Trial Outcomes & Findings for Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery (NCT NCT03317405)

NCT ID: NCT03317405

Last Updated: 2025-08-28

Results Overview

Number of participants with dermal toxicity on breast skin at the transdermal gel application site. Will be assessed by Common Terminology Criteria for Adverse Events version 4.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: Up to 60 days
• Results posted on: 2025-08-28

Participant Flow

Participant milestones

Measure	Endoxifen Hydrochloride Gel 10 mg Daily Participants apply endoxifen hydrochloride gel 5 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily Questionnaire Administration: Ancillary studies	Endoxifen Hydrochloride Gel 20 mg Daily Participants apply endoxifen hydrochloride gel 10 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily Questionnaire Administration: Ancillary studies	Placebo Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily Questionnaire Administration: Ancillary studies
Overall Study STARTED	16	8	8
Overall Study COMPLETED	15	7	7
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Measure	Endoxifen Hydrochloride Gel 10 mg Daily Participants apply endoxifen hydrochloride gel 5 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily Questionnaire Administration: Ancillary studies	Endoxifen Hydrochloride Gel 20 mg Daily Participants apply endoxifen hydrochloride gel 10 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily Questionnaire Administration: Ancillary studies	Placebo Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily Questionnaire Administration: Ancillary studies
Overall Study Withdrawal by Subject	1	0	0
Overall Study Physician Decision	0	0	1
Overall Study Surgery Rescheduled	0	1	0

Baseline Characteristics

Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery

Baseline characteristics by cohort

Measure	Endoxifen Hydrochloride Gel 10 mg Daily n=16 Participants Participants apply endoxifen hydrochloride gel 5 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily Questionnaire Administration: Ancillary studies	Endoxifen Hydrochloride Gel 20 mg Daily n=8 Participants Participants apply endoxifen hydrochloride gel 10 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily Questionnaire Administration: Ancillary studies	Placebo n=8 Participants Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily Questionnaire Administration: Ancillary studies	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	16 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	32 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 60 days

Number of participants with dermal toxicity on breast skin at the transdermal gel application site. Will be assessed by Common Terminology Criteria for Adverse Events version 4.

Outcome measures

Measure	Endoxifen Hydrochloride Gel 20 mg Daily n=8 Participants Participants apply endoxifen hydrochloride gel 10mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily	Placebo n=8 Participants Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily	Endoxifen Hydrochloride Gel 10 mg n=16 Participants Participants apply endoxifen hydrochloride gel 5 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily
Number of Participants With Dermal Toxicity on Breast Skin at the Application Site	2 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: up to 28 days

Population: Participants with right and/or left breast tissue samples pre- and post-therapy

Concentrations of (E) and (Z) Isomers ENX in right and left breast tissue at end of intervention (up to 4 weeks) in tissue samples

Outcome measures

Measure	Endoxifen Hydrochloride Gel 20 mg Daily n=5 Participants Participants apply endoxifen hydrochloride gel 10mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily	Placebo n=6 Participants Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily	Endoxifen Hydrochloride Gel 10 mg n=15 Participants Participants apply endoxifen hydrochloride gel 5 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily
Drug Concentration in Tissue Central Subareolar Left Breast E_ENX	0.25 ng/g Interval 0.16 to 0.39	0.00 ng/g Interval 0.0 to 0.0	0.16 ng/g Interval 0.16 to 0.28
Drug Concentration in Tissue Central Subareolar Right Breast Z_ENX	1.00 ng/g Interval 0.62 to 1.51	0.00 ng/g Interval 0.0 to 0.0	0.37 ng/g Interval 0.15 to 0.44
Drug Concentration in Tissue Central Subareolar Left Breast Z_ENX	0.76 ng/g Interval 0.65 to 1.01	0.00 ng/g Interval 0.0 to 0.0	0.47 ng/g Interval 0.15 to 0.79
Drug Concentration in Tissue Central Subareolar Right Breast E_ENX	0.30 ng/g Interval 0.16 to 0.58	0.00 ng/g Interval 0.0 to 0.08	0.16 ng/g Interval 0.16 to 0.16
Drug Concentration in Tissue Central Deepest Left Breast Z_ENX	1.55 ng/g Interval 0.34 to 2.85	0.00 ng/g Interval 0.0 to 0.0	0.40 ng/g Interval 0.15 to 1.73
Drug Concentration in Tissue Central Deepest Left Breast E_ENX	0.91 ng/g Interval 0.16 to 1.78	0.00 ng/g Interval 0.0 to 0.16	0.16 ng/g Interval 0.16 to 1.39
Drug Concentration in Tissue Central Deepest Right Breast Z_ENX	2.57 ng/g Interval 1.3 to 15.06	0.00 ng/g Interval 0.0 to 0.1	0.46 ng/g Interval 0.15 to 1.58
Drug Concentration in Tissue Central Deepest Right Breast E_ENX	1.70 ng/g Interval 1.13 to 17.2	0.00 ng/g Interval 0.0 to 0.0	0.28 ng/g Interval 0.16 to 1.69
Drug Concentration in Tissue Lateral Surface Left Breast Z_ENX	0.81 ng/g Interval 0.58 to 1.0	0.00 ng/g Interval 0.0 to 0.0	0.34 ng/g Interval 0.15 to 0.75
Drug Concentration in Tissue Lateral Surface Left Breast E_ENX	0.27 ng/g Interval 0.16 to 0.42	0.00 ng/g Interval 0.0 to 0.0	0.16 ng/g Interval 0.16 to 0.5
Drug Concentration in Tissue Lateral Surface Right Breast Z_ENX	1.20 ng/g Interval 0.99 to 1.27	0.00 ng/g Interval 0.0 to 0.08	0.45 ng/g Interval 0.15 to 1.38
Drug Concentration in Tissue Lateral Surface Right Breast E_ENX	0.39 ng/g Interval 0.16 to 0.47	0.00 ng/g Interval 0.0 to 0.0	0.16 ng/g Interval 0.16 to 1.12

SECONDARY outcome

Timeframe: baseline and up to 28 days

Population: Protocol adherent participants (took minimum 80% of the required doses based on diary record and the remaining gel weight) with plasma samples pre- and post-therapy

Concentration of (E) and (Z) Isomers ENX in plasma at the end of intervention (up to 4 weeks)

Outcome measures

Measure	Endoxifen Hydrochloride Gel 20 mg Daily n=5 Participants Participants apply endoxifen hydrochloride gel 10mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily	Placebo n=7 Participants Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily	Endoxifen Hydrochloride Gel 10 mg n=15 Participants Participants apply endoxifen hydrochloride gel 5 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily
Drug Concentration in Plasma Z_ENX	0.44 ng/ml Interval 0.15 to 0.54	0.00 ng/ml Interval 0.0 to 0.0	0.15 ng/ml Interval 0.15 to 0.15
Drug Concentration in Plasma E_ENX	0.00 ng/ml Interval 0.0 to 0.0	0.00 ng/ml Interval 0.0 to 0.0	0.00 ng/ml Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: baseline and up to 28 days

Population: Participants with plasma samples pre- and post-therapy

Change in plasma Estrogenic and Coagulation Parameters from baseline to end of intervention (up to 28 days) including: IGF1, IGFBP3, SHBG.

Outcome measures

Measure	Endoxifen Hydrochloride Gel 20 mg Daily n=6 Participants Participants apply endoxifen hydrochloride gel 10mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily	Placebo n=7 Participants Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily	Endoxifen Hydrochloride Gel 10 mg n=15 Participants Participants apply endoxifen hydrochloride gel 5 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily
Change in Plasma Estrogenic and Coagulation Parameters IGF1	3.0 ng/ml Interval -8.6 to 15.0	-1.0 ng/ml Interval -17.0 to 15.0	-1.7 ng/ml Interval -9.9 to 6.6
Change in Plasma Estrogenic and Coagulation Parameters IGFBP3	-2.5 ng/ml Interval -216.0 to 211.0	-60 ng/ml Interval -205.0 to 84.0	48 ng/ml Interval -29.0 to 125.0
Change in Plasma Estrogenic and Coagulation Parameters SHBG	1.9 ng/ml Interval -13.0 to 17.0	-4.4 ng/ml Interval -12.0 to 3.8	-9.4 ng/ml Interval -26.0 to 6.8

SECONDARY outcome

Timeframe: baseline and up to 60 days

Assessed using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, subscale scores range from 0 (Not at All) to 4 (Extremely) when asked about experiencing symptoms. A positive change in scores indicates an increase in symptoms experienced and a negative change in scores indicates a decrease in symptoms experienced.

Outcome measures

Measure	Endoxifen Hydrochloride Gel 20 mg Daily n=7 Participants Participants apply endoxifen hydrochloride gel 10mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily	Placebo n=7 Participants Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily	Endoxifen Hydrochloride Gel 10 mg n=15 Participants Participants apply endoxifen hydrochloride gel 5 mg to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily
Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire Gastrointestinal	-0.24 change in score on a scale Interval -0.53 to 0.06	0.10 change in score on a scale Interval -0.2 to 0.39	-0.07 change in score on a scale Interval -0.19 to 0.06
Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire Vaginal	-0.29 change in score on a scale Interval -0.77 to 0.2	-0.24 change in score on a scale Interval -0.53 to 0.06	0.13 change in score on a scale Interval -0.21 to 0.47
Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire Cognitive	-0.05 change in score on a scale Interval -1.0 to 0.88	-0.19 change in score on a scale Interval -0.62 to 0.24	-0.16 change in score on a scale Interval -0.6 to 0.29
Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire Body Pain	-0.38 change in score on a scale Interval -1.2 to 0.48	-0.10 change in score on a scale Interval -0.73 to 0.54	-0.18 change in score on a scale Interval -0.44 to 0.08
Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire Vasomotor	-0.05 change in score on a scale Interval -0.16 to 0.07	0.19 change in score on a scale Interval -0.64 to 1.0	-0.02 change in score on a scale Interval -0.26 to 0.21
Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire Sexual Problems	-0.57 change in score on a scale Interval -1.8 to 0.64	-0.29 change in score on a scale Interval -0.74 to 0.17	0.13 change in score on a scale Interval -0.15 to 0.42
Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire Body Image	-0.64 change in score on a scale Interval -1.3 to 0.0	-0.43 change in score on a scale Interval -1.4 to 0.55	-0.20 change in score on a scale Interval -0.54 to 0.14
Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire Bladder Problem	-0.86 change in score on a scale Interval -1.8 to 0.06	0.07 change in score on a scale Interval -0.1 to 0.25	0.03 change in score on a scale Interval -0.04 to 0.1

Adverse Events

Endoxifen Hydrochloride Gel 10 mg Daily

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Endoxifen Hydrochloride Gel 20 mg Daily

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Endoxifen Hydrochloride Gel 10 mg Daily n=16 participants at risk Participants apply endoxifen hydrochloride gel 5 mg to each breast skin daily and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 5 mg: Apply to each breast daily for total dose of 10 mg daily Questionnaire Administration: Ancillary studies	Endoxifen Hydrochloride Gel 20 mg Daily n=8 participants at risk Participants apply endoxifen hydrochloride gel 10 mg to each breast skin daily and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Endoxifen Hydrochloride 10 mg: Apply to each breast daily for total dose of 20 mg daily Questionnaire Administration: Ancillary studies	Placebo n=8 participants at risk Participants apply placebo to each breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery. Placebo Administration: Apply to each breast daily Questionnaire Administration: Ancillary studies
Skin and subcutaneous tissue disorders Hyperhidrosis	12.5% 2/16 • Number of events 2 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	0.00% 0/8 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	25.0% 2/8 • Number of events 2 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.
General disorders General disorders and administration site conditions - Other, specify	25.0% 4/16 • Number of events 7 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	37.5% 3/8 • Number of events 6 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	12.5% 1/8 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.
Vascular disorders Hot flashes	6.2% 1/16 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	12.5% 1/8 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	37.5% 3/8 • Number of events 5 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.
Infections and infestations Vaginal Infections	6.2% 1/16 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	0.00% 0/8 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	0.00% 0/8 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.
General disorders Fatigue	0.00% 0/16 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	0.00% 0/8 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	12.5% 1/8 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.
Psychiatric disorders Insomnia	0.00% 0/16 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	0.00% 0/8 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	12.5% 1/8 • Number of events 3 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.
Reproductive system and breast disorders Breast pain	6.2% 1/16 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	12.5% 1/8 • Number of events 2 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	12.5% 1/8 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.
Gastrointestinal disorders Nausea	6.2% 1/16 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	0.00% 0/8 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	0.00% 0/8 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.
Nervous system disorders Headache	6.2% 1/16 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	0.00% 0/8 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.	0.00% 0/8 • AEs collected from the time informed consent was signed and baseline procedures were completed through 60 days post-intervention. In total AEs collected for a period of up to 3 months.

Additional Information

Seema A. Khan

Northwestern University

Phone: 312-503-4236

Email: s-khan2@northwestern.edu

Results disclosure agreements

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

Restriction type: LTE60