525059

research-article2014

CRE0010.1177/0269215514525059Clinical RehabilitationBeneck et al.

CLINICAL
REHABILITATION

Article

Intensive, progressive exercise

improves quality of life following
lumbar microdiskectomy: a
randomized controlled trial

Clinical Rehabilitation
2014, Vol. 28(9) 892901
The Author(s) 2014
Reprints and permissions:
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DOI: 10.1177/0269215514525059
cre.sagepub.com

George J Beneck1, John M Popovich Jr2, David M

Selkowitz3, Stan Azen4 and Kornelia Kulig5
on behalf of Physical Therapy Clinical Research
Network (PTClinResNet)

Abstract
Objective: The purpose of the study was to examine changes in quality of life measures in patients who
have undergone an intensive exercise program following a single level microdiskectomy.
Design: Randomized controlled trial with blinded examiners.
Setting: The study was conducted in outpatient physical therapy clinics.
Subjects: Ninety-eight participants (53 male, 45 female) who had undergone a single-level lumbar
microdiskectomy allocated to receive exercise and education or education only.
Interventions: A 12-week periodized exercise program of lumbar extensor strength and endurance
training, and mat and upright therapeutic exercises was administered.
Outcome measures: Quality of life was tested with the Short Form 36 (SF-36). Measurements were
taken 46 weeks postsurgery and following completion of the 12-week intervention program. Since some
participants selected physical therapy apart from the study, analyses were performed for both an asrandomized (two-group) design and an as-treated (three-group) design.
Results: In the two-group analyses, exercise and education resulted in a greater increase in SF-36
scales, role physical (17.8 vs. 12.1) and bodily pain (13.4 vs. 8.4), and the physical component summary
(13.2 vs. 8.9). In the three-group analyses, post-hoc comparisons showed exercise and education
resulted in a greater increase in the SF-36 scales, physical function (10.4 vs. 5.6) and bodily pain (13.7 vs.
8.2), and the physical component summary (13.7 vs. 8.9) when compared with usual physical therapy.
Conclusions: An intensive, progressive exercise program combined with education increases quality of
life in patients who have recently undergone lumbar microdiskectomy.

1Department

of Physical Therapy California State University

Long Beach, Long Beach, CA, USA
2Center for Orthopedic Research, Michigan State University,
East Lansing, MI, USA
3Department of Physical Therapy Education, Western
University of Health Sciences, Pomona, CA, USA
4Department of Preventive Medicine, University of Southern
California, Los Angeles, CA, USA

5Division

of Biokinesiology and Physical Therapy, University of

Southern California, Los Angeles, CA, USA

Corresponding author:
George J Beneck, Department of Physical Therapy, California
State University, Long Beach, 1250 Bellflower Blvd, ET 122,
Long Beach, CA 90840, USA.
Email: gbeneck@csulb.edu

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Beneck et al.
Keywords
SF-36, lumbar microdiskectomy, intensive exercise
Received: 11 November 2013; accepted: 26 January 2014

Introduction
Lumbar diskectomy is one of the most common
neurosurgical procedures performed in the United
States. Individuals with a lumbar disk herniation,
or postspinal decompression surgeries, may present with pain and decreased ability to perform certain daily activities, which may ultimately lead to
diminished health and quality of life in this patient
population. A generic measure of perceived health
status, the Short Form 36 (SF-36, Medical
Outcomes Trust, Boston, MA), was developed as a
multipurpose, short-form health survey with only
36 questions.1,2 This questionnaire has been used to
assess quality of life in patients with low back pain
(LBP), as well as patients following various spine
surgeries.
Most studies documenting quality of life
changes in microdiskectomy patients report significant improvements.310 Many of these
improved outcomes are assessed postsurgically, or
after specific time points after the surgery, with
brief or no mention of any postsurgical care.
Weinstein et al.10 compared surgical vs. non-surgical (usual care) intervention as a treatment for disk
herniations, in which the non-surgical group consisted of physical therapy. The surgical group had
greater improvement in SF-36 scores when compared with the non-surgical group, but both demonstrated improvements. The physical therapy
intervention specifics were not reported, but the
results suggest physical therapy intervention may
improve quality of life in patients with low back
problems. To adequately assess the effects of rehabilitation on improvements in quality of life, an
attempt to control for postsurgical intervention is
necessary.
Physical therapy aimed at improving trunk
and lower extremity function may play a role in
improving quality of life in persons following
microdiskectomy. A high-intensity lumbar extensor

strengthening program has shown to promote

improvements in SF-36 scores following eight
weeks of training in persons with non-specific
LBP, however, improvements did not differ from
low-intensity or controls at a later 24-week followup.11,12 In persons four weeks after undergoing
lumbar microdiskectomy surgery, components of
the SF-36 correlated with back extensor endurance
times.13 While improvements in quality of life have
been demonstrated in patients with non-specific
LBP following an intense exercise program,12 evidence is lacking for persons who have undergone
an intensive postoperative exercise program following single-level lumbar microdiskectomy surgery. Previously, we reported the effects of an
intensive exercise program on disability and functional performance in patients following lumbar
microdiskectomy.14 Therefore, the purpose of this
study was to evaluate changes in health-related
quality of life measures in this patient population.

Methods
Study design
This study was a prospective randomized controlled trial with blinded examiners. The methods
used in the development and implementation
phases of the study protocol and the study population have been described elsewhere.14,15 The study
and its informed consent process were approved by
the Institutional Review Board of the University of
Southern California (USC).

Randomization and interventions

Adults between the ages of 18 and 60 who were
scheduled to undergo a single-level lumbar microdiskectomy for the first time between December

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Clinical Rehabilitation 28(9)

2003 and January 2006 were screened for inclusion. Participants were randomly assigned using
blocked randomization from a computer-generated
list by the Data Management Center of the
Physical Therapy Clinical Research Network
(PTClinResNet).15 After consenting to the study,
the study coordinator informed the participant
about his or her group allocation. Allocation was to
one of two groups: one session of back care education (education only), or a back care education session followed by the 12-week USC Spine Exercise
Program (exercise and education). Both the education session and the exercise program were administered by intervention physical therapists at
participating physical therapy clinics in the greater
Los Angeles area. To ensure the proper implementation of the intervention, each interventional therapist participated in eight hours of intervention
training and passed the two-hour patient-based
exam.14 Intervention therapists were required to
complete a one-page-per-day form for each session. For each participant, the first three forms
were faxed to the trials central office to check
completeness and quality.
Education comprised a one-hour one-on-one
session with the intervention therapist that occurred
after the pre-intervention testing session, four to
six weeks after surgery. This educational session
was tailored specifically for individuals who had
undergone a lumbar microdiskectomy, to help them
understand their back problem and how to care for
their back. It was guided by an educational booklet
that was created especially for this study.15
The exercise program14 comprised back extensor strength and endurance training, accompanied
by trunk and lower extremity exercise training,
which were performed within the same sessions. It
began within a few days of the education session,
and occurred three times a week for 12 weeks. The
program was systematic and individualized, thus
accommodating participants of varying levels of
fitness and symptoms, and allowing measurable
progression of the workload over the 12-week
training period. The back extensor strength and
endurance training portion of the program was
designed to load the back extensor muscles in a
graded manner using a variable-angle Roman chair.

The purpose of the trunk and lower extremity exercise training was to progressively and dynamically
develop strength, endurance, and control of movement by the trunk and lower extremity musculature
by performing exercise progressions in each of
three postures: supine, quadruped, and standing.
Exercise progression was based on each participants symptoms, use of correct technique, and rate
of perceived exertion.

Outcome measures and follow-up

All outcome measurements were obtained by evaluators who were blinded to group allocation, and
who successfully completed standardized training
in the testing procedures.14 Testing on all outcome
measures began four to six weeks after surgery.
Blinding of the intervention therapists and participants was not possible owing to the nature of the
intervention.
The SF-36 questionnaire yields an eight-scale
profile of scores, as well as physical and mental
component summary measures.2 The eight-scale
profile of the SF-36 includes physical function,
role physical, bodily pain, general health, vitality,
social function, role emotional, and mental health
components. It has been used in patients with
LBP16,17 and after lumbar surgeries.1820

Statistical analysis
Power calculations were performed based on data
from prior published studies, using an alpha level
of 0.05 and power of 0.8.2125 Accounting for attrition, each group was estimated to need approximately 50 participants.14
Coded data for all outcome measures and relevant independent measures were transferred by the
blinded evaluators to data management and analysis personnel. These data were then transferred
from hardcopy recordings to a menu-driven webbased SQL data entry system (PTClinResNet), and
then exported to SAS version 8.2 (SAS Institute
Inc., Cary, NC, USA) for statistical analysis.14
A two-group, pretest-posttest (repeated measure) design was originally planned. However, some
of the participants did not adhere with the random

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Beneck et al.

Figure 1. CONSORT flow diagram of participants through the study. Reproduced with kind permission from the
American Physical Therapy Association.14
LBP: low back pain.

assignment to a particular group and, instead, selfselected a course of physical therapy at a clinic of
their choosing. This created a third group that we
called usual physical therapy. Therefore, both a
two-group design (for those participants who completed intervention and testing as randomized) and
a three-group design (based on actual treatment
received) was used to analyze the data.
The change scores (posttest minus pretest) for
both the two-group and three-group designs were
assessed using an analysis of covariance
(ANCOVA) for each outcome measure, with the
baseline/pretest as the covariate. For the threegroup design, if the ANCOVAs for any of the outcome measures were significant, post-hoc testing

was performed using Tukeys method to determine

statistically significant pair-wise comparisons
between the groups.26 All alpha levels were 0.05.
Owing to the higher drop-out rate in the educationonly group, an intention-to-treat analysis was not
performed. Such analysis would bias in favor of
the exercise and education group.14

Results
A total of 176 patients were screened for this study
(Figure 1). Of the 176 patients screened, 98 were
randomized into either exercise and education (n =
51) or education only (n = 47). Of these 98 participants, a total of 77 completed evaluations at each of

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Clinical Rehabilitation 28(9)

the specified time points. Participant demographic

information from the exercise and education (n =
45) or education only (n = 32) groups are presented
in Table 1. Owing to lack of adherence with group
assignment, participants were further categorized
into three groups: Education and exercise (n = 43),
education only (n = 14), and usual physical therapy
(n = 20). Of all study participants completing the
intervention period, 3.9% (3/77 participants) experienced an adverse event, all considered not related
to the study.14
Analyses performed on the outcome measures
for the two-group (as randomized) assignment are
presented in Table 2. The ANCOVA results showed
significant differences in the postintervention
scores between the exercise and education group
and education only group for SF-36 role physical (P
= 0.012) and SF-36 bodily pain (P = 0.007), indicating that the exercise and education group had significantly greater improvement in these variables.
Comparisons for the three groups (as-treated
exercise and education, education only, and usual
physical therapy) are presented in Table 3. Similar
to the two-group analysis, the ANCOVA results for
the postintervention scores demonstrated significant differences in the SF-36 role physical (P =
0.041) and SF-36 bodily pain (P = 0.025). SF-36
physical function was also significantly different
(P = 0.023) when compared across the three
groups. Post-hoc comparisons showed these significant improvements existed in the exercise and
education compared with the usual physical therapy group for each variable (SF-36 bodily pain,
P = 0.029; SF-36 physical function, P = 0.034),
except for SF-36 role physical (P = 0.125). No significant differences in postintervention scores were
found between the exercise and education and education only groups, or between the education only
and usual physical therapy groups (all, P > 0.05).

Discussion
In both the randomized (two group) and as-treated
(three group) analyses, the patients treated with
exercise and education achieved greater improvements in the SF-36 role physical and bodily pain
scales and the physical component summary.

Additionally, in the as-treated analysis, the exercise and education group achieved greater improvements in SF-36 physical function scale. No
differences were identified between the exercise
and education group and the education-only group
in the as-treated analyses. This is best explained by
the loss of statistical power resulting from the high
number of participants who did not adhere to their
assignment in the education only group. The results
of the current study are similar to those of Harts
and colleagues.12 In that study, greater increases in
SF-36 scores were achieved in a group participating in a high-intensity lumbar extensor program, as
compared with both low-intensity and a control
group. However, the participants in that study had
chronic LBP without signs of nerve root compression and had not received a lumbar spine surgical
intervention. Although several studies2731 have
examined the effects of rehabilitation following
lumbar diskectomy, only one reported the effects of
rehabilitation on health-related quality of life.28 In
that study, an eight-week exercise program, targeting trunk muscle performance and hip mobility
combined with a behavioral approach including
graded activity, was compared with one session of
home exercise instruction following beginning 03
weeks following first-time lumbar microdiskectomy. Health-related quality of life was measured
using both the SF-36 and the European Quality of
Life Scale (EuroQol). In contrast to the current
study, the group receiving the home-based program
achieved greater increases in three of the SF-36
scales and the EuroQol visual analogue scale. To
our knowledge, the current study is the first to
demonstrate greater improvements in healthrelated quality of life from a standardized clinicbased exercise program in patients post lumbar
microdiskectomy.
The three scales of the SF-36, role physical,
bodily pain, and physical function, shown to
increase in the current study, are all part of the
physical component summary of the SF-36, in contrast to SF-36 scales, vitality, social function, role
emotional, and mental health, which primarily
form the mental component summary. The SF-36
role physical, bodily pain, and physical function
scales correlate most highly with, and contribute

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Beneck et al.

Table 1. Baseline demographic, primary outcomes, and participation measures by randomization groups (N = 98).
Variable

Exercise and education

(n = 51)

Demographics
Age (years)
Gender: male
Latino or Hispanic
Race
Black or African American
White
Unspecified or Other
Involved in a litigation process with
Workers Compensation
Medical history
Duration of pain episode prior to
surgery (months)
Time since first onset of low back
pain (months)
Time since first onset of sciatica
(months)
Number of previous episodes
<3
35
510
>10
unspecified
Involved spinal level(s):
L4/L5
L5/S1
L2/L3
Positive passive straight leg raise
SF-36
Physical function
Role physical
Bodily pain
General health
Vitality
Social function
Role emotional
Mental health
Physical component summary
Mental component summary

Education only
(n = 47)

39.2 (10.2)
29 (58%)
6 (12%)

41.4 (9.9)
24 (50%)
9 (19%)

0.90
0.43
0.35

1.00

1 (2%)
35 (70%)
14 (28%)
4 (9%)

1 (2%)
34 (71%)
13 (27%)
9 (19%)

6.7 (9.8)

5.9 (7.0)

0.66

82.1 (93.3)

120.7 (125.3)

0.12

33.1 (67.6)

38.7 (69.8)

0.71

13 (32%)
3 (7%)
5 (12%)
13 (32%)
7 (17%)

16 (34%)
5 (11%)
3 (6%)
18 (38%)
5 (11%)

19 (38%)
30 (60%)
1 (2%)
29 (63%)

24 (50%)
24 (50%)
0 (0%)
19 (45%)

40.5 (8.9)
32.4 (10.5)
37.7 (7.8)
51.8 (8.3)
48.1 (8.8)
35.7 (10.2)
47.8 (10.6)
50.0 (8.5)
36.8 (8.2)
50.3 (9.9)

37.6 (9.8)
31.9 (10.5)
35.6 (7.3)
49.3 ((9.2)
45.6 (9.5)
35.8 (12.1)
43.6 (13.8)
47.7 (9.5)
35.3 (8.4)
47.8 (11.3)

0.14

0.75

0.35

0.09

0.13
0.82
0.18
0.17
0.20
0.95
0.11
0.23
0.39
0.24

Values are mean (SD) for continuous variables; frequency (%) for categorical variable. Chi-square tests were used for categorical
variables and a one-way ANOVA for continuous variables.
Missing data for the following variables (exercise and education, education only): Involved in a litigation process with Workers
Compensation (4, 0); duration of pain episode prior to surgery (4, 6); time since first onset of low back pain (10, 9); time since
first onset of sciatica (12, 2); number of previous episodes (4, 6); positive passive straight leg raise (5, 5); physical Function
(0, 1).

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Clinical Rehabilitation 28(9)

Table 2. SF-36 quality of life measures based on two-group (as randomized) analyses. Values are change (baseline
post) scores (95% confidence interval).
Outcome measures

Exercise and education

(n = 45)

Education only
(n = 32)

Physical function
Role physical
Bodily pain
General health
Vitality
Social function
Role emotional
Mental health
Physical component summary
Mental component summary

9.53 (7.4 to 11.7)

17.81 (15.0 to 20.6)
13.44 (10.5 to 16.4)
2.00 (0.2 to 3.8)
7.24 (4.7 to 9.8)
15.88 (12.5 to 19.3)
6.01 (2.8 to 9.2)
4.22 (1.5 to 6.9)
13.19 (11.0 to 15.3)
4.87 (1.8 to 7.9)

7.18 (4.6 to 9.7)

12.07 (8.1 to 16.1)
8.37 (6.2 to 10.6)
0.40 (2.9 to 3.7)
6.73 (3.9 to 9.5)
12.44 (8.8 to 16.1)
4.64 (0.5 to 9.7)
2.08 (1.0 to 5.2)
8.93 (6.5 to 11.3)
4.10 (0.5 to 7.7)

0.052
0.012
0.007
0.216
0.544
0.331
0.068
0.131
0.010
0.351

The P-value is a between-group comparison of the postintervention scores using ANCOVA for the overall (covariate = baseline).

Table 3. SF-36 quality of life measures based on actual intervention received. Values are change (baselinepost)
scores (95% confidence interval).
Outcome measures

Exercise and education

(n = 43)

Education only
(n = 14)

Usual physical therapy

(n = 20)

Physical function
Role physical
Bodily pain
General health
Vitality
Social function
Role emotional
Mental health
SF-36 physical component
SF-36 mental component

10.35 (8.2 to 12.5) a

18.51 (15.8 to 21.2)
13.71 (10.8 to 16.7)a
2.05 (0.1 to 4.0)
7.33 (4.7 to 10.0)
15.85 (12.3 to 19.4)
6.69 (3.5 to 9.9)
4.13 (1.4 to 6.9)
13.65 (11.6 to 15.7)a
4.87 (1.7 to 8.0)

7.22 (2.6 to 11.9)

7.91 (3.7 to 12.1)
8.13 (4.3 to 12.0)
2.38 (2.3 to 7.1)
6.00 (0.8 to 11.2)
14.02 (8.9 to 19.1)
4.19 (14.67)
3.90 (3.5 to 11.9)
7.75 (4.4 to 11.1)
5.31 (1.2 to 11.8)

5.64 (3.0 to 8.3)

13.55 (7.7 to 19.4)
8.20 (5.3 to 11.1)
0.91 (5.0 to 3.2)
7.02 (4.0 to 10.0)
11.73 (6.7 to 16.7)
3.48 (3.2 to 10.2)
1.22 (2.3 to 4.7)
8.91 (5.4 to 12.4)
3.31 (0.6 to 7.3)

0.023
0.041
0.025
0.644
0.936
0.547
0.163
0.563
0.022
0.797

The P-value is a between-group comparison of the postintervention scores using ANCOVA for the overall (covariate = baseline).
aSignificant difference (P 0.05) for post-hoc analysis between the exercise and education group and the usual physical therapy
group.

most to, the physical component summary score32

and are reported to be the most valid SF-36 scales
for measuring physical health.33 They are also considered most responsive to interventions intended
to improve physical health.33 In contrast to just
reporting a single summary, such as the physical
component summary score, we chose to analyze
the individual scales because they have the potential of yielding a richer interpretation of the results.
Furthermore, a comparison of scoring methods
demonstrated that the best physical health test con-

sistently performed better than the physical component summary score.34

In contrast to the SF-36, condition-specific
functional measures, such as the Oswestry
Disability Index or the RolandMorris Disability
Questionnaire, focus on symptoms and dysfunctions believed to be important to both patients and
clinicians. The primary focus of these measures is
on activity restrictions and postural limitations.35
In contrast to these measures, the items in the
SF-36 pertaining to physical health encompass a

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Beneck et al.
wider array of activities and potential effects on
physical health. While there are some similarities
between these measures and the scales of the SF-36
related to physical health, these outcomes measure
different constructs.36 Furthermore, the SF-36
scales, vitality, social function, role emotional, and
mental health, provide an outcome of mental health
that is gleaned by the functional measures.35 In the
current study, no significant differences were identified between groups in either of the analyses, suggesting that the intervention benefits of the exercise
and education intervention were mainly physical.
In a systematic review examining the effects of
rehabilitation on short-term pain reduction following lumbar disk surgery,31 the authors reported
low-quality evidence indicating that exercises are
more effective than no treatment and that there is
no significant differences between supervised
exercise and home exercises for short-term pain
relief. Since that review, only one29 of four studies2730 reported greater pain reduction in persons
participating in an exercise program postdiskectomy. In nearly all studies, a visual analogue scale
was typically used to quantify back pain. In the
current study, the body pain scale of the SF-36
shows significantly greater reductions in pain in
both analyses. The body pain scale of the SF-36
differs from the visual analogue scale in that it is a
composite score calculated from two questions: (1)
pertaining to the severity of bodily pain, and (2)
how much did pain interfere with work. One could
argue that question 2 could equally be a measure of
function, and thus explain the significant differences reported in the current study.
One limitation of the study is that a large number of participants did not adhere to the original
allocation into the education-only group, which
suggested a preference for the exercise and education intervention. Since more motivated subjects
may have dropped out of the education-only group,
an analysis excluding that data may have hindered
the outcomes of that group. The more conservative
option of analyzing the evaluable data in the two
groups was chosen. Thus, several subjects who
received physical therapy outside the study were
included in the education-only group in the twogroup analysis. A more detailed discussion of this
issue can be found in our previous report.14

A second limitation is the disparity of time spent

with a physical therapist between groups, i.e. the
education and exercise group received more oneon-one time than the other groups. Measured outcomes can be influenced by time spent with a
therapist. However, it is important to point out that
greater time spent with a physical therapist may not
necessarily increase health-related quality of life
outcome measures. Two previous studies of physical therapy intervention effects on health-related
quality of life from low back disorders with greater
time spent with the therapist showed no differences
in the increase in quality of life between these
groups.37,38 Furthermore, a third study reported
greater increases in health-related quality of life in a
group that received a home-based program in contrast to participants in a clinic-based program.28
Improvements in quality of life measurements
favor individuals who performed an intensive
12-week strength and endurance training program
of the trunk and lower extremity musculature.
These postintervention improvements manifest in
domains typical of physical therapy and patientoriented outcomes. The results of this clinical trial
support the role of an intensive 12-week strength
and endurance training program of the trunk and
lower extremity musculature for patients having
undergone first-time single-level microdiskectomy.
However, the long-term effects of such a program
for patients having undergone first-time singlelevel microdiskectomy remain to be determined.

Clinical messages

I ntensive exercise may improve quality

of life following lumbar microdiskectomy more than education alone or usual
physical therapy.
Quality of life gains following intensive
exercise are in the physical domain of
the SF-36.

Acknowledgements
Physical Therapy Clinical Research Network
(PTClinResNet): Network Principal Investigator is
Carolee J Winstein and Co-Principal Investigator

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Clinical Rehabilitation 28(9)

is James Gordon (both at University of Southern

California). Project Principal and Co-Principal
Investigators are: David A Brown (Northwestern
University); Sara Mulroy and Bryan Kemp (Rancho
Los Amigos National Rehabilitation Center); Loretta
M Knutson (University of Indianapolis); Eileen G
Fowler (University of California at Los Angeles); and
Sharon K DeMuth, Kornelia Kulig, and Katherine J
Sullivan (University Southern California). The Data
Management Center is located at the University of
Southern California and is directed by Stanley P Azen.
The four-member Data Safety and Monitoring
Committee are: Nancy Byl, Chair (University of
California at San Francisco), Hugh G Watts (Shriners
Hospital for ChildrenLA Unit, Los Angeles,
California), June Isaacson Kailes (Western University,
Los Angeles, California), and Anny Xiang (University
of Southern California).

Conflict of interest
The authors declare that there is no conflict of interest.

Funding
This study was funded by a grant from the Foundation
for Physical Therapy. Institutional Review Board of the
University of Southern California.

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