Trial Outcomes & Findings for Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness (NCT NCT04011280)

Last Updated: 2023-06-22

Results Overview

Demand for participating (# of participants recruited per month); practicality of study procedures (% participants completing study procedures); acceptability of study procedures (% participants adhering to making a quit attempt within the quit window)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

Through completion of study, an average of 2 years

Results posted on

2023-06-22

Participant Flow

The protocol defined all participants who signed a written informed consent and who completed a formal screening process as "Enrolled" in the trial. Thus, following CONSORT diagram terminology, there were N = 39 enrollees. 28 participants were randomized into one of the two treatment arms and were thus allocated to treatment.

Participant milestones

Participant milestones
Measure	Low Dose Varenicline 0.5 mg twice daily with 0.5 mg daily titration over one full week Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.	Standard Dose Varenicline 1.0 mg twice daily with standard titration Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Overall Study STARTED	14	14
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose Varenicline n=14 Participants 0.5 mg twice daily with 0.5 mg daily titration over one full week Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.	Standard Dose Varenicline n=14 Participants 1.0 mg twice daily with standard titration Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.	Total n=28 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	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Continuous	50 years STANDARD_DEVIATION 9.8 • n=93 Participants	45.6 years STANDARD_DEVIATION 11.6 • n=4 Participants	47.8 years STANDARD_DEVIATION 10.8 • n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=93 Participants	13 Participants n=4 Participants	26 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Diagnosis: Bipolar Disorder (BD) or Schizophrenia Spectrum Disorder (SSD) BD	7 Participants n=93 Participants	8 Participants n=4 Participants	15 Participants n=27 Participants
Diagnosis: Bipolar Disorder (BD) or Schizophrenia Spectrum Disorder (SSD) SSD	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Cigarettes Per Day	14.5 Cigarettes STANDARD_DEVIATION 3.3 • n=93 Participants	25.2 Cigarettes STANDARD_DEVIATION 11 • n=4 Participants	19.8 Cigarettes STANDARD_DEVIATION 9.7 • n=27 Participants
Fagerström Test for Cigarette Dependence	5.4 units on a scale STANDARD_DEVIATION 1.6 • n=93 Participants	6.8 units on a scale STANDARD_DEVIATION 2 • n=4 Participants	6 units on a scale STANDARD_DEVIATION 1.9 • n=27 Participants
Minnesota Nicotine Withdrawal Scale	20.9 units on a scale STANDARD_DEVIATION 12.4 • n=93 Participants	23.5 units on a scale STANDARD_DEVIATION 12.3 • n=4 Participants	22.2 units on a scale STANDARD_DEVIATION 12.2 • n=27 Participants
Questionnaire of Smoking Urges- Brief	51.1 units on a scale STANDARD_DEVIATION 15 • n=93 Participants	51.7 units on a scale STANDARD_DEVIATION 15.1 • n=4 Participants	51.4 units on a scale STANDARD_DEVIATION 14.8 • n=27 Participants
Hospital Anxiety and Depression Scale (HADS) HADS: Anxiety	9.6 units on a scale STANDARD_DEVIATION 5.9 • n=93 Participants	12 units on a scale STANDARD_DEVIATION 6.6 • n=4 Participants	10.8 units on a scale STANDARD_DEVIATION 6.3 • n=27 Participants
Hospital Anxiety and Depression Scale (HADS) HADS: Depression	4.4 units on a scale STANDARD_DEVIATION 3.9 • n=93 Participants	6.5 units on a scale STANDARD_DEVIATION 5.5 • n=4 Participants	5.4 units on a scale STANDARD_DEVIATION 4.8 • n=27 Participants

PRIMARY outcome

Timeframe: Through completion of study, an average of 2 years

Outcome measures

Outcome measures
Measure	Low Dose Varenicline n=14 Participants 0.5 mg twice daily with 0.5 mg daily titration over one full week Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.	Standard Dose Varenicline n=14 Participants 1.0 mg twice daily with standard titration Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies Acceptability of Study Procedures	13 Participants	12 Participants
Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies Demand For Participating	1 Participants	1 Participants
Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies Practicality of Study Procedures	9 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through completion of study, an average of 2 years

Population: Due to the small sample size and our finding that practically all smokers in this sample of persons with serious mental illness would be considered "normal metabolizers" based on population normative values, Arms/Groups were combined to maximize power and to explore whether there was any correlation between the NMR values and the incidence of adverse events. Since this was an exploratory aim, the analysis was pre-specified to include all participants regardless of varenicline condition.

The nicotine metabolite ratio (NMR) as measured by the ratio of 3'-hydroxycotinine (the breakdown product of cotinine) divided by the concentration of cotinine (the breakdown product of nicotine) in a smoker's serum is a biomarker of nicotine clearance. Other researchers have found that a person's NMR might influence one's response to certain smoking cessation medications. The NMR was measured in serum using electrospray ionization liquid chromatography tandem mass spectrometry technology.

Outcome measures

Outcome measures
Measure	Low Dose Varenicline n=28 Participants 0.5 mg twice daily with 0.5 mg daily titration over one full week Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.	Standard Dose Varenicline 1.0 mg twice daily with standard titration Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Nicotine Metabolite Ratio (NMR) Exploratory Aim	1.20 ratio of molar concentrations Standard Deviation 0.75	—

Adverse Events

Low Dose Varenicline

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Standard Dose Varenicline

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low Dose Varenicline n=14 participants at risk 0.5 mg twice daily with 0.5 mg daily titration over one full week Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.	Standard Dose Varenicline n=14 participants at risk 1.0 mg twice daily with standard titration Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Psychiatric disorders Depression	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).

Other adverse events

Additional Information

Dr. Benjamin McKenna

Pacific Treatment and Research Center

Phone: 858-534-8817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Low Dose Varenicline n=14 participants at risk 0.5 mg twice daily with 0.5 mg daily titration over one full week Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.	Standard Dose Varenicline n=14 participants at risk 1.0 mg twice daily with standard titration Varenicline: The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
Psychiatric disorders Aggression	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Agitation	21.4% 3/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Anxiety	50.0% 7/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Depression	21.4% 3/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	28.6% 4/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Panic	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Sleep Disturbances	35.7% 5/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	28.6% 4/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Hallucination	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Hostility	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Intrusive Thoughts	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Mania	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Paranoia	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Psychiatric disorders Suicidal Ideation	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Gastrointestinal disorders Heartburn	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Gastrointestinal disorders Constipation	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Gastrointestinal disorders Diarrhea	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Gastrointestinal disorders Nausea	28.6% 4/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Gastrointestinal disorders Stomach Pain	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Nervous system disorders Confusion	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Nervous system disorders Dizziness	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Nervous system disorders Fatigue	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Nervous system disorders Headache	21.4% 3/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Nervous system disorders Leg Spasms	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Nervous system disorders Syncope	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Nervous system disorders Malaise	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Nervous system disorders Vertigo	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
General disorders Confusion	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
General disorders Dysgeusia	50.0% 7/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	42.9% 6/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
General disorders Increased Thirst	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
General disorders Increased Appetite	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
General disorders Weight Gain	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Infections and infestations Cold	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Infections and infestations Abscess	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Infections and infestations Flu	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Infections and infestations Gum Disease	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Infections and infestations Pharyngitis	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Infections and infestations Sinusitis	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Musculoskeletal and connective tissue disorders Back Pain	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Musculoskeletal and connective tissue disorders Leg Cramps	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Musculoskeletal and connective tissue disorders Muscle Pain	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Cardiac disorders Angina	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Cardiac disorders Increased Blood Pressure	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Cardiac disorders Coronary Heart Disease	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Cardiac disorders Palpitations	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Immune system disorders Allergies	14.3% 2/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Skin and subcutaneous tissue disorders Cellulitis	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Skin and subcutaneous tissue disorders Rash	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).
Renal and urinary disorders Frequent Urination	0.00% 0/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).	7.1% 1/14 • Adverse events were monitored throughout the 12 week active treatment phase and for one month after treatment discontinuation (i.e. through week 16).