Wednesday, April 2, 2014

Cellulite and Focused Extracorporeal Shockwave Therapy for Non-Invasive Body Contouring: a Randomized Trial

Dermatol Ther (Heidelb). Dec 2013; 3(2): 143–155.

Published online Dec 3, 2013. doi:  10.1007/s13555-013-0039-5
PMCID: PMC3889306

Cellulite and Focused Extracorporeal Shockwave Therapy for Non-Invasive Body Contouring: a Randomized Trial

Abstract

Introduction

Focused
extracorporeal shockwave therapy (ESWT) has been demonstrated to
improve wound healing and skin regeneration such as in burn wounds and
scars. We hypothesized that the combination of focused ESWT and a daily
gluteal muscle strength program is superior to SHAM-ESWT and gluteal
muscle strength training in moderate to severe cellulite.

Methods

This
was a single-center, double-blinded, randomized-controlled trial. For
allocation of participants, a 1:1 ratio randomization was performed
using opaque envelopes for the concealment of allocation. Eligible
patients were females aged 18–65 years with cellulite. The primary
outcome parameter was the photo-numeric Cellulite Severity Scale (CSS)
determined by two blinded, independent assessors. The intervention group
(group A) received six sessions of focused ESWT (2,000 impulses,
0.35 mJ/mm2, every 1–2 weeks) at both gluteal and thigh
regions plus specific gluteal strength exercise training. The control
group (group B) received six sessions of SHAM-ESWT plus specific gluteal
strength exercise training.

Results

The CSS in group A was 10.9 ± 3.8 (mean ± SE) before intervention and 8.3 ± 4.1 after 12 weeks (P = 0.001,
2.53 improvement, 95% confidence interval (CI) 1.43–3.62). The CSS in
group B was 10.0 ± 3.8 before intervention and 10.1 ± 3.8 after 12 weeks
(P = 0.876, 95% CI 1.1–0.97). The change of the CSS in group A versus group B was significantly different (P = 0.001, −24.3 effect size, 95% CI −36.5 to −12.1).

Conclusion

The combination of non-invasive, focused ESWT (0.35 mJ/mm2,
2,000 impulses, 6 sessions) in combination with gluteal strength
training was superior to gluteal strength training and SHAM-ESWT in
moderate to severe cellulite in terms of the CSS in a 3-month
perspective. Long-term results have to be evaluated in terms of the
sustainability of these effects.

Electronic supplementary material

The
online version of this article (doi:10.1007/s13555-013-0039-5) contains
supplementary material, which is available to authorized users.
Keywords: Aesthetics, Body contouring, Cellulite, Dermatology, Extracorporeal shock wave therapy, Strength training

Introduction

Cellulite is a widespread problem involving the buttocks and thighs of the female-specific anatomy [1].
The higher number of fat cells stored in female fatty tissue in
contrast to males, the gender-specific dimorphism with subdermal septae
orientated orthogonally toward the skin, and the aging process of
connective tissue lead to an imbalance between lipogenesis and lipolysis
with subsequent large fat cells bulging the skin [1].
Recently, a case–control study in 15 lean women suffering from
cellulite, and age- and body mass index (BMI)-matched controls
identified significantly reduced adiponectin expression using reverse
transcription polymerase chain reaction among the cellulite-affected
patients [2].
Cellulite appears to potentially impair quality of life of affected
females substantially. It appears that younger females affected by
cellulite suffer more in terms of impaired quality of life than more
mature females [3].
Non-randomized
clinical data suggest that extracorporeal shock wave therapy (ESWT) is
beneficial in terms of improved skin elasticity and revitalizing dermis
in females with cellulite [4, 5].
Potentially, a direct effect on the associated lymphedema is a further
potential consequence of ESWT application in cellulite. A recent Korean
prospective clinical trial evaluated the effect of four ESWT sessions
(0.056–0.068 mJ/mm2, 2,000 impulses, ESWT device from Dornier AB2) within 2 weeks in patients suffering from secondary lymphedema [6].
Both the circumference and the thickness of the skin fold of the
affected region were significantly reduced by as much as 37% in line
with a pain reduction on the visual analogue scale [6]. In systemic sclerosis, ESWT is able to again improve pain and the Rodnan skin score for skin wellness [7].
To date, a limited number of non-controlled studies (two Level III [4, 8] and two Level IV studies [9, 10]) examined the effect of ESWT on cellulite with various outcome measures (Table 1).
Table 1
Evidence
levels of currently published clinical trials on the effect of
extracorporeal shock wave therapy (ESWT) on cellulite with different
outcome measures applied
Recently, a small size (n = 25) randomized-controlled trial (RCT) with large confidence intervals (CIs) has been published (level 2 evidence) [11]. The trial involved six sessions over 4 weeks using the STORZ D-ACTOR® 200 by Storz Medical (Tägerwilen, Switzerland) improved depressions, elevations, roughness, and elasticity within 3 months.
Beyond the aforementioned RCT [11],
with small sample size and large confidence intervals, we do not have
any high-level 1b evidence to support the use of focused ESWT for
non-invasive body contouring in cellulite. In addition, we do not know
whether or not and if, to what extent the validated photo-numeric
Cellulite Severity Scale (CSS) is changed by six sessions of focused
ESWT. Currently, we do not have any high-level 1b evidence regarding the
effect of gluteal home-based strength training with or without focused
ESWT on the clinical outcome in cellulite in terms of digital images,
microcirculation and patient self-reported assessment. Given these facts
we sought to overcome these issues and performed a double-blinded, RCT
providing level 1b evidence on the use of focused ESWT in addition to
daily gluteal strength training in various degrees of cellulite. We
hypothesized that the combination of ESWT and a daily gluteal muscle
strength program is superior to SHAM-ESWT and a gluteal muscle strength
program in cellulite.

Methods

The study protocol was composed according to the most recent CONSORT 2010 recommendations for transparent reporting of RCTs [12, 13]. The study protocol according to the CONSORT recommendations has been published previously [14].

Ethics and Trial Registration

This
RCT was approved in May 22, 2009 by the ethics institutional review
board at Hannover Medical School, Germany, under the German title
“Stosswellentherapie und Krafttraining zur Therapie der Cellulite—eine
randomsiert-kontrollierte Studie” (Nr. 5206). The study is
internationally registered at ClinicalTrials.gov with ClinicalTrials.gov
identifier: NCT00947414.
All
procedures followed were in accordance with the ethical standards of the
responsible committee on human experimentation (institutional and
national) and with the Helsinki Declaration of 1975, as revised in 2000
and 2008. Informed consent was obtained from all patients for being
included in the study and for the publication of patient photographs.

Study Design

This was a single-center, double-blinded, RCT with a 1:1 parallel group randomization.

Participants

The
mean age of the enrolled participants was 41.4 years in the
intervention group and 45.0 years in the control group. BMI (mean ± SE)
was 24.2 ± 3.2 kg/m2 in the intervention group and 25.3 ± 4.5 kg/m2 in the control group.
Eligible
patients were females aged between 18 and 65 years with documented
cellulite 0° to 3° according to the Nürnberger Müller score [1].
Exclusion criteria were the following: suspected or evident pregnancy,
no cellulite, no informed consent, and age under 18 years or above
65 years. Patients were recruited by advertisements in local regional
newspapers and via the Internet. The patient enrollment flow chart
according to the CONSORT statement is outlined in Fig. 1.
Fig. 1
CONSORT patient flow chart. Modified with permission from Knobloch et al. [14]

Interventions

In CelluShock-2009 patients were randomly assigned with a 1:1 ratio to either ESWT with 0.35 mJ/mm2 in the intervention group or 0.01 mJ/mm2 in the SHAM-ESWT group. Both groups additionally participated in a home-based, daily gluteal thigh exercise program.
The intervention group received six sessions of ESWT (every 1–2 weeks) with focused shock waves (2,000 impulses, 0.35 mJ/mm2, Fig. 2) plus home-based, daily gluteal strength exercises (Figs. 3, ,4).4). The control group received six sessions of SHAM-ESWT (2,000 impulses, 0.01 mJ/mm2,
every 1–2 weeks) plus home-based, daily gluteal strength exercises.
Extracorporeal shock wave therapy was applied using a STORZ focused
Duolith machine (Taegerwilen, Suisse) as acoustic wave treatment.
Fig. 2
Placement of the shockwave probe from distal to proximal on both thighs
Fig. 3
First exercise (15 repetitions per leg twice a day over 12 weeks)
Fig. 4
Second exercise (15 repetitions per leg twice a day over 12 weeks)
In
order to increase the motivation of the participating females,
especially in terms of follow-up, we added a daily, home-based gluteal
strength exercise program. Twice a day (in the morning and the evening),
two different exercises focusing on the gluteal muscles involving the
piriformis, the gemelli, and the gluteal muscles were performed with 15
repetitions for each leg (Figs. 1, ,2).2).
The compliance to the daily gluteal workout program was noted in a
exercise log to improve and supervise participants’ compliance,
respectively.

Primary and Secondary Outcome Measures

The
primary endpoint, with respect to efficacy of the combined ESWT and
gluteal strength exercises versus SHAM-ESWT and the same gluteal
strength exercise program, was the change on digital photographs
3 months after the last ESWT treatment assessed by the validated CSS [15].
This provided reliable, comprehensive, and reproducible results.
Cellulite severity may be classified according to the result of this
assessment in the CSS in three degrees, as described in Table 2.
Table 2
Cellulite Severity Scale of mild, moderate or severe degree
The
classification was performed based on standardized photographs taken by
a professional medical photographer at baseline and 12 weeks after the
last ESWT treatment in both groups. The assessment of the anonymous
digital images was carried out by two blinded assessors who were not
aware of either the study arm or the fact that it is a baseline or a
follow-up photograph taken 12 weeks after the last ESWT treatment in
both groups.
In order to overcome the problems of
interpretation associated with multiplicity of analyses we decided to
choose the aforementioned clinical endpoint which is a visual one as the
primary endpoint and results as secondary endpoints in CelluShock.
Secondary
endpoints of the CelluShock RCT were as follows: change of
circumference of the thigh (cm), skin elasticity using the Cutometer® (Cutometer MPA 580, Kosmetik Konzept KOKO GmbH & Co KG, Leichlingen, Germany) [1619], and self-assessment of the success on a visual analogue scale 0–10 (0 = no change, 10 = fully satisfied).
All patients were measured at baseline and after 12 weeks regarding the primary and all secondary endpoints.

Power Calculation

To
detect at least a change of two points in the CSS of cellulite, with a
two-sided, 5% significance with an 80% power, a sample size of 26
participants with an estimated drop-out rate of 15% was calculated. This
was done prior to the start of trial.

Randomization and Allocation Sequence

For
allocation of participants, a 1:1 ratio randomization was performed
using opaque envelopes for the concealment of allocation. The allocation
sequence was concealed from the researcher (BJ) enrolling and assessing
participants in sequentially numbered, opaque, sealed envelopes [20].

Blinding

Blinding
was achieved for all participants enrolled in the trial, the
photographer taking the digital images for the primary outcome measure,
the two assessors of the outcome measures, all additional health care
providers, and for the analyst from the biometrical department. Only one
researcher (BJ) was aware of the group assignment performing the
randomization and the ESWT.
The
assessment of the primary and secondary outcomes was performed by
blinded assessors independently from each other, unaware whether the
digital image displayed was before or after therapy or with group
(intervention or control group) was randomized.

Statistical Analysis

The
primary endpoint was change of CSS assessed on digital, standardized
photographs by two independent expert examiners. Student’s t test was applied for parametric data, the Wilcoxon test for non-parametric data, and a level of P < 0.05
was reported as significant. An intention-to-treat analysis was
applied. SPSS (IBM Corp., New York, USA) was used to carry out the
analysis.

CONSORT Flow Chart

Figure 1 highlights the patient flow throughout the CelluShock-2009 RCT (Fig. 1).

Results

Primary Outcome Measure—Cellulite Severity Scale

The
CSS (mean ± SE) in the intervention group was 10.9 ± 3.8 before and
8.3 ± 4.1 after the combined ESWT and strength exercise intervention (P = 0.001, 2.53 improvement (+24%), 95% CI 1.43–3.62) (Figs. 5, ,6,6, ,7,7, ,8,8, ,9,9, ,10;10; Table 3). The CSS in the control group was 10.0 ± 3.8 before and 10.1 ± 3.8 after the SHAM-ESWT and strength exercise intervention (P = 0.876,
95% CI −1.1 to 0.97). The change of the CSS in the intervention group
versus the control group was significantly different (P = 0.001, −24.3 effect size, 95% −36.5 to −12.1).
Fig. 5
Improvement
of the Cellulite Severity Score from 15 to 7 in a female patient
suffering from cellulite before and 3 months after six sessions of
focused extracorporeal shockwave therapy (0.35 mJ/mm2)
Fig. 6
Improvement
of the Cellulite Severity Score from 12 to 2 in a female patient
suffering from cellulite before and 3 months after six sessions of
focused extracorporeal shockwave therapy (0.35 mJ/mm2)
Fig. 7
Improvement
of the Cellulite Severity Score from 10 to 6 in a female patient
suffering from cellulite before and 3 months after six sessions of
focused extracorporeal shockwave therapy (0.35 mJ/mm2)
Fig. 8
No
significant improvement of the Cellulite Severity Score from 13 to 11
in a female patient suffering from cellulite before and 3 months after
six sessions of sham extracorporeal shockwave therapy (0.01 mJ/mm2, control group)
Fig. 9
No
improvement of the Cellulite Severity Score from 4 to 5 in a female
patient suffering from cellulite before and 3 months after six sessions
of sham extracorporeal shockwave therapy (0.01 mJ/mm2, control group)
Fig. 10
Change
of the Cellulite Severity Score before and 3 months after six sessions
of either focused extracorporeal shockwave therapy (ESWT) (0.35 mJ/mm2, intervention group) or SHAM-ESWT (0.01 mJ/mm2, control group)
Table 3
Number
of patients in each group according to the Cellulite Severity Scale in
the intervention and the control group prior and after the intervention
The
results for the five items of the CSS, the cutometer data, and the
thigh circumferences are reported below; all values are given as
mean ± SE unless otherwise stated.

Number of Depressions

The number of depressions in the intervention group was 2.2 ± 0.8 at baseline and 1.8 ± 0.9 at follow-up (P = 0.001,
improvement 0.41, 95% CI 0.17–0.65). The number of depressions in the
control group was 2.0 ± 0.8 at baseline and 2.0 ± 0.7 at follow-up (P = 0.534,
95% CI −0.30 to 0.16). The change of the number of depressions in the
intervention versus the control group was significantly different (P = 0.012, −20.0 effect size, 95% CI −34.8 to −4.4).

Depth of Depressions

The depth of depressions in the intervention group was 2.2 ± 0.8 at baseline and 1.6 ± 0.8 at follow-up (P = 0.001,
0.61 improvement, 95% CI 0.39–0.84). The depth of depressions in the
control group was 2.0 ± 0.8 at baseline and 2.0 ± 0.7 at follow-up (P = 1.0,
95% CI −0.24 to 0.24). The change of the depth of depressions in the
intervention group versus the control group was significantly different (P = 0.001, −31.3 effect size, 95% CI −46.0 to −16.6).

Morphological Appearance of Skin Surface Alterations

The
morphological appearance of skin surface alterations in the
intervention group was 2.2 ± 0.8 at baseline and 1.6 ± 0.8 at follow-up (P = 0.001,
0.6 improvement, 95% 0.36–0.8). The morphological appearance of skin
surface alterations in the control group was 1.9 ± 0.8 at baseline and
1.9 ± 0.6 at follow-up (P = 0.837, 95% CI −0.20 to 0.25). The
change of the morphological appearance of skin surface alterations in
the intervention group versus the control group was significantly
different (P = 0.007, −16.6 effect size, 95% CI −28.7 to −4.6).

Grade of Laxity, Flaccidity or Sagging Skin

The grade of laxity, flaccidity or sagging skin in the intervention group was 2.2 ± 0.8 at baseline and 1.6 ± 0.8 at follow-up (P = 0.001,
0.5 improvement, 95% CI 0.27–0.73). The grade of laxity, flaccidity or
sagging skin in the control group was 2.0 ± 0.9 at baseline and
2.1 ± 0.8 at follow-up (P = 0.516, 95% CI −0.34 to 0.17). The
change of the grade of laxity, flaccidity or sagging skin in the
intervention group versus the control group was significantly different (P = 0.001, −25.1 effect size, 95% CI −39.6 to −10.6).

Classification Scale by Nürnberger and Müller

The
classification scale by Nürnberger and Müller in the intervention group
was 2.2 ± 0.8 at baseline and 1.8 ± 0.9 at follow-up (P = 0.001,
0.5 improvement, 95% CI 0.3–0.8). The classification scale by
Nürnberger and Müller in the control group was 2.1 ± 0.8 at baseline and
2.1 ± 0.7 at follow-up (P = 1.0, 95% CI −0.22 to 0.22). The
change of the classification scale by Nürnberger and Müller in the
intervention group versus the control group was significantly different (P = 0.043, −24.4 effect size, 95% CI −37.7 to −11.1).

Change of Circumference of the Thigh and Body Mass Index

The change of thigh circumference in the intervention group was 61.5 ± 6.2 cm at baseline to 61.0 ± 5.9 cm at follow-up (P = 0.760,
95% CI −2.91 to 3.97). There was no change of thigh circumference in
the control group (61.6 ± 6.9 cm) at baseline versus follow-up
(61.6 ± 6.9 cm; P = 0.996; 95% CI −4.28 to 4.31). Pre- and
post-treatment body weight index did not change in either group
significantly beyond 3%.

Skin Elasticity Using the Cutometer®

The skin elasticity in the intervention group was 14.1 ± 2.5% at baseline and 14.1% ± 1.6 at follow-up (P = 0.963; 95% CI −1.22 to 1.16).
The skin elasticity in the control group was 14.4% ± 1.8 at baseline and 14.1% ± 1.9 at follow-up (P = 0.676; 95% CI −0.91 to 1.38).

Discussion

The combination of focused ESWT (0.35 mJ/mm2,
2,000 impulses, 6 sessions) in combination with gluteal strength
training was superior to a gluteal strength training alone in terms of
the CSS in a 3-month perspective. The significant mean improvement was
24% in the intervention group in contrast to the control group, a
clinically meaningful difference. Second, the SHAM-ESWT and the gluteal
strength training were not able to change the CSS.
The
strengths of this double-blinded, randomized clinical trial are the
independent assessment by two expert examiners who were blinded to both
the patients and the group allocation. Both experts assessed the
digitalized standardized photographs independently and the mean of both
assessments was applied. Second, this is the first registered,
double-blinded, randomized clinical trial to assess the effects of a
gluteal strength training and the combination with focused ESWT. Third,
standardized photographs were taken by a clinical photographer
independently from the study team. Fourth, the control group received
SHAM-ESWT (0.01 mJ/mm2, 2,000 impulses, 6 sessions) which did
not appear to have any clinical effect in terms of the CSS at all, with
identical values before and after the intervention.
However,
to date we cannot estimate the long-term efficacy and sustainability of
the aforementioned clinical effects in a perspective of one or more
years. It is possible that, after a year, an additional treatment might
be warranted, such as a touch-up procedure. In our personal experience,
select cases might benefit even longer than 1 year from a set of six
focused shockwave sessions, but this is only a non-controlled
observation.
The results of this randomized clinical
study should be discussed in detail. The CSS is a validated
photo-numeric Cellulite Severity Scale, which has been published in 2009
by Dr. Hexsel and coworkers [15].
Beyond the well-known Nürnberger and Müller score ranging from 0° to
3°, this validated score appears to better reflect even modest to small
changes of a given therapeutic intervention. The CSS has a high
intraclass correlation coefficient of 0.9 or more and ranges from 1 to
15. Three clinical cellulite severity grades have been proposed by
Hexsel et al. [15] (Table 2).
Given our patients, we included the majority of patients with moderate
to severe degrees of cellulite. This is partially reflected by the mean
age beyond 40 years and the BMI beyond 24.2 kg/m2 in both groups.
As
far as the underlying mechanisms of the evident improvements in the CSS
are concerned, a “mechanical” response might be evident as well as a
“regenerative” response of the afflicted skin.
In terms
of the “mechanical” perspective, one might speculate that the focused
extracorporeal shockwave has somewhat disrupted either the fat
components or the septae or both, which might lead to a smoothening of
the afflicted skin. MR imaging has shown that fibrous septa are
visualized in 97% of the area with cellulite depressions, which are
markedly thickened in cellulite afflicted areas [21]. Shockwave energy might have weakened the fibrous septae and thus the afflicted skin became smoother.
Reduction
of lymphedema is a second potential underlying mechanism. Recently, a
significant reduction of lymphedema was reported clinically following
four ESWT sessions in females with secondary lymphedema following breast
cancer treatment [6].
In animal experiments ESWT and the vascular endothelial growth factor
(VEGF-C) hydrogel appear to exert a synergistic effect in promoting
lymphangiogenesis [22].
On
the other hand, ESWT might somewhat influence mesenchymal stem cells.
There is evolving experimental data suggesting that shockwave therapy
activation pathways in adipose-derived stem cells [23].
Clinically, diseased skin appears to normalize following shockwave
treatment such as in progressive systemic sclerosis with an up
regulation of endothelial progenitor cells and circulating endothelial
cells [24].
Energy flux density of the focused ESWT is another issue to concern. We used low to medium energy flux densities of 0.35 mJ/mm2
with 1,000 impulses on each thigh with 4 Hz. To date, we do not know in
controlled trials whether potentially higher energy flux densities such
as up to 1.24 mJ/mm2 might be even more beneficial in terms
of the potential disruption of the fibrous septae in the
cellulite-afflicted areas. On the other hand, stem-cell activation might
be achieved by rather low-energy flux densities in regard of the
aforementioned potential underlying “regenerative” mechanisms.
To date, only small size, controlled trials with wide CIs have been published [7, 25].
We tried to overcome the methodological shortcomings of previous trials
in CelluShock-2009. In regard to different techniques, there are
evolving clinical data that, for example, low-level laser therapy with
532 nm wave lengths appears to improve cellulite in a double-blind,
placebo-controlled, randomized trial [26]. 1,064 nm Nd:YAG laser appears to improve mild to moderate cellulite also [27]. Radiofrequency is able to reduce cellulite in a randomized trial [28].

Limitations

Given
our randomized, double-blinded clinical trial, some limitations have to
be considered when interpreting our data. First, the extent of
cellulite reflected by digital unprocessed images assessed by two
independent examiners was chosen to overcome some types of biases.
However, a digital image does not necessarily reflect or even replace a
clinical examination including a pinch test. However, we sought to
address as objective as possible the outcome based on digital images.
Those images were produced by a clinical plastic surgical professional
photographer under the very same circumstances to overcome issues such
as angle of the photograph, lighting, among others. To date, we can only
report the short-term results 3 months following ESWT. We do not know
the long-term effects in terms of efficacy and sustainability of six
sessions of focused ESWT in cellulite to date.

Conclusion

The combination of focused ESWT (0.35 mJ/mm2,
2,000 impulses, 6 sessions) with gluteal strength training was superior
to SHAM-ESWT and gluteal strength training in moderate to severe
cellulite in terms of the CSS in a RCT. The mean improvement was 24% in
the intervention in contrast to the control group. Second, the SHAM-ESWT
and gluteal strength training were not able to change the CSS in a
3-month perspective. Long-term data are warranted to elucidate the
sustainability of the aforementioned clinical effects.

Electronic supplementary material

Acknowledgments

Prof.
Knobloch is the guarantor for this article and takes responsibility for
the integrity of the work as a whole. Article processing charges are
supported by Storz Medical AG, Tägerwilen, Switzerland.

Conflict of interest

The
principal investigator K. Knobloch has been a speaker for Storz Medical
AG (Tägerwilen, Switzerland) after the end of this
randomized-controlled trial on various indications for ESWT which had no
influence on this RCT.
B. Joest, R. Krämer, and P. M. Vogt declare no conflict of interest.
No company had any financial or intellectual influence on the design, the execution or the results of this RCT.

Compliance with ethics guidelines

This
RCT was approved May 22, 2009 by the ethics institutional review board
at Hannover Medical School, Germany, under the German title
“Stosswellentherapie und Krafttraining zur Therapie der Cellulite—eine
randomsiert-kontrollierte Studie” (Nr. 5206). The study is
internationally registered at ClinicalTrials.gov with ClinicalTrials.gov
identifier: NCT00947414.
All
procedures followed were in accordance with the ethical standards of the
responsible committee on human experimentation (institutional and
national) and with the Helsinki Declaration of 1975, as revised in 2000
and 2008. Informed consent was obtained from all patients for being
included in the study and for the publication of patient photographs.

Open Access

This
article is distributed under the terms of the Creative Commons
Attribution Noncommercial License which permits any noncommercial use,
distribution, and reproduction in any medium, provided the original
author(s) and the source are credited.

Footnotes

ClinicalTrials.gov identifier: NCT00947414.

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