Trial Outcomes & Findings for Cholera Anti-Secretory Treatment Trial (NCT NCT04150250)

Last Updated: 2021-03-25

Results Overview

Diarrheal stool output rate is defined as the total volume of diarrheal stools (in mL, Grade 3 and above) divided by the number of hours between initiation of study drug (iOWH032 or placebo) and initiation of antibiotic therapy. Stools were graded based on consistency as follows: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) The definition of diarrhea is a grade 3 or higher stool.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Day 1 - Day 5 (up to first dose of antibiotic therapy)

Results posted on

2021-03-25

Participant Flow

A total of 47 healthy adults were enrolled at one clinical research site in the United States. Participants were confined in an inpatient isolation research ward for a duration of approximately 11 days until discharge criteria were met.

Participants were randomized in a 1:1 ratio stratified by blood type status (O vs. Non-O) to receive either iOWH032 500 mg every 8 hours for three days or matching placebo.

Participant milestones

Participant milestones
Measure	iOWH032 On Day 1, participants were challenged with 10\^6 colony-forming units (CFU) of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo On Day 1, participants were challenged with 10\^6 CFU of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Overall Study STARTED	23	24
Overall Study COMPLETED	23	22
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	iOWH032 On Day 1, participants were challenged with 10\^6 colony-forming units (CFU) of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo On Day 1, participants were challenged with 10\^6 CFU of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Cholera Anti-Secretory Treatment Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iOWH032 n=23 Participants On Day 1, participants were challenged with 10\^6 CFU of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=24 Participants On Day 1, participants were challenged with 10\^6 CFU of freshly-harvested wild-type V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever was first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Total n=47 Participants Total of all reporting groups
Age, Continuous	32.0 years STANDARD_DEVIATION 6.15 • n=5 Participants	32.3 years STANDARD_DEVIATION 5.97 • n=7 Participants	32.1 years STANDARD_DEVIATION 6.00 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Blood Type Type O	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Blood Type Non-O	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 - Day 5 (up to first dose of antibiotic therapy)

Population: Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) within 48 hours of challenge.

Outcome measures

Outcome measures
Measure	iOWH032 n=16 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Diarrheal Stool Output Rate	25.42 mL/hour Interval 7.2 to 65.9	32.57 mL/hour Interval 14.7 to 53.0

PRIMARY outcome

Timeframe: Day 1 - Day 5 (up to first dose of antibiotic therapy)

Stools were graded based on consistency as follows: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) The definition of diarrhea is a grade 3 or higher stool. For participants with symptom onset within 48 hours of challenge diarrheal stool output rate is defined as the total volume of diarrheal stools (mL, Grade 3 and above) divided by the number of hours between initiation of study product dosing and initiation of antibiotic therapy. For participants with symptom onset after 48 hours diarrheal stool output rate is defined as the total volume of diarrheal stools (mL, Grade 3 and above) divided by the number of hours between onset of symptoms and initiation of antibiotic therapy.

Outcome measures

Outcome measures
Measure	iOWH032 n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=23 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Diarrheal Stool Output Rate Including Participants With Symptom Onset After 48 Hours	25.42 mL/hour Interval 6.3 to 63.8	29.22 mL/hour Interval 12.5 to 49.6

PRIMARY outcome

Timeframe: Day 1 - Day 180

Population: All participants who received any study drug.

A serious adverse event (SAE) is any adverse event that resulted in any of the following outcomes: 1. Death 2. A life-threatening event. 3. Required inpatient hospitalization or prolongation of existing hospitalization 4. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. Congenital abnormality or birth defect 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or requires medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event.

Outcome measures

Outcome measures
Measure	iOWH032 n=23 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=24 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Number of Participants With Treatment-emergent Serious Adverse Events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 - Day 5 (up to first dose of antibiotic therapy)

The percentage of participants with moderate to severe diarrhea with onset within 48 hours following cholera challenge. Diarrhea was defined as a grade 3 or higher stool based on the following scale: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) Diarrheal stools (Grade 3-5) were graded for severity according to the following: Mild: ≤ 3 liters loose stools; Moderate: \> 3 liters loose stools; Severe: \> 5 liters loose stools.

Outcome measures

Outcome measures
Measure	iOWH032 n=16 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Percentage of Participants With Moderate to Severe Diarrhea With Onset Within 48 Hours Following Cholera Challenge	43.8 percentage of participants Interval 19.8 to 70.1	55.0 percentage of participants Interval 31.5 to 76.9

SECONDARY outcome

Timeframe: Day 1 - Day 5 (up to first dose of antibiotic therapy)

Attack rate of any diarrhea following cholera challenge is defined as the number of participants with 2 or more loose stools (Grade 3-5) totaling \> 200 mL or 1 loose (Grade 3-5) stool \> 300 mL, respectively, with onset within 48 hours of cholera challenge.

Outcome measures

Outcome measures
Measure	iOWH032 n=16 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Attack Rate of Any Diarrhea Following Cholera Challenge	93.8 percentage of participants Interval 69.8 to 99.8	100.0 percentage of participants Interval 83.2 to 100.0

SECONDARY outcome

Timeframe: Day 1 to Day 5 (prior to first dose of antibiotic)

The AUC of diarrheal stool volume and cholera organisms was computed via the trapezoidal rule.

Outcome measures

Outcome measures
Measure	iOWH032 n=16 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Area Under the Curve (AUC) of Diarrheal Stool Volume Between Challenge Dose and Initiation of Antibiotics	14.91 liters * hours Interval 9.3 to 20.8	13.80 liters * hours Interval 9.3 to 17.7

SECONDARY outcome

Timeframe: Day 1 to Day 5 (prior to first dose of antibiotic)

Quantitative cultures were performed on the first two stool samples of each 24-hour period prior to the initiation of antibiotics to determine the number of cholera organisms per gram of stool. Peak shedding represents the highest colony-forming unit (CFU) counts observed for each participant.

Outcome measures

Outcome measures
Measure	iOWH032 n=16 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Peak Shedding of Cholera Organisms	124960186.25 CFU/g Standard Deviation 163145761.682	186793500.00 CFU/g Standard Deviation 304578375.607

SECONDARY outcome

Timeframe: Day 1 to Day 5 (prior to first dose of antibiotics)

Duration of diarrheal episodes was calculated using Kaplan-Meier methods as the time from cholera challenge to the time of the first formed stool (Grade 1), after which all following stools were also formed.

Outcome measures

Outcome measures
Measure	iOWH032 n=16 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Duration of Diarrheal Episodes	156.48 hours Interval 114.1 to 217.8	169.68 hours Interval 108.9 to 216.4

SECONDARY outcome

Timeframe: Day 1 to Day 5 (prior to first dose of antibiotic therapy)

Total number of loose stools (Grade 3 and above) per participant during the interval immediately following challenge and prior to initiation of antibiotic therapy.

Outcome measures

Outcome measures
Measure	iOWH032 n=16 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Total Number of Loose (Grade 3-5) Stools	12.0 loose stools Interval 5.0 to 15.0	10.5 loose stools Interval 8.0 to 18.0

SECONDARY outcome

Timeframe: Day 1 to Day 5, prior to first dose of antibiotics

The presence of fever was defined as a body temperature of ≥ 39°C (102.1°F).

Outcome measures

Outcome measures
Measure	iOWH032 n=16 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Percentage of Participants With Fever Following Cholera Challenge	6.3 percentage of participants Interval 0.2 to 30.2	5.0 percentage of participants Interval 0.1 to 24.9

SECONDARY outcome

Timeframe: Day 1 to Day 5, prior to first dose of antibiotics

Outcome measures

Outcome measures
Measure	iOWH032 n=16 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=20 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Percentage of Participants With Vomiting Following Cholera Challenge	6.3 percentage of participants Interval 0.2 to 30.2	25.0 percentage of participants Interval 8.7 to 49.1

SECONDARY outcome

Timeframe: Day 1 - Day 8

Population: All participants who received any study drug.

Solicited adverse events (AEs) include nausea, abdominal discomfort and pain, abdominal cramps, headache, malaise, anorexia, pollakiuria, micturition urgency, sinus tachycardia, increased alertness, and were collected by interview through 7 days post-challenge (Days 1-8)

Outcome measures

Outcome measures
Measure	iOWH032 n=23 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=24 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Number of Participants With Solicited Adverse Effects Any solicited adverse event	3 Participants	2 Participants
Number of Participants With Solicited Adverse Effects Abdominal discomfort	2 Participants	0 Participants
Number of Participants With Solicited Adverse Effects Headache	1 Participants	0 Participants
Number of Participants With Solicited Adverse Effects Malaise	0 Participants	1 Participants
Number of Participants With Solicited Adverse Effects Nausea	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose of study drug up to Day 29

Population: All participants who received any study drug.

Unsolicited AEs include any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents. Investigators assigned causality of unsolicited AEs to either the study drug, cholera infection, or an alternate etiology.

Outcome measures

Outcome measures
Measure	iOWH032 n=23 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=24 Participants On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAE) Any unsolicited TEAE	18 Participants	21 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAE) Study drug-related TEAE	4 Participants	3 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAE) TEAE leading to discontinuation from study	0 Participants	0 Participants
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAE) TEAE leading to death	0 Participants	0 Participants

Adverse Events

iOWH032

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	iOWH032 n=23 participants at risk On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral iOWH032 500 mg tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.	Placebo n=24 participants at risk On Day 1, participants were challenged with 10\^6 CFU V. cholerae. At the onset of diarrhea, or at 48 hours after challenge, whichever occurred first, participants received oral matching iOWH032 placebo tablets every 8 hours for 3 days. Participants received a 3-day course of antibiotics starting 4 days post-challenge, or sooner if the participant met the criterion for severe cholera diarrhea.
Infections and infestations Pyelonephritis	0.00% 0/23 • Serious adverse events and deaths were collected from first dose of study drug up to Day 180. Non-serious adverse events are reported from first dose of study drug up to Day 29.	4.2% 1/24 • Serious adverse events and deaths were collected from first dose of study drug up to Day 180. Non-serious adverse events are reported from first dose of study drug up to Day 29.

Other adverse events

Additional Information

Gwen Ambler

PATH

Phone: 206-285-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place