Trial Outcomes & Findings for A Study to Test Different Ways to Measure the Effect of Atomoxetine on Impulsive Behavior in Young Adults With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT05278104)

Last Updated: 2025-11-14

Results Overview

The BIS-11 evaluates impulsiveness via 30 items scored on a 4-point scale (Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4). Total scores range from 30 (least impulsive) to 120 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness. The data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \<90% of planned doses), their data were included in the analysis only up to the point of discontinuation. Reported summary data was based on an ANCOVA with the BIS-11 score at baseline as a covariate and the treatment arm as fixed factor.

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.

Results posted on

2025-11-14

Participant Flow

This was a multi-center, randomized, double-blind, placebo controlled parallel-group trial in participants with attention deficit hyperactivity disorder (ADHD). Eligible participants were randomized in a 1:1 ratio to receive either placebo or atomoxetine during a 2-week double-blind treatment period.

63 male and female participants (32 atomoxetine, 31 placebo) were randomized and 62 participants were treated. Out of these, 58 completed the planned treatment and trial per protocol; 2 were erroneously randomized and discontinued (one treated and one not treated); 3 discontinued due to other reasons. All participants were free to withdraw at any time and were closely monitored.

Participant milestones

Participant milestones
Measure	Atomoxetine Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Placebo (Matching Atomoxetine) Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.
Overall Study STARTED	32	31
Overall Study Number of Patients Treated	31	31
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Atomoxetine Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Placebo (Matching Atomoxetine) Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.
Overall Study Not treated	1	0
Overall Study Adverse Event	2	1
Overall Study Exclusion criteria not met	1	0

Baseline Characteristics

A Study to Test Different Ways to Measure the Effect of Atomoxetine on Impulsive Behavior in Young Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atomoxetine n=31 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Placebo (Matching Atomoxetine) n=31 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.	Total n=62 Participants Total of all reporting groups
Age, Continuous	25.4 Years STANDARD_DEVIATION 3.3 • n=10 Participants	27.4 Years STANDARD_DEVIATION 4.4 • n=10 Participants	26.4 Years STANDARD_DEVIATION 4.0 • n=20 Participants
Sex: Female, Male Female	15 Participants n=10 Participants	17 Participants n=10 Participants	32 Participants n=20 Participants
Sex: Female, Male Male	16 Participants n=10 Participants	14 Participants n=10 Participants	30 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=10 Participants	22 Participants n=10 Participants	48 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=10 Participants	9 Participants n=10 Participants	14 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Race (NIH/OMB) Black or African American	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Race (NIH/OMB) White	27 Participants n=10 Participants	27 Participants n=10 Participants	54 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants

PRIMARY outcome

Timeframe: Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.

Population: All randomized participants who received one dose of the study drug (placebo or atomoxetine) on Day 1 and had study data available.

Outcome measures

Outcome measures
Measure	Atomoxetine n=30 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Placebo (Matching Atomoxetine) n=31 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.
Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) After Single Dose (at Day 1)	-0.8 Score on a scale Interval -2.3 to 0.8	-0.4 Score on a scale Interval -1.9 to 1.1

PRIMARY outcome

Timeframe: Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.

Population: All randomized participants who received at least 90% (not more than one missed dose) of the planned doses of the study drug (placebo or atomoxetine) up to Day 14 and had study data available.

Outcome measures

Outcome measures
Measure	Atomoxetine n=28 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Placebo (Matching Atomoxetine) n=30 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.
Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) at Steady State (at Day 14)	-2.3 Score on a scale Interval -4.1 to -0.5	-0.1 Score on a scale Interval -1.9 to 1.6

PRIMARY outcome

Timeframe: Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.

Population: All randomized participants who received one dose of the study drug (placebo or atomoxetine) on Day 1 and had study data available.

The S-UPPS-P assesses impulsivity across five traits using 20 items scored on a 4-point scale (Agree Strongly = 1; Agree Some = 2; Disagree Some = 3; Disagree Strongly = 4). Total scores range from 20 (least impulsive) to 80 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness. The data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving \<90% of planned doses), their data were included in the analysis only up to the point of discontinuation. Reported summary data was based on an ANCOVA with the S-UPPS-P score at baseline as a covariate and the treatment arm as fixed factor.

Outcome measures

Outcome measures
Measure	Atomoxetine n=30 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Placebo (Matching Atomoxetine) n=31 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.
Change From Baseline in Total Score of Short Urgency, Perseverance, Premeditation, and Sensation Seeking-Positive Urgency Impulsive Behavior Scale (S-UPPS-P) Impulsive Behavior Scale After Single Dose (at Day 1)	0.0 Score on a scale Interval -1.6 to 1.6	-0.1 Score on a scale Interval -1.7 to 1.4

PRIMARY outcome

Timeframe: Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.

Outcome measures

Outcome measures
Measure	Atomoxetine n=28 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Placebo (Matching Atomoxetine) n=30 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.
Change From Baseline in Total Score of Short Urgency, Perseverance, Premeditation, and Sensation Seeking-Positive Urgency Impulsive Behavior Scale (S-UPPS-P) Impulsive Behavior Scale at Steady State (at Day 14)	-0.2 Score on a scale Interval -1.7 to 1.4	-1.0 Score on a scale Interval -2.5 to 0.5

SECONDARY outcome

Timeframe: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days.

Population: All participants who were treated with at least one dose of study drug (i.e. placebo or atomoxetine).

Treatment emergent adverse events are adverse events that occurred after treatment administration up to 4 days after the last dose of study drug.

Outcome measures

Outcome measures
Measure	Atomoxetine n=31 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Placebo (Matching Atomoxetine) n=31 Participants Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.
Percentage of Patients With Treatment Emergent Adverse Events and Serious Adverse Events Treatment-emergent adverse events	90.3 Percentage (%) of participants	80.6 Percentage (%) of participants
Percentage of Patients With Treatment Emergent Adverse Events and Serious Adverse Events Treatment-emergent serious adverse events	0 Percentage (%) of participants	0 Percentage (%) of participants

Adverse Events

Atomoxetine

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo (Matching Atomoxetine)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Atomoxetine n=31 participants at risk Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Placebo (Matching Atomoxetine) n=31 participants at risk Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.
Cardiac disorders Palpitations	16.1% 5/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	3.2% 1/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Ear and labyrinth disorders Vertigo	3.2% 1/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Gastrointestinal disorders Abdominal pain	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Gastrointestinal disorders Constipation	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Gastrointestinal disorders Dry mouth	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Gastrointestinal disorders Dyspepsia	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Gastrointestinal disorders Nausea	45.2% 14/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	3.2% 1/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Gastrointestinal disorders Vomiting	9.7% 3/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
General disorders Fatigue	25.8% 8/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	16.1% 5/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
General disorders Feeling cold	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
General disorders Feeling hot	9.7% 3/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Infections and infestations Nasopharyngitis	16.1% 5/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Metabolism and nutrition disorders Decreased appetite	32.3% 10/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Nervous system disorders Disturbance in attention	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Nervous system disorders Dizziness	29.0% 9/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	3.2% 1/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Nervous system disorders Headache	41.9% 13/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	29.0% 9/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Nervous system disorders Paraesthesia	9.7% 3/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Psychiatric disorders Apathy	12.9% 4/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	3.2% 1/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Psychiatric disorders Initial insomnia	3.2% 1/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Psychiatric disorders Insomnia	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Psychiatric disorders Irritability	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	3.2% 1/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Psychiatric disorders Sleep disorder	9.7% 3/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	3.2% 1/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Reproductive system and breast disorders Erectile dysfunction	6.5% 2/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)
Skin and subcutaneous tissue disorders Hyperhidrosis	9.7% 3/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)	0.00% 0/31 • Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days. Treated Set (TS): All subjects who were treated with at least one dose of study drug (i.e. placebo or atomoxetine)