Trial Outcomes & Findings for Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD) (NCT NCT03658538)
NCT ID: NCT03658538
Last Updated: 2025-09-24
Results Overview
St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more quality of life limitations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2025-09-24
Participant Flow
Participants were recruited in the Baltimore/Washington are (MD, USA) between June 2019 and January 2024.
Of the 144 enrolled participants, 121 met inclusion criteria. 1 of those participants dropped out prior to completing the baseline visit and was excluded from analysis.
Participant milestones
| Measure |
Active Treatment
The active treatment arm will receive two portable active High-Efficiency Particulate Air (HEPA) air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and secondhand smoking (SHS) reduction in addition to the smoking cessation counseling received by all study participants.
Active HEPA (high-efficiency particulate air) Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA (high-efficiency particulate air) and carbon filters to support a home smoking ban and SHS (secondhand smoking) reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS (secondhand smoking) reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
Homes in the control group will receive Sham air cleaners that have the internal high-efficiency particulate air (HEPA) filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and secondhand smoking (SHS) reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
61
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Active Treatment
The active treatment arm will receive two portable active High-Efficiency Particulate Air (HEPA) air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and secondhand smoking (SHS) reduction in addition to the smoking cessation counseling received by all study participants.
Active HEPA (high-efficiency particulate air) Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA (high-efficiency particulate air) and carbon filters to support a home smoking ban and SHS (secondhand smoking) reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS (secondhand smoking) reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
Homes in the control group will receive Sham air cleaners that have the internal high-efficiency particulate air (HEPA) filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and secondhand smoking (SHS) reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Cancer diagnosis
|
1
|
0
|
|
Overall Study
Change residence
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Unblinded
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Incomplete clinical visit at 6 months due to illness
|
1
|
0
|
|
Overall Study
Evicted from home
|
1
|
0
|
Baseline Characteristics
Motivational Interviewing and Air Cleaners for Smokers With COPD (MOVE COPD)
Baseline characteristics by cohort
| Measure |
Active Treatment
n=59 Participants
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=61 Participants
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.59 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
62.18 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
62.88 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Some College Education or Above
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The difference in the overall number of participants analyzed is due to participants not having SGRQ data collected in either baseline and/or 6 months period.
St. George's Respiratory Questionnaire (SGRQ). The total score is from 0 to 100. Higher scores indicate more quality of life limitations.
Outcome measures
| Measure |
Active Treatment
n=47 Participants
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=51 Participants
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Change in Quality of Life -St. George's Respiratory Questionnaire (SGRQ)
|
-2.9 score on a scale
Interval -5.6 to -0.2
|
1.5 score on a scale
Interval -1.1 to 4.1
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The difference in the overall number of participants analyzed is due to participants not having the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ) data collected n either baseline and/or 6 months period.
Dyspnea will be assessed using the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ). The SDSOBQ scoring will range from 0 to 120 (with higher scores indicating greater difficulty breathing).
Outcome measures
| Measure |
Active Treatment
n=48 Participants
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=51 Participants
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Change in Dyspnea as Assessed by the University of California San Diego Shortness of Breath Questionnaire (SDSOBQ)
|
-4.8 score on a scale
Interval -9.3 to -0.3
|
1.3 score on a scale
Interval -3.0 to 5.7
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The difference in the overall number of participants analyzed is due to participants not having the COPD assessment test (CAT) data collected in either baseline and/or 6 months period.
Change in COPD health status will be assessed by the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control.
Outcome measures
| Measure |
Active Treatment
n=48 Participants
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=51 Participants
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Change in COPD Health Status Will be Assessed by the COPD Assessment Test (CAT)
|
-1.8 score on a scale
Interval -3.2 to -0.4
|
1.0 score on a scale
Interval -0.3 to 2.4
|
SECONDARY outcome
Timeframe: Change from baseline and 6 months post-randomizationPopulation: The difference in the overall number of participants analyzed is due to participants not having the modified Medical Research Council questionnaire (mMRC) data collected in either baseline and/or 6 months period.
Dyspnea (breathlessness) assessed by the modified Medical Research Council questionnaire (mMRC). Mean Score range is 0-4. Higher scores indicate worse COPD control.
Outcome measures
| Measure |
Active Treatment
n=48 Participants
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=51 Participants
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Change in Dyspnea (Breathlessness) as Assessed by the Modified Medical Research Council Questionnaire (mMRC)
|
-0.3 score on a scale
Interval -0.6 to -0.03
|
0.1 score on a scale
Interval -0.1 to 0.4
|
SECONDARY outcome
Timeframe: From Baseline to 6 monthsPopulation: The difference in the overall number of participants analyzed is due to participants not completing (data not collected) the exacerbation survey between baseline and 6 months
Questionnaire administered to collect participant's self report of Health Care Utilization (HCU) episodes due to COPD-related exacerbation (including need for oral corticosteroids or antibiotics for worsening respiratory symptoms, emergency department (ED) visit or hospitalization). This questionnaire will be administered at baseline and during the 6 months of follow-up. The HCU number could range from 0 (zero/no episode reported) to 1 (1 or more episodes reported) during the 6 months follow-up.
Outcome measures
| Measure |
Active Treatment
n=53 Participants
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=51 Participants
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Difference in the Proportion (Probability) of Health Care Utilization Due to COPD-related Exacerbations
Severe Exacerbations
|
0.11 Proportion of events
Interval 0.03 to 0.18
|
0.09 Proportion of events
Interval 0.01 to 0.16
|
|
Difference in the Proportion (Probability) of Health Care Utilization Due to COPD-related Exacerbations
Moderate Exacerbations
|
0.07 Proportion of events
Interval 0.004 to 0.14
|
0.19 Proportion of events
Interval 0.08 to 0.29
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The difference in the overall number of participants analyzed is due to participants not having FEV1 data collected in either baseline and/or 6 months period.
Pulmonary function testing will be assessed as FEV1% predicted, that is FEV1, adjusted for age, height, race and sex
Outcome measures
| Measure |
Active Treatment
n=38 Participants
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=45 Participants
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Lung Function as Assessed by the Post Forced Expiratory Volume in 1 Second (FEV1%) Predicted
|
-1.2 FEV1 percent predicted
Interval -3.7 to 1.2
|
-0.8 FEV1 percent predicted
Interval -3.0 to 1.4
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The difference in the overall number of participants analyzed is due to participants not having the Clinical COPD Questionnaire (CCQ) data collected in either baseline and/or 6 months period.
The Clinical COPD Questionnaire (CCQ) will be administered to evaluate health status in patients with COPD. The CCQ is a 10-item questionnaire, health-related quality of life questionnaire (HRQoL) with good psychometric properties. The total score ranges from 0 to 6, where a higher scores indicates a worse health status.
Outcome measures
| Measure |
Active Treatment
n=47 Participants
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=51 Participants
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Change in the Clinical COPD Questionnaire (CCQ)
|
-0.2 score on a scale
Interval -0.5 to -0.003
|
-0.8 score on a scale
Interval -3.0 to 1.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 monthsChange in systemic markers of inflammation in serum (Interleukin-8) will be measured by Interleukin-8 concentration in serum (units/mg).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 monthsChange in Systemic markers of inflammation in serum (C-reactive protein) will be measured by C-reactive protein concentration in serum and it will be expressed in: mg/l
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 monthsChange in Markers of oxidative stress in urine (8-isoprostane) will be measured by 8-isoprostane concentration in urine (pg/ml).
Outcome measures
Outcome data not reported
Adverse Events
Active Treatment
Serious events: 4 serious events
Other events: 3 other events
Deaths: 2 deaths
Control Arm
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Active Treatment
n=59 participants at risk
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=61 participants at risk
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.7%
1/59 • From randomization up to 6 months
|
0.00%
0/61 • From randomization up to 6 months
|
|
Gastrointestinal disorders
Gastric Mass
|
1.7%
1/59 • From randomization up to 6 months
|
0.00%
0/61 • From randomization up to 6 months
|
|
Metabolism and nutrition disorders
Syncope (Hypotension and dehydration)
|
1.7%
1/59 • From randomization up to 6 months
|
0.00%
0/61 • From randomization up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/59 • From randomization up to 6 months
|
1.6%
1/61 • From randomization up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Influenza (Hospitalized)
|
0.00%
0/59 • From randomization up to 6 months
|
1.6%
1/61 • From randomization up to 6 months
|
|
Surgical and medical procedures
Knee Scope Surgery
|
0.00%
0/59 • From randomization up to 6 months
|
1.6%
1/61 • From randomization up to 6 months
|
|
Renal and urinary disorders
Acute Kidney Injury (AKI)
|
1.7%
1/59 • From randomization up to 6 months
|
0.00%
0/61 • From randomization up to 6 months
|
Other adverse events
| Measure |
Active Treatment
n=59 participants at risk
The active treatment arm will receive two portable active HEPA air cleaners as well as 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
Active HEPA Air Cleaner: The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
Motivational interviewing: The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
The Control arm will receive only continued counseling for smoking cessation.
|
Control Arm
n=61 participants at risk
Homes in the control group will receive Sham air cleaners that have the internal HEPA filter removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status. The control arm will not receive phone based motivational interviewing to support a home smoking ban and SHS reduction, they will receive only smoking cessation counseling.
Sham Air Cleaner: The Control arm will receive sham air cleaners
|
|---|---|---|
|
Cardiac disorders
Hypertension (Elevated high blood pressure)
|
1.7%
1/59 • From randomization up to 6 months
|
0.00%
0/61 • From randomization up to 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/59 • From randomization up to 6 months
|
0.00%
0/61 • From randomization up to 6 months
|
|
Injury, poisoning and procedural complications
Adverse Reaction (Palpitations/jitters) to the Nicotine Replacement Therapy (Gum)
|
1.7%
1/59 • From randomization up to 6 months
|
0.00%
0/61 • From randomization up to 6 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/59 • From randomization up to 6 months
|
1.6%
1/61 • From randomization up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place