Trial Outcomes & Findings for Modafinil vs Placebo for the Treatment of Methamphetamine Dependence (NCT NCT00469508)

NCT ID: NCT00469508

Last Updated: 2020-03-02

Results Overview

Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 71 participants
• Primary outcome timeframe: From randomization to end of week 12
• Results posted on: 2020-03-02

Participant Flow

Study participants were 71 MA-dependent outpatients seeking treatment in the Los Angeles area recruitment from 4/07-9/08. Potential study participants were recruited from the community using advertisements for a study of experimental medications for MA dependence.

Subjects completed medical and psychiatric screening (to exclude any non-drug related Axis I disorder) and baseline assessments over a two-week/six-visit lead in.

Participant milestones

Measure	Modafinil Modafinil 400mg oral dose taken daily for 12 weeks	Placebo Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Overall Study STARTED	34	37
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	20	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modafinil vs Placebo for the Treatment of Methamphetamine Dependence

Baseline characteristics by cohort

Measure	Modafinil n=34 Participants Modafinil 400mg oral dose taken daily for 12 weeks	Placebo n=37 Participants Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=93 Participants	37 Participants n=4 Participants	71 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	39.1 years STANDARD_DEVIATION 11.1 • n=93 Participants	37.8 years STANDARD_DEVIATION 10.1 • n=4 Participants	38.4 years STANDARD_DEVIATION 10.5 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	12 Participants n=4 Participants	21 Participants n=27 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	25 Participants n=4 Participants	50 Participants n=27 Participants
Region of Enrollment United States	34 participants n=93 Participants	37 participants n=4 Participants	71 participants n=27 Participants

PRIMARY outcome

Timeframe: From randomization to end of week 12

Population: Intention to treat

Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.

Outcome measures

Measure	Modafinil n=590 Urine drug screens Modafinil 400mg oral dose taken daily for 12 weeks	Placebo n=564 Urine drug screens Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Clean Urine Drug Screen	13.1 Clean urine drug screens Standard Deviation 11.5	12.7 Clean urine drug screens Standard Deviation 13.2

SECONDARY outcome

Timeframe: 12 weeks

Population: Intention to treat

The number of persons who completed the medication phase of the trial (12 weeks of medication).

Outcome measures

Measure	Modafinil n=34 Participants Modafinil 400mg oral dose taken daily for 12 weeks	Placebo n=37 Participants Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Retention	14 participants	13 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and last observation during the 12 week treatment period

Population: Intention to treat, LOCF

To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.

Outcome measures

Measure	Modafinil n=34 Participants Modafinil 400mg oral dose taken daily for 12 weeks	Placebo n=37 Participants Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
VAS Score	-32.5 units on a scale Standard Deviation 33.8	-47.3 units on a scale Standard Deviation 32.6

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to end of treatment period (week 12).

Population: Intention to treat, LOCF

Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.

Outcome measures

Measure	Modafinil n=34 Participants Modafinil 400mg oral dose taken daily for 12 weeks	Placebo n=37 Participants Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
BDI Score	-11.8 units on a scale Standard Deviation 12.9	-7 units on a scale Standard Deviation 11.2

Adverse Events

Modafinil

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Modafinil n=34 participants at risk Modafinil 400mg oral dose taken daily for 12 weeks	Placebo n=37 participants at risk Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Ear and labyrinth disorders Otitis media	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Skin and subcutaneous tissue disorders Acute Epididymitis	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Infections and infestations Injection site abscess	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Psychiatric disorders Psychosis	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.

Other adverse events

Measure	Modafinil n=34 participants at risk Modafinil 400mg oral dose taken daily for 12 weeks	Placebo n=37 participants at risk Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Gastrointestinal disorders Abdominal Pain	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Infections and infestations Abscess Gum	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Agitation	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Psychiatric disorders Anger	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Anxiety	14.7% 5/34 • Number of events 5 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Aphasia	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Respiratory, thoracic and mediastinal disorders Asthma	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Back Pain	2.9% 1/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	5.4% 2/37 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Cardiac disorders Blood Pressure Increased	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Gastrointestinal disorders Bowel Incontinena	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Respiratory, thoracic and mediastinal disorders Bronchitis	2.9% 1/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Skin and subcutaneous tissue disorders Bruise	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Chest Pain	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders CHEST PAIN-L ARM	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Chest tightness of	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Chills	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Respiratory, thoracic and mediastinal disorders Common Cold	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Concentration Imparied	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Respiratory, thoracic and mediastinal disorders Congestion Nasal	8.8% 3/34 • Number of events 3 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Eye disorders Conjunctivitis	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Respiratory, thoracic and mediastinal disorders Coughing	14.7% 5/34 • Number of events 6 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Psychiatric disorders Delusions	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Depression	5.9% 2/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	5.4% 2/37 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Diaphoresis	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Gastrointestinal disorders Diarrhea	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 3 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Dizziness	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Drowsiness	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Drug withdrawal syndrome	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Dry Mouth	8.8% 3/34 • Number of events 3 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Gastrointestinal disorders Dyspepsia	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Ear and labyrinth disorders Earache	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Ear and labyrinth disorders Ears Feel Clogged	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Eye disorders Eye Irritation	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Fatigue	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	5.4% 2/37 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Fever	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Flank Pain	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Flu-like symptoms	8.8% 3/34 • Number of events 3 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Social circumstances Fracture Bone	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Gastrointestinal disorders Gastroenteritis	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Reproductive system and breast disorders GENITALIA EXTERNAL PAINFUL	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Psychiatric disorders Hallucitation Auditory	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Head contusion	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Headache	29.4% 10/34 • Number of events 14 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	16.2% 6/37 • Number of events 10 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Ear and labyrinth disorders Hearing decreased	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Cardiac disorders Heartbeats Increased	2.9% 1/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	5.4% 2/37 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Gastrointestinal disorders Heartburn	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Herpes Simplex	2.9% 1/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Hot Flashes	5.9% 2/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Hyperactivity	8.8% 3/34 • Number of events 6 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Infections and infestations Infection Upper Respiratory	5.9% 2/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Insomnia	29.4% 10/34 • Number of events 18 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	18.9% 7/37 • Number of events 8 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Irritability	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	5.4% 2/37 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Jitterniness	11.8% 4/34 • Number of events 9 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Musculoskeletal and connective tissue disorders Joint Ache	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Social circumstances Laceration	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Musculoskeletal and connective tissue disorders Leg cramps	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Lethargy	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Reproductive system and breast disorders Libido Decreased	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Light-headed	5.9% 2/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders MENTAL CONCENTRATION DIFFICULTY	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 2/34 • Number of events 3 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Gastrointestinal disorders Nausea	20.6% 7/34 • Number of events 7 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	10.8% 4/37 • Number of events 5 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Nerve pain	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Nervousness	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Nightmares	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	5.4% 2/37 • Number of events 4 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Nosebleed	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Musculoskeletal and connective tissue disorders Pain muscle	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Musculoskeletal and connective tissue disorders Pain neck	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Cardiac disorders Palpitation	5.9% 2/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Immune system disorders Pneumonia	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Skin and subcutaneous tissue disorders Rash	5.9% 2/34 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	5.4% 2/37 • Number of events 2 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Skin and subcutaneous tissue disorders Rash Impetiginous	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Respiratory, thoracic and mediastinal disorders Sexual Dysfunction	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Shakiness	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Shortness of breath	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Sinus Headache	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Sore Throat	11.8% 4/34 • Number of events 4 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Stomach pain	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Psychiatric disorders Suicidal ideation	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Cardiac disorders Tachycardia	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Tightness of chest	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Infections and infestations Tinea	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Vision Blurred	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Visual disturbance	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Vivid Dreams	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	0.00% 0/37 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
Gastrointestinal disorders Vomiting	2.9% 1/34 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
General disorders Wakefulness	0.00% 0/34 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks). Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.

Additional Information

Steven Shoptaw PhD

UCLA Center for Behavioral and Addiction Medicine

Phone: 310 794 0619

Email: sshoptaw@mednet.ucla.edu

Results disclosure agreements

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