Trial Outcomes & Findings for Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function (NCT NCT00094302)

NCT ID: NCT00094302

Last Updated: 2015-03-02

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3445 participants

Primary outcome timeframe

Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Results posted on

2015-03-02

Participant Flow

TOPCAT enrolled 3445 patients with heart failure and preserved ejection fraction at 233 academic and community medical centers in 6 countries between August 2006 and January 2012. Trial follow-up ended in June 2013.

Trial randomization was stratified by whether patients were enrolled into the study on the basis of having a hospitalization for heart failure within the past year (N=2,464) or having an elevated natriuretic peptide level within 60 days before randomization (N=981). The second criterion was considered only for those who did not meet the first.

Participant milestones

Participant milestones
Measure	Placebo Placebo of spironolactone	Spironolactone Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Overall Study STARTED	1723	1722
Overall Study COMPLETED	1306	1316
Overall Study NOT COMPLETED	417	406

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo of spironolactone	Spironolactone Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Overall Study Lost to Follow-up	43	41
Overall Study Physician Decision	5	8
Overall Study Withdrawal by Subject	103	111
Overall Study Death	266	246

Baseline Characteristics

Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.	Total n=3445 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	649 Participants n=5 Participants	654 Participants n=7 Participants	1303 Participants n=5 Participants
Age, Categorical >=65 years	1074 Participants n=5 Participants	1068 Participants n=7 Participants	2142 Participants n=5 Participants
Age, Continuous	68.7 years n=5 Participants	68.7 years n=7 Participants	68.7 years n=5 Participants
Sex: Female, Male Female	887 Participants n=5 Participants	888 Participants n=7 Participants	1775 Participants n=5 Participants
Sex: Female, Male Male	836 Participants n=5 Participants	834 Participants n=7 Participants	1670 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 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
Race (NIH/OMB) Black or African American	149 Participants n=5 Participants	151 Participants n=7 Participants	300 Participants n=5 Participants
Race (NIH/OMB) White	1537 Participants n=5 Participants	1525 Participants n=7 Participants	3062 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment United States	579 participants n=5 Participants	572 participants n=7 Participants	1151 participants n=5 Participants
Region of Enrollment Canada	160 participants n=5 Participants	166 participants n=7 Participants	326 participants n=5 Participants
Region of Enrollment Argentina	60 participants n=5 Participants	63 participants n=7 Participants	123 participants n=5 Participants
Region of Enrollment Brazil	82 participants n=5 Participants	85 participants n=7 Participants	167 participants n=5 Participants
Region of Enrollment Russian Federation	537 participants n=5 Participants	529 participants n=7 Participants	1066 participants n=5 Participants
Region of Enrollment Georgia	305 participants n=5 Participants	307 participants n=7 Participants	612 participants n=5 Participants
Eligibility Stratum Hospitalization in previous year for heart failure	1232 participants n=5 Participants	1232 participants n=7 Participants	2464 participants n=5 Participants
Eligibility Stratum Elevated natriuretic peptide in previous 60 days	491 participants n=5 Participants	490 participants n=7 Participants	981 participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First	6.6 Events per 100 person-years	5.9 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Cardiovascular Mortality	3.1 Events per 100 person-years	2.8 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

First incidence of aborted cardiac arrest

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Aborted Cardiac Arrest	0.09 Events per 100 person-years	0.05 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

First incidence of a hospitalization for the management of heart failure

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Hospitalization for the Management of Heart Failure	4.6 Events per 100 person-years	3.8 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
All-cause Mortality	4.6 Events per 100 person-years	4.2 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First	7.8 Events per 100 person-years	7.2 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Hospitalization for MI, stroke or the management of heart failure, whichever occurred first

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Cardiovascular-related Hospitalization	6.2 Events per 100 person-years	5.5 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure	8.3 Events per 100 person-years	6.8 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First	1.1 Events per 100 person-years	1.0 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized and did not have a history of diabetes mellitus at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=1167 Participants Placebo of spironolactone	Spironolactone n=1156 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.	0.7 Events per 100 person-years	0.7 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized and did not have a history of atrial fibrillation at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline

Outcome measures

Outcome measures
Measure	Placebo n=1117 Participants Placebo of spironolactone	Spironolactone n=1111 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.	1.4 Events per 100 person-years	1.4 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

First incidence of myocardial infarction

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Myocardial Infarction	1.1 Events per 100 person-years	1.2 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

First incidence of stroke

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Stroke	1.1 Events per 100 person-years	1.0 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.)

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Deterioration of Renal Function	2.2 Events per 100 person-years	3.2 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First	1.1 Events per 100 person-years	1.0 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.	63.1 units on a scale Standard Error 0.3	64.4 units on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Quality of Life, as Measured by the EuroQOL Visual Analog Scale.	65.9 units on a scale Standard Error 0.3	66.4 units on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants from United States, Canada and Argentina who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group. The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - "Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition?" Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina.

Outcome measures

Outcome measures
Measure	Placebo n=799 Participants Placebo of spironolactone	Spironolactone n=801 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.	1.2 units on a scale Standard Error 0.1	1.2 units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants from the United States and Canada who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada.

Outcome measures

Outcome measures
Measure	Placebo n=739 Participants Placebo of spironolactone	Spironolactone n=738 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Depression Symptoms, as Measured by Patient Health Questionnaire.	5.6 units on a scale Standard Error 0.1	5.1 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

First incidence of a hospitalization for any reason

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Hospitalization for Any Reason	20.0 Events per 100 person-years	18.8 Events per 100 person-years

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Potassium	4.32 mEq/L Standard Error 0.01	4.49 mEq/L Standard Error 0.01

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Serum Creatinine	1.11 mg/dL Standard Error 0.005	1.17 mg/dL Standard Error 0.01

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Sodium	140.95 mEq/L Standard Error 0.06	140.33 mEq/L Standard Error 0.06

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Chloride	102.33 mEq/L Standard Error 0.08	102.26 mEq/L Standard Error 0.08

SECONDARY outcome

Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Population: All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.

Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

Outcome measures

Outcome measures
Measure	Placebo n=1723 Participants Placebo of spironolactone	Spironolactone n=1722 Participants Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Estimated Glomerular Filtration Rate (GFR)	67.50 mL/min/1.73m2 Standard Error 0.29	65.20 mL/min/1.73m2 Standard Error 0.90

Adverse Events

Placebo

Serious events: 855 serious events

Other events: 1086 other events

Deaths: 0 deaths

Spironolactone

Serious events: 835 serious events

Other events: 1152 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=1723 participants at risk Placebo of spironolactone	Spironolactone n=1722 participants at risk Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders EPISTAXIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders EQUIPMENT MALFUNCTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications DRUG OVERDOSE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders DRUG TOXOCITY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders DRY EYES	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders DYSARTHRIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DYSPHAGIA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders DYSPHAGIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DYSPNEA	0.64% 11/1723 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.64% 11/1722 • Number of events 13 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders DYSPNEA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders EDEMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders EDEMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ELECTIVE BAND PROCEDURE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders ELECTROLYTE IMBALANCE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders ELECTROLYTE IMBALANCE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ELEVATED CARDIAC ENZYMES	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders ELEVATED CREATININE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders ELEVATED INR	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders ELEVATED LIVER ENZYMES	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders ELEVATED PT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures EMBOLECTOMY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations ENCEPHALITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders ENCEPHALOPATHY	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ENCEPHALOPATHY	0.29% 5/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures ENDARTERECTOMY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ENDOCARDITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ENTERITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ENTEROCOLITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders EPIDIDYMITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders EPIGASTRIC PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders EPISTAXIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders EROSION OF PACEMAKER POCKET	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders EROSION OF THE VAGINAL EPITHELIUM	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ESOPHAGEAL CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ESOPHAGITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders EXACERBATION OF THE CHRONIC CALCULOUS CHOLECYSTITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders EXTRASYSTOLE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) EYE LESION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders EYE SURGERY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders FAILURE TO THRIVE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders FAILURE TO THRIVE	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications FALL	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders FALL	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders FALL	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures FASCIOTOMY	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders FATIGUE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders FECAL IMPACTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders FEMORAL EMBOLUS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders FEVER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders FISTULA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications FISTULA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications FOOT INJURY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders FOOT PAIN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders FOOT ULCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications FRACTURE	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders FRACTURE	2.3% 39/1723 • Number of events 41 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.8% 31/1722 • Number of events 34 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders GALLSTONES	0.58% 10/1723 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations GANGRENE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders GANGRENE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GASTRECTOMY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GASTRIC BYPASS SURGERY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures GASTRIC BYPASS SURGERY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GASTRIC REFLUX	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GASTRITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GASTROENTERITIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GASTROPARESIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GATRITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders GENERAL HEALTH DECLINE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GERD	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GI BLEED	1.3% 22/1723 • Number of events 30 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.5% 25/1722 • Number of events 26 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GI DISTRESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders GOUT	0.35% 6/1723 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders GROIN PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Immune system disorders GUILLIAN BARRE SYNDROME	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders GYNECOMASTIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders GYNECOMASTIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HAND PAIN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications HEAD INJURY	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders HEAD INJURY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders HEADACHE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders HEARING LOSS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HEART	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HEART BLOCK	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HEART FAILURE	17.1% 294/1723 • Number of events 532 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	14.9% 256/1722 • Number of events 465 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Congenital, familial and genetic disorders HEART FAILURE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HEART FAILURE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations HEART FAILURE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HEART FAILURE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HEART FAILURE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HEART FAILURE	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures HEART SURGERY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HEARTBURN	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HEAT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HEEL PAIN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders HEMATOCHEZIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders HEMATOMA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HEMATOMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders HEMATOMA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders HEMATOMA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HEMATURIA	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HEMOPTYSIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders HEMORRHAGE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications HEMORRHAGE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders HEMORRHAGE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders HEMORRHAGE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders HEMORRHOIDS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures HEPARIN BRIDGING	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders HEPATIC ENCEPHALOPATHY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders HEPATOMEGALY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HERNIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders HERNIA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations HERNIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HERNIA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures HERNIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HERNIATED DISC	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders HIATAL HERNIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HIP PAIN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HIP REPLACEMENT	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures HIP REPLACEMENT	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HOSPITALIZATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYDRONEPHROSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders HYPERCALCEMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HYPERCAPNIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders HYPEREMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPERGLYCEMIA	0.12% 2/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPERKALEMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYPERKALEMIA	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.2% 20/1722 • Number of events 21 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders HYPERNATREMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders HYPERPLASIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPERTENSION	1.2% 21/1723 • Number of events 24 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.6% 27/1722 • Number of events 32 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders HYPERTENSION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HYPERTENSION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPERTHYROIDISM	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPERVOLEMIA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders HYPERVOLEMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPOGLYCEMIA	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYPOKALEMIA	0.23% 4/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPONATREMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders HYPONATREMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders HYPONATREMIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYPONATREMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPOTENSION	1.0% 18/1723 • Number of events 18 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.99% 17/1722 • Number of events 18 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPOTENSION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HYPOVENTILATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPOVOLEMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYPOVOLEMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders HYPOXEMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders HYSTERECTOMY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures ICD IMPLANTATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ICD MALFUNCTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ILEITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ILEUS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders IN-STENT RESTENOSIS	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INCREASE THIGH MASS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders INCREASING NITRONGENATED SCORIAS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations INFECTION	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications INFECTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations INFLUENZA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INTESTINAL CANCER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders INTESTINAL PERFORATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders INTRACRANIAL BLEED	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders JAUNDICE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders KIDNEY DISEASE	0.29% 5/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders KIDNEY DISEASE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders KIDNEY DISEASE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders KIDNEY DISEASE	3.0% 51/1723 • Number of events 68 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	3.7% 63/1722 • Number of events 79 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders KIDNEY DISEASE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders KIDNEY FAILURE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders KIDNEY INFECTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders KIDNEY STONE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders KNEE AMPUTATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures KNEE ARTHROPLASTY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders KNEE INJURY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders KNEE PAIN	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures KNEE SURGERY	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders LABYRINTHITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders LARYNGEAL EDEMA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures LEG AMPUTATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders LEG CLAUDICATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications LEG INJURY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders LEG PAIN	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders LEG ULCERS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LESION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders LEUKEMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders LEUKEMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEUKEMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders LIMB ISCHEMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders LIVER CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIVER CANCER	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders LIVER LACERATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders LOWER EXTREMITY EDEMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders LOWER EXTREMITY ISCHEMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER	0.17% 3/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders LUNG CONTUSION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders LYMPHANGITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOMA	0.23% 4/1723 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders MALLORY-WEISS SYNDROME	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders MALNUTRITION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders MEDICAL EXAM	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Investigations MEDICAL EXAM	1.3% 23/1723 • Number of events 33 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.3% 22/1722 • Number of events 34 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders MEDICATION ADJUSTMENT	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders MEGACOLON	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders MENINGITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders MESENTERIC ISCHEMIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders METABOLIC ACIDOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders MITRAL REGURGITATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders MITRAL VALVE REPLACEMENT	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications MOTOR VEHICLE ACCIDENT	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations MRSA INFECTION	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders MULTIPLE INFIRMITIES OF AGING	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders MULTIPLE ORGAN FAILURE	0.17% 3/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders MYASTHENIA GRAVIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders MYELOPATHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders MYOCARDIAL INFARCTION	3.9% 67/1723 • Number of events 79 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	3.8% 66/1722 • Number of events 83 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders MYOCARDIAL INFARCTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders MYOCARDIAL INFECTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders MYOCLONIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders MYOMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders MYOPATHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders NAUSEA	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NECK CANCER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures NEPHRECTOMY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders NEURONITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders NEUROPATHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders NEUROPATHY	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders NON-CALCULOUS CHOLECYSTITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders OBSTRUCTIVE UROPATHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders OBTURATIVE SUPPURATIVE GANGRENOUSE CALCULOUS CHOLECYSTITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders OEDEMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders OPISTHORCHOSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations OPISTHORCHOSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders OPTIC ATROPHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ORTHOPNEA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders OSTEOCHONDROSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations OSTEOMYELITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders OSTEOMYELITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders OVERACTIVE BLADDER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PACEMAKER IMPLANT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PALPITATIONS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders PANCREATIC CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CANCER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC MASS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders PANCREATITIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders PANCREATITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders PANCREATITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders PANCYTOPENIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders PARASTHESIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders PARKINSON'S DISEASE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PAROTID GLAND CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders PATHOLOGY OF ENDOMETRIUM	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders PENILE BLEEDING	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PERCUTANEOUS CORONARY INTERVENTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PERICARDITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders PERIPHERAL ARTERIAL DISEASE	0.35% 6/1723 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders PERIPHERAL VASCULAR DISEASE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders PERITONITIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations PERITONITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders PHLEBOTHROMBOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLEURAL EFFUSION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PLEURISY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations PNEUMONIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders PNEUMONIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	4.4% 75/1723 • Number of events 83 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.4% 76/1722 • Number of events 87 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders POLYMYALGIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders POLYP REMOVAL	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders POLYPS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) POLYPS	0.23% 4/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders POLYPS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders POST-MENOPAUSAL BLEEDING	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures PRE-CANCEROUS TUMOR SURGERY, LEFT TEMPORAL LEVEL.	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures PREVENTIVE TREATMENT	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders PROCTITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PROPHYLACTIC THERAPY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders PROSTATE CANCER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures PROSTATE SURGERY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders PROSTATIC HYPERPLASIA	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders PROSTATITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders PROSTATITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Psychiatric disorders PSYCHOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PULMONARY EDEMA	0.17% 3/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY EDEMA	0.46% 8/1723 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PULMONARY EMBOLISM	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.52% 9/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLUS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY OVERLOAD	0.06% 1/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders PURPURA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders PYELOCYSTITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations PYELONEPHRITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders PYELONEPHRITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures RADIATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders RADIOFREQUENCY ABLATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures RADIOFREQUENCY ABLATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders RECTAL PROLAPSE SURGERY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders RECTOVESICAL FISTULA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders RECTUS HEMATOMA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders REMOVAL OF ADHESIONS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders RENAL FAILURE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL MASS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures RESECTION OF CUBITAL	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY ARREST	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY CONGESTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders RESPIRATORY FAILURE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.64% 11/1723 • Number of events 13 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders RESPIRATORY INSUFFICIENCY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY INSUFFICIENCY	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT INFECTION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders RETINAL ANGIOPATHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders RETINAL DETACHMENT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders RETINOPATHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders RUPTURED ESOPHAGUS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SALMONELLOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders SCIATICA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SCLERODERMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders SCLERODERMA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders SCLERODERMA	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SCLEROTIC METASTASIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders SECONDARY TO ANTIARRHYTHMIC MEDICATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders SEIZURE	0.23% 4/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders SEPSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SEPSIS	0.87% 15/1723 • Number of events 15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.93% 16/1722 • Number of events 16 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders SEPSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SEPTIC SHOCK	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders SEPTIC SHOCK	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders SHINGLES	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders SHORTNESS OF BREATH	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders SHORTNESS OF BREATH	0.99% 17/1723 • Number of events 19 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.3% 22/1722 • Number of events 26 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders SHOT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SHOULDER INJURY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SHOULDER PAIN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SHOULDER SURGERY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Immune system disorders SICCA SYNDROME	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders SICK SINUS SYNDROME	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SINUS CANCER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders SINUS NODE DISEASE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders SINUSITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SKIN CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders SKIN DISEASE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications SKIN LACERATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SKIN LACERATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SKIN LESION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SKULL FRACTURE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders SMALL BOWEL OBSTRUCTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SPINAL STENOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders SPINAL STENOSIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures SPINAL STENOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SPINAL SURGERY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders STENT GRAFT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures STENT RESTENOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications STERNUM DIASTASIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) STOMACH CANCER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders STROKE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders STROKE	3.3% 57/1723 • Number of events 65 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.1% 71/1722 • Number of events 80 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures STROKE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SUBUNGUAL AND THECAL WHITLOW PANARICIUM OF THE LEFT HAND	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders SUPRATHERAPEUTIC INR	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders SURGICAL PROCEDURE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders SYNCOPE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders SYNCOPE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders SYNCOPE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications SYNCOPE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders SYNCOPE	1.6% 28/1723 • Number of events 30 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.2% 21/1722 • Number of events 24 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders TACHYCARDIA	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures TEE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THROAT CANCER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders THROMBOEMBOLISM	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders THROMBOEMBOLISM	0.17% 3/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders THROMBOEMBOLISM	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders THROMBOSIS	0.12% 2/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROIDECTOMY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders TOE AMPUTATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures TOE AMPUTATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations TOOTH ABSCESS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations TOOTHACHE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders TOXIC ALLERGIC ALVEOLITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders TOXIC PNEUMONITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders TRANSIENT ISCHEMIC ATTACK	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders TRANSIENT ISCHEMIC ATTACK	0.41% 7/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures TRANSURETHRAL PROSTATIC RESECTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications TRAUMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders TREMOR	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders TRICUSPID REGURGITATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures TUMOR REMOVAL	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ULCER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ULCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders ULCER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ULCER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations UPPER RESPIRATORY INFECTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY INFECTION	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URETER STONE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URETHRITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY RETENTION	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations URINARY TRACT INFECTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY TRACT INFECTION	0.93% 16/1723 • Number of events 22 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.0% 18/1722 • Number of events 18 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY TRACT STONES	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders URTICARIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders UTERINE PROLAPSE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE TUMOR	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders VAGINITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders VALVE REPLACEMENT	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures VALVE REPLACEMENT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders VARICOSE VEINS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders VENOUS INSUFFICIENCY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders VENOUS STASIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders VENTRICULAR FIBRILLATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders VERTEBROBASILAR INSUFFICIENCY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders VERTIGO	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders VERTIGO	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders VISION CHANGES	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders VOLUME OVERLOAD	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders VOMITING	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications WARFARIN ALLERGIC REACTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications WARFARIN OVERDOSE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders WEAKNESS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders WEAKNESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders WEAKNESS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders WEIGHT GAIN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders WORSENING HF	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations WOUND INFECTION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders XERODERMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders CHOLESTATIC SYNDROME	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ABDOMINAL AORTIC ANEURYSM	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ABDOMINAL AORTIC ANEURYSM	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ABDOMINAL PAIN	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders ABDOMINAL PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ABDOMINAL PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders ABDOMINAL PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ABDOMINAL VISCUS PERFORATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders ABNORMAL ELECTROLYTE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ABNORMAL LAB VALUE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ABNORMAL VAGINAL BLEEDING	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders ABNORMAL VAGINAL BLEEDING	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications ABSCESS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders ABSCESS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures ABSCESS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ACID REFLUX	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders ACTINIC KERATOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ACUTE CORONARY SYNDROME	0.52% 9/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.64% 11/1722 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders ACUTE MENIERE'S DISEASE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders ADRENAL INSUFFIENCY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders ALCOHOL WITHDRAWAL	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Immune system disorders ALLERGY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ALTERED MENTAL STATUS	0.52% 9/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders ALVEOLITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ALZHEIMER'S DISEASE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders AMYLOIDOSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Immune system disorders AMYLOIDOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders AMYOTROPHIC LATERAL SCLEROSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANAL CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders ANEMIA	1.3% 23/1723 • Number of events 26 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.87% 15/1722 • Number of events 18 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ANEMIA	0.12% 2/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ANEURYSM	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ANEURYSM	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ANGIOGRAPHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ANGIOPLASTY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ANXIETY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders AORTIC ANEURYSM	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders AORTIC ANEURYSM	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders AORTIC REGURGITATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders AORTIC STENOSIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures APPENDECTOMY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders APPENDICEAL ABCESS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders APPENDICITIS	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ARM INJURY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders ARM INJURY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ARM INJURY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ARRHYTHMIA	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ARTERIAL OCCLUSIVE DISEASE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ARTERIAL STENOSIS	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders ARTERIAL STENOSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ARTERIAL THROMBOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ARTERIAL THROMBOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures ARTHROPLASTY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ASCITES	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders ASCITES	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders ASCITES	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.29% 5/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ATAXIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ATHEROSCLEROSIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ATHEROSCLEROSIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ATRIAL FIBRILLATION	3.4% 58/1723 • Number of events 69 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.2% 73/1722 • Number of events 92 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders ATRIAL FIBRILLATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders ATRIAL FIBRILLATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ATRIAL FLUTTER	0.35% 6/1723 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders AV BLOCK	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders AV REPLACEMENT	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders AV STENOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders AZOTEMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BACK INJURY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders BACK PAIN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BACK PAIN	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations BACTERIAL INFECTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders BARIATRIC SURGERY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders BELLS PALSY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders BI BLEED	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BILE DUCT CANCER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders BILIARY COLIC	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders BINODAL DISEASE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Psychiatric disorders BIPOLAR DISORDER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders BLADDER OBSTRUCTION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders BLEEDING IN EYE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BLISTERS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders BLOOD IN STOOL	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders BLURRED VISION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BODY PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BOWEL CANCER	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders BOWEL OBSTRUCTION	0.29% 5/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders BOWEL PERFORATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders BRADYCARDIA	0.58% 10/1723 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRAIN CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders BRAIN CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders BRAIN HEMORRHAGE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications BRAIN HEMORRHAGE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders BRAIN HEMORRHAGE	0.17% 3/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRAIN TUMOR	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures BREAST REDUCTION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST TUMOR	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders BRONCHITIS	0.87% 15/1723 • Number of events 15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.64% 11/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BRUISE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BUTTOCK PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations C-DIFF INFECTION	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CABG	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures CABG	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIAC ARREST	0.70% 12/1723 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIAC ARRYTHMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIAC CATHETERIZATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders CARDIAC CIRRHOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIAC TAMPONADE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIO RENAL SYNDROME	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIOGENIC SHOCK	0.23% 4/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIOMYOPATHY	0.17% 3/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIOPULMONARY ARREST	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIOSCLEROSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CAROTID STENOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders CAROTID STENOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures CAROTID STENT	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders CATARACTS	0.29% 5/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations CELLULITIS	0.81% 14/1723 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.75% 13/1722 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders CELLULITIS	1.2% 21/1723 • Number of events 25 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.81% 14/1722 • Number of events 17 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders CENTRAL CHORIORETINAL DYSTROPHY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CHEST PAIN	8.4% 144/1723 • Number of events 186 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	8.3% 143/1722 • Number of events 203 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders CHEST PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Investigations CHEST PAIN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders CHEST PAIN	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders CHEST PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLANGIOCARCINOMA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders CHOLANGITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders CHOLE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders CHOLECYSTECTOMY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications CHOLECYSTECTOMY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures CHOLECYSTECTOMY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders CHOLECYSTITIS	0.58% 10/1723 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders CHOLECYSTITIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders CHOLESTASIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications CHOPPED WOUND OF LEFT HAND	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders CHORIORRETINOPATHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	1.2% 21/1723 • Number of events 24 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.3% 23/1722 • Number of events 32 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders CIRRHOSIS	0.06% 1/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders COLD EXTREMITIES	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders COLITIS	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders COLON CANCER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.23% 4/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders CONFUSION	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CONGESTIVE HEART FAILURE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders CONSTIPATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures CORONAROGRAPHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures CORONARY ANGIOGRAPHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CORONARY ARTERY BYPASS GRAFT	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CORONARY ARTERY DISEASE	0.99% 17/1723 • Number of events 18 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.87% 15/1722 • Number of events 15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CORONARY ARTERY STENT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CORONARY REVASCULARIZATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CORONARY VASOSPASM	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures CORRECTION THERAPY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders COUGH	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders COUMADIN TOXICITY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders CROHNS DISEASE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DEATH	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders DEATH	4.8% 83/1723 • Number of events 84 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.1% 71/1722 • Number of events 71 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications DEATH	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders DEATH	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DECREASED APPETITE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders DEEP VEIN THROMBOSIS	0.35% 6/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DEHYDRATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders DEHYDRATION	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders DEHYDRATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders DEMENTIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications DENATURED ALCOHOL POISONING	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations DENTAL ABSCESS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Psychiatric disorders DEPRESSION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DESTABILIZATION OF BLOOD PRESSURE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DEVICE CHANGE	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DEVICE IMPLANT	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DEVICE MALFUNCTION	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders DIABETES	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.81% 14/1722 • Number of events 17 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DIARRHEA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DIARRHEA	0.41% 7/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DILATED ESOPHAGUS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders DISCITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DIVERTICULITIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DIVERTICULOSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders DIZZINESS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders DIZZINESS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders DORSOPATHY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.

Other adverse events

Other adverse events
Measure	Placebo n=1723 participants at risk Placebo of spironolactone	Spironolactone n=1722 participants at risk Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Renal and urinary disorders DYSURIA	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ABDOMINAL PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ABDOMINAL PAIN	1.6% 28/1723 • Number of events 31 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.8% 31/1722 • Number of events 34 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders ABDOMINAL PAIN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ABDOMINAL PAIN	0.17% 3/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders ABNORMAL BMP	0.29% 5/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders ABNORMAL VAGINAL BLEEDING	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ABSCESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders ACTINIC KERATOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISEASE	0.87% 15/1723 • Number of events 17 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Immune system disorders ALLERGY	0.64% 11/1723 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.64% 11/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ALTERED MENTAL STATUS	0.52% 9/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.70% 12/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders ANEMIA	2.6% 44/1723 • Number of events 48 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	2.4% 41/1722 • Number of events 45 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ANEMIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ANEURYSM	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ANGINA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures ANGIOGRAPHY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ANGIOPATHY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ANKLE INJURY	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ANXIETY	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Psychiatric disorders ANXIETY	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders ARM INJURY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ARM INJURY	0.81% 14/1723 • Number of events 15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ARRHYTHMIA	0.93% 16/1723 • Number of events 18 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 13 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ARTERIAL STENOSIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.23% 4/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.64% 11/1723 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ASTHENIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.41% 7/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ATAXIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ATAXIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ATHEROSCLEROSIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ATHEROSCLEROSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ATHEROSCLEROSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ATRIAL FIBRILLATION	4.9% 85/1723 • Number of events 123 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.3% 74/1722 • Number of events 97 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ATRIAL FLUTTER	0.29% 5/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders AV BLOCK	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BACK INJURY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BACK PAIN	3.7% 64/1723 • Number of events 74 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	3.9% 67/1722 • Number of events 76 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TUMOR	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders BLEEDING	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders BLEEDING IN EYE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders BLOOD IN STOOL	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders BLURRED VISION	0.52% 9/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BODY ACHES	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BODY PAIN	0.52% 9/1723 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders BRADYCARDIA	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.2% 20/1722 • Number of events 22 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders BREAST PAIN	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.0% 18/1722 • Number of events 18 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders BREAST TENDERNESS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders BRONCHITIS	3.7% 64/1723 • Number of events 69 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	3.7% 63/1722 • Number of events 75 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.35% 6/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders BRUISE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BRUISE	0.29% 5/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders BRUISE	0.52% 9/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.64% 11/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders BUNDLE BRANCH BLOCK	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BURSITIS	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders BUTTOCK PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations C-DIFF INFECTION	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures CANCER REMOVAL	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CARDIOVERSION	0.23% 4/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders CARPEL TUNNEL RELEASE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders CARPEL TUNNEL SYNDROME	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders CARPEL TUNNEL SYNDROME	0.17% 3/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders CATARACTS	0.99% 17/1723 • Number of events 21 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.0% 18/1722 • Number of events 21 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations CELLULITIS	0.64% 11/1723 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders CELLULITIS	1.2% 20/1723 • Number of events 20 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.0% 18/1722 • Number of events 22 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures CHEMOTHERAPY	0.12% 2/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders CHEST CONGESTION	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CHEST PAIN	5.9% 102/1723 • Number of events 130 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.6% 80/1722 • Number of events 102 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders CHEST PAIN	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.64% 11/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders CHILLS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders CHOLECYSTITIS	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.81% 14/1723 • Number of events 15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders CLAUDICATION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders COLD EXTREMITIES	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders COLD SYMPTOMS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders COLITIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures COLONOSCOPY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications CONCUSSION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders CONFUSION	0.52% 9/1723 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders CONJUCTIVITIS	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders CONSTIPATION	1.5% 25/1723 • Number of events 26 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.6% 28/1722 • Number of events 31 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders CORONARY ARTERY DISEASE	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders COUGH	2.6% 44/1723 • Number of events 53 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	2.6% 44/1722 • Number of events 47 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CYST	0.81% 14/1723 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.0% 18/1722 • Number of events 19 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders CYST	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders CYSTOSCOPY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DECREASED APPETITE	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders DECREASED APPETITE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders DEEP VEIN THROMBOSIS	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DEHYDRATION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders DEHYDRATION	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.75% 13/1722 • Number of events 13 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders DEMENTIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations DENTAL ABSCESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Psychiatric disorders DEPRESSION	0.93% 16/1723 • Number of events 16 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.2% 20/1722 • Number of events 20 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders DERMATITIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders DERMATITIS	1.6% 27/1723 • Number of events 29 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.5% 25/1722 • Number of events 26 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DESTABILIZATION OF BLOOD PRESSURE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DEVICE CHANGE	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders DIABETES	2.1% 37/1723 • Number of events 40 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	2.2% 38/1722 • Number of events 42 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders DIABETES	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders DIAPHORESIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DIARRHEA	4.3% 74/1723 • Number of events 83 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.6% 79/1722 • Number of events 88 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DIVERTICULITIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DIZZINESS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders DIZZINESS	2.0% 35/1723 • Number of events 44 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	2.0% 34/1722 • Number of events 35 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders DIZZINESS	3.1% 54/1723 • Number of events 70 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	3.7% 64/1722 • Number of events 75 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders DORSOPATHY	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders DROWSINESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders DRY EYES	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DUODENITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DYSLIPIDEMIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders DYSLIPIDEMIA	0.93% 16/1723 • Number of events 18 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.75% 13/1722 • Number of events 13 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders DYSLIPIDEMIA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DYSPEPSIA	0.23% 4/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders DYSPHAGIA	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders DYSPNEA	2.1% 37/1723 • Number of events 44 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.8% 31/1722 • Number of events 32 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders EAR ACHE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders EAR INFECTION	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations EAR INFECTION	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders EAR PAIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders EDEMA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders EDEMA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders ELEVATED BILIRUBIN	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ELEVATED BNP	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders ELEVATED BUN	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ELEVATED CARDIAC ENZYMES	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders ELEVATED CREATININE	2.7% 47/1723 • Number of events 50 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	3.5% 60/1722 • Number of events 77 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders ELEVATED INR	0.12% 2/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders ELEVATED LIVER ENZYMES	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders ELEVATED LIVER ENZYMES	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders ELEVATED PSA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Psychiatric disorders EMOTIONAL LABILITY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders ENCEPHALOPATHY	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders EPIGASTRIC PAIN	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders EPISTAXIS	1.2% 21/1723 • Number of events 21 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.1% 19/1722 • Number of events 27 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders ERYTHROCYTOSIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ESOPHAGITIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders EXTRASYSTOLE	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders EYE PAIN	0.12% 2/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders EYELID CYSTS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications FALL	0.23% 4/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders FALL	0.70% 12/1723 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.87% 15/1722 • Number of events 17 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders FALL	0.23% 4/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders FATIGUE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders FATIGUE	0.99% 17/1723 • Number of events 18 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders FATTY HEPATOSIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders FEVER	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations FEVER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders FLATULENCE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders FLU LIKE SYMPTOMS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders FLUID RETENTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders FOOT INJURY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders FOOT PAIN	0.35% 6/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications FRACTURE	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders FRACTURE	1.9% 33/1723 • Number of events 34 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.6% 28/1722 • Number of events 30 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Hepatobiliary disorders GALLSTONES	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GASTRIC REFLUX	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GASTRITIS	3.4% 58/1723 • Number of events 59 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	3.0% 52/1722 • Number of events 59 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GASTROENTERITIS	0.81% 14/1723 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GI BLEED	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.64% 11/1722 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders GI DISTRESS	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders GLAUCOMA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders GOITER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders GONITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders GOUT	2.1% 36/1723 • Number of events 48 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	2.0% 34/1722 • Number of events 38 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders GYNECOMASTIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders GYNECOMASTIA	0.41% 7/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	2.6% 44/1722 • Number of events 45 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Immune system disorders HAIR LOSS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HAND INJURY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HAND PAIN	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Immune system disorders HAY FEVER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HEAD INJURY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HEADACHE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders HEADACHE	5.2% 90/1723 • Number of events 113 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.9% 84/1722 • Number of events 98 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders HEARING LOSS	0.46% 8/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HEART FAILURE	7.8% 135/1723 • Number of events 174 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	7.0% 121/1722 • Number of events 150 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HEART VALVE CALCIFICATION	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HEARTBURN	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders HEARTBURN	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders HEMATEMESIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders HEMATOMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders HEMATOMA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders HEMATURIA	0.12% 2/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HEMATURIA	0.58% 10/1723 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.64% 11/1722 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HEMOPTYSIS	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders HEMORRHOIDS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders HEMORRHOIDS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HERNIA	0.75% 13/1723 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures HERNIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations HERPES SIMPLEX	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders HIP PAIN	0.58% 10/1723 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.99% 17/1722 • Number of events 20 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HOARSENESS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HOT FLASHES	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders HYPERCALCEMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYPERCALCEMIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders HYPEREMIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPERGLYCEMIA	1.5% 26/1723 • Number of events 29 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.2% 21/1722 • Number of events 25 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPERKALEMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPERKALEMIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders HYPERKALEMIA	0.17% 3/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYPERKALEMIA	5.6% 96/1723 • Number of events 109 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	13.1% 226/1722 • Number of events 273 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPERTENSIC CRISIS	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPERTENSION	8.4% 145/1723 • Number of events 265 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	6.6% 113/1722 • Number of events 219 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HYPERTENSION	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations HYPERTHERMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPERTHYROIDISM	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYPERURICEMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPERVOLEMIA	0.35% 6/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPOGLYCEMIA	1.1% 19/1723 • Number of events 27 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders HYPOKALEMIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYPOKALEMIA	1.7% 29/1723 • Number of events 38 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.75% 13/1722 • Number of events 17 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders HYPONATREMIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders HYPONATREMIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders HYPOTENSION	3.0% 52/1723 • Number of events 59 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.1% 71/1722 • Number of events 90 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders HYPOTHYROIDISM	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.87% 15/1722 • Number of events 15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders INCREASED OF TSH	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations INFECTION	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders INFLUENZA	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations INFLUENZA	4.1% 71/1723 • Number of events 82 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	4.1% 70/1722 • Number of events 80 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders INFLUENZA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders INGROWN TOENAIL	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders INSOMNIA	2.3% 39/1723 • Number of events 55 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.7% 29/1722 • Number of events 46 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders IRON DEFICIENCY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders IRON OVERLOAD	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders KIDNEY DISEASE	3.9% 68/1723 • Number of events 76 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	7.8% 135/1722 • Number of events 182 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders KIDNEY STONE	0.46% 8/1723 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders KNEE INJURY	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders KNEE PAIN	0.70% 12/1723 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.2% 20/1722 • Number of events 22 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders LABYRINTHITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders LACTOSE INTOLERANCE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders LEG CLAUDICATION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders LEG EDEMA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders LEG INJURY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders LEG PAIN	1.7% 30/1723 • Number of events 31 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.7% 29/1722 • Number of events 30 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders LIMB EDEMA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders LOW HEMOGLOBIN	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders LOWER EXTREMITY EDEMA	2.3% 40/1723 • Number of events 44 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	2.1% 36/1722 • Number of events 41 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders LOWER EXTREMITY EDEMA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders LOWER EXTREMITY EDEMA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders LUNG MASS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders MACULAR DEGENERATION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders MEMORY LOSS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders MOUTH PAIN	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders MUSCLE INJURY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders MUSCLE PAIN	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders MUSCLE SPASM	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders MYOCARDIAL INFARCTION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders NAUSEA	2.0% 34/1723 • Number of events 37 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	3.1% 54/1722 • Number of events 57 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders NECK PAIN	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders NEURALGIA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders NEUROPATHY	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Psychiatric disorders NEUROSIS	0.75% 13/1723 • Number of events 21 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders NOCTURIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders OLIGURIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations ONYCHOMYCOSIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders ORTHOPNEA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.81% 14/1723 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.5% 26/1722 • Number of events 27 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders OSTEOCHONDROSIS	0.58% 10/1723 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.81% 14/1722 • Number of events 15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders OTITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PALPITATIONS	1.5% 26/1723 • Number of events 29 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.5% 25/1722 • Number of events 26 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders PARAGEUSIA	0.12% 2/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders PARASTHESIA	1.2% 20/1723 • Number of events 24 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.3% 23/1722 • Number of events 26 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders PARKINSON'S DISEASE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PERICARDITIS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders PERIPHERAL ARTERIAL DISEASE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders PERIPHERAL EDEMA	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PHARYNGITIS	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	1.8% 31/1723 • Number of events 32 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	2.6% 44/1722 • Number of events 49 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders POLYPS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) POLYPS	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders POLYURIA	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Reproductive system and breast disorders PROSTATIC HYPERPLASIA	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders PROTEINURIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders PRURITIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders PRURITIS	0.46% 8/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.81% 14/1722 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders PSORIASIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY EDEMA	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders PULMONARY OVERLOAD	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders PURITIS	0.17% 3/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders PYELONEPHRITIS	0.46% 8/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders RADICULITIS	0.41% 7/1723 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders RASH	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders RENAL FAILURE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT INFECTION	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders RESTLESS LEG SYNDROME	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders RETINOPATHY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders RHINITIS	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders RIB PAIN	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SCIATICA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders SCIATICA	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Immune system disorders SEASONAL ALLERGIES	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders SEIZURE	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SEPSIS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SEXUALLY TRANSMITTED DISEASE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SHINGLES	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders SHORTNESS OF BREATH	0.12% 2/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders SHORTNESS OF BREATH	2.0% 34/1723 • Number of events 40 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.6% 27/1722 • Number of events 30 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications SHOULDER INJURY	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SHOULDER INJURY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SHOULDER PAIN	0.81% 14/1723 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders SICK SINUS SYNDROME	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations SINUSITIS	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders SINUSITIS	1.1% 19/1723 • Number of events 21 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.81% 14/1722 • Number of events 17 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.99% 17/1723 • Number of events 22 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.81% 14/1722 • Number of events 15 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Injury, poisoning and procedural complications SKIN LACERATION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SKIN LACERATION	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders SKIN LACERATION	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders SKIN LESION	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders SKIN WOUND	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders SLEEP APNEA	0.75% 13/1723 • Number of events 13 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.52% 9/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders SLEEP DISTURBANCE	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders SORE THROAT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders SORE THROAT	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders SPINAL STENOSIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders STENOSING TENOSYNOVITIS	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders STOMACH ULCER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders STROKE	0.58% 10/1723 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders SUPRATHERAPEUTIC INR	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders SWEATING	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders SYNCOPE	1.4% 24/1723 • Number of events 27 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.6% 28/1722 • Number of events 28 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders TACHYCARDIA	1.2% 20/1723 • Number of events 29 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.3% 22/1722 • Number of events 25 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders TENDONITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders THROMBOPHLEBITIS	0.35% 6/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations THRUSH	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Endocrine disorders THYROID NODULE	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID NODULE	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders TINNITUS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders TMJ DISORDER	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TONGUE LESION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations TONSILLITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations TOOTH ABSCESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Surgical and medical procedures TOOTH EXTRACTION	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders TOOTHACHE	0.70% 12/1723 • Number of events 13 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders TRANSIENT ISCHEMIC ATTACK	0.64% 11/1723 • Number of events 14 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders TREMOR	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders ULCER	0.23% 4/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 8 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders ULCER	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders ULCER	0.29% 5/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders ULCER	0.35% 6/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders ULCER	0.17% 3/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations UPPER RESPIRATORY INFECTION	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.23% 4/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY INFECTION	4.5% 78/1723 • Number of events 90 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	5.0% 86/1722 • Number of events 98 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders URETHRITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URETHRITIS	0.00% 0/1723 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY HESITANCY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY INCONTINENCE	0.29% 5/1723 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.41% 7/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY RETENTION	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY TRACT INFECTION	3.9% 68/1723 • Number of events 84 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	3.5% 60/1722 • Number of events 74 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY TRACT STONES	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Renal and urinary disorders URINARY URGENCY	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Skin and subcutaneous tissue disorders URTICARIA	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders VARICOSE VEINS	0.29% 5/1723 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.46% 8/1722 • Number of events 10 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Vascular disorders VENOUS INSUFFICIENCY	0.17% 3/1723 • Number of events 4 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.58% 10/1722 • Number of events 12 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Ear and labyrinth disorders VERTIGO	0.93% 16/1723 • Number of events 20 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.64% 11/1722 • Number of events 11 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders VERTIGO	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders VISION CHANGES	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Eye disorders VISION LOSS	0.17% 3/1723 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.17% 3/1722 • Number of events 3 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders VOMITING	1.2% 20/1723 • Number of events 20 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	1.2% 20/1722 • Number of events 21 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Cardiac disorders WEAKNESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders WEAKNESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders WEAKNESS	2.0% 35/1723 • Number of events 37 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	2.6% 45/1722 • Number of events 53 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Musculoskeletal and connective tissue disorders WEAKNESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 5 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Nervous system disorders WEAKNESS	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders WEIGHT GAIN	0.93% 16/1723 • Number of events 17 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.87% 15/1722 • Number of events 17 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
General disorders WEIGHT LOSS	0.06% 1/1723 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.12% 2/1722 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Metabolism and nutrition disorders WEIGHT LOSS	0.46% 8/1723 • Number of events 9 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.29% 5/1722 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Respiratory, thoracic and mediastinal disorders WHEEZING	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.00% 0/1722 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Infections and infestations WOUND INFECTION	0.12% 2/1723 • Number of events 2 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.06% 1/1722 • Number of events 1 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.
Gastrointestinal disorders XEROSTOMIA	0.41% 7/1723 • Number of events 7 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.	0.35% 6/1722 • Number of events 6 • Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject. If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.

Additional Information

Brian Harty

New England Research Institutes

Phone: 617-972-3224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place