Trial Outcomes & Findings for A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States (NCT NCT00799058)

Last Updated: 2022-10-25

Results Overview

A composite endpoint was defined as the percentage of participants with any post-baseline abnormal finding from pelvic/speculum examination, colposcopy finding, STI diagnoses, laboratory test of DAIDS grade 3 or higher and any product-related AE. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

128 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-10-25

Participant Flow

Approximately 180 women (35-50 per RC) were scheduled to be enrolled at 5 research centers in the USA. However, following IPM's decision to give priority to development of the dapivirine vaginal ring above that of dapivirine vaginal gel, the Sponsor decided to stop enrollment into IPM 020 trial after 128 participants were randomized. It was determined that the number of participants already enrolled were sufficient to allow for meaningful analysis of the data. Total trial duration was 18 months.

Participant milestones

Participant milestones
Measure	Dapivirine Gel 4789 will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	Dapivirine Gel 4759 Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
Overall Study STARTED	43	43	42
Overall Study COMPLETED	33	34	36
Overall Study NOT COMPLETED	10	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Dapivirine Gel 4789 will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	Dapivirine Gel 4759 Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
Overall Study Withdrawal by Subject	2	2	2
Overall Study Lost to Follow-up	1	2	1
Overall Study Adverse Event	0	2	0
Overall Study Pregnancy	1	0	0
Overall Study Not adherent	3	2	1
Overall Study discontinued use of IP due to AE, but completed visits	0	0	1
Overall Study IP dispensing error	1	0	0
Overall Study not enough IP to complete trial due to IP dispending error	0	1	0
Overall Study IP discontinued too long during BV treatment	1	0	0
Overall Study lost 2 IP kits and did not have enough remaining to complete trial	0	0	1
Overall Study participant did not attend clinic visit 6 (final visit)	1	0	0

Baseline Characteristics

A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapivirine Gel 4759 n=43 Participants Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=43 Participants will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine n=42 Participants Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily	Total n=128 Participants Total of all reporting groups
Age, Continuous	27.6 years STANDARD_DEVIATION 5.9 • n=5 Participants	27.5 years STANDARD_DEVIATION 5.5 • n=7 Participants	27.5 years STANDARD_DEVIATION 5.5 • n=5 Participants	27.6 years STANDARD_DEVIATION 5.9 • n=4 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	43 Participants n=7 Participants	42 Participants n=5 Participants	128 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
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	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	10 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants	49 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	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment United States	43 participants n=5 Participants	43 participants n=7 Participants	42 participants n=5 Participants	128 participants n=4 Participants
Married	9 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	28 Participants n=4 Participants
In a relationship with one partner, not married	35 Participants n=5 Participants	38 Participants n=7 Participants	29 Participants n=5 Participants	102 Participants n=4 Participants
Cohabitating with main partner	9 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	37 Participants n=4 Participants
In a relationship with multiple partners	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Height	163.7 cm STANDARD_DEVIATION 6.8 • n=5 Participants	163.5 cm STANDARD_DEVIATION 7.4 • n=7 Participants	161.4 cm STANDARD_DEVIATION 8.9 • n=5 Participants	162.9 cm STANDARD_DEVIATION 7.8 • n=4 Participants
Weight	77.0 kg STANDARD_DEVIATION 17.5 • n=5 Participants	73.3 kg STANDARD_DEVIATION 14.9 • n=7 Participants	69.2 kg STANDARD_DEVIATION 18.8 • n=5 Participants	73.2 kg STANDARD_DEVIATION 17.3 • n=4 Participants
BMI	28.7 kg/(m^2) STANDARD_DEVIATION 6.3 • n=5 Participants	27.5 kg/(m^2) STANDARD_DEVIATION 5.9 • n=7 Participants	26.5 kg/(m^2) STANDARD_DEVIATION 6.1 • n=5 Participants	27.6 kg/(m^2) STANDARD_DEVIATION 6.1 • n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The ITT population included all trial participants who were randomized to one of the three treatment groups.

Outcome measures

Outcome measures
Measure	Dapivirine Gel 4759 n=43 Participants Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=43 Participants will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine n=42 Participants Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.	23 Participants	28 Participants	28 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: All participants who were assigned to a treatment group were analyzed as members of the group to which they were randomized, regardless of adherence to the planned course of treatment. Results are reported for participants who provided vaginal samples.

Cervicovaginal fluid specimens will be obtained to determine vaginal flora before first gel application and at Visits 3, 5, and 6. Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal flora in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g. Nugent scores were used to assess changes in vaginal flora, and were categorized into three levels: (1) negative for BV (score: 0-3); (2) altered vaginal flora (score: 4-6); and (3) BV (score: 7-10).

Outcome measures

Outcome measures
Measure	Dapivirine Gel 4759 n=43 Participants Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=43 Participants will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine n=42 Participants Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
Changes in the Vaginal Flora Week 4 : Altered Flora (4-6)	8.1 percentage of participants with data	12.5 percentage of participants with data	19.5 percentage of participants with data
Changes in the Vaginal Flora Week 0 : Abnormal Flora (7 or more)	19.0 percentage of participants with data	27.9 percentage of participants with data	21.4 percentage of participants with data
Changes in the Vaginal Flora Week 4 : Normal Flora (0-3)	67.6 percentage of participants with data	55.0 percentage of participants with data	65.9 percentage of participants with data
Changes in the Vaginal Flora Week 0 : Normal Flora (0-3)	66.7 percentage of participants with data	60.5 percentage of participants with data	54.8 percentage of participants with data
Changes in the Vaginal Flora Week 0 : Altered Flora (4-6)	14.3 percentage of participants with data	11.6 percentage of participants with data	23.8 percentage of participants with data
Changes in the Vaginal Flora Week 4 : Abnormal Flora (7 or more)	24.3 percentage of participants with data	32.5 percentage of participants with data	14.6 percentage of participants with data
Changes in the Vaginal Flora Week 12: Normal Flora (0-3)	61.8 percentage of participants with data	65.7 percentage of participants with data	59.5 percentage of participants with data
Changes in the Vaginal Flora Week 12: Altered Flora (4-6)	23.5 percentage of participants with data	20.0 percentage of participants with data	24.3 percentage of participants with data
Changes in the Vaginal Flora Week 12: Abnormal Flora (7 or more)	14.7 percentage of participants with data	14.3 percentage of participants with data	16.2 percentage of participants with data
Changes in the Vaginal Flora Week 16 (Follow-up after IP discontinuation): Normal Flora (0-3)	70.6 percentage of participants with data	66.7 percentage of participants with data	64.9 percentage of participants with data
Changes in the Vaginal Flora Week 16 (Follow-up after IP discontinuation): Altered Flora (4-6)	2.9 percentage of participants with data	18.2 percentage of participants with data	18.9 percentage of participants with data
Changes in the Vaginal Flora Week 16 (Follow-up after IP discontinuation): Abnormal Flora (7 or more)	26.5 percentage of participants with data	15.2 percentage of participants with data	16.2 percentage of participants with data

SECONDARY outcome

Timeframe: 12 weeks

Population: The PK analysis population included all participants who received at least one dose of the active IP and for whom at least one plasma, vaginal fluid or cervical tissue sample was taken. Results are provided for participants for whom samples were available.

Dapivirine levels observed in plasma will be summarized using simple descriptive statistics.

Outcome measures

Outcome measures
Measure	Dapivirine Gel 4759 n=43 Participants Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=43 Participants will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point Week 2	536.8 picograms/mililiter Standard Deviation 297.2	475.8 picograms/mililiter Standard Deviation 272.2	—
The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point Week 4	599.5 picograms/mililiter Standard Deviation 423.1	446.1 picograms/mililiter Standard Deviation 272.2	—
The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point Week 8	572.6 picograms/mililiter Standard Deviation 377.5	432.6 picograms/mililiter Standard Deviation 276.8	—
The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point Week 12	519.1 picograms/mililiter Standard Deviation 351.3	366.1 picograms/mililiter Standard Deviation 329.6	—

SECONDARY outcome

Timeframe: 12 weeks

Population: The ITT population included all trial participants who were randomized to one of the three treatment groups. Results are provided for participants who reported adherence information.

Adherence is defined as the percentage of participants who used the gel each day of the preceding 14 days, based on participant self reports.

Outcome measures

Outcome measures
Measure	Dapivirine Gel 4759 n=39 Participants Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=41 Participants will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine n=41 Participants Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
The Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women	74 percentage of participants with data	73 percentage of participants with data	71 percentage of participants with data

SECONDARY outcome

Timeframe: 12 weeks

Population: All participants who were assigned to a treatment group were analyzed as members of the group to which they were randomized, regardless of adherence to the planned course of treatment.

Cervicovaginal fluid specimens will be obtained to determine vaginal pH before first gel application and at screening, enrolment and visit 5 (week 12). Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal pH in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.

Outcome measures

Outcome measures
Measure	Dapivirine Gel 4759 n=43 Participants Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=43 Participants will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine n=42 Participants Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
Changes in the Vaginal pH Visit 5 (Week 12)	4.4 Vaginal pH Standard Deviation 0.46	4.44 Vaginal pH Standard Deviation 0.61	4.38 Vaginal pH Standard Deviation 0.47
Changes in the Vaginal pH Screening (Week 0)	4.46 Vaginal pH Standard Deviation 0.53	4.55 Vaginal pH Standard Deviation 0.63	4.55 Vaginal pH Standard Deviation 0.95
Changes in the Vaginal pH Visit 1 (Enrollment)	4.45 Vaginal pH Standard Deviation 0.52	4.48 Vaginal pH Standard Deviation 0.5	4.3 Vaginal pH Standard Deviation 0.43

SECONDARY outcome

Timeframe: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).

The distribution of dapivirine levels observed in each type of sample will be summarized using simple descriptive statistics. In addition, the proportion of women with detectable dapivirine concentrations will be calculated for each type of sample at each collection time point. Exploratory analyses of dapivirine concentration data will also be performed to take into account information reported in a diary regarding menses and tampon use throughout the trial.

Outcome measures

Outcome measures
Measure	Dapivirine Gel 4759 n=43 Participants Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=43 Participants will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point. Visit 2 (2 weeks post-enrollment)	467.1 nanogram/milliliter Standard Deviation 579.8	880.7 nanogram/milliliter Standard Deviation 1924	—
The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point. Visit 3 (4 weeks post-enrolment)	347.8 nanogram/milliliter Standard Deviation 351.9	462.6 nanogram/milliliter Standard Deviation 590.0	—
The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point. Visit 4 (8 weeks post-enrolment)	526.9 nanogram/milliliter Standard Deviation 580.1	298.1 nanogram/milliliter Standard Deviation 151	—
The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point. Visit 5a (24 hours after gel discontinuation)	192.0 nanogram/milliliter Standard Deviation 186.7	680.0 nanogram/milliliter Standard Deviation 1775	—
The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point. Visit 5b (48 hours after gel discontinuation)	98.63 nanogram/milliliter Standard Deviation 180.3	164.0 nanogram/milliliter Standard Deviation 233.1	—
The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point. Visit 5c (72 hours after gel discontinuation)	177.0 nanogram/milliliter Standard Deviation 304.9	245.6 nanogram/milliliter Standard Deviation 230.7	—

SECONDARY outcome

Population: The PK analysis population included all participants who received at least one dose of the active IP and for whom at least one plasma, vaginal fluid or cervical tissue sample was taken.

The distribution of dapivirine levels observed in vaginal tissue sample will be summarized using simple descriptive statistics.

Outcome measures

Outcome measures
Measure	Dapivirine Gel 4759 n=28 Participants Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=32 Participants will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point. Visit 5a (24 hours after gel discontinuation)	3518 nanogram/gram Standard Deviation 3579	9343 nanogram/gram Standard Deviation 18980	—
The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point. Visit 5b (48 hours after gel discontinuation)	841.0 nanogram/gram Standard Deviation 1582	1150 nanogram/gram Standard Deviation 1184	—
The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point. Visit 5c (72 hours after gel discontinuation)	4781 nanogram/gram Standard Deviation 9161	1142 nanogram/gram Standard Deviation 1337	—

SECONDARY outcome

Timeframe: 12 weeks

Population: The ITT population included all trial participants who were randomized to one of the three treatment groups. Results are reported for participants who provided questionnaire responses.

Acceptability was assessed as the percentage of participants at week 12 who were willing to use the gel every day if proven to prevent HIV.

Outcome measures

Outcome measures
Measure	Dapivirine Gel 4759 n=40 Participants Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=41 Participants will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine n=40 Participants Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
Acceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women	24 Participants	25 Participants	29 Participants

Adverse Events

Dapivirine Gel 4759

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Dapivirine Gel 4789

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

HEC-based Placebo Gel, 2.5g Containing no Dapivirine

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dapivirine Gel 4759 n=43 participants at risk Will be applied by participants once daily for12-weeks treatment period dapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily	Dapivirine Gel 4789 n=43 participants at risk will be applied by participants once daily for 12-weeks treatment period dapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily	HEC-based Placebo Gel, 2.5g Containing no Dapivirine n=42 participants at risk Will be applied once daily for 12-weeks treatment period Drug placebo: HEC-based universal placebo gel, 2.5g applied once daily
Reproductive system and breast disorders Cellulitis of the left breast	2.3% 1/43 • Number of events 1 • Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.	0.00% 0/43 • Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.	0.00% 0/42 • Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.
Gastrointestinal disorders Abdominal Pain	0.00% 0/43 • Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.	0.00% 0/43 • Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.	2.4% 1/42 • Number of events 1 • Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/43 • Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.	0.00% 0/43 • Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.	2.4% 1/42 • Number of events 1 • Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.

Other adverse events

Additional Information

Dr John Steytler

International Partnership for Microbicides

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place