Trial Outcomes & Findings for Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke (NCT NCT02460900)

Last Updated: 2025-03-13

Results Overview

7-day point-prevalence abstinence based onno self-reported tobacco use (not even a puff) during the 7 days preceding the assessment and a CO ≤10ppm as measured by Covita micro smokrlyzer at week 36.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

184 participants

Primary outcome timeframe

36 weeks

Results posted on

2025-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Varenicline and Standard of Care Participants will receive varenicline and standard of care Varenicline Standard of Care	Placebo and Standard of Care Participants will receive placebo and standard of care Placebo Standard of Care	Positively Smoke Free and Placebo Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Placebo Positively Smoke Free Placebo	Positively Smoke Free and Varenicline Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Varenicline Varenicline Positively Smoke Free
Overall Study STARTED	46	47	42	49
Overall Study COMPLETED	36	37	28	30
Overall Study NOT COMPLETED	10	10	14	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline and Standard of Care n=46 Participants Participants will receive varenicline and standard of care Varenicline Standard of Care	Placebo and Standard of Care n=47 Participants Participants will receive placebo and standard of care Placebo Standard of Care	Positively Smoke Free and Placebo n=42 Participants Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Placebo Positively Smoke Free Placebo	Positively Smoke Free and Varenicline n=49 Participants Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Varenicline Varenicline Positively Smoke Free	Total n=184 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 10.7 • n=5 Participants	52.0 years STANDARD_DEVIATION 8.5 • n=7 Participants	55.3 years STANDARD_DEVIATION 8.1 • n=5 Participants	52.6 years STANDARD_DEVIATION 10.3 • n=4 Participants	52.8 years STANDARD_DEVIATION 9.6 • n=21 Participants
Sex/Gender, Customized Male	32 participants n=5 Participants	30 participants n=7 Participants	25 participants n=5 Participants	28 participants n=4 Participants	115 participants n=21 Participants
Sex/Gender, Customized Female	14 participants n=5 Participants	17 participants n=7 Participants	14 participants n=5 Participants	21 participants n=4 Participants	66 participants n=21 Participants
Sex/Gender, Customized Transgender	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Sex/Gender, Customized Unknown	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	38 Participants n=5 Participants	43 Participants n=7 Participants	40 Participants n=5 Participants	44 Participants n=4 Participants	165 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	46 participants n=5 Participants	47 participants n=7 Participants	42 participants n=5 Participants	49 participants n=4 Participants	184 participants n=21 Participants
Less than 12 years of education	9 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	23 Participants n=4 Participants	59 Participants n=21 Participants
Employed	16 Participants n=5 Participants	15 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	46 Participants n=21 Participants
Taking antiretroviral medication	42 Participants n=5 Participants	47 Participants n=7 Participants	41 Participants n=5 Participants	47 Participants n=4 Participants	177 Participants n=21 Participants
Cigarettes smoked per day	11.7 cigarettes per day STANDARD_DEVIATION 6.8 • n=5 Participants	11.0 cigarettes per day STANDARD_DEVIATION 5.3 • n=7 Participants	11.6 cigarettes per day STANDARD_DEVIATION 7.1 • n=5 Participants	10.8 cigarettes per day STANDARD_DEVIATION 5.7 • n=4 Participants	11.3 cigarettes per day STANDARD_DEVIATION 6.2 • n=21 Participants
Smokes mentholated cigarettes	44 Participants n=5 Participants	46 Participants n=7 Participants	40 Participants n=5 Participants	48 Participants n=4 Participants	178 Participants n=21 Participants
Fagerstrom Test For Nicotine Dependence (FTND)	4.9 units STANDARD_DEVIATION 1.8 • n=5 Participants	4.2 units STANDARD_DEVIATION 2.0 • n=7 Participants	4.4 units STANDARD_DEVIATION 2.1 • n=5 Participants	4.4 units STANDARD_DEVIATION 1.9 • n=4 Participants	4.5 units STANDARD_DEVIATION 1.9 • n=21 Participants
Use alcohol in last 30 days	26 Participants n=5 Participants	26 Participants n=7 Participants	26 Participants n=5 Participants	18 Participants n=4 Participants	96 Participants n=21 Participants
Use marijuana in last 30 days	13 Participants n=5 Participants	15 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	38 Participants n=21 Participants

PRIMARY outcome

Timeframe: 36 weeks

Outcome measures

Outcome measures
Measure	Varenicline and Standard of Care n=46 Participants Participants will receive varenicline and standard of care Varenicline Standard of Care	Placebo and Standard of Care n=47 Participants Participants will receive placebo and standard of care Placebo Standard of Care	Positively Smoke Free and Placebo n=42 Participants Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Placebo Positively Smoke Free Placebo	Positively Smoke Free and Varenicline n=49 Participants Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Varenicline Varenicline Positively Smoke Free
Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks	5 Participants	4 Participants	1 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

Effect of smoking abstinence on levels of cardiac specific biomarkers

Outcome measures

Outcome data not reported

Adverse Events

Varenicline + Standard of Care

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo + Standard of Care

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Positively Smoke Free + Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Positively Smoke Free + Varenicline

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

National Heart, Lung and Blood Institute--Josh Fessel

NIH

Phone: 3018275514

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Varenicline + Standard of Care n=46 participants at risk Participants will receive varenicline	Placebo + Standard of Care n=47 participants at risk Participants will receive placebo and standard of care	Positively Smoke Free + Placebo n=42 participants at risk Participants will receive positively smoke free and placebo	Positively Smoke Free + Varenicline n=49 participants at risk Participants will receive positively smoke free and varenicline
Gastrointestinal disorders Increased appetite	15.2% 7/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	14.9% 7/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	31.0% 13/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	8.2% 4/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Nausea	19.6% 9/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.8% 6/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	9.5% 4/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	16.3% 8/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Vomiting	6.5% 3/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	6.4% 3/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	4.8% 2/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	4.1% 2/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Constipation	8.7% 4/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	10.6% 5/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	9.5% 4/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	2.0% 1/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Nervous system disorders Dizziness	6.5% 3/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.8% 6/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	2.4% 1/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.2% 6/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Weight increase	4.3% 2/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	8.5% 4/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	10.2% 5/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders GERD	10.9% 5/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	6.4% 3/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	4.8% 2/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	8.2% 4/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Dyspespsia	8.7% 4/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	6.4% 3/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	2.4% 1/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	6.1% 3/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Psychiatric disorders Abnormal dreams	13.0% 6/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.8% 6/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	7.1% 3/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	4.1% 2/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Abdominal pain	10.9% 5/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	7.1% 3/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	4.1% 2/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Musculoskeletal and connective tissue disorders Myalgia	6.5% 3/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	2.1% 1/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	7.1% 3/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	8.2% 4/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Musculoskeletal and connective tissue disorders stiffness	4.3% 2/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	2.1% 1/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	16.7% 7/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	2.0% 1/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Nervous system disorders Restlessness	10.9% 5/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	8.5% 4/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	2.4% 1/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	2.0% 1/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Nervous system disorders Headache	8.7% 4/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.8% 6/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	11.9% 5/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	8.2% 4/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Dry mouth	28.3% 13/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.8% 6/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	9.5% 4/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	6.1% 3/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Dysgeusia	4.3% 2/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	10.6% 5/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	4.8% 2/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	10.2% 5/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.5% 3/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	8.5% 4/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	2.4% 1/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	6.1% 3/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	13.0% 6/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	6.4% 3/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	7.1% 3/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	16.3% 8/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Psychiatric disorders Malaise	10.9% 5/46 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	8.5% 4/47 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/42 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	6.1% 3/49 • 12 weeks--This is the timeframe for the medication related non-serious adverse events as the medication part of the trial was discontinued after 12 weeks. 36 weeks--This is the timeframe for all cause mortality and serious adverse events All-Cause Mortality: All anticipated and unanticipated deaths due to any cause Serious Adverse Events: All anticipated and unanticipated serious adverse events Other (Not Including Serious) Adverse Events: Anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.