Trial Outcomes & Findings for Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (NCT NCT01073020)

Last Updated: 2021-06-28

Results Overview

The primary outcome variable of both parallel trials will be the percent of patients attaining glycemic control (defined as fasting plasma glucose \< 126 mg/dL and HbA1c \< 6.5%) at three years of follow-up.

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

3 years

Results posted on

2021-06-28

Participant Flow

Patients will be recruited from the Joslin Diabetes Center and Partners Healthcare. All patients with type 2 diabetes (T2DM) attending the Brigham and Women's Hospital (BWH) Bariatric Surgery Program orientation sessions (\>1200 subjects/year) will be presented with this trial as an option. Recruitment will also be from the \>13,000 T2DM patients who receive their medical care at Joslin Diabetes Center or the Partners Healthcare Primary Care Network.

After initial contact, patients will undergo the following: 1) Telephone screening (review inclusion and exclusion criteria, description of interventions), 2) Attend clinical trial orientation session (detailed description of interventions, protocol, procedures, surgical clearance, nutritional evaluation, risks, benefits), 3) Medical and surgical screening visit (sign informed consent, screening lab tests, history and physical, psychological evaluation for bariatric surgery, exercise clearance).

Participant milestones

Participant milestones
Measure	Laparoscopic Adjustable Gastric Band (LAGB) Laparoscopic Adjustable Gastric Band (LAGB): Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)	Intensive Medical Diabetes & Weight Management (LAGB Grp) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)	RYGB Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (RYGB Grp) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)
Overall Study STARTED	23	22	22	21
Overall Study COMPLETED	16	17	19	19
Overall Study NOT COMPLETED	7	5	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Laparoscopic Adjustable Gastric Band (LAGB) Laparoscopic Adjustable Gastric Band (LAGB): Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)	Intensive Medical Diabetes & Weight Management (LAGB Grp) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)	RYGB Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (RYGB Grp) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)
Overall Study Withdrawal by Subject	6	4	1	2
Overall Study Physician Decision	1	0	2	0
Overall Study Death	0	1	0	0

Baseline Characteristics

Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laparoscopic Adjustable Gastric Band (LAGB) n=23 Participants Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device)	Intensive Medical Diabetes & Weight Management (LAGB Group) n=22 Participants Intensive Medical Diabetes \& Weight Management: Intensive Medical Diabetes \& Weight Management (LAGB Group) This group selected band as preferred surgery, but were randomized to medical management.	RYGB n=22 Participants Roux-en-Y Gastric Bypass (Surgery)	Intnnsive Medical Diabetes and Weight Management (RYGB Group) n=21 Participants Intensive Medical Diabetes \& Weight Management: Intensive Medical Diabetes \& Weight Management (RYGB Group) This group selected RYGB as preferred surgery, but were randomized to medical management.	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	21 Participants n=4 Participants	88 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	51.1 years STANDARD_DEVIATION 12.1 • n=5 Participants	51.4 years STANDARD_DEVIATION 7.5 • n=7 Participants	50.7 years STANDARD_DEVIATION 7.6 • n=5 Participants	52.6 years STANDARD_DEVIATION 4.3 • n=4 Participants	51.4 years STANDARD_DEVIATION 8.3 • n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants	10 Participants n=4 Participants	47 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	41 Participants n=21 Participants
Region of Enrollment United States	23 participants n=5 Participants	22 participants n=7 Participants	22 participants n=5 Participants	21 participants n=4 Participants	88 participants n=21 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Patients not analyzed include: 7 of 23 in LAGB (4 withdrew consent before intervention,1 determined to not be a surgical candidate before intervention, and 2 withdrew consent between 1 and 3 years); 5 of 22 in IMWM (LAGB Grp) (4 withdrew consent, 1 death); 3 of 22 in the RYGB group (1 withdrew consent; 1 breast cancer diagnosis and 1 psychiatric illness pre-intervention); 2 of 21 IMWM (RYGB Grp) withdrew consent before intervention.

Outcome measures

Outcome measures
Measure	LAGB n=16 Participants Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (LAGB Grp) n=17 Participants Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	RYGB n=19 Participants Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (RYGB Grp) n=19 Participants Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)
Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up.	13 % of patients	5 % of patients	42 % of patients	0 % of patients

SECONDARY outcome

Timeframe: 3 years

Population: Randomized patients who had at least one post-randomization visit (modified intention to treat).

All participants had type 2 diabetes. Long-term diabetes control is typically evaluated in both clinical and research settings using the measurement of Hemoglobin A1c (a measure of glycated hemoglobin, proportional to average glucose levels over approximately 3 months). This endpoint (hemoglobin A1c) was measured at 3 years after intervention. Reported values are changes from baseline derived from the mixed effects model analysis, adjusted for baseline.

Outcome measures

Outcome measures
Measure	LAGB n=16 Participants Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (LAGB Grp) n=17 Participants Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	RYGB n=19 Participants Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (RYGB Grp) n=19 Participants Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)
Glycemic Control, as Measured by Hemoglobin A1c	-0.8 Percent Interval -1.6 to 0.0	0.2 Percent Interval -0.6 to 1.0	-1.8 Percent Interval -2.4 to -1.2	-0.4 Percent Interval -1.1 to 0.3

SECONDARY outcome

Timeframe: 3 years

Population: Randomized patients who had at least one post-randomization visit (modified intention to treat).

Change in body mass index 3 years after intervention

Outcome measures

Outcome measures
Measure	LAGB n=16 Participants Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (LAGB Grp) n=17 Participants Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	RYGB n=19 Participants Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (RYGB Grp) n=19 Participants Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)
Body Mass Index	-3.9 kg/m^2 Interval -5.2 to -2.6	-1.7 kg/m^2 Interval -3.0 to 0.4	-8.7 kg/m^2 Interval -10.3 to -7.1	-4.1 kg/m^2 Interval -8.8 to 0.6

SECONDARY outcome

Timeframe: 3 years

Population: Patients who had at least one post-randomization visit were analyzed (modified intention to treat).

UKPDS risk of coronary heart disease, reported as change from baseline

Outcome measures

Outcome measures
Measure	LAGB n=16 Participants Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device) Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (LAGB Grp) n=17 Participants Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	RYGB n=19 Participants Roux-en-Y Gastric Bypass (Surgery) Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)	Intensive Medical Diabetes & Weight Management (RYGB Grp) n=19 Participants Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)
Cardiovascular Risk	0.7 percent likelihood of event in next 10 y Interval -1.4 to 2.8	2.2 percent likelihood of event in next 10 y Interval 0.2 to 4.2	-2.5 percent likelihood of event in next 10 y Interval -4.3 to -0.7	0.1 percent likelihood of event in next 10 y Interval -2.0 to 2.1

Adverse Events

Laparoscopic Adjustable Gastric Band Surgery

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Intensive Medical Diabetes and Weight Management: Band Group

Serious events: 6 serious events

Other events: 0 other events

Deaths: 1 deaths

Roux-en-Y Gastric Bypass (RYGB) Surgery

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Intensive Medical Diabetes and Weight Management: RYGB Group

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Mary Elizabeth Patti MD

Joslin Diabetes Center

Phone: 617 309 1966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Laparoscopic Adjustable Gastric Band Surgery n=18 participants at risk Surgical Implantation of Allergan Adjustable Gastric Band (Device)	Intensive Medical Diabetes and Weight Management: Band Group n=22 participants at risk	Roux-en-Y Gastric Bypass (RYGB) Surgery n=19 participants at risk	Intensive Medical Diabetes and Weight Management: RYGB Group n=19 participants at risk
Cardiac disorders sudden death	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	4.5% 1/22 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Metabolism and nutrition disorders hospitalization for diabetes management	5.6% 1/18 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Cardiac disorders coronary bypass graft or stent	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	9.1% 2/22 • Number of events 8 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	5.3% 1/19 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Cardiac disorders cardiac arrest - survived	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	5.3% 1/19 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Cardiac disorders presyncope	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	10.5% 2/19 • Number of events 2 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Nervous system disorders syringomyelia repair	5.6% 1/18 • Number of events 2 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Surgical and medical procedures bariatric surgery revisions and complications	44.4% 8/18 • Number of events 11 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	42.1% 8/19 • Number of events 8 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Congenital, familial and genetic disorders Erb's palsy	5.6% 1/18 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Reproductive system and breast disorders cancer	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	4.5% 1/22 • Number of events 2 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	5.3% 1/19 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Infections and infestations cellulitis	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	4.5% 1/22 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Musculoskeletal and connective tissue disorders orthopedic procedures	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	4.5% 1/22 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	10.5% 2/19 • Number of events 2 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	5.3% 1/19 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Renal and urinary disorders renal	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	4.5% 1/22 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	15.8% 3/19 • Number of events 3 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Cardiac disorders congestive heart failure hospitalization	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	5.3% 1/19 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Cardiac disorders supraventricular arrhythmia	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	10.5% 2/19 • Number of events 2 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Cardiac disorders pulmonary embolism	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	5.3% 1/19 • Number of events 1 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
Psychiatric disorders psychiatric hospitalizations	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	10.5% 2/19 • Number of events 2 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.
General disorders panniculectomy	0.00% 0/18 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/22 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	10.5% 2/19 • Number of events 2 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.	0.00% 0/19 • 3 years Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.