Trial Outcomes & Findings for Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder (NCT NCT02909959)

NCT ID: NCT02909959

Last Updated: 2020-06-04

Results Overview

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2020-06-04

Participant Flow

Participant milestones

Measure	Sulforaphane Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Overall Study STARTED	24	24
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder

Baseline characteristics by cohort

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	16.8 years STANDARD_DEVIATION 3.9 • n=5 Participants	17.7 years STANDARD_DEVIATION 4.1 • n=7 Participants	17.2 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	24 Participants n=7 Participants	48 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	23 Participants n=5 Participants	22 Participants n=7 Participants	45 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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
Region of Enrollment United States	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Total Score at Baseline	75.6 T-score Standard Error 7.4	72.6 T-score Standard Error 4.6

PRIMARY outcome

Timeframe: Week 4

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Total Score at Week 4	74.1 T-score Standard Error 7.4	74.1 T-score Standard Error 4.6

PRIMARY outcome

Timeframe: Week 8

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Total Score at Week 8	73.7 T-score Standard Error 7.4	74.5 T-score Standard Error 4.6

PRIMARY outcome

Timeframe: Week 12

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Total Score at Week 12	75.3 T-score Standard Error 7.4	72.9 T-score Standard Error 4.6

PRIMARY outcome

Timeframe: Week 16

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Total Score at Week 16	75.5 T-score Standard Error 7.4	72.7 T-score Standard Error 4.6

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Awareness subscale measures a participant's ability to recognize social cues. This subscale comprises 8 items with scores ranging from 1 to 4 for a total range of scores from 8 to 32. A higher score represents a greater ability to recognize social cues.

Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness) Baseline	10.9 score on a scale Standard Error 2.5	10.9 score on a scale Standard Error 1.6
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness) Week 4	10.5 score on a scale Standard Error 2.5	11.3 score on a scale Standard Error 1.6
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness) Week 8	10.6 score on a scale Standard Error 2.5	11.3 score on a scale Standard Error 1.6
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness) Week 12	10.8 score on a scale Standard Error 2.5	11.0 score on a scale Standard Error 1.6
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness) Week 16	10.7 score on a scale Standard Error 2.5	11.2 score on a scale Standard Error 1.6

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Cognition subscale measures a participant's ability to interpret social behavior. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater ability to interpret social behaviors. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition) Baseline	19.1 score on a scale Standard Error 4.1	17.4 score on a scale Standard Error 2.6
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition) Week 4	18.3 score on a scale Standard Error 4.1	18.2 score on a scale Standard Error 2.6
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition) Week 8	18.2 score on a scale Standard Error 4.1	18.4 score on a scale Standard Error 2.6
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition) Week 12	18.7 score on a scale Standard Error 4.1	17.9 score on a scale Standard Error 2.6
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition) Week 16	18.7 score on a scale Standard Error 4.1	17.9 score on a scale Standard Error 2.6

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Communication subscale measures a participant's ability to assess reciprocal communication in social situations. This subscale comprises 22 items with scores ranging from 1 to 4 for a total range of scores from 22 to 88. A higher score represents a greater ability to assess reciprocal communication. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication) Week 8	32.6 score on a scale Standard Error 6.6	33.5 score on a scale Standard Error 4.1
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication) Week 12	34.1 score on a scale Standard Error 6.6	32.0 score on a scale Standard Error 4.1
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication) Baseline	34.0 score on a scale Standard Error 6.6	32.0 score on a scale Standard Error 4.1
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication) Week 4	32.4 score on a scale Standard Error 6.6	33.6 score on a scale Standard Error 4.1
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication) Week 16	34.4 score on a scale Standard Error 6.6	31.7 score on a scale Standard Error 4.1

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Motivation subscale measures the degree to which a participant is motivated to participate in social interactions. This subscale comprises 11 items with scores ranging from 1 to 4 for a total range of scores from 11 to 44. A higher score represents a greater motivation to participate in social interaction. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation) Week 8	14.6 score on a scale Standard Error 4.1	15.6 score on a scale Standard Error 2.5
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation) Baseline	15.5 score on a scale Standard Error 4.1	14.7 score on a scale Standard Error 2.5
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation) Week 4	14.8 score on a scale Standard Error 4.1	15.4 score on a scale Standard Error 2.5
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation) Week 12	15.5 score on a scale Standard Error 4.1	14.7 score on a scale Standard Error 2.5
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation) Week 16	15.9 score on a scale Standard Error 4.1	14.3 score on a scale Standard Error 2.5

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Restricted Interests/Repetitive Behaviors subscale assesses the participant's level of stereotypy and circumscribed interests. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater level of stereotypy and circumscribed interests. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors) Week 16	18.5 score on a scale Standard Error 4.5	17.7 score on a scale Standard Error 2.8
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors) Baseline	18.6 score on a scale Standard Error 4.5	17.6 score on a scale Standard Error 2.8
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors) Week 4	18.1 score on a scale Standard Error 4.5	18.2 score on a scale Standard Error 2.8
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors) Week 8	17.7 score on a scale Standard Error 4.5	18.5 score on a scale Standard Error 2.8
Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors) Week 12	18.7 score on a scale Standard Error 4.5	17.5 score on a scale Standard Error 2.8

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Social Withdrawal subscale assesses the participant's level social withdrawal. This subscale comprises 16 items with scores ranging from 0 to 3 for a total range of scores from 0 to 48. A higher score represents a greater level of social withdrawal. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Aberrant Behavior Checklist (ABC) Subscale Score (Social Withdrawal) Week 12	9.0 score on a scale Standard Error 5.1	8.1 score on a scale Standard Error 3.2
Aberrant Behavior Checklist (ABC) Subscale Score (Social Withdrawal) Baseline	8.7 score on a scale Standard Error 5.1	8.3 score on a scale Standard Error 3.2
Aberrant Behavior Checklist (ABC) Subscale Score (Social Withdrawal) Week 4	8.2 score on a scale Standard Error 5.1	8.8 score on a scale Standard Error 3.2
Aberrant Behavior Checklist (ABC) Subscale Score (Social Withdrawal) Week 8	8.2 score on a scale Standard Error 5.1	8.8 score on a scale Standard Error 3.2
Aberrant Behavior Checklist (ABC) Subscale Score (Social Withdrawal) Week 16	9.5 score on a scale Standard Error 5.1	7.5 score on a scale Standard Error 3.2

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Hyperactivity subscale assesses the participant's level hyperactivity and non-compliance. This subscale comprises 16 items with scores ranging from 0 to 3 for a total range of scores from 0 to 48. A higher score represents a greater level of hyperactivity/non-compliance. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Aberrant Behavior Checklist (ABC) Subscale Scores (Hyperactivity) Week 16	13.6 score on a scale Standard Error 5.7	11.5 score on a scale Standard Error 3.6
Aberrant Behavior Checklist (ABC) Subscale Scores (Hyperactivity) Baseline	14.3 score on a scale Standard Error 5.7	10.8 score on a scale Standard Error 3.6
Aberrant Behavior Checklist (ABC) Subscale Scores (Hyperactivity) Week 4	13.0 score on a scale Standard Error 5.7	12.1 score on a scale Standard Error 3.6
Aberrant Behavior Checklist (ABC) Subscale Scores (Hyperactivity) Week 8	12.6 score on a scale Standard Error 5.7	12.5 score on a scale Standard Error 3.6
Aberrant Behavior Checklist (ABC) Subscale Scores (Hyperactivity) Week 12	13.7 score on a scale Standard Error 5.7	11.3 score on a scale Standard Error 3.6

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Inappropriate Speech subscale assesses the participant's use of inappropriate speech. This subscale comprises 4 items with scores ranging from 0 to 3 for a total range of scores from 0 to 12. A higher score represents a greater use of inappropriate speech. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Aberrant Behavior Checklist (ABC) Subscale Score (Inappropriate Speech) Baseline	3.4 score on a scale Standard Error 1.7	2.8 score on a scale Standard Error 1.1
Aberrant Behavior Checklist (ABC) Subscale Score (Inappropriate Speech) Week 4	3.2 score on a scale Standard Error 1.7	2.9 score on a scale Standard Error 1.1
Aberrant Behavior Checklist (ABC) Subscale Score (Inappropriate Speech) Week 8	3.0 score on a scale Standard Error 1.7	3.1 score on a scale Standard Error 1.1
Aberrant Behavior Checklist (ABC) Subscale Score (Inappropriate Speech) Week 12	3.3 score on a scale Standard Error 1.7	2.9 score on a scale Standard Error 1.1
Aberrant Behavior Checklist (ABC) Subscale Score (Inappropriate Speech) Week 16	3.5 score on a scale Standard Error 1.7	2.6 score on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Stereotypy subscale assesses the participant's level of stereotypic behavior. This subscale comprises 7 items with scores ranging from 0 to 3 for a total range of scores from 0 to 21. A higher score represents a greater level of stereotypic behavior. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Aberrant Behavior Checklist (ABC) Subscale Score (Stereotypy) Week 16	1.6 score on a scale Standard Error 3.2	1.6 score on a scale Standard Error 2.0
Aberrant Behavior Checklist (ABC) Subscale Score (Stereotypy) Baseline	1.3 score on a scale Standard Error 3.2	2.2 score on a scale Standard Error 2.0
Aberrant Behavior Checklist (ABC) Subscale Score (Stereotypy) Week 4	1.1 score on a scale Standard Error 3.2	2.4 score on a scale Standard Error 2.0
Aberrant Behavior Checklist (ABC) Subscale Score (Stereotypy) Week 8	1.0 score on a scale Standard Error 3.2	2.5 score on a scale Standard Error 2.0
Aberrant Behavior Checklist (ABC) Subscale Score (Stereotypy) Week 12	1.3 score on a scale Standard Error 3.2	2.2 score on a scale Standard Error 2.0

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Irritability subscale assesses the participant's level of irritability. This subscale comprises 15 items with scores ranging from 0 to 3 for a total range of scores from 0 to 45. A higher score represents a greater level of irritability. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Aberrant Behavior Checklist (ABC) Subscale Score (Irritability) Baseline	9.6 score on a scale Standard Error 5.1	8.3 score on a scale Standard Error 3.2
Aberrant Behavior Checklist (ABC) Subscale Score (Irritability) Week 4	9.4 score on a scale Standard Error 5.1	8.6 score on a scale Standard Error 3.2
Aberrant Behavior Checklist (ABC) Subscale Score (Irritability) Week 8	9.7 score on a scale Standard Error 5.1	8.3 score on a scale Standard Error 3.2
Aberrant Behavior Checklist (ABC) Subscale Score (Irritability) Week 12	9.7 score on a scale Standard Error 5.1	8.3 score on a scale Standard Error 3.2
Aberrant Behavior Checklist (ABC) Subscale Score (Irritability) Week 16	9.8 score on a scale Standard Error 5.1	8.1 score on a scale Standard Error 3.2

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The CGI-Severity (CGI-S) scale is a 7-point, clinician-rated scale providing an overall assessment of patient functioning relative to other patients with a similar diagnosis (1=not at all ill to 7=severely ill). A higher score indicates a higher level of severity of psychopathology. This scale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Clinical Global Impression-Severity (CGI-S) Score Baseline	4.74 units on a scale Standard Error 0.6	4.56 units on a scale Standard Error 0.3
Clinical Global Impression-Severity (CGI-S) Score Week 4	4.70 units on a scale Standard Error 0.6	4.60 units on a scale Standard Error 0.3
Clinical Global Impression-Severity (CGI-S) Score Week 8	4.71 units on a scale Standard Error 0.6	4.58 units on a scale Standard Error 0.3
Clinical Global Impression-Severity (CGI-S) Score Week 12	4.72 units on a scale Standard Error 0.6	4.58 units on a scale Standard Error 0.3
Clinical Global Impression-Severity (CGI-S) Score Week 16	4.70 units on a scale Standard Error 0.6	4.60 units on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12, Week 16

The clinician-rated CGI-Improvement (CGI-I) scale rates overall improvement or worsening of illness (ie, ASD) relative to baseline. The CGI-Improvement (CGI-I) scale rates overall improvement or worsening of illness (ie, ASD) relative to baseline. Possible scores on this scale range from 1-6 with the following assigned values: 1 = "Very Much Improved"; 2 = "Much Improved; 3 = "Minimally improved"; 4 = "No change"; 5 = "Minimally worse"; 6= "Much worse." A higher score indicates worsening of illness (ie, ASD), whereas a lower score indicates improvement of illness. This scale was measured at Week 4, Week 8, Week 12, and Week 16. In this measure, the number of participants in each treatment arm determined by the study physician to be "Much Improved" or "Very Much Improved" (indicative of meaningful clinical improvement) were counted.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved Week 16 · No Improvement to Very Much Worse	24 Participants	23 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved Week 4 · Very Much Improved or Much Improved	3 Participants	1 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved Week 4 · No Improvement to Very Much Worse	21 Participants	23 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved Week 8 · Very Much Improved or Much Improved	4 Participants	2 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved Week 8 · No Improvement to Very Much Worse	20 Participants	22 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved Week 12 · Very Much Improved or Much Improved	3 Participants	4 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved Week 12 · No Improvement to Very Much Worse	21 Participants	20 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved Week 16 · Very Much Improved or Much Improved	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

The RBS-R is a 43-item, informant-based questionnaire designed to quantify a range of restricted, repetitive behaviors (RRB) observed in ASD. Scores for each item range from 0 = "Behavior does not occur" to 3 = "Behavior occurs and is a severe problem". Thus the total range is 0 to 129. A higher score indicates a higher breadth of repetitive behaviors. This scale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Repetitive Behavior Scale-Revised (RBSR) Total Score Baseline	23.0 score on a scale Standard Error 14.0	22.3 score on a scale Standard Error 8.7
Repetitive Behavior Scale-Revised (RBSR) Total Score Week 4	21.7 score on a scale Standard Error 14.0	23.5 score on a scale Standard Error 8.7
Repetitive Behavior Scale-Revised (RBSR) Total Score Week 8	23.3 score on a scale Standard Error 14.0	22.0 score on a scale Standard Error 8.7
Repetitive Behavior Scale-Revised (RBSR) Total Score Week 12	23.3 score on a scale Standard Error 14.0	22.0 score on a scale Standard Error 8.7
Repetitive Behavior Scale-Revised (RBSR) Total Score Week 16	24.2 score on a scale Standard Error 14.0	21.0 score on a scale Standard Error 8.7

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the red blood cell value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Red Blood Cell Value Baseline	5.0 10^6 cells/microliter Standard Deviation 0.3	5.1 10^6 cells/microliter Standard Deviation 0.3
Mean Red Blood Cell Value Week 12	5.1 10^6 cells/microliter Standard Deviation 0.3	5.0 10^6 cells/microliter Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the white blood cell value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean White Blood Cell Value Baseline	6.3 10^3 cells/microliter Standard Deviation 2.3	6.5 10^3 cells/microliter Standard Deviation 2.2
Mean White Blood Cell Value Week 12	6.0 10^3 cells/microliter Standard Deviation 1.8	6.9 10^3 cells/microliter Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the hemoglobin value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Hemoglobin Value Baseline	14.8 g/dL Standard Deviation 1.4	15.0 g/dL Standard Deviation 1.1
Mean Hemoglobin Value Week 12	15.0 g/dL Standard Deviation 1.2	14.5 g/dL Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the hematocrit value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Hematocrit Value Baseline	43.8 percentage of volume of whole blood Standard Deviation 3.5	44.4 percentage of volume of whole blood Standard Deviation 2.9
Mean Hematocrit Value Week 12	44.4 percentage of volume of whole blood Standard Deviation 3.0	43.2 percentage of volume of whole blood Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the mean corpuscular volume value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Corpuscular Volume Value Baseline	87.3 femtoliter Standard Deviation 3.2	86.8 femtoliter Standard Deviation 4.6
Mean Corpuscular Volume Value Week 12	87.8 femtoliter Standard Deviation 3.1	86.6 femtoliter Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the mean corpuscular hemoglobin value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Corpuscular Hemoglobin Value Baseline	29.4 picogram Standard Deviation 1.7	29.3 picogram Standard Deviation 1.8
Mean Corpuscular Hemoglobin Value Week 12	29.7 picogram Standard Deviation 1.2	29.2 picogram Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the mean corpuscular hemoglobin concentration value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Corpuscular Hemoglobin Concentration Value Baseline	33.8 g/dL Standard Deviation 1.0	33.9 g/dL Standard Deviation 1.1
Mean Corpuscular Hemoglobin Concentration Value Week 12	33.8 g/dL Standard Deviation 0.9	33.7 g/dL Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the red blood cell distribution width value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Red Blood Cell Distribution Width Value Baseline	13.6 % of volume of whole blood Standard Deviation 0.8	13.7 % of volume of whole blood Standard Deviation 1.0
Mean Red Blood Cell Distribution Width Value Week 12	13.6 % of volume of whole blood Standard Deviation 0.9	13.6 % of volume of whole blood Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the platelets value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Platelets Value Baseline	253.8 10^3 cells/microliter Standard Deviation 74.7	286.0 10^3 cells/microliter Standard Deviation 67.5
Mean Platelets Value Week 12	246.0 10^3 cells/microliter Standard Deviation 69.5	279.3 10^3 cells/microliter Standard Deviation 57.7

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the absolute neutrophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Absolute Neutrophils Value Baseline	3.5 10^3 cells/microliter Standard Deviation 2.0	3.7 10^3 cells/microliter Standard Deviation 1.8
Mean Absolute Neutrophils Value Week 12	3.3 10^3 cells/microliter Standard Deviation 1.5	6.3 10^3 cells/microliter Standard Deviation 11.0

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the absolute lymphocytes value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Absolute Lymphocytes Value Baseline	2.1 10^3 cells/microliter Standard Deviation 0.6	2.1 10^3 cells/microliter Standard Deviation 0.5
Mean Absolute Lymphocytes Value Week 12	1.9 10^3 cells/microliter Standard Deviation 0.6	3.5 10^3 cells/microliter Standard Deviation 6.9

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the absolute monocytes value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Absolute Monocytes Value Baseline	0.5 10^3 cells/microliter Standard Deviation 0.2	0.6 10^3 cells/microliter Standard Deviation 0.2
Mean Absolute Monocytes Value Week 12	0.5 10^3 cells/microliter Standard Deviation 0.1	0.9 10^3 cells/microliter Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the absolute eosinophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Absolute Eosinophils Value Baseline	0.2 10^6 cells/microliter Standard Deviation 0.1	0.1 10^6 cells/microliter Standard Deviation 0.1
Mean Absolute Eosinophils Value Week 12	0.2 10^6 cells/microliter Standard Deviation 0.1	0.2 10^6 cells/microliter Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the absolute basophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Absolute Basophils Value Baseline	0.013 10^3 cells/microliter Standard Deviation 0.034	0.013 10^3 cells/microliter Standard Deviation 0.034
Mean Absolute Basophils Value Week 12	0.004 10^3 cells/microliter Standard Deviation 0.021	0.009 10^3 cells/microliter Standard Deviation 0.029

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's sodium levels. This serum chemistry level was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Serum Chemistries (Sodium) Baseline	140.6 millimol/liter Standard Deviation 2.3	141.0 millimol/liter Standard Deviation 2.0
Mean Serum Chemistries (Sodium) Week 12	141.8 millimol/liter Standard Deviation 2.5	141.3 millimol/liter Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's potassium levels. This serum chemistry level was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Serum Chemistries (Potassium) Baseline	4.4 mmol/L Standard Deviation 0.4	4.5 mmol/L Standard Deviation 0.4
Mean Serum Chemistries (Potassium) Week 12	4.7 mmol/L Standard Deviation 0.6	4.5 mmol/L Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's chloride levels. This serum chemistry level was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Serum Chemistries (Chloride) Baseline	100.1 mmol/L Standard Deviation 2.1	99.6 mmol/L Standard Deviation 1.9
Mean Serum Chemistries (Chloride) Week 12	100.1 mmol/L Standard Deviation 2.3	100.7 mmol/L Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's bicarbonate levels. This serum chemistry level was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Serum Chemistries (Bicarbonate) Baseline	22.8 mmol/L Standard Deviation 3.0	22.3 mmol/L Standard Deviation 1.5
Mean Serum Chemistries (Bicarbonate) Week 12	23.1 mmol/L Standard Deviation 2.7	22.8 mmol/L Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's blood urea nitrogen levels. This serum chemistry level was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Serum Chemistries (Blood Urea Nitrogen) Baseline	13.0 mg/dL Standard Deviation 4.8	11.4 mg/dL Standard Deviation 2.8
Mean Serum Chemistries (Blood Urea Nitrogen) Week 12	13.3 mg/dL Standard Deviation 4.3	11.6 mg/dL Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's creatinine levels. This serum chemistry level was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Serum Chemistries (Creatinine) Baseline	0.8 mg/dL Standard Deviation 0.1	0.8 mg/dL Standard Deviation 0.2
Mean Serum Chemistries (Creatinine) Week 12	0.8 mg/dL Standard Deviation 0.1	0.8 mg/dL Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's glucose levels. This serum chemistry level was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Serum Chemistries (Glucose) Baseline	90.9 mg/dL Standard Deviation 13.0	91.1 mg/dL Standard Deviation 12.6
Mean Serum Chemistries (Glucose) Week 12	87.0 mg/dL Standard Deviation 18.3	86.3 mg/dL Standard Deviation 13.5

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's level of liver function through measure of alanine transaminase (ALT). This liver function test value was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Liver Function Tests Values (Alanine Transaminase) Baseline	22.1 IU/L Standard Deviation 16.7	26.0 IU/L Standard Deviation 18.0
Mean Liver Function Tests Values (Alanine Transaminase) Week 12	29.6 IU/L Standard Deviation 40.7	20.7 IU/L Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's level of liver function through measure of aspartate transaminase. This liver function test value was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Liver Function Tests Values (Aspartate Transaminase) Baseline	22.3 IU/L Standard Deviation 10.2	21.9 IU/L Standard Deviation 5.8
Mean Liver Function Tests Values (Aspartate Transaminase) Week 12	25.2 IU/L Standard Deviation 10.6	19.8 IU/L Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's level of liver function through measure of total bilirubin. This liver function test value was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Liver Function Tests Values (Total Bilirubin) Baseline	0.5 mg/dL Standard Deviation 0.3	0.4 mg/dL Standard Deviation 0.3
Mean Liver Function Tests Values (Total Bilirubin) Week 12	0.5 mg/dL Standard Deviation 0.2	0.5 mg/dL Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline, Week 12

This measure assesses the change in the patient's value of thyroid stimulating hormone. This hormone value was measured at Baseline and Week 12.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Mean Value of Thyroid Stimulating Hormone (TSH) Baseline	2.3 milli-international units/ microliter Standard Deviation 1.2	2.2 milli-international units/ microliter Standard Deviation 1.2
Mean Value of Thyroid Stimulating Hormone (TSH) Week 12	2.3 milli-international units/ microliter Standard Deviation 1.2	1.8 milli-international units/ microliter Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

This measure assesses the change in the patient's weight (lbs). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Least Squares Mean of Vital Signs (Weight) Week 16	146.8 pounds Standard Error 28.1	148.6 pounds Standard Error 17.4
Least Squares Mean of Vital Signs (Weight) Baseline	147.1 pounds Standard Error 28.1	148.3 pounds Standard Error 17.4
Least Squares Mean of Vital Signs (Weight) Week 4	147.2 pounds Standard Error 28.1	148.2 pounds Standard Error 17.4
Least Squares Mean of Vital Signs (Weight) Week 8	146.8 pounds Standard Error 28.1	148.6 pounds Standard Error 17.4
Least Squares Mean of Vital Signs (Weight) Week 12	146.9 pounds Standard Error 28.1	148.6 pounds Standard Error 17.4

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

This measure assesses the change in the patient's height (centimeters). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Least Squares Mean of Vital Signs (Height) Baseline	173.9 centimeters Standard Error 6.5	173.3 centimeters Standard Error 4.0
Least Squares Mean of Vital Signs (Height) Week 4	173.9 centimeters Standard Error 6.5	173.3 centimeters Standard Error 4.0
Least Squares Mean of Vital Signs (Height) Week 8	173.9 centimeters Standard Error 6.5	173.3 centimeters Standard Error 4.0
Least Squares Mean of Vital Signs (Height) Week 12	173.9 centimeters Standard Error 6.5	173.3 centimeters Standard Error 4.0
Least Squares Mean of Vital Signs (Height) Week 16	173.9 centimeters Standard Error 6.5	173.3 centimeters Standard Error 4.0

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

This measure assesses the change in the patient's systolic and diastolic blood pressure. This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Least Squares Mean of Vital Signs (Blood Pressure) Week 4 Systolic	116.3 mmHg Standard Error 6.6	115.5 mmHg Standard Error 4.1
Least Squares Mean of Vital Signs (Blood Pressure) Baseline Systolic	115.2 mmHg Standard Error 6.6	116.7 mmHg Standard Error 4.1
Least Squares Mean of Vital Signs (Blood Pressure) Baseline Diastolic	69.8 mmHg Standard Error 4.5	70.6 mmHg Standard Error 2.8
Least Squares Mean of Vital Signs (Blood Pressure) Week 4 Diastolic	69.7 mmHg Standard Error 4.5	70.7 mmHg Standard Error 2.8
Least Squares Mean of Vital Signs (Blood Pressure) Week 8 Systolic	116.4 mmHg Standard Error 6.6	115.4 mmHg Standard Error 4.1
Least Squares Mean of Vital Signs (Blood Pressure) Week 8 Diastolic	69.6 mmHg Standard Error 4.5	70.8 mmHg Standard Error 2.8
Least Squares Mean of Vital Signs (Blood Pressure) Week 12 Systolic	116.2 mmHg Standard Error 6.6	115.7 mmHg Standard Error 4.1
Least Squares Mean of Vital Signs (Blood Pressure) Week 12 Diastolic	71.0 mmHg Standard Error 4.5	69.4 mmHg Standard Error 2.8
Least Squares Mean of Vital Signs (Blood Pressure) Week 16 Systolic	116.2 mmHg Standard Error 6.6	115.7 mmHg Standard Error 4.1
Least Squares Mean of Vital Signs (Blood Pressure) Week 16 Diastolic	71.1 mmHg Standard Error 4.5	69.3 mmHg Standard Error 2.8

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

This measure assesses the change in the patient's heart rate (beats per minute). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Outcome measures

Measure	Sulforaphane n=24 Participants Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 Participants Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Least Squares Mean of Vital Signs (Heart Rate) Week 4	88.0 Beats per Minute Standard Error 8.6	85.6 Beats per Minute Standard Error 5.4
Least Squares Mean of Vital Signs (Heart Rate) Week 8	87.8 Beats per Minute Standard Error 8.6	85.7 Beats per Minute Standard Error 5.4
Least Squares Mean of Vital Signs (Heart Rate) Baseline	86.1 Beats per Minute Standard Error 8.6	87.5 Beats per Minute Standard Error 5.4
Least Squares Mean of Vital Signs (Heart Rate) Week 12	86.5 Beats per Minute Standard Error 8.6	87.0 Beats per Minute Standard Error 5.4
Least Squares Mean of Vital Signs (Heart Rate) Week 16	90.0 Beats per Minute Standard Error 8.6	83.5 Beats per Minute Standard Error 5.4

Adverse Events

Sulforaphane

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sulforaphane n=24 participants at risk Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Placebo n=24 participants at risk Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Psychiatric disorders Aggression	8.3% 2/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	8.3% 2/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Psychiatric disorders Anxiety	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	0.00% 0/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Gastrointestinal disorders Appetite Decrease	0.00% 0/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Psychiatric disorders Difficulty Falling Asleep	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	0.00% 0/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Nervous system disorders Headache	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Psychiatric disorders Irritability	12.5% 3/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	16.7% 4/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Skin and subcutaneous tissue disorders Localized Rash	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	0.00% 0/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Psychiatric disorders Restlessness	8.3% 2/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Psychiatric disorders Sedation	0.00% 0/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Psychiatric disorders Self-injurious Behavior	0.00% 0/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	8.3% 2/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Psychiatric disorders Stereotypy	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Gastrointestinal disorders Stomach Discomfort	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	0.00% 0/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Psychiatric disorders Suicidal Ideation	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	0.00% 0/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
General disorders Fatigue	0.00% 0/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.	4.2% 1/24 • Adverse events were assessed from baseline to week 16 (a total of 16 weeks). Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.

Additional Information

Laura Politte, MD

University of North Carolina at Chapel Hill

Phone: 919-350-1726

Email: lpolitte@wakemed.org

Results disclosure agreements

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