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Medicine
American Journal of Sports
DOI: 10.1177/0363546507307505
2008; 36; 33 originally published online Oct 16, 2007; Am. J. Sports Med.
Ida Buist, Steef W. Bredeweg, Willem van Mechelen, Koen A. P. M. Lemmink, Gert-Jan Pepping and Ron L. Diercks
Runners: A Randomized Controlled Trial
No Effect of a Graded Training Program on the Number of Running-Related Injuries in Novice
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Running is a sport practiced by many individuals to
improve cardiorespiratory function, health, and well-being.
In conjunction with the positive effects of running on
health and fitness, it is important to consider the risk of a
running-related injury (RRI). Research has shown that the
incidence of RRI is high; incidence rates of RRI vary from
30% to 79%,
3,11-14,24,28
and from 7 to 59 RRIs per 1000 hours
of running.
3,11,12,19
Most RRIs are overuse injuries of the lower extremity.
8
The causes of these overuse RRIs are multifactorial.
8
Four
factors have been related consistently to running injuries: (1)
lack of running experience, (2) previous injury, (3) running to
compete, and (4) excessive weekly running distance.
26
It is
estimated that 60% of all RRIs can be attributed to training
errors, that is, running too much too soon.
8
Little research has been performed on the prevention of
RRI in the running population. Several controlled studies on
No Effect of a Graded Training Program on
the Number of Running-Related Injuries
in Novice Runners
A Randomized Controlled Trial
Ida Buist,*
†‡
MSc, Steef W. Bredeweg,
†‡
MD, Willem van Mechelen,
§
MD, PhD,
Koen A. P. M. Lemmink,
†¶
PhD, Gert-Jan Pepping,
†‡¶
PhD, and Ron L. Diercks,
†‡
MD, PhD
From the
†
University Center for Sport, Exercise and Health, and
‡
Center for Sports Medicine,
University Medical Center Groningen, University of Groningen, Groningen, The Netherlands,
§
Department of Public and Occupational Health/EMGO Institute, VU University Medical Center,
Amsterdam, The Netherlands, and
¶
Center for Human Movement Sciences, University Medical
Center Groningen, University of Groningen, Groningen, The Netherlands
Background: Although running has positive effects on health and fitness, the incidence of a running-related injury (RRI) is high.
Research on prevention of RRI is scarce; to date, no studies have involved novice runners.
Hypothesis: A graded training program for novice runners will lead to a decrease in the absolute number of RRIs compared with
a standard training program.
Study Design: Randomized controlled trial; Level of evidence, 1.
Methods: GRONORUN (Groningen Novice Running) is a 2-armed randomized controlled trial comparing a standard 8-week
training program (control group) and an adapted, graded, 13-week training program (intervention group), on the risk of sustain-
ing an RRI. Participants were novice runners (N = 532) preparing for a recreational 4-mile (6.7-km) running event. The graded 13-
week training program was based on the 10% training rule. Both groups registered information on running characteristics and
RRI using an Internet-based running log. The primary outcome measure was RRIs per 100 participants. An RRI was defined as
any musculoskeletal complaint of the lower extremity or back causing a restriction of running for at least 1 week.
Results: The graded training program was not preventive for sustaining an RRI (χ
2
= 0.016, df = 1, P = .90). The incidence of RRI
was 20.8% in the graded training program group and 20.3% in the standard training program group.
Conclusions: This randomized controlled trial showed no effect of a graded training program (13 weeks) in novice runners,
applying the 10% rule, on the incidence of RRI compared with a standard 8-week training program.
Keywords: running-related injuries; incidence; prevention; training program; novice runners
33
*Address correspondence to Ida Buist, MSc, University Center for Sport,
Exercise and Health, University Medical Center Groningen, University of
Groningen, Hanzeplein 1, 9700 RB Groningen, The Netherlands (e-mail:
i.buist@sport.umcg.nl).
No potential conflict of interest declared.
The American Journal of Sports Medicine, Vol. 36, No. 1
DOI: 10.1177/0363546507307505
© 2008 American Orthopaedic Society for Sports Medicine
© 2008 American Orthopaedic Society for Sports Medicine. All rights reserved. Not for commercial use or unauthorized distribution.
at University of Groningen on April 29, 2008 http://ajs.sagepub.comDownloaded from
34 Buist et al The American Journal of Sports Medicine
the prevention of RRI exist.
2,5,7,15,17,18,21-23,27
However, to our
knowledge, there are no studies that have examined the
effect of a preventive intervention on RRI in novice runners.
The principle that the volume of exercise should be
increased gradually over time is widely regarded as criti-
cal for reducing the risk of an overuse injury.
25
This gen-
eral principle is also applicable in running. To minimize
the risk of RRI, an increase in training volume by no more
than 10% a week is mentioned; this is called the 10%
rule.
10
In a training program based on the 10% rule, the
body is thought to adapt more gradually to the external
impact forces of running. However, so far no studies have
examined the effect of such a modified training program on
the injury incidence in novice runners.
Therefore, the aim of the Groningen Novice Running
(GRONORUN) study was to determine the effect of a mod-
ified (ie, graded) training program for novice runners,
based on the 10% rule, on the incidence of RRI. We hypoth-
esized that when the human body gets more time for adap-
tation to running, the incidence of RRI will decrease.
METHODS
Design
The GRONORUN study is a randomized controlled trial
with a 13-week follow-up (ISRCTN37259753). A description
of the design of the GRONORUN trial is published else-
where.
4
Participants were randomized into an intervention
group (13-week graded training program) or a control group
(an 8-week standard training program). The study design,
procedures, and informed consent procedure were approved
by the Medical Ethics Committee of the University Medical
Center Groningen, The Netherlands. All participants pro-
vided written informed consent. Guidelines according to the
Consort Statement were followed.
16
Participants and Randomization
Recruitment was assisted by advertisements in local
media to enlist participants who wanted to start a “begin-
ners program” in preparing for the Groningen 4-mile recre-
ational running event. To participate in the beginners
program, it was not necessary to ultimately participate in
the 4-mile running event itself. Healthy participants
between 18 and 65 years of age, who had not sustained an
injury of the lower extremity in the last 3 months before
inclusion and who had not been running in the previous 12
months, were eligible for inclusion in the study.
Participants were excluded if there were absolute con-
traindications for vigorous physical activities according to
the American College of Sports Medicine,
1
or in case of
unwillingness to keep a running log.
After baseline measurements and informed consent,
participants were assigned to the graded training program
or the standard training program. To ensure that both
training groups were equal in terms of a priori injury risk,
a stratified randomization was performed. Participants
were stratified for current sporting activities status (no
sport, axial loading sports, nonaxial loading sports), previ-
ous injury (none, 3-12 months ago, >12 months ago), and
gender. From each stratum, participants were allocated to
the graded training program or standard training program
group by drawing a sealed opaque envelope.
Baseline Measurements
The baseline questionnaire covered demographic variables
such as age, gender, body weight, and height. Previous mus-
culoskeletal complaints of the lower extremity and back
were assessed per anatomical site. Current sports participa-
tion was assessed by questions concerning type of sport and
mean hours of sports participation. Furthermore, a question
on running experience in the past (“Have you ever partici-
pated in running on a regular basis?”) was used to assess
the novelty to running.
Training Program
All participants received the same general written and
oral information. They were instructed to walk for 5 min-
utes as a warm-up and cool-down. Both groups trained
individually 3 times a week, on a self-chosen course and
surface. All were advised to run at a comfortable pace at
which they could converse without losing breath. The
graded training group and the standard training group
started, respectively, 13 and 8 weeks before the Groningen
4-mile run. In training sessions, combinations of running
and walking were used (Table 1).
Outcome Measures
The primary outcome measure of the GRONORUN trial is
the absolute number of RRIs, expressed per 100 runners.
An RRI was defined as any musculoskeletal complaint of
the lower extremity or back causing a restriction of run-
ning for at least 1 week. The effect of the graded training
program was evaluated by the differences between propor-
tions of injured runners in both groups. Additional analy-
ses were done on the time until an event (RRI), the number
of RRIs per 1000 hours of exposure in both groups, and the
anatomical distribution of RRIs. Information on RRI and
exposure data was collected using an Internet-based run-
ning log. If an RRI was the reason for not adhering to the
training program, information on anatomical site and
severity was asked. When participants did not enter their
Internet-based training log after 1 week, a reminder was
send by e-mail automatically. Participants who dropped
out of the program and who did not complete their entire
running log were contacted by a research assistant to
ensure that RRI was not the reason for dropping out.
Statistics
A power calculation was carried out for the main outcome
variable RRI using a logistic rank survival power analysis.
For the GRONORUN trial, we expected a baseline injury
incidence of 30%.
4
With a hypothesized 25% reduction of
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Vol. 36, No. 1, 2008 Graded Training and Running-Related Injuries 35
RRI in the graded training program group compared with
the standard training program group, a total of 436 run-
ners (2 × 218) were needed for a power of 80% and an alpha
of 0.05.
4
Assuming an attrition of 15% in the intervention
period, a total of 512 (2 × 256) novice runners were needed
to detect an effect of the intervention.
Baseline characteristics of participants in the graded
training program group and standard training program
group were compared using 2-tailed t tests for normally
distributed continuous variables. The χ
2
statistic was used
for discrete variables. To evaluate the effect of the graded
training program on RRI, a χ
2
test was used. The log-rank
test is used to compare the Kaplan-Meier curves of the
graded training program group and the standard training
program group, analyzing the difference between the
training groups in the probability of an RRI at any time
point. Cox proportional hazards regression analysis was
performed to correct for differences in body mass index
(BMI) between randomized groups at baseline. All analy-
ses were performed following the “intention to treat” prin-
ciple. Differences were considered statistically significant
at P < .05. All analyses were performed using SPSS version
12.0 (SPSS Inc, Chicago, Ill).
RESULTS
Randomization/Sample Attrition
The flow of participants is shown in Figure 1. An informa-
tion pack about the GRONORUN study and an appoint-
ment for a baseline assessment were sent to a total of 603
volunteers. Twenty-three (3.8% of 603) did not react on the
invitation and another 25 (4.1% of 603) failed to attend the
baseline assessment. Among those participants who
attended the baseline assessment, 23 of 555 (4.1%) were
excluded because they did not meet the study eligibility
criteria. Thus, 532 novice runners were randomized into
the graded training program group and the standard
training program group. A participant was lost to follow-up
(ie, excluded from the final analysis) if she or he did not
start running or if no exposure data were available.
Significantly more participants of the standard training
program group were lost to follow-up because they did not
start running—32 of 268 (11.9%) versus 14 of 264 (5.3%) of
the graded training program group.
The baseline characteristics of participants in the graded
training program group and the standard training program
group, including the variables that were used for stratifica-
tion, are provided in Table 2. Of the 532 randomized partic-
ipants, 306 (57.5%) were female. Forty-seven percent of all
randomized participants had never run on a regular basis
before. Randomization groups were not similar in BMI. The
graded training program group showed a small (25.2 vs 24.4
kg/m
2
), but significantly higher (P < .05), difference in BMI.
As shown in Table 2, running experience and activity
level were not the same in all participants but were
equally distributed over both training groups.
Effect of the Graded Training Program
The incidence of RRI was 20.8% (52 of 250) in the graded
training program group and 20.3% (48 of 236) in the standard
training program group. The graded training program was
not preventive for sustaining an RRI (χ
2
= 0.016, df = 1, P =
.90). Because the exposure to running in both training groups
was not equal, survival curves (ie, Kaplan-Meier curves) were
made for both training groups (Figure 2A). Figure 2B shows
the survival curves of injured participants in the standard
training group and the graded training group. The mean sur-
vival time of injured runners in the graded training group
was 212 minutes (standard deviation [SD] = 160), compared
with 167 minutes in the standard training group (SD = 153).
The log-rank test showed no difference between the graded
training program group and the standard training program
group (P = .18). Cox regression analyses, adjusted for BMI,
revealed no significant effect of the graded training program
on injury risk (odds ratio [OR] = 0.8; 95% confidence interval
[CI], 0.6-1.3).
Occurrence of Running-Related Injuries
Altogether 100 RRIs were recorded: 52 in the graded train-
ing program group and 48 in the standard training program
group. A summary of injury incidence is provided in Table 3.
The absolute number of RRIs per week in each training
group is illustrated in Figure 3. In the first 7 weeks of the
standard training program, 47 RRIs were registered, com-
pared with 34 in the graded training program (relative
risk [RR] = 1.38). Most of the RRIs in the graded training
program group were seen in the fifth week of the program.
In this training week, the participants ran 44 minutes (see
Table 1). In the standard training program group, most of
the injuries were seen in the second week, when partici-
pants had to run 46 minutes. Descriptive information on
RRIs is shown in Table 4. The most frequently injured body
parts were the lower leg (40%) and the knee (37%).
TABLE 1
Training Program in Minutes Per Week for
the Graded Training Program Group and the Standard
Training Program Group
Graded Standard
Training Group Training Group
Run Walk Run Walk
(min/wk) (min/wk) (min/wk) (min/wk)
Week 1 30 30
Week 2 34 25.5
Week 3 36 24
Week 4 40 20
Week 5 44 22
Week 6 48 16 Week 1 30 30
Week 7 54 18 Week 2 46 22
Week 8 56 18 Week 3 60 18
Week 9 64 14 Week 4 50 16
Week 10 72 18 Week 5 74 16
Week 11 80 15 Week 6 90 21
Week 12 90 0 Week 7 95 5
Week 13 30 0 Week 8 30 0
© 2008 American Orthopaedic Society for Sports Medicine. All rights reserved. Not for commercial use or unauthorized distribution.
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36 Buist et al The American Journal of Sports Medicine
Randomization
Stratified by injury history, gender and sporting activities
(N=532)
Requests for participation and available for inclusion
(N=603)
Baseline assessment
(N=555)
Appointment for baseline assessment
(N=580)
23 were excluded:
8 were not novice runners
13 were injured (<3 months) at
baseline
2 had contraindications for
vigorous physical activity
25 failed to attend baseline
assessment
Allocated to graded training
program (n = 264)
32 Did not start running
14 Did not start running
236 Included in Analysis250 Included in Analysis
Allocated to standard training
program (n = 268)
23 did not react on
invitation
Invitations for novice runners to participate in the GRONORUN trial in
local media
Figure 1. The flow of participants through each stage of the GRONORUN (Groningen Novice Running) trial.
TABLE 2
Baseline Characteristics of Participants in Graded Training Program and Standard Training Program Groups
a
Characteristic Dimension/Qualifier Graded Training Program Standard Training Program Total
n 264 (113 men, 151 women) 268 (113 men, 155 women) 532 (226 men, 306 women)
Age
b
Years 40.4 (10.0) 39.2 (10.2) 39.8 (10.1)
Weight
b
Kg 78.7 (13.9) 77.0 (14.2) 77.8 (14.0)
BMI
bc
kg/m
2
25.2 (3.7) 24.6 (3.2) 24.9 (3.5)
Running experience No 131 (49.6%) 119 (44.4%) 250 (47.0%)
Yes 133 (50.4%) 149 (55.6%) 282 (53.0%)
Previous injury No 131 (49.6%) 127 (47.4%) 258 (48.5%)
>3, ≤12 months ago 69 (26.1%) 66 (24.6%) 135 (25.4%)
>12 months ago 64 (24.2%) 75 (28.0%) 139 (26.1%)
Sporting activities No 130 (49.2%) 119 (44.4%) 249 (46.8%)
With axial load 70 (26.5%) 79 (29.5%) 149 (28.0%)
Without axial load 64 (24.2%) 70 (26.1%) 134 (25.2%)
a
BMI, body mass index.
b
Values are mean ± standard deviation (in parentheses)
c
P < .05
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Vol. 36, No. 1, 2008 Graded Training and Running-Related Injuries 37
Compliance With the Program
Compliance with the program was expressed in the pro-
portion of recommended training sessions. The graded
training program group completed 24.6 ± 11.2 training ses-
sions during the intervention period (66.4% of the recom-
mended volume). The compliance in the standard training
program group (64.5% of the recommended volume) was
comparable with that of the graded training program
group. Compliance with the program was 70.6% in the
graded training program group and 69.0% in the standard
training program group if only the noninjured participants
were taken into account.
DISCUSSION
The GRONORUN trial was designed to study the effect of
a graded (ie, 10%) training program on the incidence of
RRIs. The results showed no significant effect of the more
gradual increase of running on the number of RRIs per 100
runners at risk compared with a standard 8-week training
program. On the basis of these results, our hypothesis—
that when the human body gets more time for adaptation
to running, the incidence of RRIs will decrease—should be
rejected.
To explain the absence of an effect, a variety of reasons
are discussed. A dose-response relationship has been
described between running (duration, intensity), recovery
time (frequency per week), and strengthening (or, when the
load is too much, weakening) of the musculoskeletal sys-
tem.
6
Repeatedly applied stress leads to positive remodel-
ing of musculoskeletal tissue if sufficient time is provided
between stress applications. Adequate recovery time (ie,
time between the training sessions) will result in a positive
adaptation of the musculoskeletal system to an adequate
stress stimulus of running. Hreljac
9
called this phenome-
non the stress-frequency relationship. Given this relation-
ship, various reasons for the absence of an effect in the
current study are conceivable.
First, the contrast in duration of running (ie, minutes
per week) between the 2 training programs (graded vs
standard) may have been too small to cause an effect. This
is a hypothesis that can be studied by adapting (lengthen-
ing) the graded training program in a future study. On the
other hand, if participants who are allocated to the control
group have to wait too long to start running, the number of
participants lost to follow-up probably would become too
high. Second, the intensity of running might have been a
confounding factor. Although the participants in both
groups were advised to run only at a comfortable pace at
which they could converse without breathlessness, we did
not measure the intensity of running. Third, the absence of
an effect may have been caused by the similarity of weekly
running frequency in both groups. With reference to the
dose-response relationship in running, it may not only be
the absolute training duration per week but also the inten-
sity of the training sessions as well as the frequency that
need to be taken into consideration. When there is inade-
quate time between stress applications, an overuse injury
can occur.
8,20
Additional analyses showed that the number of RRIs per
1000 hours of running exposure was 30 (95% CI, 22-38) in
the graded training program group versus 38 (95% CI, 27-
49) in the standard training group. Even though this seems
TABLE 3
Incidence of RRI per 100 Runners at Risk and per 1000
Hours of Running Exposure in Graded and Standard
Training Program Groups
a
Graded Standard
Training Training
Program Program Total
(n = 250) (n = 236) (N = 486)
Absolute number 52 48 100
of RRIs
RRI/100 runners 20.8 20.3 20.6
at risk
b
(15.8-25.8) (15.2-25.4) (17.0-24.2)
RRI/1000 hours 30 38 33
of exposure
b
(22-38) (27-49) (27-40)
a
RRI, running-related injury.
b
Numbers in parentheses represent 95% confidence interval.
Figure 2. A, Kaplan-Meier plot of RRI (running-related injury)
survival between all participants of the graded training program
group and standard training program group. Approximately
80% in both groups stayed injury free. B, Kaplan-Meier plot
of RRI survival between injured participants of the graded
training program group and standard training program group.
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38 Buist et al The American Journal of Sports Medicine
a disparity, the number of RRIs per 1000 hours of exposure
was not significantly different. Care should be taken when
interpreting this result as the study was not set up in a way
that could identify such an effect size. It takes many more
participants than we had to identify an effect expressed in the
number of RRIs per 1000 hours of exposure to running. The
results of the additional analyses on survival time also
showed no differences between the graded training program
group and the standard training group. Although the mean
time to the occurrence of an RRI was 45 minutes longer (212
vs 167 minutes) in participants of the graded training pro-
gram, this difference in exposure time was not significant.
In the literature, little information is available on the inci-
dence of RRI in novice runners. In the GRONORUN trial,
the overall incidence of RRI was 20.6 per 100 runners.
Differences in the definition of RRI, as well as the way of
collecting information on RRI, make it difficult to compare
the GRONORUN study with another. Furthermore, only
few of the studies in the literature followed runners for a
comparable short period of time.
The “Vancouver Sun Run” study
24
showed an injury inci-
dence of 29.5 per 100 runners at risk in a group of novice
runners following a 13-week training program, preparing
for a 10-km running event. The training program of the
Vancouver Sun Run
24
was designed by sports physicians to
minimize the risk of sustaining an injury during the train-
ing period. The recommended running frequency was iden-
tical to that used in the GRONORUN trial, that is, 3 times
a week. Unfortunately, neither the content nor the ration-
ale for the program was reported.
Comparison of the incidence of RRI in the GRONORUN
study to the Vancouver Sun Run study is complicated by
differences in definition of an RRI. In the Vancouver Sun
Run study, a runner was defined injured in case of report-
ing running-related pain during or after running. In our
trial, severity (ie, restriction of running) and a minimal
duration of 1 week was added. If our definition was
changed in to the definition used by Taunton et al,
24
the
number of RRIs would be 34.3 per 100 runners at risk—
higher than in the Vancouver Sun Run study.
A second study that also involved runners with little or no
running experience showed an incidence of 58 RRIs per 100
runners at risk.
3
In this study, participants trained for a 15-
km run during the first period of 28 weeks. Any running-
related pain causing restriction in running distance, speed,
duration, or frequency was considered to be an injury. When
the overall incidence per 1000 hours of running exposure is
compared with data from the literature, it can be concluded
that the incidence was higher (33/1000 hours) than that
reported in the literature (12/1000 hours).
3
A significant dif-
ference between this study and the GRONORUN trial is that
participants were intending to run a marathon at the end of
TABLE 4
Absolute Number and Percentage of RRIs
per Anatomical Site per Group
a
Graded Training Standard Training
Program, n = 250 Program, n = 236 Total N = 486
(% of injuries) (% of injuries) (% of injuries)
Hip/back 6 (11.5%) 3 (6.3%) 9 (9%)
Upper leg 2 (3.8%) 2 (4.2%) 4 (4%)
Knee 17 (32.7%) 20 (41.7%) 37 (37%)
Lower leg 22 (42.3%) 18 (37.5%) 40 (40%)
Ankle/foot 5 (9.6%) 5 (10.4%) 10 (10%)
Total 52 (100%) 48 (100%) 100 (100%)
a
RRIs, running-related injuries.
Figure 3. The absolute number of new running-related injuries (RRIs) per group in each week of the training program.
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Vol. 36, No. 1, 2008 Graded Training and Running-Related Injuries 39
the training period of 20 months. In the GRONORUN trial,
participants were recruited only to train for a 4-mile run.
As shown in other studies, over 75% of the RRIs were
localized from the knee and below.
3,14,24
The anatomical
distribution of RRIs in the GRONORUN trial was in agree-
ment with these findings, that is, the knee (37%) and the
lower leg (40%) were the most injured body parts.
Prevention of RRIs is an important issue in sports medi-
cine. Running, as a form of recreational exercise, is a sport
practiced by many individuals to improve cardiorespiratory
function and health. Novice runners are often physically inac-
tive before they start to run. In the Vancouver Sun Run
study
24
and our study, almost half of the participants were
primarily sedentary and deconditioned people. On the
Internet and in running stores and running magazines, many
so-called “training programs for novice runners” preparing for
a 5-km or 10-km running event in a relatively short period of
time can be found. To prevent RRIs, which still happen in 20%
to 50% of the novice runner population, the current results
show that more research is needed on the relationship
between intensity, frequency, and the duration of training and
injury risk, and other potentially possible modifiable risk fac-
tors. In a future study, the intervention duration should be
lengthened, taking the increase of weekly product of running
frequency, intensity, and duration into careful consideration.
CONCLUSIONS
This study showed that there is no effect of a graded “10%
rule” training program for novice runners on the number
of RRIs per 100 runners at risk, compared with a standard
training program. We hypothesized that novice runners
need adequate time for the musculoskeletal system to
adapt to running. Preparing to participate in a 4-mile run,
it does not matter how you get there (either fast or slow)—
the risk of sustaining an RRI is the same. Future research
should focus on the dose-response relationship between
running and the development of RRIs in (novice) recre-
ational and competitive runners.
ACKNOWLEDGMENT
This study was funded by the Netherlands Organisation
for Health Research and Development (ZonMW), grant
number 750-10-003.
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