Trial Outcomes & Findings for PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV (NCT NCT02401230)

NCT ID: NCT02401230

Last Updated: 2018-02-19

Results Overview

HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 86 participants
• Primary outcome timeframe: Baseline, Post-Intervention (Day 8)
• Results posted on: 2018-02-19

Participant Flow

Participants were recruited March 2015 through November 2016.

Of the 86 subjects consented for study participation, 76 were randomized to a study intervention.

Participant milestones

Measure	Rectal Gel Lubricant Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Overall Study STARTED	26	25	25
Overall Study COMPLETED	20	19	21
Overall Study NOT COMPLETED	6	6	4

Reasons for withdrawal

Measure	Rectal Gel Lubricant Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Overall Study Adverse Event	3	2	0
Overall Study Withdrawal by Subject	2	1	1
Overall Study Lost to Follow-up	1	3	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Rectal Gel Lubricant n=20 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=19 Participants Subjects took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada n=21 Participants Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=19 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	19 Participants n=19 Participants	21 Participants n=21 Participants	60 Participants n=60 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=19 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants
Sex: Female, Male Female	0 Participants n=20 Participants	0 Participants n=19 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants
Sex: Female, Male Male	20 Participants n=20 Participants	19 Participants n=19 Participants	21 Participants n=21 Participants	60 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	19 participants n=19 Participants	21 participants n=21 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: Baseline, Post-Intervention (Day 8)

Population: The analysis population includes participants for whom the assay could be accurately performed. Data were not available for analysis in the case of an insufficient sample to perform this assay, poor performance of the assay, or technical issues in the laboratory.

HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use.

Outcome measures

Measure	Rectal Gel Lubricant n=10 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=6 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada n=10 Participants Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Percentage of CD4 Positive T-Cells Baseline	62 percentage positive T-cells Interval 50.0 to 70.0	70 percentage positive T-cells Interval 39.0 to 76.0	58 percentage positive T-cells Interval 32.0 to 67.0
Median Percentage of CD4 Positive T-Cells Day 8	66 percentage positive T-cells Interval 29.0 to 72.0	58 percentage positive T-cells Interval 39.0 to 71.0	51 percentage positive T-cells Interval 14.0 to 61.0

PRIMARY outcome

Timeframe: Baseline, Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

The median cumulative amount of p24 produced in a rectal explant challenge assay as measured by ELISA from participants prior to product use and on day 8 after product use.

Outcome measures

Measure	Rectal Gel Lubricant n=4 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=8 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada n=5 Participants Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Cumulative Amount of p24 Baseline	250 pg/mL Interval 138.0 to 608.0	287 pg/mL Interval 80.0 to 944.0	276 pg/mL Interval 82.0 to 786.0
Median Cumulative Amount of p24 Day 8	363 pg/mL Interval 102.0 to 494.0	133 pg/mL Interval 68.0 to 363.0	284 pg/mL Interval 114.0 to 369.0

SECONDARY outcome

Timeframe: Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median plasma FTC concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Plasma Emtricitabine (FTC) Concentration	248 ng/ml Interval 71.0 to 277.0	340 ng/ml Interval 8.0 to 509.0	—

SECONDARY outcome

Timeframe: Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median plasma TDF concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Plasma Tenofovir (TDF) Concentration	52 ng/ml Interval 27.0 to 73.0	64 ng/ml Interval 17.0 to 87.0	—

SECONDARY outcome

Timeframe: Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median rectal secretions FTC concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Rectal Secretion Emtricitabine (FTC) Concentration	320 ng/swab Interval 43.0 to 661.0	382 ng/swab Interval 38.0 to 570.0	—

SECONDARY outcome

Timeframe: Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median rectal secretions TDF concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Rectal Secretion Tenofovir (TDF) Concentration	812 ng/swab Interval 170.0 to 1535.0	780 ng/swab Interval 61.0 to 3160.0	—

SECONDARY outcome

Timeframe: Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median blood PBMC FTC concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration	4980 fmol/million cells Interval 1554.0 to 5730.0	4020 fmol/million cells Interval 1399.0 to 5370.0	—

SECONDARY outcome

Timeframe: Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median blood PBMC TDF concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration	45 fmol/million cells Interval 25.0 to 57.0	48 fmol/million cells Interval 24.0 to 62.0	—

SECONDARY outcome

Timeframe: Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median rectal tissue FTC concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Rectal Tissue Emtricitabine (FTC) Concentration	104 fmol/mg tissue Interval 4.0 to 203.0	112 fmol/mg tissue Interval 16.0 to 137.0	—

SECONDARY outcome

Timeframe: Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median rectal tissue TDF concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Rectal Tissue Tenofovir (TDF) Concentration	510 fmol/mg tissue Interval 4.0 to 1191.0	280 fmol/mg tissue Interval 19.0 to 561.0	—

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median rectal tissue dATP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration Baseline	131 fmol/mg tissue Interval 12.0 to 262.0	74 fmol/mg tissue Interval 19.0 to 200.0	—
Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration Post-Intervention (Day 8)	60 fmol/mg tissue Interval 14.0 to 155.0	66 fmol/mg tissue Interval 19.0 to 134.0	—

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median rectal tissue dCTP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration Baseline	246 fmol/mg tissue Interval 7.0 to 414.0	58 fmol/mg tissue Interval 10.0 to 395.0	—
Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration Post-Intervention (Day 8)	43 fmol/mg tissue Interval 6.0 to 131.0	36 fmol/mg tissue Interval 11.0 to 97.0	—

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (Day 8)

Population: Number of participants who provided a viable sample.

Median blood dATP concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

Outcome measures

Measure	Rectal Gel Lubricant n=19 Participants Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=21 Participants Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration Baseline	149 fmol/million cells Interval 16.0 to 187.0	140 fmol/million cells Interval 25.0 to 221.0	—
Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration Post-Intervention (Day 8)	204 fmol/million cells Interval 56.0 to 269.0	122 fmol/million cells Interval 35.0 to 238.0	—

Adverse Events

Rectal Gel Lubricant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Truvada

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Rectal Gel Lubricant + Truvada

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rectal Gel Lubricant n=20 participants at risk Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.	Truvada n=19 participants at risk Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.	Rectal Gel Lubricant + Truvada n=21 participants at risk Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/20 • Adverse events were collected throughout study duration (1 year and 7 months).	0.00% 0/19 • Adverse events were collected throughout study duration (1 year and 7 months).	4.8% 1/21 • Number of events 1 • Adverse events were collected throughout study duration (1 year and 7 months).
Infections and infestations Gastroenteritis	10.0% 2/20 • Number of events 2 • Adverse events were collected throughout study duration (1 year and 7 months).	5.3% 1/19 • Number of events 1 • Adverse events were collected throughout study duration (1 year and 7 months).	4.8% 1/21 • Number of events 1 • Adverse events were collected throughout study duration (1 year and 7 months).
Psychiatric disorders Anxiety	10.0% 2/20 • Number of events 2 • Adverse events were collected throughout study duration (1 year and 7 months).	0.00% 0/19 • Adverse events were collected throughout study duration (1 year and 7 months).	0.00% 0/21 • Adverse events were collected throughout study duration (1 year and 7 months).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/20 • Adverse events were collected throughout study duration (1 year and 7 months).	5.3% 1/19 • Number of events 1 • Adverse events were collected throughout study duration (1 year and 7 months).	0.00% 0/21 • Adverse events were collected throughout study duration (1 year and 7 months).
Nervous system disorders Headache	0.00% 0/20 • Adverse events were collected throughout study duration (1 year and 7 months).	0.00% 0/19 • Adverse events were collected throughout study duration (1 year and 7 months).	4.8% 1/21 • Number of events 1 • Adverse events were collected throughout study duration (1 year and 7 months).

Additional Information

Dr. Colleen Kelley

Emory University

Phone: 404-712-1823

Email: colleen.kelley@emory.edu

Results disclosure agreements

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