Trial Outcomes & Findings for Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge (NCT NCT01107405)
NCT ID: NCT01107405
Last Updated: 2012-03-21
Results Overview
Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
Visit 4 (8 hr re-challenge)
Results posted on
2012-03-21
Participant Flow
This 2 week ocular allergy study was conducted at 2 ophthalmology clinics in the United States. The first participant was enrolled on 4/22/2010 and the last participant visit was 5/30/2010.
238 participants were screened, a total of 101 participants with seasonal and perennial allergy were randomized into the study. These 101 participants comprised the safety population, 90 of which completed the study. The ITT population was comprised of 97 subjects (4 excluded due to no post CAC-assessment).
Participant milestones
| Measure |
Loteprednol Etabonate Base (QD)
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
18
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
Loteprednol Etabonate Base (QD)
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge
Baseline characteristics by cohort
| Measure |
Loteprednol Etabonate Base (QD)
n=21 Participants
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
n=20 Participants
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
n=20 Participants
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
n=20 Participants
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
n=20 Participants
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<=19 years
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
8 participants
n=10 Participants
|
|
Age, Customized
20 - 64 years
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
18 participants
n=5 Participants
|
19 participants
n=4 Participants
|
18 participants
n=21 Participants
|
91 participants
n=10 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
98 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Visit 4 (8 hr re-challenge)Population: Visit 4, Re-challenge Ocular Itching Scores - Primary Analysis ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.
Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Outcome measures
| Measure |
Loteprednol Etabonate Base (QD)
n=21 Participants
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
n=20 Participants
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
n=18 Participants
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
n=19 Participants
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
n=19 Participants
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
|---|---|---|---|---|---|
|
Ocular Itching
3 Min
|
1.48 Units on a Scale
Standard Deviation 1.040
|
1.84 Units on a Scale
Standard Deviation 0.978
|
1.82 Units on a Scale
Standard Deviation 0.954
|
1.93 Units on a Scale
Standard Deviation 0.794
|
2.68 Units on a Scale
Standard Deviation 0.916
|
|
Ocular Itching
5 Min
|
1.63 Units on a Scale
Standard Deviation 1.036
|
2.13 Units on a Scale
Standard Deviation 0.988
|
1.96 Units on a Scale
Standard Deviation 0.960
|
2.12 Units on a Scale
Standard Deviation 0.918
|
2.78 Units on a Scale
Standard Deviation 0.924
|
|
Ocular Itching
7 Min
|
1.54 Units on a Scale
Standard Deviation 1.035
|
2.03 Units on a Scale
Standard Deviation 1.097
|
1.89 Units on a Scale
Standard Deviation 0.993
|
2.04 Units on a Scale
Standard Deviation 0.951
|
2.71 Units on a Scale
Standard Deviation 0.899
|
PRIMARY outcome
Timeframe: Visit 4 (8 hr re-challenge)Population: Visit 4, Re-challenge Conjunctival Hyperemia Scores, ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.
Outcome measures
| Measure |
Loteprednol Etabonate Base (QD)
n=21 Participants
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
n=20 Participants
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
n=18 Participants
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
n=19 Participants
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
n=19 Participants
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
|---|---|---|---|---|---|
|
Conjunctival Redness
7 min
|
1.76 Units on a scale
Standard Deviation 0.620
|
1.99 Units on a scale
Standard Deviation 0.709
|
2.11 Units on a scale
Standard Deviation 0.649
|
2.16 Units on a scale
Standard Deviation 0.619
|
2.59 Units on a scale
Standard Deviation 0.501
|
|
Conjunctival Redness
15 min
|
1.95 Units on a scale
Standard Deviation 0.660
|
2.13 Units on a scale
Standard Deviation 0.829
|
2.28 Units on a scale
Standard Deviation 0.766
|
2.18 Units on a scale
Standard Deviation 0.600
|
2.71 Units on a scale
Standard Deviation 0.597
|
|
Conjunctival Redness
20 min
|
2.02 Units on a scale
Standard Deviation 0.720
|
2.06 Units on a scale
Standard Deviation 0.811
|
2.28 Units on a scale
Standard Deviation 0.691
|
2.16 Units on a scale
Standard Deviation 0.585
|
2.74 Units on a scale
Standard Deviation 0.592
|
SECONDARY outcome
Timeframe: Visit 3 (initial challenge)Population: Visit 3 Ocular Itching Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.
Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Outcome measures
| Measure |
Loteprednol Etabonate Base (QD)
n=21 Participants
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
n=20 Participants
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
n=18 Participants
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
n=19 Participants
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
n=19 Participants
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
|---|---|---|---|---|---|
|
Ocular Itching
3 Min
|
2.50 units on a scale
Standard Deviation 0.829
|
2.00 units on a scale
Standard Deviation 0.778
|
2.31 units on a scale
Standard Deviation 0.889
|
2.28 units on a scale
Standard Deviation 0.946
|
2.50 units on a scale
Standard Deviation 1.000
|
|
Ocular Itching
5 min
|
2.45 units on a scale
Standard Deviation 0.781
|
2.15 units on a scale
Standard Deviation 0.745
|
2.46 units on a scale
Standard Deviation 1.016
|
2.47 units on a scale
Standard Deviation 0.979
|
2.63 units on a scale
Standard Deviation 0.863
|
|
Ocular Itching
7 min
|
2.38 units on a scale
Standard Deviation 0.872
|
2.21 units on a scale
Standard Deviation 0.783
|
2.21 units on a scale
Standard Deviation 1.044
|
2.38 units on a scale
Standard Deviation 1.062
|
2.45 units on a scale
Standard Deviation 0.810
|
SECONDARY outcome
Timeframe: Visit 3 (initial challenge)Population: Visit 3 Conjunctival Hyperemia Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.
Outcome measures
| Measure |
Loteprednol Etabonate Base (QD)
n=21 Participants
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
n=20 Participants
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
n=18 Participants
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
n=19 Participants
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
n=19 Participants
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
|---|---|---|---|---|---|
|
Conjunctival Redness
7 min
|
2.14 units on a scale
Standard Deviation 0.584
|
2.05 units on a scale
Standard Deviation 0.484
|
2.22 units on a scale
Standard Deviation 0.593
|
2.25 units on a scale
Standard Deviation 0.486
|
2.41 units on a scale
Standard Deviation 0.663
|
|
Conjunctival Redness
15 min
|
2.26 units on a scale
Standard Deviation 0.509
|
2.20 units on a scale
Standard Deviation 0.737
|
2.28 units on a scale
Standard Deviation 0.664
|
2.43 units on a scale
Standard Deviation 0.415
|
2.42 units on a scale
Standard Deviation 0.795
|
|
Conjunctival Redness
20 min
|
2.31 units on a scale
Standard Deviation 0.541
|
2.24 units on a scale
Standard Deviation 0.631
|
2.18 units on a scale
Standard Deviation 0.706
|
2.33 units on a scale
Standard Deviation 0.590
|
2.42 units on a scale
Standard Deviation 0.834
|
SECONDARY outcome
Timeframe: Visit 4 (initial challenge)Population: Visit 4 Ocular Itching Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.
Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Outcome measures
| Measure |
Loteprednol Etabonate Base (QD)
n=21 Participants
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
n=20 Participants
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
n=18 Participants
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
n=19 Participants
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
n=19 Participants
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
|---|---|---|---|---|---|
|
Ocular Itching
3 Min
|
2.02 units on a scale
Standard Deviation 0.978
|
1.93 units on a scale
Standard Deviation 1.130
|
2.04 units on a scale
Standard Deviation 0.913
|
2.17 units on a scale
Standard Deviation 0.846
|
2.55 units on a scale
Standard Deviation 0.880
|
|
Ocular Itching
5 min
|
2.19 units on a scale
Standard Deviation 1.040
|
2.14 units on a scale
Standard Deviation 1.071
|
2.15 units on a scale
Standard Deviation 0.888
|
2.32 units on a scale
Standard Deviation 0.853
|
2.82 units on a scale
Standard Deviation 0.877
|
|
Ocular Itching
7 min
|
2.11 units on a scale
Standard Deviation 1.026
|
2.11 units on a scale
Standard Deviation 0.985
|
2.13 units on a scale
Standard Deviation 0.917
|
2.22 units on a scale
Standard Deviation 0.953
|
2.71 units on a scale
Standard Deviation 0.875
|
SECONDARY outcome
Timeframe: Visit 4 (initial challenge)Population: Visit 4 Conjunctival Hyperemia Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.
Outcome measures
| Measure |
Loteprednol Etabonate Base (QD)
n=21 Participants
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
n=20 Participants
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
n=18 Participants
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
n=19 Participants
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
n=19 Participants
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
|---|---|---|---|---|---|
|
Conjunctival Redness
7 min
|
1.96 units on a scale
Standard Deviation 0.755
|
2.19 units on a scale
Standard Deviation 0.683
|
2.26 units on a scale
Standard Deviation 0.661
|
2.22 units on a scale
Standard Deviation 0.353
|
2.70 units on a scale
Standard Deviation 0.445
|
|
Conjunctival Redness
15 min
|
2.05 units on a scale
Standard Deviation 0.793
|
2.19 units on a scale
Standard Deviation 0.777
|
2.28 units on a scale
Standard Deviation 0.717
|
2.36 units on a scale
Standard Deviation 0.459
|
2.83 units on a scale
Standard Deviation 0.479
|
|
Conjunctival Redness
20 min
|
2.15 units on a scale
Standard Deviation 0.777
|
2.16 units on a scale
Standard Deviation 0.828
|
2.28 units on a scale
Standard Deviation 0.701
|
2.29 units on a scale
Standard Deviation 0.573
|
2.80 units on a scale
Standard Deviation 0.544
|
Adverse Events
Loteprednol Etabonate Base (QD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Loteprednol Etabonate Base (BID)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Loteprednol Etabonate Base (QID)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Loteprednol Etabonate Suspension (QID)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vehicle of Loteprednol Etabonate
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Loteprednol Etabonate Base (QD)
n=21 participants at risk
Loteprednol etabonate ophthalmic base dosed once/day.
|
Loteprednol Etabonate Base (BID)
n=20 participants at risk
Loteprednol etabonate ophthalmic base dosed two times/day
|
Loteprednol Etabonate Base (QID)
n=20 participants at risk
Loteprednol etabonate ophthalmic base dosed four times/day.
|
Loteprednol Etabonate Suspension (QID)
n=20 participants at risk
Loteprednol etabonate ophthalmic suspension dosed four times/day
|
Vehicle of Loteprednol Etabonate
n=20 participants at risk
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
|
|---|---|---|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/21 • 14 days
|
5.0%
1/20 • Number of events 2 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
5.0%
1/20 • Number of events 2 • 14 days
|
|
Eye disorders
Eye pain
|
0.00%
0/21 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
|
Eye disorders
Eye pruritis
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 2 • 14 days
|
|
Eye disorders
Blurred vision
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 2 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngial pain
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
0.00%
0/21 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
|
Investigations
Blood oestrogen decreased
|
0.00%
0/21 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/21 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to any presentation of results, draft versions of manuscripts will be made available to co-authors and to the Sponsor for review and comment. At least 30 days in the case of abstracts or 60 days in the case of full papers should be allowed for comments prior to submission for consideration of acceptance of presentation or publication.
- Publication restrictions are in place
Restriction type: OTHER