Trial Outcomes & Findings for PF-04191834 Single Dose Bronchodilatory Study In Asthma. (NCT NCT00723021)
NCT ID: NCT00723021
Last Updated: 2013-02-01
Results Overview
The FEV1 is the maximal volume of air that can be forcefully exhaled in one second
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Baseline, 12 hours (hrs) post-dose
Results posted on
2013-02-01
Participant Flow
Participant milestones
| Measure |
Treatment Sequence 1
Placebo/Zileuton CR 1200 mg/PF-04191834 30 mg/PF-04191834 2000 mg/PF-04191834 100 mg
|
Treatment Sequence 2
PF-04191834 100 mg/PF-04191834 30 mg/PF-04191834 2000 mg/Placebo/Zileuton CR 1200 mg
|
Treatment Sequence 3
PF-04191834 2000 mg/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 30 mg/Placebo
|
Treatment Sequence 4
PF-04191834 30 mg/Placebo/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 2000 mg
|
Treatment Sequence 5
Zileuton CR 1200 mg/PF-04191834 2000 mg/Placebo/PF-04191834 100 mg/PF-04191834 30 mg
|
|---|---|---|---|---|---|
|
Intervention Period 1
STARTED
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 1
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 2
STARTED
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 2
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 3
STARTED
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 3
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 4
STARTED
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 4
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
|
Intervention Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Intervention Period 5
STARTED
|
3
|
3
|
3
|
3
|
2
|
|
Intervention Period 5
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
|
Intervention Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1
Placebo/Zileuton CR 1200 mg/PF-04191834 30 mg/PF-04191834 2000 mg/PF-04191834 100 mg
|
Treatment Sequence 2
PF-04191834 100 mg/PF-04191834 30 mg/PF-04191834 2000 mg/Placebo/Zileuton CR 1200 mg
|
Treatment Sequence 3
PF-04191834 2000 mg/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 30 mg/Placebo
|
Treatment Sequence 4
PF-04191834 30 mg/Placebo/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 2000 mg
|
Treatment Sequence 5
Zileuton CR 1200 mg/PF-04191834 2000 mg/Placebo/PF-04191834 100 mg/PF-04191834 30 mg
|
|---|---|---|---|---|---|
|
Intervention Period 4
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
PF-04191834 Single Dose Bronchodilatory Study In Asthma.
Baseline characteristics by cohort
| Measure |
All Participants
n=15 Participants
Participants receiving any of the 5 treatments (PF-04191834 30 mg, PF-04191834 100 mg, PF-04191834 2000 mg, Zileuton CR 1200 mg and Placebo) in a randomized fashion first
|
|---|---|
|
Age Continuous
|
33.5 years
STANDARD_DEVIATION 9.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 hours (hrs) post-dosePopulation: All enrolled participants treated who had at least 1 concentration in at least 1 treatment period
The FEV1 is the maximal volume of air that can be forcefully exhaled in one second
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=14 Participants
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
n=15 Participants
Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Baseline
|
2.624 L
Standard Deviation 0.3939
|
2.626 L
Standard Deviation 0.3860
|
2.585 L
Standard Deviation 0.5200
|
2.579 L
Standard Deviation 0.4131
|
2.609 L
Standard Deviation 0.4502
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change at 12 Hours Postdose
|
0.064 L
Standard Deviation 0.3098
|
0.164 L
Standard Deviation 0.1859
|
0.152 L
Standard Deviation 0.2072
|
0.265 L
Standard Deviation 0.3047
|
0.131 L
Standard Deviation 0.1566
|
PRIMARY outcome
Timeframe: Baseline, 24 hours (hrs) post-dosePopulation: All enrolled participants treated who had at least 1 concentration in at least 1 treatment period
The FEV1 is the maximal volume of air that can be forcefully exhaled in one second
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=14 Participants
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
n=15 Participants
Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Baseline
|
2.624 L
Standard Deviation 0.3939
|
2.626 L
Standard Deviation 0.3860
|
2.585 L
Standard Deviation 0.5200
|
2.579 L
Standard Deviation 0.4131
|
2.609 L
Standard Deviation 0.4502
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change at 24 Hours Postdose
|
0.122 L
Standard Deviation 0.2553
|
0.014 L
Standard Deviation 0.2318
|
0.103 L
Standard Deviation 0.2616
|
0.162 L
Standard Deviation 0.1559
|
0.151 L
Standard Deviation 0.1338
|
SECONDARY outcome
Timeframe: Baseline, 12 hours (hrs) post-dosePopulation: All enrolled participants treated who had at least 1 concentration in at least 1 treatment period
The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=14 Participants
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
n=15 Participants
Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC)
Baseline
|
3.852 L
Standard Deviation 0.8865
|
3.891 L
Standard Deviation 0.8625
|
3.720 L
Standard Deviation 0.8930
|
3.792 L
Standard Deviation 0.9100
|
3.821 L
Standard Deviation 0.9914
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Change at 12 Hours Postdose
|
0.025 L
Standard Deviation 0.3306
|
0.284 L
Standard Deviation 0.4150
|
0.210 L
Standard Deviation 0.4792
|
0.266 L
Standard Deviation 0.3184
|
0.140 L
Standard Deviation 0.2750
|
SECONDARY outcome
Timeframe: Baseline,24 hours (hrs) post-dosePopulation: All enrolled participants treated who had at least 1 concentration in at least 1 treatment period
The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=14 Participants
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
n=15 Participants
Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC)
Baseline
|
3.852 L
Standard Deviation 0.8865
|
3.891 L
Standard Deviation 0.8625
|
3.720 L
Standard Deviation 0.8930
|
3.792 L
Standard Deviation 0.9100
|
3.821 L
Standard Deviation 0.9914
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Change at 24 Hours Postdose
|
0.162 L
Standard Deviation 0.2322
|
0.051 L
Standard Deviation 0.2839
|
0.229 L
Standard Deviation 0.3657
|
0.171 L
Standard Deviation 0.2070
|
0.219 L
Standard Deviation 0.2977
|
SECONDARY outcome
Timeframe: Baseline, 12 hours (hrs) post-dosePopulation: All enrolled participants treated who had at least 1 concentration in at least 1 treatment period
The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=14 Participants
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
n=15 Participants
Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
Baseline
|
1.951 L/Sec
Standard Deviation 0.4550
|
1.901 L/Sec
Standard Deviation 0.4228
|
1.807 L/Sec
Standard Deviation 0.4452
|
1.915 L/Sec
Standard Deviation 0.4488
|
1.959 L/Sec
Standard Deviation 0.4378
|
|
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
Change at 12 Hours Postdose
|
0.091 L/Sec
Standard Deviation 0.3556
|
0.340 L/Sec
Standard Deviation 0.4238
|
0.269 L/Sec
Standard Deviation 0.3033
|
0.297 L/Sec
Standard Deviation 0.3871
|
0.187 L/Sec
Standard Deviation 0.3757
|
SECONDARY outcome
Timeframe: Baseline, 24 hours (hrs) post-dosePopulation: All enrolled participants treated who had at least 1 concentration in at least 1 treatment period
The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=14 Participants
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
n=15 Participants
Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
Baseline
|
1.951 L
Standard Deviation 0.4550
|
1.901 L
Standard Deviation 0.4228
|
1.807 L
Standard Deviation 0.4452
|
1.915 L
Standard Deviation 0.4488
|
1.959 L
Standard Deviation 0.4378
|
|
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
Change at 24 Hours Postdose
|
0.146 L
Standard Deviation 0.3049
|
0.038 L
Standard Deviation 0.1952
|
0.196 L
Standard Deviation 0.2169
|
0.151 L
Standard Deviation 0.2030
|
0.208 L
Standard Deviation 0.3483
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.Population: All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
1979 ng*h/mL
Standard Deviation 482
|
5547 ng*h/mL
Standard Deviation 1388
|
29990 ng*h/mL
Standard Deviation 8812
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.Population: All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
154 ng/mL
Standard Deviation 29
|
426 ng/mL
Standard Deviation 118
|
2146 ng/mL
Standard Deviation 410
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 Participants
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
6 hrs
Interval 5.0 to 14.0
|
6 hrs
Interval 4.0 to 14.0
|
10 hrs
Interval 4.0 to 14.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.Population: Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be \>10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 and 24 hours following dosing in each period.Population: Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be \>10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-04191834 30 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-04191834 100 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
PF-04191834 2000 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Zileuton CR 1200 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Participants received single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
|
PF-04191834 30 mg
n=14 participants at risk
Participants received a single oral dose of PF-04191834 30 mg in any treatment period
|
PF-04191834 100 mg
n=15 participants at risk
Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
|
PF-04191834 2000 mg
n=15 participants at risk
Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
|
Zileuton CR 1200 mg
n=15 participants at risk
Paticipants received single oral dose of zileuton CR1200 mg (2 x 600 mg tablets) in any treatment period
|
|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/15
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15
|
0.00%
0/14
|
6.7%
1/15
|
6.7%
1/15
|
6.7%
1/15
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15
|
0.00%
0/14
|
6.7%
1/15
|
6.7%
1/15
|
6.7%
1/15
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/15
|
6.7%
1/15
|
|
General disorders
Fatigue
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/15
|
6.7%
1/15
|
|
General disorders
Pain
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/15
|
6.7%
1/15
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/15
|
7.1%
1/14
|
0.00%
0/15
|
0.00%
0/15
|
6.7%
1/15
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Infections and infestations
Viral upper respiratory tract
|
6.7%
1/15
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/15
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15
|
0.00%
0/14
|
6.7%
1/15
|
6.7%
1/15
|
6.7%
1/15
|
|
Nervous system disorders
Headache
|
13.3%
2/15
|
21.4%
3/14
|
6.7%
1/15
|
6.7%
1/15
|
33.3%
5/15
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Vascular disorders
Phlebitis
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER