Trial Outcomes & Findings for Musical Intervention and Physiological Stress and Inflammatory Biomarkers in Mechanically Ventilated ICU Patients (NCT NCT06120660)
NCT ID: NCT06120660
Last Updated: 2026-03-25
Results Overview
Serum cortisol levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the music intervention or standard care using standard laboratory assays. This measure reflects the acute physiological stress response.
COMPLETED
NA
110 participants
Only one intervention per person will be performed. Serum levels will be measured before and after the intervention (minute 0 and 60).
2026-03-25
Participant Flow
Patients were consecutively recruited between October 1, 2023, and June 28, 2025, in the intensive care unit of a tertiary-level public university hospital in Spain. Eligible participants were identified daily by the research team through review of ICU admissions and clinical records. Legal representatives were approached for informed consent once eligibility criteria were confirmed.
No significant events occurred between enrollment and randomization. All enrolled participants met eligibility criteria at the time of enrollment and were randomly assigned to the intervention or control group without exclusions or withdrawals prior to group assignment.
Participant milestones
| Measure |
Music Intervention
Participants received a single 60-minute session of a standardized musical composition delivered through active noise-cancelling headphones while undergoing invasive mechanical ventilation under deep sedation. The intervention was administered once, between 16:00 and 17:00, in addition to standard ICU care.
|
Standard Care (Control)
Participants received standard intensive care unit management without any auditory intervention. No headphones or music were used, and patients remained exposed to the usual acoustic environment of the ICU during the observation period.
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|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Music Intervention
n=55 Participants
Adult ICU patients (≥18 years) receiving invasive mechanical ventilation under deep sedation (BIS 40-60), randomly assigned to receive a single 60-minute standardized music intervention through active noise-cancelling headphones. Patients were continuously monitored for hemodynamic, respiratory, and neurological parameters. No changes to standard sedation or care were made other than the music intervention.
|
Standard Care (Control)
n=55 Participants
Adult ICU patients (≥18 years) receiving invasive mechanical ventilation under deep sedation (BIS 40-60), randomly assigned to standard ICU care without music intervention. Continuous monitoring of hemodynamic, respiratory, and neurological parameters was maintained. Sedation protocols were unchanged, and patients were exposed to the typical ICU acoustic environment. No additional interventions were applied.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.33 Years
STANDARD_DEVIATION 12.92 • n=55 Participants
|
65.05 Years
STANDARD_DEVIATION 10.38 • n=55 Participants
|
63.69 Years
STANDARD_DEVIATION 11.74 • n=110 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=55 Participants
|
19 Participants
n=55 Participants
|
36 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=55 Participants
|
36 Participants
n=55 Participants
|
74 Participants
n=110 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
55 Participants
n=55 Participants
|
55 Participants
n=55 Participants
|
110 Participants
n=110 Participants
|
|
APACHE II Score
|
20.7 Points on a scale
STANDARD_DEVIATION 6.29 • n=55 Participants
|
21.2 Points on a scale
STANDARD_DEVIATION 7.65 • n=55 Participants
|
20.99 Points on a scale
STANDARD_DEVIATION 6.97 • n=110 Participants
|
|
Days on IMV
|
4.18 Days
STANDARD_DEVIATION 4.80 • n=55 Participants
|
3.55 Days
STANDARD_DEVIATION 3.44 • n=55 Participants
|
4.09 Days
STANDARD_DEVIATION 3.30 • n=110 Participants
|
|
Reason for ICU Admission
Neurological
|
20 Participants
n=55 Participants
|
25 Participants
n=55 Participants
|
45 Participants
n=110 Participants
|
|
Reason for ICU Admission
Respiratory
|
15 Participants
n=55 Participants
|
14 Participants
n=55 Participants
|
29 Participants
n=110 Participants
|
|
Reason for ICU Admission
Trauma
|
10 Participants
n=55 Participants
|
9 Participants
n=55 Participants
|
19 Participants
n=110 Participants
|
|
Reason for ICU Admission
Other
|
10 Participants
n=55 Participants
|
7 Participants
n=55 Participants
|
17 Participants
n=110 Participants
|
|
Ventilatory Mode
Volume assist-control
|
43 Participants
n=55 Participants
|
41 Participants
n=55 Participants
|
84 Participants
n=110 Participants
|
|
Ventilatory Mode
Pressure support
|
11 Participants
n=55 Participants
|
14 Participants
n=55 Participants
|
25 Participants
n=110 Participants
|
|
Ventilatory Mode
Pressure assist-control
|
1 Participants
n=55 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=110 Participants
|
PRIMARY outcome
Timeframe: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention (minute 0 and 60).Population: All enrolled participants were included in the analysis for serum cortisol. No participants were excluded.
Serum cortisol levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the music intervention or standard care using standard laboratory assays. This measure reflects the acute physiological stress response.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Levels of Serum Cortisol
Baseline (minute 0)
|
13.13 µg/dL
Standard Deviation 8.47
|
15.93 µg/dL
Standard Deviation 7.76
|
|
Levels of Serum Cortisol
Post-intervention (minute 60)
|
11.56 µg/dL
Standard Deviation 7.69
|
16.07 µg/dL
Standard Deviation 6.79
|
PRIMARY outcome
Timeframe: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.Population: All enrolled participants were included in the analysis for serum prolactin. No participants were excluded.
Serum prolactin levels were measured from venous blood samples obtained immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. This biomarker reflects neuroendocrine stress response and can indicate changes related to the music intervention.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Levels of Prolactin
Baseline (minute 0)
|
46.18 ng/mL
Standard Deviation 72.70
|
45.74 ng/mL
Standard Deviation 60.31
|
|
Levels of Prolactin
Post-intervention (minute 60)
|
45.20 ng/mL
Standard Deviation 73.88
|
46.36 ng/mL
Standard Deviation 61.26
|
PRIMARY outcome
Timeframe: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.Population: All enrolled participants were included in the analysis for serum interleukin-6. No participants were excluded.
Serum interleukin-6 (IL-6) levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. IL-6 is a pro-inflammatory cytokine and its serum concentration reflects acute systemic inflammatory activity.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Levels of Interleukin 6
Post-intervention (minute 60)
|
150.30 pg/mL
Standard Deviation 223.99
|
111.66 pg/mL
Standard Deviation 104.65
|
|
Levels of Interleukin 6
Baseline (minute 0)
|
148.76 pg/mL
Standard Deviation 229.16
|
110.60 pg/mL
Standard Deviation 105.20
|
SECONDARY outcome
Timeframe: BIS values will be measured immediately before and after the intervention (minute 0 and 60).Population: All enrolled participants were included in the analysis for BIS. No participants were excluded.
The Bispectral Index (BIS) is a processed electroencephalographic scale used to quantify the depth of sedation or anesthesia. BIS values range from 0 to 100, where 100 represents a fully awake state and 0 represents EEG silence. Lower scores indicate deeper sedation, while higher scores indicate lighter sedation. BIS values were obtained using standard BIS monitoring immediately before (minute 0) and after the intervention (minute 60). No subscales exist; the BIS value is a single composite index.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Bispectral Index (BIS)
Baseline (minute 0)
|
50.07 BIS units
Standard Deviation 8.30
|
51.94 BIS units
Standard Deviation 8.89
|
|
Bispectral Index (BIS)
Post-intervention (minute 60)
|
49.30 BIS units
Standard Deviation 8.64
|
52.83 BIS units
Standard Deviation 8.89
|
SECONDARY outcome
Timeframe: Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.Population: All enrolled participants were included in the analysis for systolic blood pressure. No participants were excluded.
Systolic blood pressure was obtained using standard ICU monitoring before (minute 0) and after (minute 60) the intervention. This measure reflects hemodynamic response to the music intervention or standard care.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Systolic Blood Pressure
Baseline (minute 0)
|
130.38 mmHg
Standard Deviation 17.82
|
134.89 mmHg
Standard Deviation 22.71
|
|
Systolic Blood Pressure
Post-intervention (minute 60)
|
127.62 mmHg
Standard Deviation 20.74
|
132.36 mmHg
Standard Deviation 21.42
|
SECONDARY outcome
Timeframe: Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.Population: All enrolled participants were included in the analysis for diastolic blood pressure. No participants were excluded.
Diastolic blood pressure was obtained using standard ICU monitoring before (minute 0) and after (minute 60) the intervention. This measure reflects autonomic and vascular response to the music intervention or standard care.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Diastolic Blood Pressure
Baseline (minute 0)
|
64.10 mmHg
Standard Deviation 11.59
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63.07 mmHg
Standard Deviation 12.54
|
|
Diastolic Blood Pressure
Post-intervention (minute 60)
|
63.16 mmHg
Standard Deviation 11.03
|
61.60 mmHg
Standard Deviation 10.32
|
SECONDARY outcome
Timeframe: Heart rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.Population: All enrolled participants were included in the analysis for heart rate. No participants were excluded.
Heart rate was obtained using standard ICU monitoring before (minute 0) and after (minute 60) the intervention. Heart rate reflects autonomic and physiological stress response to the music intervention or standard care.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Heart Rate
Baseline (minute 0)
|
75.07 bpm
Standard Deviation 20.98
|
76.89 bpm
Standard Deviation 16.84
|
|
Heart Rate
Post-intervention (minute 60)
|
76.52 bpm
Standard Deviation 19.88
|
76.40 bpm
Standard Deviation 15.65
|
SECONDARY outcome
Timeframe: Respiratory rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.Population: All enrolled participants were included in the analysis for respiratory rate. No participants were excluded.
Respiratory rate was obtained using standard ICU respiratory monitoring before (minute 0) and after (minute 60) the intervention. Respiratory rate reflects ventilatory response to the music intervention or standard care.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Respiratory Rate
Post-intervention (minute 60)
|
18.12 breaths/min
Standard Deviation 3.86
|
18.94 breaths/min
Standard Deviation 4.04
|
|
Respiratory Rate
Baseline (minute 0)
|
17.96 breaths/min
Standard Deviation 3.98
|
19.25 breaths/min
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: Oxygen saturation was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.Population: All enrolled participants were included in the analysis for oxygen saturation. No participants were excluded.
Oxygen saturation (SpO₂) was obtained using standard ICU pulse oximetry before (minute 0) and after (minute 60) the intervention. This measure reflects oxygenation status and respiratory response to the music intervention or standard care.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Oxygen Saturation
Baseline (minute 0)
|
98.49 percentage
Standard Deviation 1.87
|
98.03 percentage
Standard Deviation 2.12
|
|
Oxygen Saturation
Post-intervention (minute 60)
|
98.51 percentage
Standard Deviation 1.70
|
98.02 percentage
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Intracranial pressure was measured before (minute 0) and after (minute 60) the intervention in patients with an invasive ICP monitor.Population: Only participants with invasive intracranial pressure monitors were included in this analysis (19 in the music group and 11 in the control group). No other participants had available ICP data.
Intracranial pressure (ICP) was obtained from invasive intraparenchymal or ventricular monitoring devices in patients who had such monitors in place. Measurements were taken at baseline (minute 0) and post-intervention (minute 60). ICP reflects cerebral compliance and intracranial dynamics.
Outcome measures
| Measure |
Music Intervention
n=19 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=11 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Intracranial Pressure
Baseline (minute 0)
|
9.84 mmHg
Standard Deviation 3.35
|
7.00 mmHg
Standard Deviation 5.86
|
|
Intracranial Pressure
Post-intervention (minute 60)
|
9.00 mmHg
Standard Deviation 3.32
|
9.60 mmHg
Standard Deviation 7.30
|
SECONDARY outcome
Timeframe: Sedative medication infusion rates were measured at baseline (minute 0) and after the intervention (minute 60).Population: Only participants who were receiving a given medication at baseline or post-intervention were included in each drug-specific row. Therefore, the number of analyzed participants differs across drugs and time points.
This outcome includes multiple sedative, analgesic, and neuromuscular-blocking agents used in the ICU. Each drug is reported using its appropriate clinical unit (e.g., mg/kg/h for intravenous medications and ml/h for inhaled anesthetics such as sevoflurane). Mean and standard deviation are presented separately for the music intervention group and the control group at baseline and post-intervention. Each drug appears as an independent row, and units do not mix within rows.
Outcome measures
| Measure |
Music Intervention
n=55 Participants
Patients in the intervention group received a single 60-minute session of standardized music therapy delivered via active noise-cancelling headphones while under invasive mechanical ventilation and deep sedation (BIS 40-60). Hemodynamic, respiratory, and neurological parameters were continuously monitored during the session. Serum cortisol, prolactin, and interleukin 6 levels were measured before and after the intervention.
|
Standard Care (Control)
n=55 Participants
Patients in the control group received standard ICU care without any auditory or music intervention. They remained sedated under invasive mechanical ventilation with hemodynamic, respiratory, and neurological parameters continuously monitored. Serum cortisol, prolactin, and interleukin 6 levels were measured at the same time points as the intervention group.
|
|---|---|---|
|
Sedation Medication Use
Dexmedetomidine - Baseline (mg/kg/h)
|
0.002 mg/kg/h
Standard Deviation 0.001
|
0.001 mg/kg/h
Standard Deviation 0.000
|
|
Sedation Medication Use
Dexmedetomidine - Post (mg/kg/h)
|
0.002 mg/kg/h
Standard Deviation 0.001
|
0.001 mg/kg/h
Standard Deviation 0.000
|
|
Sedation Medication Use
Fentanyl - Baseline (mg/kg/h)
|
0.495 mg/kg/h
Standard Deviation 0.201
|
0.518 mg/kg/h
Standard Deviation 0.209
|
|
Sedation Medication Use
Fentanyl - Post (mg/kg/h)
|
0.495 mg/kg/h
Standard Deviation 0.201
|
0.518 mg/kg/h
Standard Deviation 0.209
|
|
Sedation Medication Use
Midazolam - Baseline (mg/kg/h)
|
0.107 mg/kg/h
Standard Deviation 0.049
|
0.100 mg/kg/h
Standard Deviation 0.058
|
|
Sedation Medication Use
Midazolam - Post (mg/kg/h)
|
0.107 mg/kg/h
Standard Deviation 0.097
|
0.049 mg/kg/h
Standard Deviation 0.058
|
|
Sedation Medication Use
Propofol - Baseline (mg/kg/h)
|
1.717 mg/kg/h
Standard Deviation 1.388
|
1.752 mg/kg/h
Standard Deviation 1.211
|
|
Sedation Medication Use
Propofol - Post (mg/kg/h)
|
1.489 mg/kg/h
Standard Deviation 1.170
|
1.726 mg/kg/h
Standard Deviation 1.070
|
|
Sedation Medication Use
Remifentanil - Baseline (mg/kg/h)
|
0.005 mg/kg/h
Standard Deviation 0.002
|
0.006 mg/kg/h
Standard Deviation 0.003
|
|
Sedation Medication Use
Remifentanil - Post (mg/kg/h)
|
0.005 mg/kg/h
Standard Deviation 0.002
|
0.005 mg/kg/h
Standard Deviation 0.002
|
|
Sedation Medication Use
Cisatracurium - Baseline (mg/kg/h)
|
0.210 mg/kg/h
Standard Deviation 0.062
|
0.156 mg/kg/h
Standard Deviation 0.016
|
|
Sedation Medication Use
Cisatracurium - Post (mg/kg/h)
|
0.210 mg/kg/h
Standard Deviation 0.062
|
0.156 mg/kg/h
Standard Deviation 0.016
|
Adverse Events
Music Intervention
Standard Care (Control)
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