Trial Outcomes & Findings for Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds (NCT NCT04095104)

NCT ID: NCT04095104

Last Updated: 2025-05-23

Results Overview

(Number enrolled divided by number eligible) x 100

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-05-23

Participant Flow

Participant milestones

Measure	Phentermine & Topiramate Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care. Dosing schedule for active medication group: * Week 1: 4mg phentermine + 25mg immediate release topiramate * Week 2: 8mg phentermine + 50mg immediate release topiramate * Week 3: 12mg phentermine + 75mg immediate release topiramate Goal Dose: · Weeks 4-12: 16mg phentermine + 100mg immediate release topiramate Discontinuation (at study Visit 4): * Week 13: Discontinue Phentermine + Decrease topiramate to 50mg * Week 14: Decrease topiramate to 25mg for 7 days, then discontinue Notes: 1. Participants who do not tolerate goal doses will be maintained at the highest tolerated dose. 2. All topiramate and phentermine doses will be taken once daily in the morning.	Placebo Participants were randomized to receive placebo tablets that were compounded to look identical to phentermine and topiramate plus standard post-bariatric care. Dosing escalation, goal dose, and discontinuation for placebo group was identical to the active group.
Overall Study STARTED	6	7
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Phentermine & Topiramate Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care. Dosing schedule for active medication group: * Week 1: 4mg phentermine + 25mg immediate release topiramate * Week 2: 8mg phentermine + 50mg immediate release topiramate * Week 3: 12mg phentermine + 75mg immediate release topiramate Goal Dose: · Weeks 4-12: 16mg phentermine + 100mg immediate release topiramate Discontinuation (at study Visit 4): * Week 13: Discontinue Phentermine + Decrease topiramate to 50mg * Week 14: Decrease topiramate to 25mg for 7 days, then discontinue Notes: 1. Participants who do not tolerate goal doses will be maintained at the highest tolerated dose. 2. All topiramate and phentermine doses will be taken once daily in the morning.	Placebo Participants were randomized to receive placebo tablets that were compounded to look identical to phentermine and topiramate plus standard post-bariatric care. Dosing escalation, goal dose, and discontinuation for placebo group was identical to the active group.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

Baseline characteristics by cohort

Measure	Phentermine & Topiramate n=6 Participants Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.	Placebo n=7 Participants Participants were randomized to receive placebo tablets (compounded to look like phentermine and topiramate) plus standard post-bariatric care.	Total n=13 Participants Total of all reporting groups
Age, Continuous	16.7 years n=5 Participants	17.9 years n=7 Participants	17.3 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

(Number enrolled divided by number eligible) x 100

Outcome measures

Measure	All Eligible Participants Before Randomization n=68 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Enrollment Rate	19 percentage of participants	—

PRIMARY outcome

Timeframe: 24 months

Number who do not complete the study divided by number enrolled

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=7 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Dropout Rate	0 percentage who withdrew among enrolled	7.7 percentage who withdrew among enrolled

PRIMARY outcome

Timeframe: 12 weeks

Population: The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.

Presence of amphetamine in the urine at any study visit

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Number of Participants Adherent to Study Drugs	5 Participants	0 Participants

PRIMARY outcome

Timeframe: 24 months

Population: The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.

Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Frequency of Adverse Events	16 unique adverse events per participant Interval 10.0 to 27.0	8 unique adverse events per participant Interval 1.0 to 16.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Percent BMI Change	-3.61 percent change Interval -13.0 to 2.86	1.89 percent change Interval -0.06 to 4.62

SECONDARY outcome

Timeframe: Baseline and 12 weeks

(Baseline weight - weight at 12 weeks)/Baseline weight x 100

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Percent Weight Change	-4.72 percent change Interval -12.14 to 2.61	0.83 percent change Interval -6.94 to 6.47

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: For 1 member of the active group and 2 members of the placebo group, it was not appropriate to calculate a % above the 95th%ile either because BMI was \<95th%ile or they were \>19 completed years at the time point.

(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)

Outcome measures

Measure	All Eligible Participants Before Randomization n=5 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=4 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in BMI Percent of the 95th%Ile	-6.2 percentile change Interval -19.0 to 4.0	2 percentile change Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

(Heart rate at baseline - Heart rate at 12 weeks)

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Heart Rate	2.89 beats per minute Interval -16.67 to 47.33	-0.83 beats per minute Interval -16.0 to 6.33

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Systolic Blood Pressure	3.33 mmHg Interval -4.0 to 23.0	0.78 mmHg Interval -6.67 to 10.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Diastolic Blood Pressure	-1.33 mmHg Interval -20.0 to 11.67	4.17 mmHg Interval -6.67 to 20.67

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Total cholesterol at baseline - Total cholesterol at 12 weeks

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Total Cholesterol (mg/dL)	-18 mg/dL Interval -47.0 to 33.0	6 mg/dL Interval -16.0 to 37.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Triglycerides at baseline - Triglycerides at 12 weeks

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Triglycerides (mg/dL)	-7.17 mg/dL Interval -42.0 to 55.0	-6.33 mg/dL Interval -71.0 to 47.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

LDL at baseline - LDL at 12 weeks

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in LDL Cholesterol (mg/dL)	-12.73 mg/dL Interval -39.0 to 26.2	7.43 mg/dL Interval 0.2 to 21.6

SECONDARY outcome

Timeframe: Baseline and 12 weeks

HDL at baseline - HDL at 12 weeks

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in HDL Cholesterol (mg/dL)	-3.83 mg/dL Interval -9.0 to 3.0	-0.17 mg/dL Interval -9.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

ALT at baseline - ALT at 12 weeks

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Alanine Aminotransferase (ALT) (U/L)	3.33 U/L Interval -14.0 to 16.0	0.83 U/L Interval -4.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

HbA1c at baseline - HbA1c at 12 weeks

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Hemoglobin A1c (HbA1c) (%)	0.05 Percentage of glycated hemoglobin Interval -0.3 to 0.7	0.10 Percentage of glycated hemoglobin Interval -0.1 to 0.3

SECONDARY outcome

Timeframe: Baseline and 12 weeks

% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in % Fat Mass	-1.0 percentage of fat mass Interval -4.8 to 1.6	1.0 percentage of fat mass Interval -1.3 to 3.8

SECONDARY outcome

Timeframe: Baseline and 12 weeks

RMR at baseline - RMR at 12 weeks measured by indirect calorimetry

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Resting Metabolic Rate (RMR)	-97.8 kilocalories per day Interval -249.2 to 87.0	-32.1 kilocalories per day Interval -110.5 to 44.6

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The average kilocalorie intake of 3 days was calculated each at baseline and 12 weeks. Kilocalories were calculated based on a standardized self-reported log of two weekdays and 1 weekend day.

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Daily Kilocalorie Intake	-339.32 kilocalories Interval -1409.39 to 412.08	94.85 kilocalories Interval -266.99 to 719.63

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: VAS hunger ratings were missing from 1 participant in each the active and placebo groups

The adolescent/young adult will report subjective hunger before each meal and snack for 24 hours using a visual analogue slider scale (0= no hunger, 100 = most hunger) and this score will be averaged over the 24 hour period.

Outcome measures

Measure	All Eligible Participants Before Randomization n=5 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=5 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Hunger	-10.76 units on a scale Interval -36.0 to 11.0	0.20 units on a scale Interval -39.0 to 44.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: VAS missing from 1 participant each in the active and placebo groups

The adolescent/young adult will report subjective satiety 30 minutes after each meal and snack for 24 hours using a visual analogue slider scale (0= no fullness, 100 = most full) and this score will be averaged over the 24 hour period.

Outcome measures

Measure	All Eligible Participants Before Randomization n=5 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=5 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Satiety	-1.8 units on a scale Interval -14.0 to 33.0	-0.2 units on a scale Interval -20.0 to 24.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Validated questionnaire: Eating in the Absence of Hunger-Parent (EAH-P) completed by the parent/guardian about their adolescent/young adult. This measure has 14 items.

Each item is on a 5-point Likert scale ranging from 1= "never" to 5= "always". A higher score indicates more eating in the absence of hunger.

Total scores (minimum 14 to maximum 70) are calculated by taking the sum of the 14 items at each time point.

The mean change in total scores by group are presented.

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Eating in the Absence of Hunger	-7.3 units on a scale Interval -23.0 to 0.0	-0.5 units on a scale Interval -5.0 to 7.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item questionnaire that assesses 3 eating behaviors: Cognitive Dietary Restraint, Disinhibited Eating, and Predisposition to hunger. Cognitive restraint was the domain of highest interest for this study and is reported here. Higher scores in each domain indicate more of each of those behaviors.

The cognitive restraint domain score is calculated by taking the average of the 21 items in that domain. Each of the 21 items has a score of 0 or 1.

MINIMUM mean score for this measure is: 0 and MAXIMUM mean score is 1. MINIMUM total score for this measure is: 0 and MAXIMUM total score is 21 (relevant to the "Full Range" in the data table below)

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Cognitive Restraint	-0.83 units on a scale Interval -7.0 to 5.0	-0.33 units on a scale Interval -7.0 to 3.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

"Impact of Weight on Quality of Life-Kids" questionnaire will be completed by the adolescents age <=19.

Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.

Higher scores indicate higher quality of life.

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report	-0.38 units on a transformed scale Interval -6.48 to 7.41	3.61 units on a transformed scale Interval -8.33 to 17.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

"Impact of Weight on Quality of Life-Kids Parent Proxy" questionnaire will be completed by the parent of the adolescent/young adult.

Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.

Higher scores indicate higher quality of life.

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult	4.94 units on a transformed scale Interval 0.92 to 12.96	-0.62 units on a transformed scale Interval -15.74 to 25.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

PedsQL instrument will be completed by the adolescent/young adult. The CHANGE in total scale score is reported here. The total scale score at each time point ranges from a MIN of 0 to a MAX of 100.

Items are rated on a 0-4 scale. Items are reverse scored and linearly transformed to a 0-100 scale, such that 0=100, 1=75, 2=50, 3=25, and 4=0.

Scale Scores are calculated as the sum of the items over the number of items answered.

Higher scores indicated better health-related quality of life.

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report	-3.67 units on a transformed scale Interval -18.0 to 7.0	3.17 units on a transformed scale Interval -18.0 to 18.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The adolescent/young adult will complete the 20-item Center for Epidemiologic Studies Depression Scale (CES-D).

Each item is rated on a 0 to 3 scale (positive items are reverse scored). Minimum score is 0 and maximum is 60. Higher scores indicate more depressive symptoms. Total score is calculated by summing each of the 20 individual items scores.

Outcome measures

Measure	All Eligible Participants Before Randomization n=6 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=6 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Change in Depression	6.5 units on a scale Interval 1.0 to 15.0	-2.5 units on a scale Interval -11.0 to 5.0

SECONDARY outcome

Timeframe: At 12 weeks

The participating family will be asked to complete a satisfaction questionnaire that will assess reasons for participation, experience during study visits, satisfaction with the effect of the study drug, ease of communication with study staff, and study burden.

The outcome presented here is the average of the parent and adolescent/young adult dyad's response to the statement: "My overall experience was positive" [1=Strongly disagree, 5=Strongly agree]

Outcome measures

Measure	All Eligible Participants Before Randomization n=12 Participants The enrollment rate was calculated before randomization to active or placebo groups.	Placebo n=12 Participants Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.
Participant Satisfaction: Questionnaire	4.75 units on a scale Interval 4.5 to 5.0	4.75 units on a scale Interval 4.0 to 5.0

Adverse Events

Phentermine & Topiramate

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phentermine & Topiramate n=6 participants at risk Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.	Placebo n=6 participants at risk Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.
Musculoskeletal and connective tissue disorders Hospital admission	16.7% 1/6 • Number of events 1 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).

Other adverse events

Measure	Phentermine & Topiramate n=6 participants at risk Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.	Placebo n=6 participants at risk Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.
General disorders Restlessness	100.0% 6/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Psychiatric disorders Depressed mood	66.7% 4/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
General disorders Difficulty with sleep	66.7% 4/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
General disorders Fatigue	83.3% 5/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Psychiatric disorders Irritability	100.0% 6/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Nervous system disorders Paresthesias	100.0% 6/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Psychiatric disorders Anxiety	83.3% 5/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Nervous system disorders Difficulty with concentration/attention	83.3% 5/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Gastrointestinal disorders Nausea/Vomiting	66.7% 4/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Gastrointestinal disorders Change in Taste	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Eye disorders Eye discomfort	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	66.7% 4/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
General disorders Flushing	66.7% 4/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Nervous system disorders Memory problems	66.7% 4/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Reproductive system and breast disorders Menstruation change	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	75.0% 3/4 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Gastrointestinal disorders Abdominal pain	66.7% 4/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Gastrointestinal disorders Constipation	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Gastrointestinal disorders Diarrhea	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Nervous system disorders Mental fogginess	66.7% 4/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Skin and subcutaneous tissue disorders Rash	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Respiratory, thoracic and mediastinal disorders Shortness of breath	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Nervous system disorders Word finding difficulties	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Musculoskeletal and connective tissue disorders Back, side, and/or groin pain	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Infections and infestations COVID disease	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Gastrointestinal disorders Dry mouth	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Infections and infestations Fever	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Eye disorders Blurry vision	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
General disorders Decreased sweating	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Nervous system disorders Headache	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Musculoskeletal and connective tissue disorders Myalgias	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Cardiac disorders Palpitations	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Gastrointestinal disorders Esophageal fullness	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Musculoskeletal and connective tissue disorders Finger fracture	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
General disorders Inability to cool down	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
General disorders Swelling in arms, legs, face	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Nervous system disorders Syncope	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Reproductive system and breast disorders Vaginal pain	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/4 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Psychiatric disorders Depression Score by CES-D that increased from normal to elevated (>=20) on study	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Psychiatric disorders Suicidality screen (CSSRS) positivity on study	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Metabolism and nutrition disorders Low bicarbonate (<20mmol/L)	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Metabolism and nutrition disorders Low potassium (<3.5mmol/L)	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Renal and urinary disorders Elevated creatinine	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Pregnancy, puerperium and perinatal conditions Positive urine pregnancy test	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/4 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Cardiac disorders Elevated systolic blood pressure (>=120mmHg)	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	33.3% 2/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Cardiac disorders Elevated diastolic BP (>=80mmHg)	16.7% 1/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	50.0% 3/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
Cardiac disorders Elevated heart rate (>=100 beats per minute)	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).
General disorders Elevated temperature (measured)	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).	0.00% 0/6 • Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).

Additional Information

Jaime Moore, MD MPH

University of Colorado School of Medicine

Phone: 303-724-8419

Email: jaime.moore@cuanschutz.edu

Results disclosure agreements

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