Trial Outcomes & Findings for Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters (NCT NCT05615870)
NCT ID: NCT05615870
Last Updated: 2025-10-02
Results Overview
An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing
COMPLETED
NA
230 participants
24 Weeks
2025-10-02
Participant Flow
Two enrolled participants terminated the study prior to randomization due to withdrawal of consent and ineligibility.
Participant milestones
| Measure |
Intervention Group (Active Filter)
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Control Group (No Filter)
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
115
|
|
Overall Study
COMPLETED
|
100
|
94
|
|
Overall Study
NOT COMPLETED
|
13
|
21
|
Reasons for withdrawal
| Measure |
Intervention Group (Active Filter)
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Control Group (No Filter)
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
13
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Unable to complete study activities after moving residences
|
0
|
2
|
|
Overall Study
Terminated from the experimental or control intervention only and continued with the study
|
1
|
0
|
|
Overall Study
The participant thought the study was done and shipped the devices back.
|
0
|
1
|
Baseline Characteristics
Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
Baseline characteristics by cohort
| Measure |
Intervention Group (Active Filter)
n=113 Participants
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Control Group (No Filter)
n=115 Participants
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.0 Months
STANDARD_DEVIATION 2.9 • n=5 Participants
|
4.3 Months
STANDARD_DEVIATION 2.9 • n=7 Participants
|
4.1 Months
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Rurality (RUCA code)
Metropolitan
|
79 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Rurality (RUCA code)
Micropolitan
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Rurality (RUCA code)
Small town
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Rurality (RUCA code)
Rural
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Rurality (RUCA code)
Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: The analysis population included all participants who were randomized to either HEPA filtration (intervention group) or inactive filter unit (control group) with available outcome data
An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing
Outcome measures
| Measure |
Intervention Group (Active Filter)
n=110 Participants
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Control Group (No Filter)
n=109 Participants
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
|---|---|---|
|
Number of Caregiver-reported Symptom-free Days (SFDs)
|
118.01 Days
Standard Deviation 42.66
|
112.60 Days
Standard Deviation 46.33
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The analysis population included all participants who are randomized to either HEPA filtration (intervention group) or inactive filter unit (control group) with available data of Unscheduled Healthcare Visits
Caregiver reported number of hospitalizations, emergency department or urgent care visits, other unscheduled medical visits, and the sum of total counts of all metrics for respiratory complaints
Outcome measures
| Measure |
Intervention Group (Active Filter)
n=109 Participants
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Control Group (No Filter)
n=109 Participants
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
|---|---|---|
|
Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints
Emergency Department (ED) or Urgent Care (UC) visits
|
0.68 Visits
Standard Deviation 1.25
|
0.68 Visits
Standard Deviation 1.32
|
|
Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints
Other unscheduled healthcare visits (UHVs) for respiratory complaints
|
1.11 Visits
Standard Deviation 1.65
|
1.48 Visits
Standard Deviation 1.99
|
|
Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints
Hospitalizations
|
0.28 Visits
Standard Deviation 0.91
|
0.16 Visits
Standard Deviation 0.60
|
|
Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints
A sum of counts (or total counts) of all metrics
|
2.06 Visits
Standard Deviation 2.83
|
2.31 Visits
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Participants who were randomized to either HEPA filtration (intervention group) or inactive filter unit (control group) and answered the quality of life (QOL) survey.
QOL score is measured by the Pediatric Quality of Life Inventory TM (PedsQLTM) Infants Scales questionnaire. The scores are reverse-scored and linearly transformed to a 0-100 scale. Higher scores mean a better outcome.
Outcome measures
| Measure |
Intervention Group (Active Filter)
n=100 Participants
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Control Group (No Filter)
n=95 Participants
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
|---|---|---|
|
Total Quality of Life (QOL) Score
|
81.34 Scores on a scale
Standard Deviation 9.99
|
82.13 Scores on a scale
Standard Deviation 10.68
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Participants who were randomized to either HEPA filtration (intervention group) or inactive filter unit (control group) with available PM2.5 data
PM2.5 levels (Particulate Matter ≤ 2.5 micrometers in diameter) are measured by in-home monitors and scaled to unit of micrograms per cubic meter per week. Higher levels mean a worse outcome.
Outcome measures
| Measure |
Intervention Group (Active Filter)
n=102 Participants
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Control Group (No Filter)
n=100 Participants
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
|---|---|---|
|
Average Particulate Matter (PM2.5) Levels
Common room
|
10.70 µg/m³/week
Standard Deviation 15.91
|
15.27 µg/m³/week
Standard Deviation 16.86
|
|
Average Particulate Matter (PM2.5) Levels
Sleep space
|
11.08 µg/m³/week
Standard Deviation 18.77
|
21.45 µg/m³/week
Standard Deviation 33.14
|
|
Average Particulate Matter (PM2.5) Levels
Average of common room and sleep space
|
10.66 µg/m³/week
Standard Deviation 15.53
|
17.96 µg/m³/week
Standard Deviation 21.35
|
Adverse Events
Intervention Group (Active Filter)
Control Group (No Filter)
Serious adverse events
| Measure |
Intervention Group (Active Filter)
n=113 participants at risk
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Control Group (No Filter)
n=115 participants at risk
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Medical or emergency department/urgent care visit for respiratory complaint
|
0.88%
1/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.00%
0/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Trouble breathing
|
0.88%
1/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.87%
1/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Wheeze
|
0.88%
1/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.00%
0/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Other - bronchiolitis, hospitalization for hypoxia & increased work of breathing, and respiratory di
|
4.4%
5/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.00%
0/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Other - Respiratory Distress, Reactive airway disease with wheezing, Hypoxemia and nasal congestion
|
0.00%
0/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
4.3%
5/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Infections and infestations
Other - Bronchiolitis
|
5.3%
6/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
4.3%
5/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Nervous system disorders
Other - seizure like activity
|
0.88%
1/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.00%
0/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Surgical and medical procedures
VSD repair surgery
|
0.88%
1/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.00%
0/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Injury, poisoning and procedural complications
Other - Patient had bilateral ear tubes placed
|
0.88%
1/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.00%
0/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Metabolism and nutrition disorders
Other - Hospitalization due to failure to thrive
|
0.00%
0/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.87%
1/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
Other adverse events
| Measure |
Intervention Group (Active Filter)
n=113 participants at risk
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
Control Group (No Filter)
n=115 participants at risk
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Other - Subglottic stenosis requiring micro laryngoscopy and bronchoscopy / Reactive Airway Disease
|
3.5%
4/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.00%
0/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Medical or emergency department/urgent care visit for respiratory complaint
|
1.8%
2/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.00%
0/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Other - Rhinitis, Coughing, Wheezing
|
0.00%
0/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
4.3%
5/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Infections and infestations
Other - Cough
|
0.88%
1/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.87%
1/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Immune system disorders
Other- Viral induced asthma
|
0.00%
0/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
1.7%
2/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Gastrointestinal disorders
Other - Constipation issues that required emergency room visit
|
0.00%
0/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
0.87%
1/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
|
Nervous system disorders
Other - Seizure
|
0.00%
0/113 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
1.7%
2/115 • From November 24, 2022, to May 22, 2024 (1 year, 5.9 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place