Trial Outcomes & Findings for Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia (NCT NCT00607919)

NCT ID: NCT00607919

Last Updated: 2011-12-15

Results Overview

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 209 participants
• Primary outcome timeframe: Baseline, 16 weeks
• Results posted on: 2011-12-15

Participant Flow

The study comprised a 16-week placebo-controlled, double-blind acute phase and followed by an optional 16-week open-label in which all participants were treated with Atomoxetine.

Participant milestones

Measure	Atomoxetine/Atomoxetine Participants were assigned to Atomoxetine treatment in both acute and open-label phase Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	Placebo/Atomoxetine Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Acute Phase STARTED	120	89
Acute Phase COMPLETED	86	73
Acute Phase NOT COMPLETED	34	16
Open-Label Phase STARTED	84	71
Open-Label Phase COMPLETED	74	59
Open-Label Phase NOT COMPLETED	10	12

Reasons for withdrawal

Measure	Atomoxetine/Atomoxetine Participants were assigned to Atomoxetine treatment in both acute and open-label phase Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	Placebo/Atomoxetine Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Acute Phase Adverse Event	9	2
Acute Phase Entry Criteria Not Met	1	1
Acute Phase Lack of Efficacy	1	2
Acute Phase Lost to Follow-up	9	3
Acute Phase Parent/Caregiver Decision	6	4
Acute Phase Protocol Violation	5	1
Acute Phase Withdrawal by Subject	3	3
Open-Label Phase Adverse Event	1	5
Open-Label Phase Lost to Follow-up	4	1
Open-Label Phase Protocol Violation	2	2
Open-Label Phase Withdrawal by Subject	2	2
Open-Label Phase Parent/Caregiver Decision	1	2

Baseline Characteristics

Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia

Baseline characteristics by cohort

Measure	Atomoxetine/Atomoxetine n=120 Participants Participants were assigned to Atomoxetine treatment in both acute and open-label phase Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	Placebo/Atomoxetine n=89 Participants Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	Total n=209 Participants Total of all reporting groups
Age Continuous	12.24 years STANDARD_DEVIATION 1.72 • n=5 Participants	12.44 years STANDARD_DEVIATION 1.90 • n=7 Participants	12.32 years STANDARD_DEVIATION 1.80 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	34 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	55 Participants n=7 Participants	129 Participants n=5 Participants
Race/Ethnicity, Customized African	13 participants n=5 Participants	11 participants n=7 Participants	24 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	86 participants n=5 Participants	66 participants n=7 Participants	152 participants n=5 Participants
Race/Ethnicity, Customized East Asian	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	18 participants n=5 Participants	11 participants n=7 Participants	29 participants n=5 Participants
Race/Ethnicity, Customized West Asian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	120 participants n=5 Participants	89 participants n=7 Participants	209 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result.

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=47 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=54 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint	-20.01 units on a scale Standard Error 1.45	-12.27 units on a scale Standard Error 1.41	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

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). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=62 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=58 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=27 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint Hyperactivity-Impulsivity Score	-8.23 units on a scale Standard Deviation 5.90	-5.18 units on a scale Standard Deviation 6.01	-6.26 units on a scale Standard Deviation 5.10
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint Inattention Score	-10.64 units on a scale Standard Deviation 7.59	-7.79 units on a scale Standard Deviation 6.52	-10.33 units on a scale Standard Deviation 7.95
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint Total Score	-18.87 units on a scale Standard Deviation 11.68	-12.98 units on a scale Standard Deviation 10.75	-16.59 units on a scale Standard Deviation 11.31

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

The ADHDRS-IV-Teacher 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). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=21 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=22 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=11 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint Hyperactivity-Impulsivity Score	-2.71 units on a scale Standard Deviation 3.98	-1.99 units on a scale Standard Deviation 6.54	-0.82 units on a scale Standard Deviation 4.92
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint Inattention Score	-4.48 units on a scale Standard Deviation 5.17	-0.99 units on a scale Standard Deviation 5.33	-2.27 units on a scale Standard Deviation 5.24
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint Total Score	-7.19 units on a scale Standard Deviation 6.83	-2.98 units on a scale Standard Deviation 10.83	-3.09 units on a scale Standard Deviation 9.21

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=51 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=55 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=22 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint Basic Reading Skills (Tests 1, 13)	1.75 units on a scale Standard Deviation 6.04	0.87 units on a scale Standard Deviation 6.75	-0.41 units on a scale Standard Deviation 7.99
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint Letter-Word Identification (Test 1)	1.18 units on a scale Standard Deviation 7.20	-0.07 units on a scale Standard Deviation 6.63	-0.32 units on a scale Standard Deviation 8.04
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint Passage Comprehension (Test 9)	-0.92 units on a scale Standard Deviation 11.43	-1.02 units on a scale Standard Deviation 8.94	-4.50 units on a scale Standard Deviation 9.04
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint Reading Comprehension (Test 9, 17)	-0.08 units on a scale Standard Deviation 9.68	-1.09 units on a scale Standard Deviation 8.81	-5.00 units on a scale Standard Deviation 7.45
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint Reading Fluency (Test 2)	-0.24 units on a scale Standard Deviation 7.91	-0.11 units on a scale Standard Deviation 9.19	1.36 units on a scale Standard Deviation 8.77
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint Reading Vocabulary (Test 17)	0.51 units on a scale Standard Deviation 8.92	-0.16 units on a scale Standard Deviation 9.45	-3.95 units on a scale Standard Deviation 8.60
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint Spelling (Test 7)	-0.22 units on a scale Standard Deviation 7.32	-4.16 units on a scale Standard Deviation 12.13	-0.41 units on a scale Standard Deviation 5.68
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint Spelling of Sounds (Test 20)	5.67 units on a scale Standard Deviation 16.07	3.31 units on a scale Standard Deviation 13.49	8.45 units on a scale Standard Deviation 19.78
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint Word Attack (Test 13)	2.27 units on a scale Standard Deviation 6.75	1.13 units on a scale Standard Deviation 9.75	-0.36 units on a scale Standard Deviation 7.88

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

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.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=51 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=55 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=22 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint Phonological Memory	2.22 units on a scale Standard Deviation 10.61	0.96 units on a scale Standard Deviation 10.16	1.36 units on a scale Standard Deviation 11.33
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint Rapid Digit Naming	0.26 units on a scale Standard Deviation 2.06	0.16 units on a scale Standard Deviation 1.75	0.23 units on a scale Standard Deviation 1.23
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint Rapid Letter Naming	0.31 units on a scale Standard Deviation 1.76	0.24 units on a scale Standard Deviation 1.64	0.14 units on a scale Standard Deviation 1.52
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint Rapid Naming	1.06 units on a scale Standard Deviation 11.00	0.35 units on a scale Standard Deviation 9.75	-0.59 units on a scale Standard Deviation 10.83
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint Phonological Awareness	5.20 units on a scale Standard Deviation 9.49	2.00 units on a scale Standard Deviation 9.34	6.82 units on a scale Standard Deviation 11.50
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint Memory for Digits	0.47 units on a scale Standard Deviation 2.16	0.13 units on a scale Standard Deviation 1.76	-0.50 units on a scale Standard Deviation 1.90
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint Non-word Repetition	0.57 units on a scale Standard Deviation 1.79	0.51 units on a scale Standard Deviation 2.00	0.82 units on a scale Standard Deviation 2.52
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint Blending Words	0.96 units on a scale Standard Deviation 1.90	0.95 units on a scale Standard Deviation 1.97	1.86 units on a scale Standard Deviation 1.86
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint Elision	0.88 units on a scale Standard Deviation 2.18	-0.24 units on a scale Standard Deviation 2.34	0.27 units on a scale Standard Deviation 1.91

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

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.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=51 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=55 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=21 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint Accuracy Score	0.71 units on a scale Standard Deviation 2.22	0.40 units on a scale Standard Deviation 2.02	0.95 units on a scale Standard Deviation 2.16
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint Comprehension Score	0.37 units on a scale Standard Deviation 2.35	0.65 units on a scale Standard Deviation 2.50	-0.33 units on a scale Standard Deviation 1.93
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint Fluency Score	0.78 units on a scale Standard Deviation 2.81	0.33 units on a scale Standard Deviation 2.82	1.14 units on a scale Standard Deviation 2.94
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint Oral Reading Quotient	-1.43 units on a scale Standard Deviation 23.34	2.87 units on a scale Standard Deviation 20.43	2.43 units on a scale Standard Deviation 10.93
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint Rate Score	0.20 units on a scale Standard Deviation 1.65	0.05 units on a scale Standard Deviation 1.54	0.38 units on a scale Standard Deviation 2.27

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

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. Scores range from 45-146. Higher scores indicate higher reading proficiency.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=61 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=57 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=26 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint Phonemic Decoding Efficiency	1.92 units on a scale Standard Deviation 6.01	1.21 units on a scale Standard Deviation 5.19	1.77 units on a scale Standard Deviation 6.78
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint Sight Word Efficiency	1.38 units on a scale Standard Deviation 5.78	1.19 units on a scale Standard Deviation 4.80	0.69 units on a scale Standard Deviation 8.84
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint Total Word Reading Efficiency Standard Score	-0.57 units on a scale Standard Deviation 21.98	2.81 units on a scale Standard Deviation 11.90	-5.88 units on a scale Standard Deviation 25.98

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) 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).

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=54 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=56 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=23 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Phonological Loop Component Score (n=51, 54, 21)	3.57 units on a scale Standard Deviation 10.79	1.63 units on a scale Standard Deviation 9.00	2.24 units on a scale Standard Deviation 9.78
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Central Executive Component Score (n=41, 44,12)	7.34 units on a scale Standard Deviation 10.65	-0.89 units on a scale Standard Deviation 13.65	2.17 units on a scale Standard Deviation 11.77
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Visuo-Spatial Sketchpad Score (n=47, 43, 21)	4.15 units on a scale Standard Deviation 11.96	-0.47 units on a scale Standard Deviation 12.85	3.67 units on a scale Standard Deviation 10.77
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Digit Recall (n=54, 56, 23)	0.17 units on a scale Standard Deviation 3.42	0.55 units on a scale Standard Deviation 3.01	0.22 units on a scale Standard Deviation 4.45
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Word List Matching (n=54, 56, 23)	-0.20 units on a scale Standard Deviation 7.08	0.05 units on a scale Standard Deviation 8.65	2.04 units on a scale Standard Deviation 9.24
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Word List Recall (n=54, 56, 23)	1.00 units on a scale Standard Deviation 3.29	0.02 units on a scale Standard Deviation 3.15	0.35 units on a scale Standard Deviation 2.98
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Non-Word List Recall (n=53, 56, 23)	0.89 units on a scale Standard Deviation 2.74	0.71 units on a scale Standard Deviation 2.20	0.43 units on a scale Standard Deviation 3.53
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Block Recall (n=54, 56, 23)	-0.37 units on a scale Standard Deviation 4.20	-0.80 units on a scale Standard Deviation 4.18	0.70 units on a scale Standard Deviation 4.24
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Mazes Memory (n=54, 56, 23)	1.94 units on a scale Standard Deviation 5.90	1.18 units on a scale Standard Deviation 5.94	0.78 units on a scale Standard Deviation 7.33
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Listening Recall (n=54, 56, 23)	1.52 units on a scale Standard Deviation 3.32	1.00 units on a scale Standard Deviation 3.77	0.04 units on a scale Standard Deviation 5.90
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Counting Recall (n=54, 56, 23)	0.50 units on a scale Standard Deviation 4.63	0.45 units on a scale Standard Deviation 5.07	0.48 units on a scale Standard Deviation 5.41
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint Backward Digit Recall (n=54, 56, 23)	1.30 units on a scale Standard Deviation 3.87	0.16 units on a scale Standard Deviation 3.62	1.26 units on a scale Standard Deviation 4.20

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=58 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=57 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=26 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint LPS Happy/Social Score	0.57 units on a scale Standard Deviation 4.19	0.53 units on a scale Standard Deviation 4.80	1.38 units on a scale Standard Deviation 3.73
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint LPS Self Control Score	6.06 units on a scale Standard Deviation 8.54	4.29 units on a scale Standard Deviation 10.60	7.49 units on a scale Standard Deviation 8.46
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint LPS Total Score	6.51 units on a scale Standard Deviation 11.61	4.82 units on a scale Standard Deviation 14.20	9.05 units on a scale Standard Deviation 10.63

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=56 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=57 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=23 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint Total Score-Parent Variation (n= 56, 57, 23)	-7.82 units on a scale Standard Deviation 10.98	-4.64 units on a scale Standard Deviation 9.67	-8.24 units on a scale Standard Deviation 9.90
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint Total Score-Teacher Variation (n= 22, 22, 11)	-8.82 units on a scale Standard Deviation 11.77	-1.64 units on a scale Standard Deviation 6.53	-3.47 units on a scale Standard Deviation 8.83
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint Total Score-Youth Variation (n= 56, 57, 23)	-4.71 units on a scale Standard Deviation 9.27	-4.21 units on a scale Standard Deviation 6.85	-6.17 units on a scale Standard Deviation 7.71

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=58 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=57 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine n=25 Participants Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint Physical Standard Section Score	4.09 units on a scale Standard Deviation 10.34	1.32 units on a scale Standard Deviation 12.06	3.04 units on a scale Standard Deviation 5.99
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint Family Standard Section Score	0.39 units on a scale Standard Deviation 12.52	-3.12 units on a scale Standard Deviation 11.66	-1.00 units on a scale Standard Deviation 12.26
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint Academic Standard Section Score	5.91 units on a scale Standard Deviation 9.01	4.23 units on a scale Standard Deviation 12.77	5.52 units on a scale Standard Deviation 6.78
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint Affect Standard Section Score	3.62 units on a scale Standard Deviation 10.32	2.35 units on a scale Standard Deviation 10.81	3.56 units on a scale Standard Deviation 10.58
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint Competence Standard Section Score	6.64 units on a scale Standard Deviation 12.99	4.95 units on a scale Standard Deviation 12.05	5.20 units on a scale Standard Deviation 9.06
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint Social Standard Section Score	4.36 units on a scale Standard Deviation 11.73	2.72 units on a scale Standard Deviation 11.14	3.88 units on a scale Standard Deviation 10.39
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint Standard Total Score	4.72 units on a scale Standard Deviation 9.47	1.98 units on a scale Standard Deviation 10.19	3.44 units on a scale Standard Deviation 7.70

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

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). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=45 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=21 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint Hyperactivity-Impulsivity Score	-9.8 units on a scale Standard Deviation 6.17	-8.29 units on a scale Standard Deviation 4.61	—
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint Inattention Score	-13.84 units on a scale Standard Deviation 6.56	-14.33 units on a scale Standard Deviation 7.16	—
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint Total Score	-23.64 units on a scale Standard Deviation 10.43	-22.62 units on a scale Standard Deviation 9.07	—

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

The ADHDRS-IV-Teacher 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). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=23 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=9 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint Hyperactivity-Impulsivity Score	-1.87 units Standard Deviation 4.80	-2.89 units Standard Deviation 4.48	—
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint Inattention Score	-4.28 units Standard Deviation 6.08	-4.19 units Standard Deviation 4.11	—
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint Total Score	-6.15 units Standard Deviation 8.51	-7.08 units Standard Deviation 7.34	—

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=45 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=21 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint Basic Reading Skills (Tests 1, 13	2.73 units on a scale Standard Deviation 6.51	-0.24 units on a scale Standard Deviation 5.37	—
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint Letter-Word Identification (Test 1)	1.69 units on a scale Standard Deviation 7.19	0.24 units on a scale Standard Deviation 5.73	—
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint Passage Comprehension (Test 9)	2.31 units on a scale Standard Deviation 9.18	1.24 units on a scale Standard Deviation 5.63	—
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint Reading Comprehension (Tests 9, 17)	2.89 units on a scale Standard Deviation 9.07	0.86 units on a scale Standard Deviation 7.04	—
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint Reading Fluency (Test 2)	2.69 units on a scale Standard Deviation 9.04	3.24 units on a scale Standard Deviation 8.64	—
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint Reading Vocabulary (Test 17)	2.60 units on a scale Standard Deviation 8.55	-0.14 units on a scale Standard Deviation 10.57	—
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint Spelling (Test 7)	0.60 units on a scale Standard Deviation 7.74	0.38 units on a scale Standard Deviation 5.96	—
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint Spelling of Sounds (Test 20)	2.98 units on a scale Standard Deviation 10.77	5.90 units on a scale Standard Deviation 14.17	—
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint Word Attack (Test 13)	3.27 units on a scale Standard Deviation 7.09	-0.90 units on a scale Standard Deviation 6.59	—

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

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.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=45 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=21 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint Blending Words	1.31 units on a scale Standard Deviation 2.01	1.90 units on a scale Standard Deviation 2.98	—
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint Elision	1.07 units on a scale Standard Deviation 2.00	0.71 units on a scale Standard Deviation 3.05	—
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint Memory for Digits	0.87 units on a scale Standard Deviation 2.17	-0.05 units on a scale Standard Deviation 2.13	—
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint Rapid Letter Naming	0.43 units on a scale Standard Deviation 2.06	0.90 units on a scale Standard Deviation 2.34	—
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint Non-word Repetition	0.93 units on a scale Standard Deviation 2.27	0.43 units on a scale Standard Deviation 3.03	—
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint Phonological Awareness	7.33 units on a scale Standard Deviation 9.50	5.33 units on a scale Standard Deviation 15.99	—
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint Phonological Memory	4.93 units on a scale Standard Deviation 10.57	-0.67 units on a scale Standard Deviation 12.44	—
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint Rapid Digit Naming	0.43 units on a scale Standard Deviation 1.91	0.62 units on a scale Standard Deviation 2.31	—
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint Rapid Naming	1.30 units on a scale Standard Deviation 11.27	1.76 units on a scale Standard Deviation 12.35	—

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

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.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=45 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=20 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint Accuracy Score	0.82 units on a scale Standard Deviation 1.30	0.95 units on a scale Standard Deviation 1.82	—
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint Comprehension Score	0.04 units on a scale Standard Deviation 1.73	-0.30 units on a scale Standard Deviation 1.59	—
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint Fluency Score	0.76 units on a scale Standard Deviation 1.40	1.10 units on a scale Standard Deviation 2.63	—
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint Oral Reading Quotient	2.64 units on a scale Standard Deviation 15.05	-1.30 units on a scale Standard Deviation 21.22	—
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint Rate Score	0.58 units on a scale Standard Deviation 1.74	0.15 units on a scale Standard Deviation 1.98	—

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

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. Scores range from 45-146. Higher scores indicate higher reading proficiency.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=45 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=21 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint Phonemic Decoding Efficiency	2.64 units on a scale Standard Deviation 6.54	5.33 units on a scale Standard Deviation 6.98	—
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint Sight Word Efficiency	1.93 units on a scale Standard Deviation 6.51	4.62 units on a scale Standard Deviation 8.74	—
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint Total Word Reading Efficiency Standard Score	2.56 units on a scale Standard Deviation 17.35	1.52 units on a scale Standard Deviation 20.64	—

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) 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).

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=45 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=21 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Phonological Loop Component Score (n=43, 20)	3.67 units on a scale Standard Deviation 11.27	1.70 units on a scale Standard Deviation 9.66	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Central Executive Component Score (n=38, 14)	6.53 units on a scale Standard Deviation 11.34	1.64 units on a scale Standard Deviation 11.30	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Visuo-Spatial Sketchpad Component Score (n=40, 20)	3.85 units on a scale Standard Deviation 12.89	2.65 units on a scale Standard Deviation 9.96	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Digit Recall (n=45, 21)	-0.04 units on a scale Standard Deviation 2.92	0.52 units on a scale Standard Deviation 4.08	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Word List Matching (n=45, 21)	2.38 units on a scale Standard Deviation 7.96	1.95 units on a scale Standard Deviation 8.22	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Word List Recall (n=45, 21)	1.49 units on a scale Standard Deviation 3.00	0.33 units on a scale Standard Deviation 2.50	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Non-Word List Recall (n=44, 21)	0.55 units on a scale Standard Deviation 2.90	-0.67 units on a scale Standard Deviation 4.39	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Block Recall (n=45, 21)	0.71 units on a scale Standard Deviation 3.88	1.05 units on a scale Standard Deviation 4.24	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Mazes Memory (n=45, 21)	2.33 units on a scale Standard Deviation 7.04	3.48 units on a scale Standard Deviation 7.77	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Listening Recall (n=45, 21)	2.18 units on a scale Standard Deviation 4.01	-1.05 units on a scale Standard Deviation 6.42	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Counting Recall (n=45, 21)	1.53 units on a scale Standard Deviation 4.65	1.24 units on a scale Standard Deviation 6.54	—
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint Backward Digit Recall (n=45, 21)	1.07 units on a scale Standard Deviation 3.24	2.29 units on a scale Standard Deviation 5.20	—

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=45 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=21 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint LPS Happy/Social Score (n=45, 21)	1.57 units on a scale Standard Deviation 4.37	2.14 units on a scale Standard Deviation 4.30	—
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint LPS Self Control Score (n=45, 20)	9.10 units on a scale Standard Deviation 10.73	10.44 units on a scale Standard Deviation 10.42	—
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint LPS Total Score (n=45, 20)	10.67 units on a scale Standard Deviation 14.27	12.64 units on a scale Standard Deviation 13.95	—

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=45 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=21 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint Total Score-Parent Variation (n=45, 21)	-10.40 units on a scale Standard Deviation 11.94	-10.83 units on a scale Standard Deviation 10.84	—
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint Total Score-Teacher Variation (n=23, 9)	-7.00 units on a scale Standard Deviation 12.82	-7.89 units on a scale Standard Deviation 5.18	—
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint Total Score-Youth Variation (n=45, 21)	-4.36 units on a scale Standard Deviation 7.57	-5.43 units on a scale Standard Deviation 8.44	—

SECONDARY outcome

Timeframe: Baseline, 32 weeks

Population: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).

The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).

Outcome measures

Measure	ADHD+ Dyslexia (D): Atomoxetine n=45 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD+ Dyslexia (D): Placebo n=21 Participants Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine	ADHD Alone: Atomoxetine Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint Social Standard Section Score	4.84 units on a scale Standard Deviation 11.84	2.38 units on a scale Standard Deviation 11.75	—
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint Academic Standard Section Score	6.02 units on a scale Standard Deviation 9.72	5.43 units on a scale Standard Deviation 6.98	—
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint Affect Standard Section Score	4.29 units on a scale Standard Deviation 11.14	3.14 units on a scale Standard Deviation 10.45	—
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint Competence Standard Section Score	6.76 units on a scale Standard Deviation 11.77	5.19 units on a scale Standard Deviation 7.94	—
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint Family Standard Section Score	0.16 units on a scale Standard Deviation 14.40	0.33 units on a scale Standard Deviation 9.79	—
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint Physical Standard Section Score	6.09 units on a scale Standard Deviation 12.00	2.43 units on a scale Standard Deviation 7.20	—
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint Standard Total Score	5.61 units on a scale Standard Deviation 10.82	3.48 units on a scale Standard Deviation 7.21	—

Adverse Events

Atomoxetine/Atomoxetine

Serious events: 1 serious events

Other events: 108 other events

Deaths: 0 deaths

Placebo/Atomoxetine

Serious events: 0 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Measure	Atomoxetine/Atomoxetine n=120 participants at risk Participants were assigned to Atomoxetine treatment in both acute and open-label phase Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with atomoxetine	Placebo/Atomoxetine n=89 participants at risk Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Infections and infestations Wound infection staphylococcal	0.83% 1/120 • Number of events 1	0.00% 0/89

Other adverse events

Measure	Atomoxetine/Atomoxetine n=120 participants at risk Participants were assigned to Atomoxetine treatment in both acute and open-label phase Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with atomoxetine	Placebo/Atomoxetine n=89 participants at risk Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
Gastrointestinal disorders Abdominal discomfort	5.8% 7/120 • Number of events 8	2.2% 2/89 • Number of events 2
Gastrointestinal disorders Abdominal pain upper	19.2% 23/120 • Number of events 31	6.7% 6/89 • Number of events 8
Gastrointestinal disorders Diarrhoea	5.8% 7/120 • Number of events 7	3.4% 3/89 • Number of events 3
Gastrointestinal disorders Nausea	28.3% 34/120 • Number of events 42	5.6% 5/89 • Number of events 6
Gastrointestinal disorders Vomiting	13.3% 16/120 • Number of events 24	9.0% 8/89 • Number of events 9
General disorders Fatigue	25.8% 31/120 • Number of events 34	10.1% 9/89 • Number of events 11
General disorders Irritability	11.7% 14/120 • Number of events 15	9.0% 8/89 • Number of events 11
General disorders Pyrexia	1.7% 2/120 • Number of events 3	6.7% 6/89 • Number of events 6
General disorders Therapeutic response unexpected	5.0% 6/120 • Number of events 12	2.2% 2/89 • Number of events 2
Investigations Weight decreased	5.0% 6/120 • Number of events 6	1.1% 1/89 • Number of events 1
Metabolism and nutrition disorders Decreased appetite	18.3% 22/120 • Number of events 22	4.5% 4/89 • Number of events 5
Nervous system disorders Dizziness	12.5% 15/120 • Number of events 16	5.6% 5/89 • Number of events 5
Nervous system disorders Headache	22.5% 27/120 • Number of events 36	18.0% 16/89 • Number of events 21
Nervous system disorders Somnolence	8.3% 10/120 • Number of events 12	0.00% 0/89
Psychiatric disorders Aggression	5.0% 6/120 • Number of events 6	0.00% 0/89
Respiratory, thoracic and mediastinal disorders Cough	5.0% 6/120 • Number of events 6	9.0% 8/89 • Number of events 8
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 6/120 • Number of events 6	6.7% 6/89 • Number of events 6
Skin and subcutaneous tissue disorders Rash	5.0% 6/120 • Number of events 6	6.7% 6/89 • Number of events 6

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60