Trial Outcomes & Findings for Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial) (NCT NCT03406975)

Last Updated: 2022-10-18

Results Overview

Percentage of excess weight loss in participants at 12 months from randomization. Calculated as (weight loss/baseline excess weight) x 100, where weight loss is defined as follow-up weight minus the initial weight, and baseline excess weight is defined as index weight minus ideal weight X (X=25 kg/m²)

Recruitment status

COMPLETED

Study phase

Target enrollment

208 participants

Primary outcome timeframe

12 months

Results posted on

2022-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group: Lifestyle Modification Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Level 1: Lifestyle Modification vs ESG STARTED	123	85	0
Level 1: Lifestyle Modification vs ESG COMPLETED	75	62	0
Level 1: Lifestyle Modification vs ESG NOT COMPLETED	48	23	0
Level 2: Crossover Lifestyle to ESG STARTED	0	0	73
Level 2: Crossover Lifestyle to ESG COMPLETED	0	0	72
Level 2: Crossover Lifestyle to ESG NOT COMPLETED	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data collected from each study are being reported separately to avoid multi-counted participants.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=110 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=77 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=72 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Percentage of Excess Weight Loss (EWL)	3.2 percentage of EWL Standard Deviation 18.6	49.2 percentage of EWL Standard Deviation 32.0	44.1 percentage of EWL Standard Deviation 35.7

SECONDARY outcome

Timeframe: 12 months

Total number of participants with ≥25% excess weight loss at 12 months from randomization

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=110 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=77 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=72 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Number of Participants With ≥25% EWL	13 Participants	59 Participants	51 Participants

SECONDARY outcome

Timeframe: 12 months

Total number participants off or with reduction in antihypertensive medications

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=48 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=36 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=29 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Number of Participants Off Or With Reduction in Antihypertensive Medications	9 Participants	13 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline, 12 months

Change in blood pressure measured in units of millimeters of mercury (mmHg)

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=72 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=58 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=50 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Change in Blood Pressure Systolic	-0.7 mmHg Standard Deviation 14.5	-5.2 mmHg Standard Deviation 16.1	-3.5 mmHg Standard Deviation 18.5
Change in Blood Pressure Diastolic	0.1 mmHg Standard Deviation 10.3	-3.3 mmHg Standard Deviation 12.0	-3.0 mmHg Standard Deviation 11.6

SECONDARY outcome

Timeframe: Baseline, 24 months

Change in blood pressure for participants that received ESG intervention measured in units of millimeters of mercury (mmHg)

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=58 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Change in Blood Pressure for ESG Intervention From Baseline to 24 Months Systolic	-4.0 mmHg Standard Deviation 16.0	—	—
Change in Blood Pressure for ESG Intervention From Baseline to 24 Months Diastolic	-2.4 mmHg Standard Deviation 10.0	—	—

SECONDARY outcome

Timeframe: 12 months

Total number of participants off or with reduction in diabetes medications

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=27 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=13 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=14 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Number of Participants Off or With Reduction in Diabetes Medications	3 Participants	11 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline, 12 months

Change in HgbA1c levels

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=80 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=55 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=47 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Change in HgbA1c	0.13 Percent of Glycosylated Hemoglobin Standard Deviation 0.46	-0.36 Percent of Glycosylated Hemoglobin Standard Deviation 0.67	-0.4 Percent of Glycosylated Hemoglobin Standard Deviation 0.56

SECONDARY outcome

Timeframe: Baseline, 24 months

Change in HgbA1c levels for participants that received the ESG intervention

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=45 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Change in HgbA1c for ESG Intervention From Baseline to 24 Months	-0.1 Percent of Glycosylated Hemoglobin Standard Deviation 1.0	—	—

SECONDARY outcome

Timeframe: 12 months

Percentage of total body weight loss in participants

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=110 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=77 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=72 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Percentage of Total Body Weight Loss (TBWL)	0.8 percentage of TBWL Standard Deviation 5.0	13.6 percentage of TBWL Standard Deviation 8.0	12.3 percentage of TBWL Standard Deviation 8.3

SECONDARY outcome

Timeframe: 12 months

Total number of participants to achieve ≥5% total body weight loss

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=110 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=77 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=72 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Number of Participants to Achieve ≥5% TBWL	18 Participants	70 Participants	61 Participants

SECONDARY outcome

Timeframe: 12 months

Total number of participants to achieve ≥10% total body weight loss

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=110 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=77 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=72 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Number of Participants to Achieve ≥10% TBWL	6 Participants	48 Participants	40 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Those ESG patients who have achieved \>25% EWL at the end of Level 1 will not undergo a repeat endoscopy and will continue to follow-up with a lifestyle intervention in Level 2. Those ESG patients who have not achieved \>25% EWL at the end of Level 1 will undergo a repeat upper endoscopy at 52

Total number of participants to have esophagitis at repeat endoscopy

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=18 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Esophagitis at Repeat Endoscopy	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: Not all participants provided answers to all the domains of the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire

Changes in impact of weight on quality of life score assessed using self-reported IWQOL-lite questionnaire consisting of five domains: physical function (11 items, score range from 11-55 with higher scores indicating more negative outcome), self-esteem (7 items, score range from 7-35 with higher scores indicating more negative outcome), sexual life (4 items, score range from 4-20 with higher scores indicating more negative outcome), public distress (5 items, score range from 5-25 with higher scores indicating more negative outcome), and work (4 items, score range from 4-20 with higher scores indicating more negative outcome).

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=86 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=65 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=58 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Physical Function (11 items)	-2.5 score on a scale Standard Deviation 6.6	-12.0 score on a scale Standard Deviation 7.4	-8.6 score on a scale Standard Deviation 6.9
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Self-Esteem (7 items)	-1.6 score on a scale Standard Deviation 5.2	-9.2 score on a scale Standard Deviation 7.1	-7.8 score on a scale Standard Deviation 6.7
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Sexual Life (4 items)	-1.4 score on a scale Standard Deviation 3.9	-4.2 score on a scale Standard Deviation 4.1	-2.6 score on a scale Standard Deviation 3.5
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Public Distress (5 items)	-0.9 score on a scale Standard Deviation 3.2	-2.5 score on a scale Standard Deviation 2.9	-1.8 score on a scale Standard Deviation 3.1
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Work Results (4 items)	-0.3 score on a scale Standard Deviation 2.7	-2.2 score on a scale Standard Deviation 2.7	-1.9 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: Not all participants provided answers to all the domains of the SF-36 Health Status Survey questionnaire

Changes in subject's view of health assessed using self-reported SF-36 Health Status Survey consisting of 8 scaled scores: physical function (10-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to physical health (4-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to emotional problems (3-item, score range from 0-100 with higher scores indicating more positive outcome), energy/fatigue (4-items, score range from 0-100 with higher scores indicating more positive outcome), emotional well-being (5-items, score range from 0-100 with higher scores indicating more positive outcome), social functioning (2-items, score range from 0-100 with higher scores indicating more positive outcome), pain (2-items, score range from 0-100 with higher scores indicating more positive outcome), general health (5-items, score range from 0-100 with higher scores indicating more positive outcome)

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=86 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=65 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=58 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Changes in Health Status Survey Scores Physical Functioning	2.1 score on a scale Standard Deviation 25.5	18.9 score on a scale Standard Deviation 26.9	18.4 score on a scale Standard Deviation 22.5
Changes in Health Status Survey Scores Physical Health	4.9 score on a scale Standard Deviation 37.7	18.4 score on a scale Standard Deviation 33.7	15.1 score on a scale Standard Deviation 31.0
Changes in Health Status Survey Scores Emotional Problems	-0.8 score on a scale Standard Deviation 30.7	4.7 score on a scale Standard Deviation 30.8	8.6 score on a scale Standard Deviation 30.3
Changes in Health Status Survey Scores Energy/Fatigue	9.0 score on a scale Standard Deviation 18.5	14.1 score on a scale Standard Deviation 26.1	13.0 score on a scale Standard Deviation 20.0
Changes in Health Status Survey Scores Emotional Well-Being	2.1 score on a scale Standard Deviation 13.2	1.5 score on a scale Standard Deviation 18.5	4.6 score on a scale Standard Deviation 14.5
Changes in Health Status Survey Scores Social Functioning	3.2 score on a scale Standard Deviation 18.3	9.0 score on a scale Standard Deviation 29.2	8.8 score on a scale Standard Deviation 20.0
Changes in Health Status Survey Scores Pain	4.4 score on a scale Standard Deviation 21.5	10.1 score on a scale Standard Deviation 17.6	7.3 score on a scale Standard Deviation 23.0
Changes in Health Status Survey Scores General Health	4.0 score on a scale Standard Deviation 14.7	20.4 score on a scale Standard Deviation 19.2	12.6 score on a scale Standard Deviation 14.5

SECONDARY outcome

Timeframe: Baseline

Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score \< 10; major depression, 10 ≤ score \< 20; severe major depression, x ≥ 20

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=108 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=75 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=71 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Number of Participants With Major Depression or Severe Major Depression at Baseline Number with Major Depression	14 Participants	7 Participants	9 Participants
Number of Participants With Major Depression or Severe Major Depression at Baseline Number with Severe Major Depression	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=88 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=67 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=59 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Number of Participants With Major Depression or Severe Major Depression at 12 Months Number with Major Depression	10 Participants	2 Participants	1 Participants
Number of Participants With Major Depression or Severe Major Depression at 12 Months Number with Severe Major Depression	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 12 months

Change in eating behaviors evaluated using the self-reported Three Factor Eating Questionnaire (TFEQ) consisting of 3 domains: cognitive restraint (6-items, score range from 0-100 with higher score indicating more restraint), uncontrolled eating (9-items, score range from 0-100 with lower score indicating more control), and emotional eating (3-items, score range 0-100 with higher score indicating eating with negative emotions)

Outcome measures

Outcome measures
Measure	Control Group: Lifestyle Modification n=86 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=64 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=58 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Change in Eating Behaviors Cognitive Restraint	4.6 score on a scale Standard Deviation 17.6	12.6 score on a scale Standard Deviation 19.5	6.0 score on a scale Standard Deviation 18.1
Change in Eating Behaviors Uncontrolled Eating	-8.7 score on a scale Standard Deviation 18.0	-14.4 score on a scale Standard Deviation 23.4	-10.4 score on a scale Standard Deviation 16.1
Change in Eating Behaviors Emotional Eating	-6.7 score on a scale Standard Deviation 23.5	-18.3 score on a scale Standard Deviation 29.8	-7.7 score on a scale Standard Deviation 24.0

Adverse Events

Control Group: Lifestyle Modification

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

Treatment Group: Overstitch ESG Procedure

Serious events: 12 serious events

Other events: 77 other events

Deaths: 0 deaths

Crossover Group: Lifestyle Intervention to ESG Procedure

Serious events: 4 serious events

Other events: 64 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Barham Abu Dayyeh

Mayo Clinic

Phone: 507-266-4347

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control Group: Lifestyle Modification n=123 Participants Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=85 Participants Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=73 Participants Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Total n=281 Participants Total of all reporting groups
Age, Continuous Level 1: Lifestyle Modification vs ESG	46.0 years n=123 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	49.0 years n=85 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	46.5 years n=208 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Age, Continuous Level 2: Crossover Lifestyle to ESG	—	—	46 years n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	46 years n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Sex: Female, Male Level 1: Lifestyle Modification vs ESG · Female	104 Participants n=123 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	74 Participants n=85 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	178 Participants n=208 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Sex: Female, Male Level 1: Lifestyle Modification vs ESG · Male	19 Participants n=123 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	11 Participants n=85 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	30 Participants n=208 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Sex: Female, Male Level 2: Crossover Lifestyle to ESG · Female	—	—	66 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	66 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Sex: Female, Male Level 2: Crossover Lifestyle to ESG · Male	—	—	7 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	7 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG · White	67 Participants n=123 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	58 Participants n=85 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	125 Participants n=208 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG · African American	19 Participants n=123 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	12 Participants n=85 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	31 Participants n=208 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG · Asian	3 Participants n=123 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	0 Participants n=85 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	3 Participants n=208 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG · Hispanic/Latino	19 Participants n=123 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	13 Participants n=85 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	32 Participants n=208 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG · Other	10 Participants n=123 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	1 Participants n=85 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	11 Participants n=208 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG · Deferred	5 Participants n=123 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	1 Participants n=85 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	6 Participants n=208 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG · White	—	—	40 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	40 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG · African American	—	—	11 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	11 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG · Asian	—	—	2 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	2 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG · Hispanic/Latino	—	—	10 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	10 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG · Other	—	—	6 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	6 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG · Deferred	—	—	4 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	4 Participants n=73 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Region of Enrollment United States	123 participants n=123 Participants • Data collected from each year are being reported separately to avoid multi-counted participants.	85 participants n=85 Participants • Data collected from each year are being reported separately to avoid multi-counted participants.	73 participants n=73 Participants • Data collected from each year are being reported separately to avoid multi-counted participants.	73 participants n=73 Participants • Data collected from each year are being reported separately to avoid multi-counted participants.

Measure	Control Group: Lifestyle Modification n=110 participants at risk Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Treatment Group: Overstitch ESG Procedure n=77 participants at risk Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.	Crossover Group: Lifestyle Intervention to ESG Procedure n=73 participants at risk Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months. Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Gastrointestinal disorders Abdominal Pain	0.91% 1/110 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	3.9% 3/77 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Gastrointestinal disorders Abscess intra abdominal	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Gastrointestinal disorders Bloody Stool	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Gastrointestinal disorders Bowel impaction	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Injury, poisoning and procedural complications Broken Hip	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Cardiac disorders Chest Pain	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
General disorders ED Visit-Sore Throat	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
General disorders ER Visit-Coffee ground emesis	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
General disorders ER Visit-Dehydration	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Injury, poisoning and procedural complications Esophageal mucosal tear due to device malfunction	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/77 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.4% 1/73 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Gastrointestinal disorders Gangrenous cholecystitis	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
General disorders Headache/migraine	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Infections and infestations Hospitalization-Cellulitis	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Psychiatric disorders Hospitalization-Mental Health	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Gastrointestinal disorders Hospitalization-Obstruction Intestinal (HCC)	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Metabolism and nutrition disorders Malnutrition	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/77 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.4% 1/73 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Injury, poisoning and procedural complications Motor Vehicle Accident	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
General disorders Nausea	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	2.6% 2/77 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
General disorders Nausea and vomiting	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Reproductive system and breast disorders Pleural effusion	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.3% 1/77 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
General disorders Post ESG Hospital Stay	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/77 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.4% 1/73 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
General disorders Readminission	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/77 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	1.4% 1/73 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants
General disorders Vomiting	0.00% 0/110 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	2.6% 2/77 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants	0.00% 0/73 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 years on all participants