Trial Outcomes & Findings for Dosage of Epidural Morphine in Elderly Patients (NCT NCT04316871)
NCT ID: NCT04316871
Last Updated: 2025-03-05
Results Overview
The mean total PCA morphine consumption (mg) in the first 72 hr. postoperatively
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
96 participants
Primary outcome timeframe
72 hours
Results posted on
2025-03-05
Participant Flow
The study was conducted at South Egypt Cancer institute and Assiut university hospitals according to Consolidated Standards of Reporting Trials (CONSORT) statement. Patients were recruited from the departments of surgical oncology between March 2020 and June 2021.
A total of 102 patients were assessed for eligibility. Three of them refused to participate in the study, and three did not meet the inclusion criteria.
Participant milestones
| Measure |
Group A (1.5 mg)
Participants were allocated to receive epidural morphine 1.5 mg group.
|
Group B (3 mg)
Participants were allocated to receive epidural morphine 3 mg group.
|
Group C (4.5mg)
Participants were allocated to receive epidural morphine 4.5 mg group.
|
Group D (0 mg)
Participants were allocated to receive epidural morphine 0 mg group.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
22
|
22
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group A (1.5 mg)
Participants were allocated to receive epidural morphine 1.5 mg group.
|
Group B (3 mg)
Participants were allocated to receive epidural morphine 3 mg group.
|
Group C (4.5mg)
Participants were allocated to receive epidural morphine 4.5 mg group.
|
Group D (0 mg)
Participants were allocated to receive epidural morphine 0 mg group.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
2
|
2
|
Baseline Characteristics
Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
Baseline characteristics by cohort
| Measure |
Group A
n=22 Participants
Participants allocated to receive 1.5 mg epidural morphine.
|
Group B
n=22 Participants
Participants allocated to receive 3 mg epidural morphine.
|
Group C
n=22 Participants
Participants allocated to receive 4.5 mg epidural morphine.
|
Group D
n=22 Participants
Participants allocated to receive 0 mg epidural morphine.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.82 Years
STANDARD_DEVIATION 7.500 • n=99 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
65.32 Years
STANDARD_DEVIATION 5.498 • n=107 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
65.27 Years
STANDARD_DEVIATION 5.373 • n=206 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
64.32 Years
STANDARD_DEVIATION 4.145 • n=7 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
65.43 Years
STANDARD_DEVIATION 5.629 • n=31 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
16 Participants
n=107 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
12 Participants
n=206 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
15 Participants
n=7 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
57 Participants
n=31 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
6 Participants
n=107 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
10 Participants
n=206 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
7 Participants
n=7 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
31 Participants
n=31 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
|
Race/Ethnicity, Customized
Egyptian Population
|
22 Participants
n=99 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
22 Participants
n=107 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
22 Participants
n=206 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
22 Participants
n=7 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
88 Participants
n=31 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
|
Region of Enrollment
Egypt
|
22 participants
n=99 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
22 participants
n=107 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
22 participants
n=206 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
22 participants
n=7 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
88 participants
n=31 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
|
Body Mass Index
|
25 kg/m^2
STANDARD_DEVIATION 3.423 • n=99 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
26.18 kg/m^2
STANDARD_DEVIATION 3.202 • n=107 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
24.59 kg/m^2
STANDARD_DEVIATION 4.148 • n=206 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
26.18 kg/m^2
STANDARD_DEVIATION 3.711 • n=7 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
25.49 kg/m^2
STANDARD_DEVIATION 3.621 • n=31 Participants • Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural.
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: Main statistical test is ANOVA\\t-test to detect the difference of PCA morphine consumption between the four groups.
The mean total PCA morphine consumption (mg) in the first 72 hr. postoperatively
Outcome measures
| Measure |
Group A
n=22 Participants
Participants allocated to receive 1.5 mg epidural morphine.
|
Group B
n=22 Participants
Participants allocated to receive 3 mg epidural morphine.
|
Group C
n=22 Participants
Participants allocated to receive 4.5 mg epidural morphine.
|
Group D
n=22 Participants
Participants allocated to receive 0 mg epidural morphine.
|
|---|---|---|---|---|
|
Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption.
|
27.182 mg
Standard Deviation 5.6115
|
9.182 mg
Standard Deviation 3.5273
|
6.273 mg
Standard Deviation 3.4307
|
38.136 mg
Standard Deviation 4.8037
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Main statistical test is ANOVA\\t-test to detect the difference of between the four groups.
Visual Analog Scale is a visual chart scored from 0 (no pain) to 10 ( the worst pain ever) used by the patient to report the severity of their pain to assess the pain intensity, and all patients were instructed how to evaluate their pain and how to use the patient-controlled analgesia.
Outcome measures
| Measure |
Group A
n=22 Participants
Participants allocated to receive 1.5 mg epidural morphine.
|
Group B
n=22 Participants
Participants allocated to receive 3 mg epidural morphine.
|
Group C
n=22 Participants
Participants allocated to receive 4.5 mg epidural morphine.
|
Group D
n=22 Participants
Participants allocated to receive 0 mg epidural morphine.
|
|---|---|---|---|---|
|
Visual Analog Scale
|
3.95 units on a scale
Standard Deviation 1.09
|
2.00 units on a scale
Standard Deviation 0.756
|
1.68 units on a scale
Standard Deviation 1.041
|
4.32 units on a scale
Standard Deviation 1.129
|
SECONDARY outcome
Timeframe: Modified Ramsay Sedation Scale at 2 hours postoperativePopulation: Main statistical test is ANOVA\\t-test to detect the difference between the four groups.
It is an six-point scale informed by degree of responsiveness to verbal and tactile stimulus where awake levels were as follows: I = anxious, agitated, or restless; II = cooperative, oriented, and tranquil; III = response to command, and asleep levels were dependent on the patient's response to a light glabellar tap or loud auditory stimulus; IV = brisk response; V = a sluggish response; and VI = no response
Outcome measures
| Measure |
Group A
n=22 Participants
Participants allocated to receive 1.5 mg epidural morphine.
|
Group B
n=22 Participants
Participants allocated to receive 3 mg epidural morphine.
|
Group C
n=22 Participants
Participants allocated to receive 4.5 mg epidural morphine.
|
Group D
n=22 Participants
Participants allocated to receive 0 mg epidural morphine.
|
|---|---|---|---|---|
|
Modified Ramsay Sedation Scale
|
1.95 score on a scale
Standard Deviation 0.375
|
2.18 score on a scale
Standard Deviation 0.395
|
3.05 score on a scale
Standard Deviation 0.375
|
1.86 score on a scale
Standard Deviation 0.468
|
SECONDARY outcome
Timeframe: 72 hoursIt is a subjective scale to assess the nauseating side effects of morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Nausea scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent; 1. if the side effect was minimal and did not require treatment; 2. if the side effect was moderate or severe and required treatment.
Outcome measures
| Measure |
Group A
n=22 Participants
Participants allocated to receive 1.5 mg epidural morphine.
|
Group B
n=22 Participants
Participants allocated to receive 3 mg epidural morphine.
|
Group C
n=22 Participants
Participants allocated to receive 4.5 mg epidural morphine.
|
Group D
n=22 Participants
Participants allocated to receive 0 mg epidural morphine.
|
|---|---|---|---|---|
|
Nausea Score
|
4.41 scores on a scale
Standard Deviation 0.796
|
4.45 scores on a scale
Standard Deviation 0.739
|
4.59 scores on a scale
Standard Deviation 0.734
|
4.82 scores on a scale
Standard Deviation 0.733
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Main statistical test is ANOVA\\t-test to detect the difference of between the four groups.
It is a subjective scale to assess the vomiting as a side effect of epidural morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Vomiting scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent; 1. if the side effect was minimal and did not require treatment; 2. if the side effect was moderate or severe and required treatment.
Outcome measures
| Measure |
Group A
n=22 Participants
Participants allocated to receive 1.5 mg epidural morphine.
|
Group B
n=22 Participants
Participants allocated to receive 3 mg epidural morphine.
|
Group C
n=22 Participants
Participants allocated to receive 4.5 mg epidural morphine.
|
Group D
n=22 Participants
Participants allocated to receive 0 mg epidural morphine.
|
|---|---|---|---|---|
|
Vomiting Score
|
3.18 score on a scale
Standard Deviation 0.958
|
3.00 score on a scale
Standard Deviation 1.902
|
3.86 score on a scale
Standard Deviation 2.122
|
1.45 score on a scale
Standard Deviation 1.224
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Main statistical test is ANOVA\\t-test to detect the difference of between the four groups.
It is a subjective scale to assess the pruritus as a side effect of morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Pruritus scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent; 1. if the side effect was minimal and did not require treatment; 2. if the side effect was moderate or severe and required treatment.
Outcome measures
| Measure |
Group A
n=22 Participants
Participants allocated to receive 1.5 mg epidural morphine.
|
Group B
n=22 Participants
Participants allocated to receive 3 mg epidural morphine.
|
Group C
n=22 Participants
Participants allocated to receive 4.5 mg epidural morphine.
|
Group D
n=22 Participants
Participants allocated to receive 0 mg epidural morphine.
|
|---|---|---|---|---|
|
Pruritus Score
|
3.36 score on a scale
Standard Deviation 0.953
|
3.68 score on a scale
Standard Deviation 1.086
|
3.23 score on a scale
Standard Deviation 0.752
|
1.91 score on a scale
Standard Deviation 1.377
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=22 participants at risk
Participants allocated to receive 1.5 mg epidural morphine.
|
Group B
n=22 participants at risk
Participants allocated to receive 3 mg epidural morphine.
|
Group C
n=22 participants at risk
Participants allocated to receive 4.5 mg epidural morphine.
|
Group D
n=22 participants at risk
Participants allocated to receive 0 mg epidural morphine.
|
|---|---|---|---|---|
|
Nervous system disorders
Modified Ramsay Sedation Score; level V
|
0.00%
0/22 • 72 hours
Postoperative sedation effect of epidural morphine was frequently assessed by Modified Ramsay sedation scale. All-Cause Mortality and serious adverse events were not monitored/assessed.
|
0.00%
0/22 • 72 hours
Postoperative sedation effect of epidural morphine was frequently assessed by Modified Ramsay sedation scale. All-Cause Mortality and serious adverse events were not monitored/assessed.
|
4.5%
1/22 • Number of events 3 • 72 hours
Postoperative sedation effect of epidural morphine was frequently assessed by Modified Ramsay sedation scale. All-Cause Mortality and serious adverse events were not monitored/assessed.
|
0.00%
0/22 • 72 hours
Postoperative sedation effect of epidural morphine was frequently assessed by Modified Ramsay sedation scale. All-Cause Mortality and serious adverse events were not monitored/assessed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place