Trial Outcomes & Findings for Prehospital Telemedicine Feasibility/Acceptability Pilot (NCT NCT05967624)
NCT ID: NCT05967624
Last Updated: 2026-02-19
Results Overview
Each subject will be remotely assessed by a Medical Control Physician using the HIPAA-compliant Zoom Pro web application pre-loaded on a tablet device. The remote medical control physician and the transport team member at the patient bedside in the ambulance will score the Respiratory Observation Checklist simultaneously. The range for agreement is 0 to 1.0, where 0=no agreement and 1 is perfect agreement. The following scale: 0.01-0.20=none to slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial, 0.81-1.0=almost perfect agreement will be used.
COMPLETED
NA
20 participants
During transport to the hospital via ambulance, up to 4 hours
2026-02-19
Participant Flow
Participant milestones
| Measure |
Teleconsultation Group
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prehospital Telemedicine Feasibility/Acceptability Pilot
Baseline characteristics by cohort
| Measure |
Teleconsultation Group
n=20 Participants
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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|---|---|
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Age, Continuous
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0.9 years
n=4 Participants
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Sex: Female, Male
Female
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7 Participants
n=4 Participants
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Sex: Female, Male
Male
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13 Participants
n=4 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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5 Participants
n=4 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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15 Participants
n=4 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=4 Participants
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Race/Ethnicity, Customized
White
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15 Participants
n=4 Participants
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Race/Ethnicity, Customized
Black or African American
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1 Participants
n=4 Participants
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Race/Ethnicity, Customized
Asian
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1 Participants
n=4 Participants
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Race/Ethnicity, Customized
Unknown or Not Reported
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3 Participants
n=4 Participants
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Region of Enrollment
United States
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20 Participants
n=4 Participants
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PRIMARY outcome
Timeframe: During transport to the hospital via ambulance, up to 4 hoursPopulation: Two calls did not connect so the overall number analyzed is 18.
Each subject will be remotely assessed by a Medical Control Physician using the HIPAA-compliant Zoom Pro web application pre-loaded on a tablet device. The remote medical control physician and the transport team member at the patient bedside in the ambulance will score the Respiratory Observation Checklist simultaneously. The range for agreement is 0 to 1.0, where 0=no agreement and 1 is perfect agreement. The following scale: 0.01-0.20=none to slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial, 0.81-1.0=almost perfect agreement will be used.
Outcome measures
| Measure |
Teleconsultation Group
n=18 Participants
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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Agreement in Assessment of Respiratory Distress
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0.83 proportion agreement
Interval 0.58 to 0.96
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SECONDARY outcome
Timeframe: Immediately after the transport was completed, up to 48 hoursPopulation: There were 3 transport nurses and 2 physicians and the scores represent an average of the 20 ambulance encounters.
The total usability score is measured by the Telehealth Usability Questionnaire (TUQ), a 21-item questionnaire which is a validated measure of all the key usability characteristics of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). Users \[transport nurses and physicians\] rate items on 7-point Likert-scales (1=disagree to 7=agree) in 6 separate domains (usefulness, ease of use and learnability, interface quality, interaction quality, reliability, satisfaction and future use). The investigators modified this questionnaire to specifically address the usability of the study telemedicine platform. The range of the total usability score is 1-7. Low scores reflect a worse outcome, while high scores are a better outcome.
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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Total Usability Score
Nurses
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6 score on a scale
Standard Deviation 0.9
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Total Usability Score
Physicians
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5.7 score on a scale
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: Immediately after the transport was completed, up to 48 hoursPopulation: There were 3 transport nurses and 2 physicians and the scores represent an average of the 20 ambulance encounters.
This will be measured by TUQ items #11 and #14 within the "Interaction Quality" domain. Users \[transport nurses and physicians\] will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and standard deviation (SD) for each item will be reported. Higher scores suggest higher quality.
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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Video Quality
Nurses- "I could easily talk to the patient/clinician using the telemedicine system."
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6.6 units on a scale
Standard Deviation 0.8
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Video Quality
Physicians- "I could easily talk to the patient/clinician using the telemedicine system".
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6.2 units on a scale
Standard Deviation 0.8
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Video Quality
Nurses- "Using the telemedicine system, I can see the patient/clinician as if we met in person."
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6.2 units on a scale
Standard Deviation 1.3
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Video Quality
Physicians- "Using the telemedicine system, I can see the patient/clinician as if we met in person."
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3.9 units on a scale
Standard Deviation 1.3
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SECONDARY outcome
Timeframe: immediately after the transport was completed, up to 48 hoursPopulation: There were 3 transport nurses and 2 physicians and the scores represent an average of the 20 ambulance encounters.
This will be measured by TUQ items #12 and #13 within the "Interaction Quality" domain. Users \[transport nurses and physicians\] will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and SD for each item will be reported. Higher scores suggest higher quality.
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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|---|---|
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Audio Quality
Nurses- "I could hear the patient/clinician easily using the telemedicine system."
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6.3 units on a scale
Standard Deviation 1.2
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Audio Quality
Physicians- "I could hear the patient/clinician easily using the telemedicine system."
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6.2 units on a scale
Standard Deviation 0.9
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Audio Quality
Nurses- "I felt I was able to express myself effectively."
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6.9 units on a scale
Standard Deviation 0.3
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Audio Quality
Physicians- "I felt I was able to express myself effectively."
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6.1 units on a scale
Standard Deviation 0.8
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SECONDARY outcome
Timeframe: immediately after the transport was completed, up to 48 hoursThe number of attempts transport team providers make to successfully connect with the medical control physician via video-call will be recorded. Adequacy of successful video-call connection is defined as ≤2 attempts to achieve a video-call connection.
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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Adequacy of Successful Video-call Connections
Adequate (≤2 attempts)
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14 encounters
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Adequacy of Successful Video-call Connections
Inadequate (>2 attempts)
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6 encounters
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SECONDARY outcome
Timeframe: Success/failure was assessed during transport, up to 4 hoursStudy investigators will note any problems with tablet mounts in the ambulance cabin (e.g., location makes call activation difficult), as well as specific qualitative comments from participants regarding tablet mount strategy. If no problems are noted the tablet mount will be considered successful and the percentage of successful table mounts will be reported.
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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Percentage of Successful Tablet Mounts
Successful
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100 percentage of mounts
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Percentage of Successful Tablet Mounts
Not successful
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0 percentage of mounts
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SECONDARY outcome
Timeframe: during ambulance transport, up to 4 hoursThis will be measured as the proportion of video-calls where clinicians are able to observe all ten items on the Respiratory Observation Checklist. This checklist tool has been previously validated for rapid, reliable assessment of children by teleconsultants in emergency settings. Medical control physicians will score 9 observable signs and a global assessment of respiratory distress dichotomously (present/absent).
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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|---|---|
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Percentage of Calls With Adequate Video Quality for Assessment
Optimal video quality for assessment
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33.3 percentage of video quality
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Percentage of Calls With Adequate Video Quality for Assessment
Video quality not optimal for assessment
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66.7 percentage of video quality
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SECONDARY outcome
Timeframe: up to 240 minutesThis is the time interval (minutes) from when BCH receives the patient transport request from the referring facility to the time the transport team arrives at the referring facility. This will be abstracted from transport records.
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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Time to Arrival at Referring Facility
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66.0 minutes
Interval 50.0 to 78.5
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SECONDARY outcome
Timeframe: up to 240 minutesThis is the time interval (minutes) from when the BCH transport team arrives at the referring facility to when the transport team leaves the referring facility. This will be abstracted from transport records.
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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Scene Time
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51.5 minutes
Interval 42.0 to 56.0
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SECONDARY outcome
Timeframe: up to 240 minutesThis is the time interval (minutes) from when the BCH transport team leaves the referring facility to the time of arrival at BCH/BMC (the destination facility). This will be abstracted from transport records.
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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Time to Arrival at Destination Facility
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58.5 minutes
Interval 49.0 to 70.5
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SECONDARY outcome
Timeframe: up to 240 minutesThis time interval encompasses the time from when the transport team is dispatched to the referring facility to when they arrive at the destination (receiving facility). This will be abstracted from transport records.
Outcome measures
| Measure |
Teleconsultation Group
n=20 encounters
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Teleconsultation: Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
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Total Transport Time
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173.5 minutes
Interval 159.0 to 202.5
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Adverse Events
Teleconsultation Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place