Trial Outcomes & Findings for The LIFE Study - Lifestyle Interventions and Independence for Elders (NCT NCT01072500)

NCT ID: NCT01072500

Last Updated: 2018-05-07

Results Overview

The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1635 participants
• Primary outcome timeframe: Median 2.7 years/Average 2.6 years
• Results posted on: 2018-05-07

Participant Flow

1,635 participants were randomized over 21-months, with the target of 1,600 reached late Nov 2011. The 1st randomization occurred 3/12/10, and the final randomization on 12/27/11. Participants in the recruitment pipeline completed screening and testing visits and were randomized; hence, the total randomized exceeded the target.

Participant milestones

Measure	Physical Activity The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.	Successful Aging (Health Education) The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Overall Study STARTED	818	817
Overall Study COMPLETED	794	803
Overall Study NOT COMPLETED	24	14

Reasons for withdrawal

Measure	Physical Activity The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.	Successful Aging (Health Education) The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Overall Study Death	2	2
Overall Study Lost to Follow-up	5	2
Overall Study Withdrawal by Subject	17	10

Baseline Characteristics

The LIFE Study - Lifestyle Interventions and Independence for Elders

Baseline characteristics by cohort

Measure	Physical Activity n=818 Participants The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.	Successful Aging n=817 Participants The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.	Total n=1635 Participants Total of all reporting groups
Education College (13-17)	321 participants n=5 Participants	320 participants n=7 Participants	641 participants n=5 Participants
Education Post Graduate	194 participants n=5 Participants	208 participants n=7 Participants	402 participants n=5 Participants
Education Other	32 participants n=5 Participants	26 participants n=7 Participants	58 participants n=5 Participants
Education Unknown	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Total SPPB Score	7.4 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	7.3 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	7.4 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants
3MSE Score, 0-100 scale, mean	91.5 units on a scale STANDARD_DEVIATION 5.6 • n=5 Participants	91.6 units on a scale STANDARD_DEVIATION 5.5 • n=7 Participants	91.5 units on a scale STANDARD_DEVIATION 5.5 • n=5 Participants
CHAMPS 18 Total Score	15.9 hours/week STANDARD_DEVIATION 32.1 • n=5 Participants	18.2 hours/week STANDARD_DEVIATION 33.8 • n=7 Participants	17.0 hours/week STANDARD_DEVIATION 33.0 • n=5 Participants
Age, Continuous	78.7 years STANDARD_DEVIATION 5.2 • n=5 Participants	79.1 years STANDARD_DEVIATION 5.2 • n=7 Participants	78.9 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	547 Participants n=5 Participants	551 Participants n=7 Participants	1098 Participants n=5 Participants
Sex: Female, Male Male	271 Participants n=5 Participants	266 Participants n=7 Participants	537 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	31 participants n=5 Participants	30 participants n=7 Participants	61 participants n=5 Participants
Race/Ethnicity, Customized White	604 participants n=5 Participants	635 participants n=7 Participants	1239 participants n=5 Participants
Race/Ethnicity, Customized African American	163 participants n=5 Participants	125 participants n=7 Participants	288 participants n=5 Participants
Race/Ethnicity, Customized Asian	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Race/Ethnicity, Customized Other/Mixed	10 participants n=5 Participants	17 participants n=7 Participants	27 participants n=5 Participants
Race/Ethnicity, Customized Refused/Missing	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Education No formal eduction	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Education Elementary School (k-8)	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants
Education High school/equivalent (9-12)	248 participants n=5 Participants	236 participants n=7 Participants	484 participants n=5 Participants
Total Cholesterol	179.3 mg/dL STANDARD_DEVIATION 39.6 • n=5 Participants	178.5 mg/dL STANDARD_DEVIATION 39.9 • n=7 Participants	178.9 mg/dL STANDARD_DEVIATION 39.8 • n=5 Participants
Systolic Blood Pressure	127.9 mmHg STANDARD_DEVIATION 18.1 • n=5 Participants	127.0 mmHg STANDARD_DEVIATION 17.8 • n=7 Participants	127.4 mmHg STANDARD_DEVIATION 18.0 • n=5 Participants
Diastolic Blood Pressure	68.7 mmHg STANDARD_DEVIATION 10.3 • n=5 Participants	67.7 mmHg STANDARD_DEVIATION 10.1 • n=7 Participants	68.2 mmHg STANDARD_DEVIATION 10.2 • n=5 Participants
Weight (kg)	81.9 kg STANDARD_DEVIATION 18.4 • n=5 Participants	82.0 kg STANDARD_DEVIATION 19.3 • n=7 Participants	81.9 kg STANDARD_DEVIATION 18.8 • n=5 Participants
Body Mass Index, mean	30.1 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants	30.3 kg/m^2 STANDARD_DEVIATION 6.2 • n=7 Participants	30.2 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants
High blood pressure/hypertension	573 participants n=5 Participants	578 participants n=7 Participants	1151 participants n=5 Participants
Heart Attack/Coronary/MI	60 participants n=5 Participants	69 participants n=7 Participants	129 participants n=5 Participants
Heart failure/congestive heart failure	26 participants n=5 Participants	45 participants n=7 Participants	71 participants n=5 Participants
Pacemaker	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants
Stroke	57 participants n=5 Participants	52 participants n=7 Participants	109 participants n=5 Participants
Cancer	178 participants n=5 Participants	192 participants n=7 Participants	370 participants n=5 Participants
Diabetes/High Blood Sugar	198 participants n=5 Participants	216 participants n=7 Participants	414 participants n=5 Participants
Chronic lung disease	130 participants n=5 Participants	123 participants n=7 Participants	253 participants n=5 Participants

PRIMARY outcome

Timeframe: Median 2.7 years/Average 2.6 years

The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes.

Outcome measures

Measure	Physical Activity n=818 Participants The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.	Successful Aging n=817 Participants The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Major Mobility Disability, Defined as Incapacity to Walk 400 Meters	246 participants	290 participants

SECONDARY outcome

Timeframe: Median 2.7 years/Average 2.6 years

The assessment of major mobility disability (the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When MMD could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 m walk within 15 minutes.) at two consecutive time points or MMD followed by death.

Outcome measures

Measure	Physical Activity n=818 Participants The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.	Successful Aging n=817 Participants The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Persistent Mobility Disability (Assessed Every 6 Months)	120 participants	162 participants

Adverse Events

Physical Activity

Serious events: 404 serious events

Other events: 181 other events

Deaths: 0 deaths

Successful Aging

Serious events: 373 serious events

Other events: 88 other events

Deaths: 0 deaths

Serious adverse events

Measure	Physical Activity n=818 participants at risk The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.	Successful Aging n=817 participants at risk The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Infections and infestations ABDOMINAL INFECTION	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders ABDOMINAL PAIN	1.5% 12/818 • Number of events 12 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.73% 6/817 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders ACUTE CORONARY SYNDROME	0.73% 6/818 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.73% 6/817 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.49% 4/818 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.49% 4/817 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Endocrine disorders ADRENAL INSUFFICIENCY	0.12% 1/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Immune system disorders ALLERGIC REACTION	0.61% 5/818 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Immune system disorders ANAPHYLAXIS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Blood and lymphatic system disorders ANEMIA	1.2% 10/818 • Number of events 15 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.73% 6/817 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations ANORECTAL INFECTION	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Psychiatric disorders ANXIETY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders AORTIC VALVE DISEASE	0.37% 3/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders APNEA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations APPENDICITIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations APPENDICITIS PERFORATED	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders ARTHRITIS	1.7% 14/818 • Number of events 15 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	1.8% 15/817 • Number of events 15 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders ASPIRATION	0.12% 1/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders ASYSTOLE	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders ATAXIA	0.24% 2/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders ATRIAL FIBRILLATION	2.8% 23/818 • Number of events 28 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	2.3% 19/817 • Number of events 23 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders ATRIAL FLUTTER	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders BACK PAIN	1.3% 11/818 • Number of events 11 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.86% 7/817 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations BILIARY TRACT INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations BLADDER INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations BONE INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations BRONCHIAL INFECTION	0.98% 8/818 • Number of events 9 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.49% 4/817 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders BRONCHIAL OBSTRUCTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Skin and subcutaneous tissue disorders BULLOUS DERMATITIS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders CARDIAC ARREST	0.73% 6/818 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.86% 7/817 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders CARDIAC DISORDERS - OTHER, SPECIFY	1.3% 11/818 • Number of events 11 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.98% 8/817 • Number of events 8 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations CATHETER RELATED INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders CENTRAL NERVOUS SYSTEM NECROSIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders CEREBROSPINAL FLUID LEAKAGE	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders CHEST PAIN - CARDIAC	2.2% 18/818 • Number of events 24 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	1.5% 12/817 • Number of events 14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders CHEST WALL PAIN	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Hepatobiliary disorders CHOLECYSTITIS	0.37% 3/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders CHRONIC KIDNEY DISEASE	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders COGNITIVE DISTURBANCE	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders COLITIS	0.49% 4/818 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders COLONIC FISTULA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders COLONIC HEMORRHAGE	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders COLONIC OBSTRUCTION	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders COLONIC PERFORATION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders CONDUCTION DISORDER	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Psychiatric disorders CONFUSION	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders CONSTIPATION	0.12% 1/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders COUGH	0.49% 4/818 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Investigations CREATININE INCREASED	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders DEATH NOS	0.49% 4/818 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders DEHYDRATION	1.5% 12/818 • Number of events 12 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	1.1% 9/817 • Number of events 9 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Psychiatric disorders DELIRIUM	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders DEPRESSED LEVEL OF CONSCIOUSNESS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Psychiatric disorders DEPRESSION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations DEVICE RELATED INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders DIARRHEA	0.37% 3/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.49% 4/817 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders DIZZINESS	1.2% 10/818 • Number of events 11 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.61% 5/817 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders DYSESTHESIA	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders DYSPEPSIA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders DYSPHAGIA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders DYSPNEA	1.5% 12/818 • Number of events 12 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.86% 7/817 • Number of events 8 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders EDEMA LIMBS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders EDEMA TRUNK	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations ENCEPHALITIS INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders ENCEPHALOPATHY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Endocrine disorders ENDOCRINE DISORDERS - OTHER, SPECIFY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders ENTEROCOLITIS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations ENTEROCOLITIS INFECTIOUS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders ESOPHAGEAL OBSTRUCTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders ESOPHAGEAL STENOSIS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders ESOPHAGEAL ULCER	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders FACIAL MUSCLE WEAKNESS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders FACIAL NERVE DISORDER	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications FALL	3.4% 28/818 • Number of events 29 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	3.8% 31/817 • Number of events 35 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders FATIGUE	0.37% 3/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders FEVER	0.12% 1/818 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders FLU LIKE SYMPTOMS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications FRACTURE	2.2% 18/818 • Number of events 19 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	2.3% 19/817 • Number of events 19 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders GAIT DISTURBANCE	0.12% 1/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations GALLBLADDER INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Hepatobiliary disorders GALLBLADDER NECROSIS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Hepatobiliary disorders GALLBLADDER OBSTRUCTION	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Hepatobiliary disorders GALLBLADDER PAIN	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders GASTRIC HEMORRHAGE	0.49% 4/818 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders GASTRIC ULCER	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.49% 4/817 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders GASTRITIS	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	0.61% 5/818 • Number of events 8 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	3.8% 31/818 • Number of events 49 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	3.3% 27/817 • Number of events 46 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Psychiatric disorders HALLUCINATIONS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders HEADACHE	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders HEART FAILURE	2.4% 20/818 • Number of events 24 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	2.0% 16/817 • Number of events 23 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Vascular disorders HEMATOMA	0.37% 3/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders HEMATURIA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders HEMORRHOIDS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Hepatobiliary disorders HEPATIC FAILURE	0.12% 1/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Hepatobiliary disorders HEPATIC HEMORRHAGE	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Hepatobiliary disorders HEPATOBILIARY DISORDERS - OTHER, SPECIFY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders HICCUPS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications HIP FRACTURE	0.49% 4/818 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.49% 4/817 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders HYDROCEPHALUS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders HYPERCALCEMIA	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders HYPERGLYCEMIA	0.73% 6/818 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders HYPERKALEMIA	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Endocrine disorders HYPERPARATHYROIDISM	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Vascular disorders HYPERTENSION	0.73% 6/818 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.98% 8/817 • Number of events 8 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Endocrine disorders HYPERTHYROIDISM	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders HYPERURICEMIA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders HYPOCALCEMIA	0.12% 1/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders HYPOGLYCEMIA	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.49% 4/817 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders HYPONATREMIA	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Endocrine disorders HYPOPARATHYROIDISM	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Vascular disorders HYPOTENSION	0.98% 8/818 • Number of events 8 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.61% 5/817 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders ILEAL OBSTRUCTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Immune system disorders IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	0.73% 6/818 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders INJECTION SITE REACTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Investigations INR INCREASED	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders INTRA-ABDOMINAL HEMORRHAGE	0.37% 3/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders INTRACRANIAL HEMORRHAGE	0.49% 4/818 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications INTRAOPERATIVE CARDIAC INJURY	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders ISCHEMIA CEREBROVASCULAR	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders JEJUNAL OBSTRUCTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders JOINT EFFUSION	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations JOINT INFECTION	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders JOINT RANGE OF MOTION DECREASED	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders JOINT RANGE OF MOTION DECREASED CERVICAL SPINE	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders JOINT RANGE OF MOTION DECREASED LUMBAR SPINE	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations KIDNEY INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations LARYNGITIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders LETHARGY	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders LOWER GASTROINTESTINAL HEMORRHAGE	0.24% 2/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations LUNG INFECTION	1.8% 15/818 • Number of events 17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	1.8% 15/817 • Number of events 16 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders MALAISE	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Psychiatric disorders MANIA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS LOWER LIMB	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	1.1% 9/818 • Number of events 9 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	2.1% 17/817 • Number of events 18 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DEFORMITY	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders MYALGIA	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders MYOCARDIAL INFARCTION	1.7% 14/818 • Number of events 14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	1.5% 12/817 • Number of events 13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders MYOSITIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders NAUSEA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders NECK PAIN	0.49% 4/818 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	2.9% 24/818 • Number of events 31 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	2.3% 19/817 • Number of events 31 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	0.49% 4/818 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders NON-CARDIAC CHEST PAIN	1.3% 11/818 • Number of events 11 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.98% 8/817 • Number of events 9 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders OBSTRUCTION GASTRIC	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations OVARIAN INFECTION	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
General disorders PAIN	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.98% 8/817 • Number of events 9 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders PALPITATIONS	0.12% 1/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders PANCREATIC NECROSIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders PANCREATITIS	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.61% 5/817 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders PAROXYSMAL ATRIAL TACHYCARDIA	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders PERICARDITIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Vascular disorders PERIPHERAL ISCHEMIA	0.24% 2/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations PHARYNGITIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Investigations PLATELET COUNT DECREASED	0.24% 2/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.37% 3/818 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	2.1% 17/818 • Number of events 23 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	1.3% 11/817 • Number of events 11 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders PRESYNCOPE	0.61% 5/818 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations PROSTATE INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Reproductive system and breast disorders PROSTATIC OBSTRUCTION	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Surgical and medical procedures PROSTECTOMY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders PROTEINURIA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders RADICULITIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders RECTAL HEMORRHAGE	0.37% 3/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders RECTAL PERFORATION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders RECTAL STENOSIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders RENAL AND URINARY DISORDERS - OTHER, SPECIFY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.61% 5/817 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders RENAL CALCULI	0.37% 3/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Reproductive system and breast disorders REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.61% 5/818 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.49% 4/817 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	0.86% 7/818 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.98% 8/817 • Number of events 9 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders RESTRICTIVE CARDIOMYOPATHY	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations SALIVARY GLAND INFECTION	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders SEIZURE	0.37% 3/818 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations SEPSIS	0.86% 7/818 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications SEROMA	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders SINUS BRADYCARDIA	0.37% 3/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.86% 7/817 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations SINUSITIS	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.49% 4/817 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations SKIN INFECTION	0.73% 6/818 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.86% 7/817 • Number of events 9 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Skin and subcutaneous tissue disorders SKIN ULCERATION	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.98% 8/818 • Number of events 8 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations SOFT TISSUE INFECTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Musculoskeletal and connective tissue disorders SOFT TISSUE NECROSIS UPPER LIMB	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications SPINAL FRACTURE	0.49% 4/818 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders STOMACH PAIN	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders STROKE	1.8% 15/818 • Number of events 19 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	2.7% 22/817 • Number of events 25 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Psychiatric disorders SUICIDE ATTEMPT	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Surgical and medical procedures SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	8.2% 67/818 • Number of events 75 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	9.1% 74/817 • Number of events 86 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders SYNCOPE	1.6% 13/818 • Number of events 15 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	1.8% 15/817 • Number of events 17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Vascular disorders THROMBOEMBOLIC EVENT	1.3% 11/818 • Number of events 12 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	1.2% 10/817 • Number of events 12 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders TRANSIENT ISCHEMIC ATTACKS	1.2% 10/818 • Number of events 10 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.98% 8/817 • Number of events 9 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders TREMOR	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Metabolism and nutrition disorders TUMOR LYSIS SYNDROME	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations UPPER RESPIRATORY INFECTION	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders URINARY INCONTINENCE	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders URINARY RETENTION	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations URINARY TRACT INFECTION	1.3% 11/818 • Number of events 11 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	1.6% 13/817 • Number of events 14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders URINARY TRACT OBSTRUCTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Renal and urinary disorders URINARY TRACT PAIN	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.24% 2/817 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Reproductive system and breast disorders UTERINE PAIN	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Reproductive system and breast disorders VAGINAL HEMORRHAGE	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Vascular disorders VASCULAR DISORDERS - OTHER, SPECIFY	0.61% 5/818 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Nervous system disorders VASOVAGAL REACTION	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Cardiac disorders VENTRICULAR TACHYCARDIA	0.24% 2/818 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Ear and labyrinth disorders VERTIGO	0.61% 5/818 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.73% 6/817 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Vascular disorders VISCERAL ARTERIAL ISCHEMIA	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Gastrointestinal disorders VOMITING	0.49% 4/818 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.37% 3/817 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Respiratory, thoracic and mediastinal disorders WHEEZING	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Investigations WHITE BLOOD CELL DECREASED	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.12% 1/818 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.00% 0/817 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Infections and infestations WOUND INFECTION	0.24% 2/818 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.
Injury, poisoning and procedural complications WRIST FRACTURE	0.00% 0/818 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	0.12% 1/817 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.

Other adverse events

Measure	Physical Activity n=818 participants at risk The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.	Successful Aging n=817 participants at risk The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
General disorders non-serious AES	22.1% 181/818 • Number of events 181 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.	10.8% 88/817 • Number of events 88 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term.

Additional Information

Michael Miller

Wake Forest School of Medicine

Phone: 336-716-6837

Email: mmiller@wakehealth.edu

Results disclosure agreements

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