)
Spelling	-2.90 (3.73)	-1.72 (3.00)
Spelling of Sounds	3.33 (3.11)	0.30 (2.59)
Basic Reading Skills	2.87 (1.44)	-3.80 (1.19)
Passage Comprehension Score	4.51 (3.30)	-6.92 (2.74)
Reading Vocabulary Score	3.02 (2.04)	-4.84 (1.78)

48. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	5	6
Word Attack Score	-2.65 (1.81)	-2.62 (1.63)
Letter Word Identification	0.50 (3.19)	-1.07 (3.00)
Reading Vocabulary Score	0.64 (2.17)	-4.08 (2.08)
Reading Fluency	5.46 (2.77)	6.21 (2.84)
Reading Comprehension	0.86 (2.25)	-2.49 (2.07)
Spelling	0.45 (2.46)	0.86 (2.32)
Spelling of Sounds	-10.17 (3.40)	-3.52 (3.23)
Basic Reading Skills	-1.29 (1.06)	-2.17 (1.00)
Passage Comprehension Score	0.15 (2.06)	0.52 (1.85)

49. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	5	6
Word Attack Score	-1.56 (2.06)	-0.58 (1.85)
Letter Word Identification	-3.89 (4.46)	-1.61 (4.01)
Reading Vocabulary Score	5.15 (5.51)	-3.62 (4.26)
Reading Fluency	13.05 (2.32)	4.88 (1.11)
Reading Comprehension	3.86 (2.94)	3.26 (2.67)
Spelling	2.07 (4.66)	1.15 (3.81)
Spelling of Sounds	-2.65 (3.02)	2.65 (2.90)
Basic Reading Skills	-2.70 (3.56)	-1.97 (3.17)
Passage Comprehension Score	6.86 (3.42)	2.31 (3.00)

50. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	6
Phonological Awareness	-1.19 (4.03)	2.06 (2.82)
Phonological Memory	-6.96 (3.71)	-1.76 (3.23)
Rapid Naming Score	7.24 (5.91)	-2.42 (4.82)

51. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	5	6
Phonological Awareness	3.54 (1.51)	5.29 (1.42)
Phonological Memory	-2.65 (3.34)	0.12 (2.88)
Rapid Naming Score	2.65 (2.02)	1.21 (1.64)

52. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	5
Phonological Awareness	-0.33 (2.89)	9.67 (2.61)
Phonological Memory	3.59 (3.37)	0.84 (3.58)
Rapid Naming Score	1.53 (2.36)	3.51 (2.05)

53. Secondary Outcome

Title	Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone
Description	The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	6
Least Squares Mean (Standard Error) [units on a scale]	-0.17 (1.808)	4.17 (1.808)

54. Secondary Outcome

Title	Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
Description	The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	10	11
ADHD + Dyslexia	3.74 (1.261)	1.38 (1.151)
ADHD Alone	2.03 (4.179)	1.37 (4.179)

55. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	6
Oral Reading Rate	0.27 (0.43)	-0.64 (0.36)
Accuracy	0.40 (0.62)	-0.69 (0.48)
Fluency	0.52 (0.67)	-0.64 (0.49)
Reading Comprehension	0.06 (1.40)	-0.76 (1.20)
Oral Reading Quotient	-3.04 (10.51)	-4.91 (8.62)

56. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	6
Oral Reading Rate	0.37 (0.73)	0.31 (0.66)
Accuracy	0.07 (0.84)	0.45 (0.68)
Fluency	0.33 (1.15)	0.52 (1.08)
Reading Comprehension	1.75 (1.42)	3.64 (1.29)
Oral Reading Quotient	7.16 (4.57)	12.92 (4.32)

57. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	6
Oral Reading Rate	0.36 (0.99)	-0.35 (0.70)
Accuracy	-1.29 (1.00)	0.15 (0.82)
Fluency	-0.54 (0.76)	-0.38 (0.57)
Reading Comprehension	3.46 (1.05)	-0.04 (0.75)
Oral Reading Quotient	8.27 (8.94)	-3.13 (5.38)

58. Secondary Outcome

Title	Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	6
Digit Recall Score	-1.77 (1.78)	0.45 (1.48)
Word List Matching Score	3.98 (4.14)	1.84 (2.99)
Word List Recall Score	-0.68 (2.56)	-1.90 (2.27)
Nonword List Recall Score	2.25 (0.71)	-0.40 (0.55)
Block Recall Score	1.57 (1.55)	-1.73 (1.07)
Mazes Memory Score	6.90 (3.29)	1.27 (2.76)
Listening Recall Score	3.44 (1.11)	-1.23 (0.95)
Counting Recall Score	-2.05 (2.23)	-2.21 (1.87)
Backward Digit Recall Score	2.74 (4.47)	2.49 (2.21)

59. Secondary Outcome

Title	Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	5	6
Digit Recall Score	-1.25 (0.63)	1.83 (0.59)
Word List Matching Score	-4.48 (1.74)	-4.40 (1.60)
Word List Recall Score	2.34 (0.66)	2.28 (0.61)
NonWord List Recall	2.17 (1.00)	0.64 (1.57)
Block Recall Score	-1.71 (2.57)	3.81 (1.89)
Mazes Memory Score	-2.82 (2.69)	1.28 (2.55)
Listening Recall Score	1.93 (1.80)	0.49 (1.45)
Counting Recall Score	1.34 (2.52)	-0.89 (2.46)
Backward Recall Score	0.76 (2.03)	-0.14 (1.94)

60. Secondary Outcome

Title	Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	5	5
Digit Recall Score	2.56 (2.92)	-0.97 (2.19)
Word List Matching Score	-1.22 (3.84)	-1.71 (3.48)
Word List Recall Score	-1.23 (1.41)	1.71 (1.22)
NonWord List Recall	-1.29 (1.02)	-1.12 (0.87)
Block Recall Score	-1.14 (1.96)	0.59 (1.72)
Mazes Memory Score	1.11 (2.35)	-2.51 (2.00)
Listening Recall Score	-1.12 (3.23)	-0.09 (2.94)
Counting Recall Score	-0.03 (4.53)	-2.90 (3.75)
Backward Recall Score	-0.68 (2.03)	-0.46 (1.83)

61. Secondary Outcome

Title	Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
Description	The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	6
Least Squares Mean (Standard Error) [units on a scale]	-6.96 (5.240)	7.13 (5.240)

62. Secondary Outcome

Title	Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
Description	The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	10	11
ADHD + Dyslexia	-0.90 (8.646)	14.59 (7.892)
ADHD Alone	1.01 (4.416)	3.69 (4.461)

63. Secondary Outcome

Title	Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
Description	The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	6	18
Least Squares Mean (Standard Error) [units on a scale]	3.02 (2.537)	0.27 (1.457)

64. Secondary Outcome

Title	Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia
Description	The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame	From Week 16, Up to Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.

Arm/Group Title	ATX/ATX	ATX/PLA
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	10	32
ADHD + Dyslexia	-0.32 (3.991)	-6.38 (1.946)
ADHD alone	-6.29 (2.546)	-8.83 (1.561)

65. Secondary Outcome

Title	The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia
Description	The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame	16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	16	15
Count of Participants [Participants]	13 28.9%	11 25%

66. Secondary Outcome

Title	The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
Description	The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame	16 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	Atomoxetine	Placebo
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Measure Participants	28	29
ADHD + Dyslexia	12 26.7%	14 31.8%
ADHD alone	12 26.7%	8 18.2%

67. Secondary Outcome

Title	The Number of Participants With TEAE in Participants With Dyslexia
Description	The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame	From 16 Weeks Up to Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	ATX/ATX	ATX/PLA	PLA/ATX
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	7	6	12
Count of Participants [Participants]	3 6.7%	2 4.5%	8 38.1%

68. Secondary Outcome

Title	The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
Description	The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame	From Week 16 Up to Week 32

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	ATX/ATX	ATX/PLA	PLA/ATX
Arm/Group Description	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	12	12	18
ADHD + Dyslexia	2 4.4%	2 4.5%	10 47.6%
ADHD Alone	3 6.7%	4 9.1%	8 38.1%

69. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame	32 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	Atomoxetine	Placebo	ATX/ATX	ATX/PLA	PLA/ATX
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.	Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.	These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.	These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..	These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Measure Participants	45	44	18	18	35
Count of Participants [Participants]	35 77.8%	31 70.5%	8 38.1%	8 7.3%	25 NaN

70. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline WJ III measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Letter Word Identification	-3.42 (5.18)
Word Attack Score	-2.74 (6.54)
Reading Vocabulary	-0.63 (7.87)
Reading Fluency	5.37 (10.45)
Reading Comprehension	-1.84 (6.98)
Spelling	2.21 (5.70)
Spelling of Sounds	-2.16 (18.35)
Basic Reading Skills	-3.58 (5.10)
Passage Comprehension	-2.11 (7.89)

71. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline CTOPP measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Phonological Awareness	3.63 (11.12)
Phonological Memory	2.05 (3.88)
Rapid Naming Score	0.63 (10.75)

72. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Oral Reading Rate	0.74 (1.52)
Accuracy	0.68 (2.60)
Fluency	0.74 (1.97)
Reading Comprehension	-0.16 (2.95)
Oral Reading Quotient	-3.42 (24.58)

73. Secondary Outcome

Title	Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants
Description	The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline TOWRE measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Least Squares Mean (Standard Error) [units on a scale]	0.20 (1.487)

74. Secondary Outcome

Title	Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Digit Recall Score	2.47 (4.50)
Word List Matching Score	-0.95 (5.38)
Word List Recall Score	1.79 (2.53)
Nonword List Recall Score	0.58 (4.31)
Block Recall Score	1.63 (4.83)
Mazes Memory Score	1.11 (7.72)
Listening Recall Score	-0.58 (3.61)
Counting Recall Score	0.37 (3.44)
Backward Digit Recall Score	2.95 (4.17)

75. Secondary Outcome

Title	Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
Description	The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All participants who had evaluable baseline and post baseline BADD-A measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Least Squares Mean (Standard Error) [units on a scale]	1.42 (3.572)

76. Secondary Outcome

Title	Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants
Description	The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.
Time Frame	Baseline, 16 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Least Squares Mean (Standard Error) [units on a scale]	0.15 (1.055)

77. Secondary Outcome

Title	Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Description	WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had baseline and post-baseline WJ III measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Letter Word Identification	-0.37 (5.45)
Word Attack Score	-3.58 (7.23)
Reading Vocabulary	0.79 (7.79)
Reading Comprehension	0.47 (7.99)
Reading Fluency	7.84 (11.69)
Spelling	1.95 (4.49)
Spelling of Sounds	3.63 (18.94)
Basic Reading Skills Score	-2.00 (5.35)
Passage Comprehension	0.05 (9.34)

78. Secondary Outcome

Title	Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Description	The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.
Time Frame	Baseline, 32 weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline CTOPP measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Phonological Awareness	3.63 (11.12)
Phonological Memory	2.05 (3.88)
Rapid Naming Score	0.63 (10.75)

79. Secondary Outcome

Title	Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Description	The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Oral Reading Rate	0.74 (1.52)
Accuracy	0.68 (2.60)
Fluency	0.74 (1.97)
Comprehension	-0.16 (2.95)
Oral Reading Quotient	-3.42 (24.58)

80. Secondary Outcome

Title	Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants
Description	The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline TOWRE measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Least Squares Mean (Standard Error) [units on a scale]	4.05 (1.578)

81. Secondary Outcome

Title	Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Description	WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Digit Recall Score	2.47 (4.50)
Word List Matching Score	-0.95 (5.38)
Word List Recall Score	1.79 (2.53)
Nonword List Recall Score	0.58 (4.31)
Block Recall Score	1.63 (4.83)
Mazes Memory Score	1.11 (7.72)
Listening Recall Score	-0.58 (3.61)
Counting Recall Score	0.37 (3.44)
Backwards Digit Recall Score	2.95 (4.17)

82. Secondary Outcome

Title	Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
Description	The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline BADD-A measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Least Squares Mean (Standard Error) [units on a scale]	5.74 (3.991)

83. Secondary Outcome

Title	Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants
Description	The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.
Time Frame	Baseline, 32 Weeks

Outcome Measure Data

Analysis Population Description

All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.

Arm/Group Title	Healthy Participants
Arm/Group Description	Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Measure Participants	19
Least Squares Mean (Standard Error) [units on a scale]	1.17 (1.046)

Adverse Events

Adverse Event Reporting Description	The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
Arm/Group Title	Atomoxetine		Placebo		ATX/ATX		ATX/PLA		PLA/ATX
Arm/Group Description	Atomoxetine 1.0 to 1.4 mg/kg was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.		Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.		These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.		These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.		These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
All Cause Mortality
	Atomoxetine		Placebo		ATX/ATX		ATX/PLA		PLA/ATX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Atomoxetine		Placebo		ATX/ATX		ATX/PLA		PLA/ATX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/44 (0%)		0/18 (0%)		0/18 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Atomoxetine		Placebo		ATX/ATX		ATX/PLA		PLA/ATX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/45 (77.8%)		31/44 (70.5%)		8/18 (44.4%)		8/18 (44.4%)		25/35 (71.4%)
Gastrointestinal disorders
Abdominal discomfort	0/45 (0%)	0	4/44 (9.1%)	4	0/18 (0%)	0	0/18 (0%)	0	2/35 (5.7%)	2
Abdominal pain upper	10/45 (22.2%)	10	12/44 (27.3%)	12	0/18 (0%)	0	0/18 (0%)	0	4/35 (11.4%)	4
Constipation	0/45 (0%)	0	1/44 (2.3%)	1	0/18 (0%)	0	1/18 (5.6%)	1	0/35 (0%)	0
Nausea	7/45 (15.6%)	7	5/44 (11.4%)	5	0/18 (0%)	0	0/18 (0%)	0	1/35 (2.9%)	1
Vomiting	2/45 (4.4%)	2	0/44 (0%)	0	0/18 (0%)	0	1/18 (5.6%)	1	2/35 (5.7%)	2
General disorders
Fatigue	15/45 (33.3%)	15	5/44 (11.4%)	5	0/18 (0%)	0	1/18 (5.6%)	1	3/35 (8.6%)	3
Therapeutic response unexpected	13/45 (28.9%)	20	10/44 (22.7%)	12	2/18 (11.1%)	2	3/18 (16.7%)	5	5/35 (14.3%)	6
Infections and infestations
Influenza	3/45 (6.7%)	3	2/44 (4.5%)	2	1/18 (5.6%)	1	0/18 (0%)	0	0/35 (0%)	0
Rhinitis	4/45 (8.9%)	4	4/44 (9.1%)	4	0/18 (0%)	0	0/18 (0%)	0	1/35 (2.9%)	1
Upper respiratory tract infection	1/45 (2.2%)	1	2/44 (4.5%)	2	1/18 (5.6%)	1	1/18 (5.6%)	1	2/35 (5.7%)	2
Injury, poisoning and procedural complications
Animal bite	0/45 (0%)	0	0/44 (0%)	0	1/18 (5.6%)	1	0/18 (0%)	0	0/35 (0%)	0
Contusion	1/45 (2.2%)	1	3/44 (6.8%)	4	0/18 (0%)	0	0/18 (0%)	0	0/35 (0%)	0
Joint dislocation	0/45 (0%)	0	0/44 (0%)	0	0/18 (0%)	0	1/18 (5.6%)	1	0/35 (0%)	0
Investigations
Monocyte count decreased	0/45 (0%)	0	0/44 (0%)	0	1/18 (5.6%)	1	0/18 (0%)	0	0/35 (0%)	0
Neutrophil count decreased	0/45 (0%)	0	0/44 (0%)	0	1/18 (5.6%)	1	0/18 (0%)	0	0/35 (0%)	0
Weight decreased	8/45 (17.8%)	8	2/44 (4.5%)	2	0/18 (0%)	0	0/18 (0%)	0	9/35 (25.7%)	9
White blood cell count decreased	0/45 (0%)	0	0/44 (0%)	0	1/18 (5.6%)	1	0/18 (0%)	0	0/35 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	8/45 (17.8%)	8	2/44 (4.5%)	2	0/18 (0%)	0	0/18 (0%)	0	8/35 (22.9%)	8
Increased appetite	1/45 (2.2%)	1	3/44 (6.8%)	3	0/18 (0%)	0	0/18 (0%)	0	0/35 (0%)	0
Musculoskeletal and connective tissue disorders
Tendonitis	0/45 (0%)	0	0/44 (0%)	0	1/18 (5.6%)	1	0/18 (0%)	0	0/35 (0%)	0
Nervous system disorders
Disturbance in attention	0/45 (0%)	0	0/44 (0%)	0	0/18 (0%)	0	1/18 (5.6%)	1	1/35 (2.9%)	1
Dizziness	4/45 (8.9%)	4	0/44 (0%)	0	0/18 (0%)	0	0/18 (0%)	0	1/35 (2.9%)	1
Headache	12/45 (26.7%)	12	6/44 (13.6%)	6	0/18 (0%)	0	0/18 (0%)	0	3/35 (8.6%)	3
Psychomotor hyperactivity	0/45 (0%)	0	0/44 (0%)	0	0/18 (0%)	0	1/18 (5.6%)	1	0/35 (0%)	0
Somnolence	0/45 (0%)	0	0/44 (0%)	0	1/18 (5.6%)	1	1/18 (5.6%)	1	0/35 (0%)	0
Psychiatric disorders
Abnormal behaviour	0/45 (0%)	0	2/44 (4.5%)	2	0/18 (0%)	0	0/18 (0%)	0	2/35 (5.7%)	2
Attention deficit/hyperactivity disorder	0/45 (0%)	0	0/44 (0%)	0	0/18 (0%)	0	1/18 (5.6%)	1	0/35 (0%)	0
Emotional disorder	3/45 (6.7%)	3	1/44 (2.3%)	1	0/18 (0%)	0	0/18 (0%)	0	4/35 (11.4%)	4
Initial insomnia	0/45 (0%)	0	1/44 (2.3%)	1	0/18 (0%)	0	1/18 (5.6%)	1	2/35 (5.7%)	2
Irritability	3/45 (6.7%)	3	1/44 (2.3%)	1	0/18 (0%)	0	0/18 (0%)	0	5/35 (14.3%)	5
Mood swings	1/45 (2.2%)	1	0/44 (0%)	0	0/18 (0%)	0	1/18 (5.6%)	1	0/35 (0%)	0
Nightmare	0/45 (0%)	0	3/44 (6.8%)	3	0/18 (0%)	0	0/18 (0%)	0	0/35 (0%)	0
Personality change	0/45 (0%)	0	0/44 (0%)	0	0/18 (0%)	0	1/18 (5.6%)	1	0/35 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	0/18 (0%)	0	0/17 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/12 (8.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	3/45 (6.7%)	3	4/44 (9.1%)	4	0/18 (0%)	0	0/18 (0%)	0	0/35 (0%)	0
Nasal congestion	3/45 (6.7%)	3	2/44 (4.5%)	2	0/18 (0%)	0	0/18 (0%)	0	0/35 (0%)	0
Oropharyngeal pain	0/45 (0%)	0	0/44 (0%)	0	2/18 (11.1%)	2	1/18 (5.6%)	1	1/35 (2.9%)	1
Skin and subcutaneous tissue disorders
Skin hyperpigmentation	0/45 (0%)	0	0/44 (0%)	0	1/18 (5.6%)	1	0/18 (0%)	0	0/35 (0%)	0
Social circumstances
Educational problem	1/45 (2.2%)	1	1/44 (2.3%)	1	0/18 (0%)	0	1/18 (5.6%)	1	0/35 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.