Trial Outcomes & Findings for Assessing Open Access Audio (NCT NCT04452331)

NCT ID: NCT04452331

Last Updated: 2025-04-03

Results Overview

This outcome tests the hypothesis that blood pressure control improves in patients with blood pressure \> 140/90 when they have access to an audio recording of their visit with their provider regarding blood pressure management compared to those who do not. An improvement in blood pressure is defined as a reduction of 10 or more mmHg in either the systolic or diastolic blood pressure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1553 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-04-03

Participant Flow

Although providers are also engaged as part of the intervention, all trial enrollment, randomization, assignment, and analysis is by patient visit. It is only the patient's assignment that affects which study arm a visit with a provider falls into. Accordingly, providers are not considered "participants enrolled" for purposes of study result reporting.

Participant milestones

Measure	OAA Intervention Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Unaware Control Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit No Access, Provider Unaware of Recording: Patient does not obtain access to audio recording and provider is unaware visit is being recorded.
Overall Study STARTED	691	694	168
Overall Study COMPLETED	691	694	168
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing Open Access Audio

Baseline characteristics by cohort

Measure	OAA Intervention n=691 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Unaware Control n=168 Participants Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit No Access, Provider Unaware of Recording: Patient does not obtain access to audio recording and provider is unaware visit is being recorded.	Total n=1553 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 10.8 • n=5 Participants	61.9 years STANDARD_DEVIATION 11.6 • n=7 Participants	61.3 years STANDARD_DEVIATION 10.8 • n=5 Participants	62.2 years STANDARD_DEVIATION 11.2 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	35 Participants n=7 Participants	3 Participants n=5 Participants	72 Participants n=4 Participants
Sex: Female, Male Male	657 Participants n=5 Participants	659 Participants n=7 Participants	165 Participants n=5 Participants	1481 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	27 Participants n=7 Participants	7 Participants n=5 Participants	59 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	639 Participants n=5 Participants	649 Participants n=7 Participants	158 Participants n=5 Participants	1446 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	18 Participants n=7 Participants	3 Participants n=5 Participants	48 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) Black or African American	517 Participants n=5 Participants	504 Participants n=7 Participants	132 Participants n=5 Participants	1153 Participants n=4 Participants
Race (NIH/OMB) White	140 Participants n=5 Participants	151 Participants n=7 Participants	24 Participants n=5 Participants	315 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	22 Participants n=7 Participants	8 Participants n=5 Participants	55 Participants n=4 Participants
Clinical setting Diabetes clinic	146 Participants n=5 Participants	146 Participants n=7 Participants	0 Participants n=5 Participants	292 Participants n=4 Participants
Clinical setting Primary care clinic	545 Participants n=5 Participants	548 Participants n=7 Participants	168 Participants n=5 Participants	1261 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

This outcome tests the hypothesis that blood pressure control improves in patients with blood pressure > 140/90 when they have access to an audio recording of their visit with their provider regarding blood pressure management compared to those who do not. An improvement in blood pressure is defined as a reduction of 10 or more mmHg in either the systolic or diastolic blood pressure.

Outcome measures

Measure	OAA Intervention n=691 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Blood Pressure Systolic	131.6 mmHg Interval 129.9 to 133.3	131.8 mmHg Interval 130.1 to 133.5	—
Blood Pressure Diastolic	78.2 mmHg Interval 77.3 to 79.2	79.5 mmHg Interval 78.6 to 80.5	—

PRIMARY outcome

Timeframe: 4-6 months

This outcome tests the hypothesis that HgB A1c improves in patients with Hgb A1c > 7 when they have access to an audio recording of their discussion with their provider regarding diabetes management compared to when they do no. An improvement is defined as a decrease of 1% or more.

Outcome measures

Measure	OAA Intervention n=691 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Glycosylated Hemoglobin (HgB A1c)	6.95 percent Interval 6.79 to 7.12	6.83 percent Interval 6.66 to 7.0	—

PRIMARY outcome

Timeframe: From index visit to end of study data collection, an average of 512 days

This outcome tests the hypothesis that return visit adherence (RVA) improves in patients with non-adherence when they have access to an audio recording of their discussion with their provider. The outcome is the predicted proportion of visits scheduled between the time of the index visit and the end of the study that the patient attends (adjusted for clinic). For example, a value of 0.73 means that, adjusted for clinic, a patient in the given arm attends 73% of visits scheduled between their index visit and the study end date.

Outcome measures

Measure	OAA Intervention n=12704 scheduled visits Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=12685 scheduled visits Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Return Visit Adherence (RVA)	0.733 Proportion of future visits attended Interval 0.72 to 0.75	0.732 Proportion of future visits attended Interval 0.72 to 0.75	—

PRIMARY outcome

Timeframe: 6 months

This outcome tests the hypothesis that prescription adherence improves in patients when they have access to an audio recording of their discussion with their provider compared to when they do not. Adherence is defined as having at least 80% proportion days covered (PDF). PDC is the total number of days covered by refills in a measurement period divided by the number of days between the first fill and the end of the measurement period. Non-adherence is defined as a PDC<80% during the 6 months prior to the audio recorded visit. The outcome is the probability that a patient's PDC is at least 80% following their participation, adjusted for clinic.

Outcome measures

Measure	OAA Intervention n=691 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Prescription Refill Rate (Probability That Proportion Days Covered >= 80%)	0.05 Probability of >=80% PDC Interval 0.04 to 0.06	0.04 Probability of >=80% PDC Interval 0.03 to 0.05	—

PRIMARY outcome

Timeframe: 2 weeks

Population: Random samples from arms 1 and 2

This outcome tests the hypothesis that patient activation is higher in patients when they have access to an audio recording of their visit with their provider compared to when they do not. Patients are called by phone post visit to answer PAM 10, a 10 item questionnaire with a 5 point Likert response that scores their perceived knowledge, skills, and confident in their capacity to follow their treatment plan with scores from 0-100. A higher score indicates higher patient activation.

Outcome measures

Measure	OAA Intervention n=295 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=301 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Patient Activation Measure (PAM)	9.44 score on a scale Interval 9.26 to 9.62	9.54 score on a scale Interval 9.37 to 9.71	—

PRIMARY outcome

Timeframe: Recorded visit

Population: Arm 2 random subsample compared with Arm 3, excluding visits with no recordings due to recorder failure.

This outcome tests the hypothesis that physicians communicate more effectively when they are aware the visit is being recorded for the patient to when they are not. Communication behavior will be rated off the audio recording by a research assistant utilizing the SEGUE checklist. Outcome measure is total proportion achieved score on 32 item SEGUE instrument, ranging from 0 to 1 with a higher score indicating more effective communication.

Outcome measures

Measure	OAA Intervention n=158 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=158 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
SEGUE Framework for Evaluating and Scoring Communication Behavior.	0.85 score on a scale Interval 0.83 to 0.87	0.82 score on a scale Interval 0.8 to 0.83	—

PRIMARY outcome

Timeframe: Recorded visit

Population: Arm 2 random subsample vs. Arm 3, excluding visits with recorder failure or on phone

This outcome tests the hypothesis that physicians are more likely to contextualize the care plan when they are aware the visit is being recorded for the patient to when they are not. Contextualization of care will be rated off of the audio recording by a research assistant trained in Content Coding for Contextualization of Care (4C Coding), which determines each contextual red flag audible during the visit, whether the physician probed each red flag, each contextual factor identified by physician probe, and whether the physician addressed the contextual factor in the care plan. Outcome measure is the predicted probability of an encounter in which the care plan was contextualized (either the physician found no contextual factors present after investigating red flags, or physician found a contextual factor(s) and incorporated them into the plan), adjusted for clinic.

Outcome measures

Measure	OAA Intervention n=158 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=160 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Contextualization of Care	0.51 Predicted probability of contextual plan Interval 0.45 to 0.56	0.41 Predicted probability of contextual plan Interval 0.35 to 0.47	—

SECONDARY outcome

Timeframe: 6 months

This outcome tests the hypothesis that emergency department visit rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of ED visits made by the patient in the 6 months following the audio recorded visit, adjusted for clinic.

Outcome measures

Measure	OAA Intervention n=691 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Emergency Department Utilization	1.03 ED visits Interval 0.88 to 1.19	0.96 ED visits Interval 0.83 to 1.12	—

SECONDARY outcome

Timeframe: 6 months

This outcome tests the hypothesis that inpatient admission rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of inpatient hospital admissions of the patient (of any duration) during the 6 month period following the audio recorded visit.

Outcome measures

Measure	OAA Intervention n=691 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Hospital Admission Rate	0.26 Hospital admissions Interval 0.21 to 0.33	0.28 Hospital admissions Interval 0.22 to 0.35	—

SECONDARY outcome

Timeframe: Six month

Comparison of HgA1c among Arm 1 patients who did and did not access their visit recording

Outcome measures

Measure	OAA Intervention n=153 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=520 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Glycated Hemoglobin (Access vs. Non-access)	6.53 percent Interval 6.2 to 6.85	6.95 percent Interval 6.78 to 7.12	6.73 percent Interval 6.58 to 6.88

SECONDARY outcome

Timeframe: Six month

Comparison of ED visit rate among Arm 1 patients who did and did not access their visit recording. The ED visit rate is the number of emergency department visits in the 6 months following the patient's recorded visit, adjusted for clinic.

Outcome measures

Measure	OAA Intervention n=153 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=520 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
ED Visit Rate (Access vs. Non-access)	0.69 ED visits Interval 0.57 to 0.84	1.05 ED visits Interval 0.97 to 1.14	0.93 ED visits Interval 0.86 to 1.0

SECONDARY outcome

Timeframe: From recorded visit to study end date, an average of 512 days

Population: Patients in OAA intervention arm (accessed and not access) exclude 11 patients who did not have the opportunity to access a recording due to recorder failure.

Comparison of RVA among Arm 1 patients who did and did not access their visit recording. The outcome is the predicted proportion of visits scheduled between the time of the index visit and the end of the study that the patient attends (adjusted for clinic). For example, a value of 0.73 means that, adjusted for clinic, a patient in the given arm attends 73% of visits scheduled between their index visit and the study end date.

Outcome measures

Measure	OAA Intervention n=153 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=527 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Return Visit Attendance (Access vs. Non-access)	0.78 Proportion of return visits attended Interval 0.75 to 0.82	0.71 Proportion of return visits attended Interval 0.7 to 0.73	0.73 Proportion of return visits attended Interval 0.72 to 0.75

SECONDARY outcome

Timeframe: 6 months

Comparison of probability of prescription refill adherence (PDC>=80%) among Arm 1 patients who did and did not access their visit recording. Adherence is defined as having at least 80% proportion days covered (PDF). PDC is the total number of days covered by refills in a measurement period divided by the number of days between the first fill and the end of the measurement period. Non-adherence is defined as a PDC<80% during the 6 months prior to the audio recorded visit. The outcome is the probability that a patient's PDC is at least 80% following their participation, adjusted for clinic.

Outcome measures

Measure	OAA Intervention n=153 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=520 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Probability That Proportion of Days Covered by Prescription >= 80% (Access vs. Non-access)	0.09 Probability of at least 80% PDC Interval 0.06 to 0.13	0.04 Probability of at least 80% PDC Interval 0.03 to 0.05	0.05 Probability of at least 80% PDC Interval 0.03 to 0.05

SECONDARY outcome

Timeframe: Six month

Comparison of blood pressure among Arm 1 patients who did and did not access their visit recording

Outcome measures

Measure	OAA Intervention n=153 Participants Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.	OAA Physician Aware Control n=520 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.	OAA Physician Aware Control n=694 Participants Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
Blood Pressure (Access vs. Non-access) Diastolic	78.0 mmHg Interval 76.3 to 79.6	79.5 mmHg Interval 78.6 to 80.4	80.5 mmHg Interval 79.7 to 81.3
Blood Pressure (Access vs. Non-access) Systolic	130.7 mmHg Interval 127.8 to 133.7	133.0 mmHg Interval 131.3 to 134.6	132.7 mmHg Interval 131.3 to 134.1

Adverse Events

OAA Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OAA Physician Aware Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OAA Physician Unaware Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alan Schwartz

University of Illinois Chicago

Phone: 3129962070

Email: alansz@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place