Trial Outcomes & Findings for Rural Engagement in Primary Care for Optimizing Weight Reduction (NCT NCT02456636)

NCT ID: NCT02456636

Last Updated: 2020-12-07

Results Overview

Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1432 participants
• Primary outcome timeframe: Baseline and 6, 18 and 24 months
• Results posted on: 2020-12-07

Participant Flow

Patients from 36 medical practices were recruited via mailings and in-clinic referrals. Initial eligibility was assessed via telephone screen. Patients then completed a baseline survey, physician clearance was documented, and finally BMI was verified at the initial study visit. The recruitment period was from 2/15/2016 through 10/2/2017.

Participant milestones

Measure	Fee-for-Service (In Clinic Individual Counseling) Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Overall Study STARTED	478	479	475
Overall Study 6 Month	474	474	468
Overall Study 18 Month	467	463	461
Overall Study COMPLETED	410	410	400
Overall Study NOT COMPLETED	68	69	75

Reasons for withdrawal

Measure	Fee-for-Service (In Clinic Individual Counseling) Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Overall Study Death	0	3	0
Overall Study Pregnancy	1	3	5
Overall Study Physician Decision	4	5	4
Overall Study Withdrawal by Subject	13	14	16
Overall Study Lost to Follow-up	50	44	50

Baseline Characteristics

Enrolled minus deaths and medical removals.

Baseline characteristics by cohort

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling	Total n=1407 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • Enrolled minus deaths and medical removals.	0 Participants n=7 Participants • Enrolled minus deaths and medical removals.	0 Participants n=5 Participants • Enrolled minus deaths and medical removals.	0 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Age, Categorical Between 18 and 65 years	385 Participants n=5 Participants • Enrolled minus deaths and medical removals.	343 Participants n=7 Participants • Enrolled minus deaths and medical removals.	372 Participants n=5 Participants • Enrolled minus deaths and medical removals.	1100 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Age, Categorical >=65 years	88 Participants n=5 Participants • Enrolled minus deaths and medical removals.	125 Participants n=7 Participants • Enrolled minus deaths and medical removals.	94 Participants n=5 Participants • Enrolled minus deaths and medical removals.	307 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Age, Continuous	54.1 years STANDARD_DEVIATION 11.5 • n=5 Participants • Enrolled minus deaths and medical removals.	55.7 years STANDARD_DEVIATION 12.0 • n=7 Participants • Enrolled minus deaths and medical removals.	54.1 years STANDARD_DEVIATION 11.9 • n=5 Participants • Enrolled minus deaths and medical removals.	54.7 years STANDARD_DEVIATION 11.8 • n=4 Participants • Enrolled minus deaths and medical removals.
Sex: Female, Male Female	377 Participants n=5 Participants • Enrolled minus deaths and medical removals.	343 Participants n=7 Participants • Enrolled minus deaths and medical removals.	361 Participants n=5 Participants • Enrolled minus deaths and medical removals.	1081 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Sex: Female, Male Male	96 Participants n=5 Participants • Enrolled minus deaths and medical removals.	125 Participants n=7 Participants • Enrolled minus deaths and medical removals.	105 Participants n=5 Participants • Enrolled minus deaths and medical removals.	326 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Race/Ethnicity, Customized White, Non-Hispanic	463 Participants n=5 Participants • Enrolled minus deaths and medical removals.	442 Participants n=7 Participants • Enrolled minus deaths and medical removals.	448 Participants n=5 Participants • Enrolled minus deaths and medical removals.	1353 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Race/Ethnicity, Customized Other	10 Participants n=5 Participants • Enrolled minus deaths and medical removals.	26 Participants n=7 Participants • Enrolled minus deaths and medical removals.	18 Participants n=5 Participants • Enrolled minus deaths and medical removals.	54 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Region of Enrollment United States · Isolated rural	244 Participants n=5 Participants • Enrolled minus deaths and medical removals.	203 Participants n=7 Participants • Enrolled minus deaths and medical removals.	212 Participants n=5 Participants • Enrolled minus deaths and medical removals.	659 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Region of Enrollment United States · Small rural	78 Participants n=5 Participants • Enrolled minus deaths and medical removals.	83 Participants n=7 Participants • Enrolled minus deaths and medical removals.	89 Participants n=5 Participants • Enrolled minus deaths and medical removals.	250 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Region of Enrollment United States · Large rural	151 Participants n=5 Participants • Enrolled minus deaths and medical removals.	182 Participants n=7 Participants • Enrolled minus deaths and medical removals.	165 Participants n=5 Participants • Enrolled minus deaths and medical removals.	498 Participants n=4 Participants • Enrolled minus deaths and medical removals.
Weight, kg	103.1 kg STANDARD_DEVIATION 15.4 • n=5 Participants • Enrolled minus deaths and medical removals	102.9 kg STANDARD_DEVIATION 15.5 • n=7 Participants • Enrolled minus deaths and medical removals	102.7 kg STANDARD_DEVIATION 15.6 • n=5 Participants • Enrolled minus deaths and medical removals	102.9 kg STANDARD_DEVIATION 15.5 • n=4 Participants • Enrolled minus deaths and medical removals
Body Mass Index (BMI)	36.9 kg/m^2 STANDARD_DEVIATION 4.0 • n=5 Participants • Enrolled minus deaths and medical removals.	36.7 kg/m^2 STANDARD_DEVIATION 3.9 • n=7 Participants • Enrolled minus deaths and medical removals.	36.6 kg/m^2 STANDARD_DEVIATION 3.9 • n=5 Participants • Enrolled minus deaths and medical removals.	36.7 kg/m^2 STANDARD_DEVIATION 4.0 • n=4 Participants • Enrolled minus deaths and medical removals.

PRIMARY outcome

Timeframe: Baseline and 6, 18 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation Mean Weight change at 6 months	-5.73 kg Interval -6.79 to -4.67	-8.34 kg Interval -9.37 to -7.31	-7.72 kg Interval -8.76 to -6.68
Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation Mean Weight change at 18 months	-3.35 kg Interval -4.57 to -2.14	-5.58 kg Interval -6.77 to -4.39	-5.17 kg Interval -6.37 to -3.97
Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation Mean Weight change at 24 months	-2.56 kg Interval -3.79 to -1.34	-4.43 kg Interval -5.63 to -3.23	-3.92 kg Interval -5.13 to -2.71

PRIMARY outcome

Timeframe: Baseline and 6, 18 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Adjusted for affiliation, sex, race/ethnicity, education, diabetes, cardiovascular disease, and travel time to clinic.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Weight Change Over 24 Months; Adjusted Mean weight change at 6 months	-6.01 kg Interval -7.72 to -4.31	-8.62 kg Interval -10.23 to -7.0	-7.97 kg Interval -9.63 to -6.32
Mean Weight Change Over 24 Months; Adjusted Mean weight change at 18 months	-3.65 kg Interval -5.46 to -1.83	-5.84 kg Interval -7.57 to -4.12	-5.44 kg Interval -7.2 to -3.68
Mean Weight Change Over 24 Months; Adjusted Mean weight change at 24 months	-2.85 kg Interval -4.67 to -1.03	-4.69 kg Interval -6.42 to -2.96	-4.19 kg Interval -5.96 to -2.42

SECONDARY outcome

Timeframe: Baseline and 6, 18 and 24 months

Population: Enrolled minus deaths and medical removals.

Comparison in percent weight loss from baseline of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation Mean % weight change at 6 months	-5.58 percentage from baseline Interval -6.49 to -4.68	-8.20 percentage from baseline Interval -9.08 to -7.32	-7.52 percentage from baseline Interval -8.41 to -6.63
Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation Mean % weight change at 18 months	-3.23 percentage from baseline Interval -4.27 to -2.19	-5.47 percentage from baseline Interval -6.49 to -4.46	-5.06 percentage from baseline Interval -6.09 to -4.03
Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation Mean % weight change at 24 months	-2.48 percentage from baseline Interval -3.53 to -1.43	-4.30 percentage from baseline Interval -5.33 to -3.27	-3.83 percentage from baseline Interval -4.87 to -2.79

SECONDARY outcome

Timeframe: Baseline and 6, 18 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean change in systolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation Mean change Systolic BP at 6 months	-2.41 mmHg Interval -4.57 to -0.25	-2.08 mmHg Interval -4.19 to 0.03	-2.27 mmHg Interval -4.39 to -0.15
Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation Mean change Systolic BP at 18 months	-0.27 mmHg Interval -2.53 to 1.98	-0.10 mmHg Interval -2.3 to 2.1	-1.28 mmHg Interval -3.5 to 0.94
Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation Mean change Systolic BP at 24 months	-0.58 mmHg Interval -2.8 to 1.63	0.12 mmHg Interval -2.05 to 2.28	-1.60 mmHg Interval -3.77 to 0.58

SECONDARY outcome

Timeframe: Baseline and 6, 18 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean change in diastolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation Mean change Diastolic BP at 6 months	-2.23 mmHg Interval -3.68 to -0.77	-2.42 mmHg Interval -3.85 to -0.99	-2.02 mmHg Interval -3.45 to -0.59
Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation Mean change Diastolic BP at 18 months	-1.03 mmHg Interval -2.52 to 0.47	-1.97 mmHg Interval -3.43 to -0.51	-0.49 mmHg Interval -1.96 to 0.98
Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation Mean change Diastolic BP at 24 months	-0.88 mmHg Interval -2.37 to 0.61	-0.95 mmHg Interval -2.41 to 0.51	-0.60 mmHg Interval -2.07 to 0.87

SECONDARY outcome

Timeframe: Baseline and 6 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean change in fasting glucose will be compared across all treatment arms; unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Fasting Glucose; Unadjusted Except for Affiliation Mean change fasting glucose at 6 months	-1.69 mg/dl Interval -4.27 to 0.9	-3.71 mg/dl Interval -6.24 to -1.17	-4.48 mg/dl Interval -7.06 to -1.89
Mean Change in Fasting Glucose; Unadjusted Except for Affiliation Mean change fasting glucose at 24 months	3.07 mg/dl Interval -0.07 to 6.21	0.94 mg/dl Interval -2.17 to 4.04	0.29 mg/dl Interval -2.88 to 3.47

SECONDARY outcome

Timeframe: Baseline and 6 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean change in fasting cholesterol will be compared across all treatment arms; unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation Mean change fasting cholesterol at 6 months	-6.20 mg/dl Interval -9.52 to -2.87	-8.22 mg/dl Interval -11.48 to -4.96	-5.89 mg/dl Interval -9.21 to -2.56
Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation Mean change fasting cholesterol at 24 months	-3.85 mg/dl Interval -7.76 to 0.06	-1.69 mg/dl Interval -5.55 to 2.18	-0.74 mg/dl Interval -4.68 to 3.21

SECONDARY outcome

Timeframe: Baseline and 6 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean change in fasting triglycerides will be compared across all treatment arms; unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation Mean change fasting triglycerides at 6 months	-12.61 mg/dl Interval -20.25 to -4.97	-25.39 mg/dl Interval -32.88 to -17.91	-18.61 mg/dl Interval -26.31 to -10.9
Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation Mean change fasting triglycerides at 24 months	-0.46 mg/dl Interval -8.22 to 7.3	-19.17 mg/dl Interval -26.78 to -11.56	-10.40 mg/dl Interval -18.23 to -2.57

SECONDARY outcome

Timeframe: Baseline and 6 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean change in fasting low density lipoprotein (LDL) will be compared across all treatment arms; unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation Mean change fasting LDL at 6 months	-3.38 mg/dl Interval -6.73 to -0.02	-4.05 mg/dl Interval -7.31 to -0.79	-2.94 mg/dl Interval -6.27 to 0.39
Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation Mean change fasting LDL at 24 months	-5.26 mg/dl Interval -9.13 to -1.39	-1.38 mg/dl Interval -5.17 to 2.41	-0.83 mg/dl Interval -4.72 to 3.05

SECONDARY outcome

Timeframe: Baseline and 6 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean change in fasting high density lipoprotein (HDL) will be compared across all treatment arms; unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation Mean change fasting HDL at 6 months	0.25 mg/dl Interval -1.27 to 1.77	0.76 mg/dl Interval -0.73 to 2.24	-0.05 mg/dl Interval -1.56 to 1.46
Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation Mean change fasting HDL at 24 months	1.32 mg/dl Interval -0.22 to 2.85	1.88 mg/dl Interval 0.38 to 3.39	2.12 mg/dl Interval 0.6 to 3.65

SECONDARY outcome

Timeframe: Baseline and 6 and 24 months

Population: Enrolled minus deaths and medical removals.

Change in physical quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation Mean change SF-12 Physical Score at 6 months	1.71 units on a scale Interval 0.83 to 2.59	2.69 units on a scale Interval 1.82 to 3.56	2.61 units on a scale Interval 1.72 to 3.49
Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation Mean change SF-12 Physical Score at 24 months	1.39 units on a scale Interval 0.43 to 2.34	1.50 units on a scale Interval 0.55 to 2.46	0.89 units on a scale Interval -0.08 to 1.85

SECONDARY outcome

Timeframe: Baseline and 6 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean change in mental quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation Mean change SF-12 Mental Score at 6 months	1.49 units on a scale Interval 0.35 to 2.64	1.92 units on a scale Interval 0.79 to 3.05	-0.09 units on a scale Interval -1.23 to 1.06
Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation Mean change SF-12 Mental Score at 24 months	0.89 units on a scale Interval -0.28 to 2.05	0.93 units on a scale Interval -0.22 to 2.09	-0.07 units on a scale Interval -1.24 to 1.1

SECONDARY outcome

Timeframe: Baseline and 6 and 24 months

Population: Enrolled minus deaths and medical removals.

The Impact of Weight on Quality of Life-Lite (IWQOL-L) measure consists of a total score and five subscales--physical function, self-esteem, sexual life, public distress, and work. The total score ranges from 0 to 100 with higher scores indicating better quality of life. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation Mean change IWQOL Total Score at 6 months	11.16 units on a scale Interval 9.72 to 12.6	11.70 units on a scale Interval 10.28 to 13.11	11.73 units on a scale Interval 10.29 to 13.17
Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation Mean change IWQOL Total Score at 24 months	11.83 units on a scale Interval 10.23 to 13.42	11.32 units on a scale Interval 9.74 to 12.89	11.23 units on a scale Interval 9.63 to 12.83

SECONDARY outcome

Timeframe: Baseline and 6 and 24 months

Population: Enrolled minus deaths and medical removals.

Measured using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 (better) to 21 (worse). Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation Mean Change PSQI Score at 24 months	-0.62 units on a scale Interval -0.95 to -0.29	-0.75 units on a scale Interval -1.08 to -0.43	-0.56 units on a scale Interval -0.89 to -0.23
Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation Mean Change PSQI Score at 6 months	-0.70 units on a scale Interval -0.99 to -0.41	-0.90 units on a scale Interval -1.19 to -0.61	-0.97 units on a scale Interval -1.26 to -0.67

SECONDARY outcome

Timeframe: Baseline and 6, 18 and 24 months

Population: Enrolled minus deaths and medical removals.

Mean change in stress measured using the Perceived Stress Scale (PSS). Scores range from 0 to 40. Higher numbers represent greater levels of stress. Measures will be collected at baseline, 6 months, 18 months and 24 months. Unadjusted except for affiliation.

Outcome measures

Measure	Fee-for-Service (In Clinic Individual Counseling) n=473 Participants Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home (In Clinic Group Counseling) n=468 Participants Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (Phone Group Counseling) n=466 Participants Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation Mean change in PSS Score at 6 months	0.03 units on a scale Interval -0.39 to 0.46	-0.33 units on a scale Interval -0.75 to 0.09	-0.26 units on a scale Interval -0.68 to 0.17
Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation Mean change in PSS Score at 18 months	0.53 units on a scale Interval 0.11 to 0.96	0.46 units on a scale Interval 0.04 to 0.88	0.69 units on a scale Interval 0.26 to 1.12
Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation Mean change in PSS Score at 24 months	-0.56 units on a scale Interval -1.0 to -0.12	-0.31 units on a scale Interval -0.74 to 0.13	-0.58 units on a scale Interval -1.02 to -0.14

Adverse Events

Fee-for-Service (FFS; In Clinic Individual Counseling)

Serious events: 94 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient Centered Medical Home(PCMH;In Clinic Group Counseling)

Serious events: 88 serious events

Other events: 0 other events

Deaths: 3 deaths

Disease Management (DM; Phone Group Counseling)

Serious events: 82 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fee-for-Service (FFS; In Clinic Individual Counseling) n=478 participants at risk Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office.	Patient Centered Medical Home(PCMH;In Clinic Group Counseling) n=479 participants at risk Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional.	Disease Management (DM; Phone Group Counseling) n=475 participants at risk Participants will take part in group weight-management counseling by telephone. Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Blood and lymphatic system disorders Anemia	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Blood and lymphatic system disorders Myelofibrosis, bone marrow transplant	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Atrial fibrillation	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/479 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Atrial fibrillation with rapid ventricular response	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Atrial fibrillation with rapid ventricular response, ablation	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Bradycardia	0.42% 2/478 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Cardiac arrest, secondary to ventricular fibrillation	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Chest pain, cardiac, cardiac catheterization	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Chest pain, cardiac, myocardial infarction ruled out	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Chest pain, cardiac, unspecified EKG changes	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Chest pain, etiology unkown, myocardial infaction ruled out	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Chest pain, non-cardiac	0.42% 2/478 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/479 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/475 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Coronary artery disease	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Coronary artery disease, coronary artery bypass graft	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Coronary artery disease, heart catheterizatrion	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Coronary artery disease, heart catheterizatrion, stent placement	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Coronary artery disease, occluded stent, cardiac catheterization	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Heart palpitations	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Myocardial infarction	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/475 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Myocardial infarction, cardiac catheterization, stent placement	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Myocardial Infarction, coronary artery bypass graft	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Myocardial infarction, Non-ST-elevation, cardiac catheterization	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Tachycardia	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Cardiac disorders Tachycardia, supraventricular	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Congenital, familial and genetic disorders Congential scoliosis, broken rod, type unspecified, surgical repair	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Ear and labyrinth disorders Vertigo	0.42% 2/478 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Endocrine disorders Enlarged thyroid, benign, partial thyroidectomy	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Endocrine disorders Hyperthyroidism, total thyroidectomy	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Endocrine disorders Hypothyroidism	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Endocrine disorders Multinodular goiter, total thyroidectomy	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Abdominal pain, chronic	0.42% 2/478 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Appendicitis	0.63% 3/478 • Number of events 3 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Clostridium difficile colitis	0.42% 2/478 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Cystic fibrosis exacerbation	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Diverticulitis	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Diverticulosis	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Gastroesophageal reflux disesase	0.42% 2/478 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Gastrointestinal bleed	0.42% 2/478 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Hernia, hiatal, surgical repair	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Hernia, incisional, surgical repair	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/475 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Hernia, inguinal, surgical repair	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Hernia, umbilical, surgical repair	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Hernia, unspecified, surgical repair	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Nausea, vomiting, intractable	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Gastrointestinal disorders Small bowel obstruction	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
General disorders Withdrawal reaction, acute, baclofen	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Hepatobiliary disorders Cholecystitis	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Hepatobiliary disorders Cholelithiasis, cholecysytectomy	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/479 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Hepatobiliary disorders Cholestasis	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Immune system disorders Allergic reaction, bee sting	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Immune system disorders Allergic reaction, severe, etiology unspecified	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Immune system disorders Anaphylaxis, medication, not specified	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Immune system disorders Medication reaction, IV contrast, chest pain	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Immune system disorders Multiple sclerosis, exacerbation	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Acute febrile illness	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Cellulitis, location not specified, post cat bile	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Cellulitis, lower extermity	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Cellulitis, mastectomy wound	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Cellulitis, preauricular	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Cellulitis, upper extremity	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Infection, leg wound	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Infection, pacemaker	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Infection, pericarditis	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Infection, periprosthetic, knee arthroplasty	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Infection, toe wound	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/475 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Infection, urinary tract	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Lyme disease	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Sepsis, secondary to Group A strep infection	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Sepsis, secondary to influenza	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Sepsis, secondary to pneumonia	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Infections and infestations Sepsis, secondary to urinary tract infection	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Injury, poisoning and procedural complications Concussion	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Metabolism and nutrition disorders Dehydration, severe	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Achilles tendon injury, surgical repair	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Back pain	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Back pain, laminectomy	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Bunion, bunionectomy	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Cervical Sprain	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Charcot arthropathy, foot, surgical repair	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Dislocation, internal hip prosthesis	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Fracture, ankle, surgical repair	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/479 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Fracture, humerus	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Fracture, knee, arthroplasty	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Fracture, ribs	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Injury, unspecifed, ankle, surgical repair	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Knee pain, arthroscopy	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Lumbar degenerative disc disease, decompression surgery	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Lumbar degenerative disc disease, decompression, fusion surgery	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Osteoarthritis, cervical spine	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Osteoarthritis, cervical spine, discectomy, fusion	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Osteoarthritis, hip, arthoplasty	0.84% 4/478 • Number of events 4 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.84% 4/479 • Number of events 4 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	1.3% 6/475 • Number of events 6 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Osteoarthritis, knee, arthroplasty	1.5% 7/478 • Number of events 7 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	2.3% 11/479 • Number of events 11 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	1.9% 9/475 • Number of events 9 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Osteoarthritis, knee, arthroplasty revision	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Osteoarthritis, knee, arthroplasty, bilateral	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.63% 3/479 • Number of events 3 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Osteoarthritis, rotator cuff tear, shoulder, arthroplasty	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/479 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Osteomyelitis, ankle, surgery	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Osteomyelitis, shoulder, arthoplasty revision	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Pain, ankle, arthroplasty revision	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Rib pain	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Musculoskeletal and connective tissue disorders Ruptured cervical vertebrae, surgical repair	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenomatoid nodule, partial thyroidectomy	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer, lung, non-small cell	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer, prostate	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer, prostate, prostatectomy	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer, renal	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer, thyroid, total thyroidectomy	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer, uterine	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Nervous system disorders Migraine	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Nervous system disorders Subdural hematoma	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Psychiatric disorders Depression	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Psychiatric disorders Gunshot wound, self-inflicted	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Psychiatric disorders Insomnia	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Psychiatric disorders Suicidal ideation	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Psychiatric disorders Suicide attempt	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Renal and urinary disorders Acute kidney injury	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/479 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Renal and urinary disorders Pyleonephritis, acute	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Renal and urinary disorders Renal failure, acute	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Renal and urinary disorders Renal insufficency	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Renal and urinary disorders Renal lithiasis	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Chronic endocervicitis, paratubal cysts, hysterectomy, bilateral salpingo-oophorectomy	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Erectile dysfunction, penile implant	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Fallopian tube torsion, surgical repair	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Menorrhagia	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Menorrhagia, Hysterectomy	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/479 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Menorrhagia, hysterectomy, recotocele repair	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Pelvic floor injury, hysterectomy, bladder sling	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Post-hysterectomy prolapse, surgical repair	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Tubo-ovarian abscess	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Reproductive system and breast disorders Uterine leiomyoma	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease, exacerbation	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Influenza	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.84% 4/478 • Number of events 4 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/479 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Pneumonitis, interstitial	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Respiratory failure, acute	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Respiratory failure, acute, secondary to bilateral pneumonia	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Respiratory failure, acute, secondary to Influenza B	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Sinusitis	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Tonsilitis, tonsillectomy	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Respiratory, thoracic and mediastinal disorders Tonsillar hemorrhage, post tonsillectomy	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Surgical and medical procedures Obesity Gastric Bypass	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Abdominal aortic aneurysm	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Capillary hemorrhage, leg	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Cerebrovascular accident	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.63% 3/479 • Number of events 3 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Deep vein thrombosis	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Hemorrhage, subarachnoid	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Hypertension	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Hypertensive urgency	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Pulmonary embolus	0.21% 1/478 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Stroke-like symptoms	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Syncope	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Syncope, near	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/475 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Syncope, recurrent	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/479 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Transient ischemic attack	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.42% 2/479 • Number of events 2 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/475 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
Vascular disorders Uncontrolled bleeding, post transurethral prostatectomy	0.00% 0/478 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.00% 0/479 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.	0.21% 1/475 • Number of events 1 • Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months. Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.

Other adverse events

Adverse event data not reported

Additional Information

Christie Befort, PhD

University of Kansas Medical Center

Phone: 913 588-3338

Email: cbefort@kumc.edu

Results disclosure agreements

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