Trial Outcomes & Findings for The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease (NCT NCT00939211)
NCT ID: NCT00939211
Last Updated: 2011-08-05
Results Overview
Maximum FEV1 value
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Results posted on
2011-08-05
Participant Flow
The study has been performed at four centers in Sweden. The first subject entered the study on 23 June 2009 and the last subject completed the study on 6 November 2009.
Participant milestones
| Measure |
Entire Study Population
|
|---|---|
|
AZD9164 100 Mcg First, Then Placebo
STARTED
|
28
|
|
AZD9164 100 Mcg First, Then Placebo
COMPLETED
|
28
|
|
AZD9164 100 Mcg First, Then Placebo
NOT COMPLETED
|
0
|
|
AZD9164 400 Mcg First, Then Placebo
STARTED
|
28
|
|
AZD9164 400 Mcg First, Then Placebo
COMPLETED
|
28
|
|
AZD9164 400 Mcg First, Then Placebo
NOT COMPLETED
|
0
|
|
AZD9164 1200 Mcg First, Then Placebo
STARTED
|
28
|
|
AZD9164 1200 Mcg First, Then Placebo
COMPLETED
|
28
|
|
AZD9164 1200 Mcg First, Then Placebo
NOT COMPLETED
|
0
|
|
Spiriva 18 Mcg First, Then Placebo
STARTED
|
28
|
|
Spiriva 18 Mcg First, Then Placebo
COMPLETED
|
28
|
|
Spiriva 18 Mcg First, Then Placebo
NOT COMPLETED
|
0
|
|
Placebo
STARTED
|
28
|
|
Placebo
COMPLETED
|
28
|
|
Placebo
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Overall Number of Baseline Participants
n=28 Participants
|
|---|---|
|
Age Continuous
|
64.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 hMaximum FEV1 value
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 Participants
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 Participants
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
|
1.71 L
Standard Deviation 0.36
|
1.79 L
Standard Deviation 0.39
|
1.72 L
Standard Deviation 0.39
|
1.71 L
Standard Deviation 0.35
|
1.63 L
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: 22 h, 24 h, 26 hTrough FEV1 value
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 Participants
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 Participants
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose
|
1.58 L
Standard Deviation 0.38
|
1.63 L
Standard Deviation 0.38
|
1.62 L
Standard Deviation 0.38
|
1.57 L
Standard Deviation 0.35
|
1.52 L
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 hAverage FEV1 value
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 Participants
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 Participants
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose
|
1.57 L
Standard Deviation 0.36
|
1.63 L
Standard Deviation 0.39
|
1.56 L
Standard Deviation 0.38
|
1.58 L
Standard Deviation 0.35
|
1.50 L
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: 15 min15 min FEV1 value
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 Participants
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 Participants
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose
|
1.42 L
Standard Deviation 0.38
|
1.30 L
Standard Deviation 0.42
|
1.25 L
Standard Deviation 0.44
|
1.55 L
Standard Deviation 0.36
|
1.49 L
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hAverage systolic blood pressure value
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 Participants
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 Participants
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
|
125.5 mmHg
Standard Deviation 15.6
|
127.9 mmHg
Standard Deviation 14.8
|
127.3 mmHg
Standard Deviation 14.9
|
128.0 mmHg
Standard Deviation 13.3
|
126.5 mmHg
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hAverage diastolic blood pressure value
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 Participants
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 Participants
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
|
73.1 mmHg
Standard Deviation 7.9
|
75.6 mmHg
Standard Deviation 8.2
|
74.2 mmHg
Standard Deviation 6.7
|
74.8 mmHg
Standard Deviation 6.2
|
73.5 mmHg
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hAverage pulse value
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 Participants
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 Participants
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Pulse, Average Effect Over 0 - 4 Hours Post-dose
|
61.1 bpm
Standard Deviation 7.6
|
62.9 bpm
Standard Deviation 7.1
|
64.8 bpm
Standard Deviation 8.0
|
60.2 bpm
Standard Deviation 7.6
|
61.3 bpm
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hAverage heart rate value
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 Participants
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 Participants
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Heart Rate, Average Effect Over 0 - 4 Hours Post-dose
|
61.0 bpm
Standard Deviation 6.9
|
62.8 bpm
Standard Deviation 7.8
|
65.2 bpm
Standard Deviation 7.4
|
61.1 bpm
Standard Deviation 7.4
|
61.3 bpm
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 0, 30 min, 2 h, 4 hAverage QTcF value
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 Participants
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 Participants
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
QTcF, Average Effect Over 0 - 4 Hours Post-dose
|
400 ms
Standard Deviation 23.1
|
399 ms
Standard Deviation 25.8
|
396 ms
Standard Deviation 25.0
|
401 ms
Standard Deviation 26.8
|
398 ms
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 hMaximum plasma concentration of AZD9164
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=27 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Plasma AZD9164 Cmax
|
0.529 nmol/L
Interval 0.24 to 1.55
|
3.629 nmol/L
Interval 1.31 to 13.9
|
20.02 nmol/L
Interval 6.15 to 70.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 hArea under the AZD9164 plasma concentration curve
Outcome measures
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=27 Participants
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 Participants
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Plasma AZD9164 AUC0-24
|
2.90 nmol*h/L
Interval 1.2 to 16.2
|
15.2 nmol*h/L
Interval 6.9 to 66.8
|
58.1 nmol*h/L
Interval 21.8 to 217.0
|
—
|
—
|
Adverse Events
AZD9164 100 Mcg First, Then Placebo for Spiriva
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AZD9164 400 Mcg First, Then Placebo for Spiriva
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
AZD9164 1200 Mcg First, Then Placebo for Spiriva
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Spiriva 18 Mcg First, Then Placebo for AZD9164
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo for Spiriva First, Then Placebo for AZD9164
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD9164 100 Mcg First, Then Placebo for Spiriva
n=28 participants at risk
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 400 Mcg First, Then Placebo for Spiriva
n=28 participants at risk
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
AZD9164 1200 Mcg First, Then Placebo for Spiriva
n=28 participants at risk
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
|
Spiriva 18 Mcg First, Then Placebo for AZD9164
n=28 participants at risk
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
|
Placebo for Spiriva First, Then Placebo for AZD9164
n=28 participants at risk
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/28
|
21.4%
6/28
|
64.3%
18/28
|
3.6%
1/28
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/28
|
17.9%
5/28
|
28.6%
8/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
1/28
|
7.1%
2/28
|
25.0%
7/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Nervous system disorders
Headache
|
3.6%
1/28
|
10.7%
3/28
|
7.1%
2/28
|
3.6%
1/28
|
3.6%
1/28
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
2/28
|
10.7%
3/28
|
0.00%
0/28
|
0.00%
0/28
|
7.1%
2/28
|
|
General disorders
Chest Discomfort
|
0.00%
0/28
|
7.1%
2/28
|
14.3%
4/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/28
|
7.1%
2/28
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/28
|
0.00%
0/28
|
7.1%
2/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Nervous system disorders
Tremor
|
0.00%
0/28
|
0.00%
0/28
|
7.1%
2/28
|
0.00%
0/28
|
0.00%
0/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites. AZ has the right to request delays: up to 60 days for confidential information, and an additional 90 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER