Trial Outcomes & Findings for Evaluation of the Aurora Xi New Nomogram Software 2.0 (NCT NCT06122935)
NCT ID: NCT06122935
Last Updated: 2025-11-12
Results Overview
The primary objective of this study is to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6) in donors using the Aurora Xi New Nomogram algorithm is less than double the SHAE rate in donors using the Aurora Xi Optimized Nomogram algorithm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6735 participants
Primary outcome timeframe
From venipuncture through 72 hours post-donation.
Results posted on
2025-11-12
Participant Flow
A total of 6,735 subjects were enrolled in the study at 3 investigative sites and completed 52,468 Per Protocol procedures.
Unit of analysis: Procedures
Participant milestones
| Measure |
Test Group
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
|---|---|---|
|
Overall Study
STARTED
|
3363 26351
|
3372 26117
|
|
Overall Study
COMPLETED
|
3363 26351
|
3372 26117
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Aurora Xi New Nomogram Software 2.0
Baseline characteristics by cohort
| Measure |
Test Group
n=3363 Participants
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
n=3372 Participants
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
Total
n=6735 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
36.9 years
STANDARD_DEVIATION 12.38 • n=10 Participants
|
36.5 years
STANDARD_DEVIATION 12.53 • n=10 Participants
|
36.7 years
STANDARD_DEVIATION 12.46 • n=20 Participants
|
|
Sex: Female, Male
Female
|
1521 Participants
n=10 Participants
|
1526 Participants
n=10 Participants
|
3047 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
1842 Participants
n=10 Participants
|
1846 Participants
n=10 Participants
|
3688 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
630 Participants
n=10 Participants
|
642 Participants
n=10 Participants
|
1272 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2704 Participants
n=10 Participants
|
2710 Participants
n=10 Participants
|
5414 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=10 Participants
|
20 Participants
n=10 Participants
|
49 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
28 Participants
n=10 Participants
|
17 Participants
n=10 Participants
|
45 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
46 Participants
n=10 Participants
|
38 Participants
n=10 Participants
|
84 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
39 Participants
n=10 Participants
|
35 Participants
n=10 Participants
|
74 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
275 Participants
n=10 Participants
|
272 Participants
n=10 Participants
|
547 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
2831 Participants
n=10 Participants
|
2853 Participants
n=10 Participants
|
5684 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
144 Participants
n=10 Participants
|
157 Participants
n=10 Participants
|
301 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
3363 participants
n=10 Participants
|
3372 participants
n=10 Participants
|
6735 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From venipuncture through 72 hours post-donation.The primary objective of this study is to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6) in donors using the Aurora Xi New Nomogram algorithm is less than double the SHAE rate in donors using the Aurora Xi Optimized Nomogram algorithm.
Outcome measures
| Measure |
Test Group
n=26351 Procedures
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
n=26117 Procedures
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
|---|---|---|
|
Rate of Significant Hypotensive Adverse Events
|
43 Procedure with a SHAE
|
42 Procedure with a SHAE
|
SECONDARY outcome
Timeframe: From Venipuncture through 72 Hours post-donation.To determine if the incidence rate of SHAEs per donor status (first-time donor) observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).
Outcome measures
| Measure |
Test Group
n=1038 Procedures
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
n=1043 Procedures
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
|---|---|---|
|
Rate of Severe Hypotensive Adverse Events Relative to Donor Type
|
9 Number of Participants with a SHAE
|
5 Number of Participants with a SHAE
|
SECONDARY outcome
Timeframe: From venipuncture through 72 hours post-donation.To determine if the incidence rate of SHAEs for female donors observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).
Outcome measures
| Measure |
Test Group
n=11377 Procedures
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
n=11372 Procedures
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
|---|---|---|
|
Rate of Severe Hypotensive Adverse Events Relative to Sex
|
31 Procedure with a SHAE
|
29 Procedure with a SHAE
|
SECONDARY outcome
Timeframe: From venipuncture through 72 hours post-donation.To determine if the incidence rate of SHAEs for donors ≤20 years of age observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).
Outcome measures
| Measure |
Test Group
n=1292 Procedures
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
n=1452 Procedures
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
|---|---|---|
|
Rate of Severe Hypotensive Adverse Events Relative to Age
|
5 Procedure with a SHAE
|
5 Procedure with a SHAE
|
SECONDARY outcome
Timeframe: From venipuncture through 72 hours post-donation.To determine if the incidence rate of SHAEs for donors weighting ≤124 lbs observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).
Outcome measures
| Measure |
Test Group
n=476 Procedures
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
n=465 Procedures
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
|---|---|---|
|
Rate of Severe Hypotensive Adverse Events Relative to Weight
|
1 Procedure with a SHAE
|
2 Procedure with a SHAE
|
SECONDARY outcome
Timeframe: From venipuncture through 72 hours post-donation.To determine if the incidence rate of hypotensive severe/injury adverse events (IQPP DAE Classification 1.5 or 1.6) observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).
Outcome measures
| Measure |
Test Group
n=26351 Procedures
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
n=26117 Procedures
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
|---|---|---|
|
Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6)
|
10 Procedure with a SHAE
|
8 Procedure with a SHAE
|
SECONDARY outcome
Timeframe: From venipuncture through end of the procedure.Population: Procedures in which a SHAE occurred.
To determine if the time from start of plasmapheresis procedure to the first SHAE observed with the New Nomogram (Test arm) is non-inferior to the time observed with the Optimized Nomogram (Control arm).
Outcome measures
| Measure |
Test Group
n=44 Participants
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
n=42 Participants
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
|---|---|---|
|
Time From Start of Plasmapheresis Procedure to the First SHAE
|
44.26 minutes
Standard Deviation 10.22
|
40.53 minutes
Standard Deviation 40.20
|
Adverse Events
Test Group
Serious events: 0 serious events
Other events: 338 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 309 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Group
n=26351 participants at risk
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
|
Control Group
n=26117 participants at risk
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
|
|---|---|---|
|
Cardiac disorders
IQPP 1.1 Hypotensive, Prefaint, No LOC (Minor)
|
0.84%
221/26351 • Number of events 221 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.77%
201/26117 • Number of events 201 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
Cardiac disorders
IQPP 1.2 Hypotensive, Prefaint, No LOC (Moderate)
|
0.07%
19/26351 • Number of events 19 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.09%
24/26117 • Number of events 24 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
Cardiac disorders
IQPP 1.3 Hypotensive, LOC (brief)
|
0.05%
14/26351 • Number of events 14 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.03%
8/26117 • Number of events 8 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
Cardiac disorders
IQPP 1.4 Hypotensive, LOC (prolonged)
|
0.00%
1/26351 • Number of events 1 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.01%
2/26117 • Number of events 2 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
Cardiac disorders
IQPP 1.5 Hypotensive, Severe (With or Without LOC)
|
0.03%
9/26351 • Number of events 9 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.03%
8/26117 • Number of events 8 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
Cardiac disorders
IQPP 1.6 Hypotensive, Injury
|
0.00%
1/26351 • Number of events 1 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.00%
0/26117 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
Injury, poisoning and procedural complications
IQPP 3. Local Injury Related to Phlebotomy
|
0.11%
28/26351 • Number of events 28 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.13%
33/26117 • Number of events 33 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
Blood and lymphatic system disorders
IQPP 4. Citrate Reaction
|
0.13%
34/26351 • Number of events 34 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.10%
26/26117 • Number of events 26 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
General disorders
IQPP 7.1 Allergic, Local
|
0.01%
3/26351 • Number of events 3 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.00%
0/26117 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
General disorders
IQPP 8. Hyperventilation
|
0.03%
8/26351 • Number of events 8 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.02%
6/26117 • Number of events 6 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
|
General disorders
IQPP 9. Other
|
0.00%
0/26351 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
0.00%
1/26117 • Number of events 1 • Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The protocol, procedures, and data pertaining to this study will be treated as confidential information. Publication of data and/or information derived from these studies must be done with the prior review and approval of the Sponsor. Scientific personnel may share authorship with investigators on abstracts, oral presentations and manuscripts. The first author will be the person assuming primary responsibility for the abstract or manuscript.
- Publication restrictions are in place
Restriction type: OTHER