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ORIGINAL ARTICLE

Botulinum toxin type A (Botox) for the


neuromuscular correction of excessive gingival
display on smiling (gummy smile)
Mario Polo
San Juan, Puerto Rico

Introduction: Previously, botulinum toxin type A (BTX-A) (Botox; Allergan, Irvine, Calif) was shown to be
effective in reducing excessive gingival display in 5 patients with gummy smiles. This study was conducted
to determine whether the doses and the primary injection sites used in the pilot study for the correction of
gummy smiles provide consistent, statistically significant, and esthetically pleasing results. Methods: Thirty
patients received BTX-A injections to reduce excessive gingival display. Gingival display was defined as the
difference between the lower margin of the upper lip and the superior margin of the right incisor. Patients
were followed at 2, 4, 8, 12, 16, 20, and 24 weeks postinjection, with changes documented by photographs
and videos. At week 2, the patients rated the effects of BTX-A. A group of specialty clinicians also evaluated
the effects of BTX-A. Results: Preinjection gingival display averaged 5.2 ⫾ 1.4 mm in the 30 patients. At 2
weeks postinjection, mean gingival display had declined to 0.09 mm (⫾ 1.06 mm) in 30 patients (t ⫽ 26.01,
P ⬍.00001). The average lip-drop at 2 weeks was 5.1 mm for 30 patients. Gingival display gradually
increased from 2 weeks postinjection through 24 weeks, but, at 24 weeks, average gingival display had not
returned to baseline values. Based on predictions from a third-order polynomial equation, the baseline
average of 5.2 mm would not be reached until 30 to 32 weeks postinjection. Patients and specialty evaluators
rated the effects of BTX-A as highly favorable. Conclusions: BTX-A injections for the neuromuscular
correction of gummy smiles caused by hyperfunctional upper lip elevator muscles was effective and
statistically superior to baseline smiles, although the effect is transitory. (Am J Orthod Dentofacial Orthop
2008;133:195-203)

D
uring the last decade, the demand for cosmetic ways; the 2 primary ones are alignment of the dentition
services has increased considerably in many and balancing of the patient’s profile. Additionally,
parts of the world. Several medical specialties measures to improve the smile are often-sought proce-
providing cosmetic services have witnessed increases dures. In particular, those with a “gummy smile,” so
in procedures that enhance physical traits, reverse the called due to excessive display of gingival tissue in the
effects of aging, and improve esthetics. Cosmetic sur- maxilla on smiling, can be self-conscious, embarrassed,
gical procedures, the use of botulinum toxin type A or even psychologically affected, and thus seek inter-
(BTX-A) (Botox; Allergan, Irvine, Calif) and dermal vention.5
fillers, orthodontic and orthognathic procedures, dental Previously, Polo reported the benefits of BTX-A
bleaching, and other dental cosmetic procedures are were reported in 5 patients with gummy smiles.6 The
widely requested by adults.1-4 An undeniable psycho- purpose of that pilot study was to determine whether
logical benefit of cosmetic procedures is the increase in injecting BTX-A at particular muscle sites could pro-
self-esteem.5 In turn, improvement in self-esteem vide an alternative therapy for gummy smiles caused by
changes the scope of several of these cosmetic proce- hypercontractibility or excessive muscle contraction.
dures to another level: therapeutic. In orthodontics, The results were encouraging. The objective of this
facial esthetics are enhanced in several conventional investigation was to determine whether the doses and
the primary injection sites used in the pilot study for the
Private practice; orthodontist, medical faculty, Department of Surgery, San correction of gummy smiles provide consistent, statis-
Jorge Children’s Hospital/Plastic and Reconstructive Center, San Juan, Puerto tically significant, and esthetically pleasing results. A
Rico.
Reprint requests to: Mario Polo, 702 La Torre De Plaza, 525 F.D. Roosevelt diversified group of health care professionals involved
Ave, San Juan, PR 00918-0702, e-mail, drmariopolo@mariopolo.com. in various cosmetic treatments also served as evalua-
Submitted, December 12, 2006; revised and accepted, April 3, 2007. tors. The goal was to identify a consistent, minimally
0889-5406/$34.00
Copyright © 2008 by the American Association of Orthodontists. invasive alternative for the correction of gummy smiles
doi:10.1016/j.ajodo.2007.04.033 caused by hyperfunctional upper lip elevator muscles.
195
196 Polo American Journal of Orthodontics and Dentofacial Orthopedics
February 2008

Gummy smiles with etiology other than hyperfunc-


tional upper lip elevator muscles (eg, vertical maxillary
excess or delayed passive dental eruption) are beyond
the scope of this study. Hyperfunctional, or hypertonic,
muscles are excessively active muscles with greater
than normal contraction potential. The term short upper
lip is sometimes used to describe the upper lip when
referring to this muscular state. A diminished vertical
dimension or length of the upper lip along its midline
portion (philtrum) is often observed. The National
Library of Medicine and the National Institutes of
Health’s website at www.pubmed.gov presently lists 37
citations for “hyperfunctional muscles.” Fig 1. Reference points and linear measurements for
preinjection and postinjection assessments.
MATERIAL AND METHODS
This study’s inclusion criteria were excessive gin- graphic and video recording session. Photos were
gival display on smiling secondary to hyperfunctional obtained by using a Nikon D70s Digital SLR camera
upper lip elevator muscles (when etiology also included with a Nikkor 60-mm micro lens (Nikon, Tokyo,
another factor, ie, delayed passive dental eruption or Japan). Videos were captured with a Canon PowerShot
excessive gingival tissue due to hypertrophy, the sec- S230 Digital Elph camera (Canon, Tokyo, Japan).
ond factor was corrected before the study); at least Facial photos and videos were taken at a distance of 4
3.0-mm gingival display on unrestricted, nonposed, feet from the subjects. Facial photos and videos were
“full-blown” smiling; and no vertical maxillary excess, again taken during the first follow-up visit at week 2.
as determined by lateral radiographic skull views and Only photos, no videos, were taken during the remain-
cephalometric measurements. Subjects with known al- ing follow-up visits. The same equipment was used in
lergy to BTX-A or albumin, or history of previous all sessions throughout the study (preinjection and 7
BTX-A injections to the head or neck were excluded postinjection visits). Effort was placed on subjects
from the study. Also excluded were persons with achieving nonposed, spontaneous smiles, as described
amyotrophic lateral sclerosis, motor neuropathy, myas- by Sarver and Ackerman.7 The photos and videos were
thenia gravis, or Lambert-Eaton syndrome; pregnant downloaded into a PowerMac G4 and evaluated on a
women and those planning a pregnancy or capable of 23-in Apple Cinema HD Digital Display (Apple Com-
becoming pregnant by not using or not willing to use a puter, San Jose, Calif). Adobe Photoshop CS2 software
reliable form of birth control during the study; breast- (Adobe Systems, San Jose, Calif) was used.
feeding women; subjects participating in a study of Close-up perioral photos were also taken at all 8
another drug or device; patients using certain medica- visits. Extreme effort was placed on obtaining standard-
tions such as aminoglycosides, anticholinesterases, and ized, nonposed, spontaneous smiles. To elicit full,
other agents interfering with neuromuscular transmis- unrestricted, unposed, spontaneous smiles, extremely
sion; and those with vertical maxillary excess. A funny jokes were told to the subjects. No attempt to
negative blood pregnancy test (␤ hCG test), performed restrain or control the smiles was ever made. The
1 to 4 hours before injection was required for all female following reference points (RP) and linear measure-
subjects of child-bearing age. ments were established (Fig 1).
The trial protocol, risks of the intervention, possible
1. RP1: the lowest margin of the upper lip perpendic-
side effects of BTX-A, and legal rights were presented
ular and superior to the midportion of the maxillary
to the subjects and the parents, if applicable, before
central incisor’s gingival margin.
their participation in the study. All subjects (or parent
2. RP2: the maxillary central incisor’s gingival margin
when the subject was younger than 21 years) signed an
at its midpoint.
informed consent. The institutional review board and
3. RP3: the midpoint of the incisal edge of the
medical ethics committee from a local hospital and
maxillary central incisor.
research center approved the study protocol .
During the initial visit, all forms and consents were The measurements recorded were A ⫽ RP1 to RP2,
again explained to each subjects, all forms were signed, and B ⫽ RP1 to RP3 minus RP1 to RP2. The latter was
and the subject’s medical history was reviewed. Before recorded only for the subjects whose RP1 fell below the
injection, all subjects underwent a standardized photo- gingival-dental margin after injection.
American Journal of Orthodontics and Dentofacial Orthopedics Polo 197
Volume 133, Number 2

Fig 2. Musculature of the face: pinpointing sites for injection.

BTX-A was diluted according to the manufacturer’s dentists, all involved in performing cosmetic proce-
recommendations to yield 2.5 units per 0.1 mL by dures, also evaluated the before and after photographic
adding 4.0 mL normal saline solution to 100 units of and video records and rated the results on a 1 to 5 point
vacuum-dried Clostridium botulinum toxin type A. scale. Six of the specialty evaluators had used BTX-A
Under sterile conditions, 2.5 units were then injected in in their practices for cosmetic procedures.
all subjects at 2 sites per side (a total of 4 sites) in both For this investigation’s analytical purpose, the hy-
overlapping points of the right and left levator labii pothesized goal for gingival exposure was set at zero.8
superioris alaeque nasi (LLSAN) and levator labii The t test, paired 2-sample for means, was used to
superioris (LLS) and the LLS and zygomaticus minor determine statistical significance, which occurred at
(Zm) muscle sites (Fig 2). The injection sites were P ⬍.00001.
determined by muscle animation (smiling) and palpa-
tion on contraction to ensure precise muscle location RESULTS
before injection, because small anatomical variations in Thirty Hispanic subjects (29 female, 1 male) with
localization sometimes occur. A review of pertinent excessive gingival display secondary to hyperfunc-
anatomic considerations in anatomy textbooks is highly tional upper lip elevator muscles were enrolled in the
recommended. No local anesthesia was administered. study. Their ages ranged from 15 to 41 years (mean,
No electromyographic guidance was used. 24.4 years). The numbers of patients evaluated at
Follow-up visits were at 2, 4, 8, 12, 16, 20, and 24 baseline and each follow-up appointment are shown in
weeks postinjection. At the 2-week postinjection visit, the Table. All 30 subjects were evaluated at the week-2
all subjects completed a statistically validated question- and week-24 follow-up visits. A compliance rate of
naire. They reported the onset of changes in upper lip 88% between all subjects and the 7 follow-up visits was
position on smiling; side effects, if any; their rating of observed (185 of 210 postinjection visits). Nineteen of
satisfaction (smile esthetic improvement and results on the 30 patients who completed all 7 follow-up appoint-
a 1 to 5 point scale [5, excellent; 4, very good; 3. good; ments were classified as completers. Figure 3 shows
2. fair; 1, poor]); their willingness to undergo this gingival exposure before and after treatment during the
procedure again in the future; and whether they would 7 observation periods (2-24 weeks) between all subjects
recommend it to others with a similar condition. Dy- and the completers. As shown, data of the completers
namic evaluation tools (videos) in addition to conven- were nearly identical to those of all patients at each
tional static means (photos) were used to evaluate the follow-up visit.
data. Measurements, with Adobe Photoshop’s ruler Preinjection gingival display averaged 5.2 mm (⫾
tool, were also taken at the 8 visits to quantify changes 1.4 mm) in the 30 subjects. At 2 weeks postinjection,
in gingival exposure. A group of 12 physicians and mean gingival display had declined to 0.09 mm
198 Polo American Journal of Orthodontics and Dentofacial Orthopedics
February 2008

Table. Postinjection follow-up visits


Baseline 2 wks 4 wks 8 wks 12 wks 16 wks 20 wks 24 wks

Patients (n) 30 30 27 28 28 23 19 30

All patients Completers only

4
Gingival Exposure (mm)

0
Baseline 2 wks 4 wks 8 wks 12 wks 16 wks 20 wks 24 wks
Weeks After Injection

Fig 3. Gingival exposure before and after treatment with BTX-A in all subjects (n ⫽ 39) and in those
who completed all follow-up appointments (n ⫽ 19).

(⫾ 1.06 mm [t ⫽ 26.01; P ⬍.00001]) (Figs 4 and 5). and the mean postinjection display was 0.4 mm (mean
The photographs and video images can be viewed at change, 4.9 mm). An outlying patient with baseline
http://www.mariopolo.com/html/botox_gallery/html. exposure of 10.7 mm was excluded from this analysis.
In 9 patients, upper lip position at 2 weeks postinjection Responses to the questionnaires showed positive
was below the gingival-dental border, resulting in results. Subjects reported the upper lip “starting to feel
negative values of gingival display. Therefore, at 2 somewhat different upon smiling” 1 to 5 days after the
weeks and the succeeding follow-up visits, all negative procedure. Fifty percent of the subjects noted results at
values were set to zero gingival display. The mean 2 days postinjection (mean, 2.5 days). When asked
reduction in gingival display at 2 weeks for all 30 when “a definite change upon smiling” was noticed, the
subjects was 5.1 mm. On average, the gingival display subjects’ answers ranged from 1 to 7 days (mean, 3.2
reduction for subjects with baseline gingival display days); 43% reported 3 days. In terms of their satisfac-
less than 5 mm was negative, with the lip descending tion with therapy, the subjects rated their perception of
below the upper margin of the reference tooth. improvement in smile esthetics on a 1 to 5 scale (5,
Gingival display gradually increased from 2 weeks excellent; 4, very good; 3. good; 2. fair; 1, poor). A
postinjection through 24 weeks, but, at 24 weeks, mean of 4.66 was obtained. Also, the subjects were
average gingival display still had not returned to asked their willingness to undergo the procedure again:
baseline values. Based on predictions from a third- 26 replied positively; 4, maybe; and 0, negatively.
order polynomial equation, the baseline average of 5.2 When asked whether they would recommend the pro-
mm would not be reached until 30 to 32 weeks cedure to others with a similar condition, 29 answered
postinjection (Fig 6). At 2 weeks postinjection, 9 “yes,” and 1 replied “maybe.”
subjects (31%) had RP1 below the gingival-dental BTX-A treatment was safe and well tolerated. Four
margin. These subjects had a mean of 4.3 mm of subjects reported greater pain at injection sites than that
gingival exposure preinjection. Their mean postinjec- of other injections. Two reported slightly more pain,
tion exposure was ⫺1.0 mm, with a mean change and 2 reported moderately more pain. Four subjects
(decrease) of 5.3 mm. Twenty patients (69%) had reported twitching at the injection site. One subject
positive gingival display after injection (Fig 7). The experienced headache after the injection session, and
mean preinjection display for this group was 5.3 mm, another reported dizziness.
American Journal of Orthodontics and Dentofacial Orthopedics Polo 199
Volume 133, Number 2

Fig 4. Effects of BTX-A on excessive gingival display: preinjection (left) and postinjection (right)
photographs.

A group of physicians and dentists, all involved in DISCUSSION


performing cosmetic procedures and 6 of them using
BTX-A for other cosmetic applications, evaluated and Muscles of facial expression responsible for upper
rated the preinjection and 2-weeks postinjection facial lip elevation and lateral retraction upon smiling are
photos and videos. These 12 practitioners included 2 LLSAN, LLS, Zm, zygomaticus major (ZM), risorius,
from each of the following fields: plastic surgery, and, to a lesser degree, the depressor septi nasi muscle.
dermatology, ophthalmology, maxillofacial surgery, All of these muscles interact with the orbicularis oris
and orthodontics, and 1 each from periodontics and muscle in the production of a smile (Fig 2).The mech-
cosmetic dentistry. Their mean rating of the result of anism involved is well described in 2 cadaver studies, 1
the BTX-A injections was 4.65 (range, 4.0-4.97). by Rubin et al9 and another by Pessa.10 Both investi-
200 Polo American Journal of Orthodontics and Dentofacial Orthopedics
February 2008

Fig 5. Preinjection (left) and postinjection (right) photographs of same patient.

Based on post-injection data from 2 weeks


6 to 24 weeks, the predicted return to the
baseline average of 5.2mm of gingival 3 2
display is 30-32 weeks. y = 0.0094x - 0.0199x + 0.0403x + 0.3281
2
R = 0.9809
5
Gingival Display (mm)

0
2 wks 4 wks 8 wks 12 wks 16 wks 20 wks 24 wks

-1
Weeks Following Injection

Fig 6. Predicted return to baseline after BTX-A injection.

gations evaluated the origin of the nasolabial fold. excessive contraction of the LLS muscles, according to
Rubin et al9 concluded that the LLS, the ZM, and the Rubin.11 Several investigators have addressed the gin-
superior fibers of the buccinator muscles under the gival smile line and the differential diagnosis of excess
nasolabial fold are responsible for the production of a gingival display.12-14
full smile. Pessa10 indicated that the LLSAN was respon- Kokich et al15 explored esthetics as related to the
sible for the formation of the medial portion of the fold gingiva to upper lip distance as perceived by orthodon-
and minimally responsible for the elevation of the upper tists, general dentists, and lay people. Noticeable or
lip and smile formation. He also found that the ZM and unattractive gingival exposure in that study ranged
the Zm muscles are primarily responsible for the produc- from 2 to 4 mm in these 3 groups. Sarver8 stated that
tion of the smile. “most orthodontists and dentists prefer that the eleva-
In another review, Rubin11 classified smiles into 3 tion of the lip for the posed smile stop at the gingival
types: the “Mona Lisa” smile, with sharply elevated margins of the maxillary incisors.” He also noted that a
corners of the mouth, dominated mostly by the action slight amount of exposure is acceptable and that,
of the ZM; the canine smile, with strong elevation of contrary to a posed smile, an unposed smile is “natural
the upper lip near the midline; and the full denture in that it expresses authentic human emotion,” with lip
smile, with significant contracture of all upper lip elevation in the unposed smile “often more animated.”
elevators and lower lip depressors muscles, resulting in However, parameters that dictate esthetic vs nones-
a significant exposure of the maxillary and mandibular thetic gingival exposure do not exist and could vary on
dentition. The canine, or gummy, smile is dominated by an individual basis.
American Journal of Orthodontics and Dentofacial Orthopedics Polo 201
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6
5.3 Overshoot
Undershoot
5
4.3 20 pts

4
9 pts
Mean Gingival Exposure (mm)

Change = 4.9mm
2

Change = 5.3mm
1
0.4

*one outlying pt with baseline exposure of


-1 10.7mm was excluded from this analysis
-1.0

-2
Baseline 2 weeks

Fig 7. Relationship between patients with gingival exposure postinjection and those without.

Sarver and Ackerman7 introduced a dynamic smile with corrugator and procerus muscle activity, and, in
visualization and quantification process in orthodontic 2004, approval was obtained for the treatment of
diagnosis and treatment planning by means of video primary axillary hyperhidrosis. The National Institutes
imaging. Ackerman et al16 described posed vs non- of Health Consensus Conference of 1990 also included
posed smiles in patients with excessive gingival display it as a safe and effective therapy for other nonlabeled
and suggested that the photographic analysis of an uses.20 The use of BTX-A for many facial cosmetic
unstrained, posed smile might be a standard orthodontic procedures has been described extensively in the liter-
record. Subjects’ unposed smiles were used for data ature.21-27
evaluation in this study with both static photographic In this study, the author and several specialty
records and animated, dynamic video imaging. evaluators observed effects other than the expected
effect of gingival exposure reduction by weakening the
BTX-A, the smile, and esthetics contractibility of specific upper lip elevator muscles—
BTX-A has been under clinical investigation since LLSAN, LLS, and Zm—and the subsequent increase in
the late 1970s for the treatment of several conditions the relative length of the upper lip on smiling . The
associated with excessive muscle contraction.17 Pro- most frequent effect was a marked effacement or
duced by the anaerobic bacterium C botulinum,18 there reduction of the nasolabial fold. This effect was also
are 7 serotypes of BTX. BTX-A is the most potent and described by Kane,21 who reported on the use of
the most commonly used clinically type. Botox is a BTX-A for the improvement of the nasolabial folds. A
purified BTX-A isolated from the fermentation of C marked reduction of hypercontractibility of the trans-
botulinum. It is a stable, sterile, vacuum-dried powder verse portion of the nasalis muscle upon smiling, as
that is diluted with saline solution without preserva- expressed by prominent skin elevation at this site, was
tives. BTX-A blocks neuromuscular transmission by observed in 4 subjects (Fig 8). Effacement of periocular
binding to acceptor sites on motor or sympathetic nerve rhytides at the inferior portion of the orbicularis oculi
terminals, thus inhibiting the release of acetylcholine. muscles also occurred in several subjects (Fig 9). The
This inhibition occurs as the neurotoxin cleaves SNAP- last 2 observations could be attributed to the effect
25, a protein integral to the successful docking and caused by injecting BTX-A into the LLSAN, the LLS,
release of acetylcholine from vesicles in nerve endings. and the Zm muscles and their respective anatomical
When injected intramuscularly at therapeutic doses, relationships with the nasalis and orbicularis oculi
BTX-A produces partial chemical denervation of the muscles. The origins of the muscles injected are in
muscle, resulting in localized reduction in muscle extreme proximity to the nasalis or the orbicularis oculi
activity.18,19 Botox has been approved by the Food and muscles, with some muscular fibers intermeshing (Fig
Drug Administration as a safe and effective therapy for 2): the LLSAN lateral to the origin of the nasalis, and
blepharospasm, strabismus, cervical dystonia, and the LLS and Zm inferolateral to the orbicularis oculi
hemifacial spasm since 1989; in 2002, it received (refer to textbooks on facial anatomy). With chemod-
approval for the treatment of glabellar lines associated enervation of selected muscles after injecting BTX-A,
202 Polo American Journal of Orthodontics and Dentofacial Orthopedics
February 2008

Fig 8. Preinjection (left) and postinjection (right) views of nasal area .

Fig 9. Preinjection (left) and postinjection (right) photographs of periocular area.

muscle pull on adjacent muscles where fibers could be patients with gummy smile and hyperfunctional upper
intermeshed should be expected. The BTX-A injections lip elevator muscles being considered for this procedure
could also diffuse to these adjacent sites. These theories should have at least 5.0 mm of gingival display. Those
could explain these 2 observations made by 7 of this with a significantly shorter philtrum and an inverted
study’s evaluators. V-shaped upper lip near its midportion seemed to
Twenty subjects with a mean baseline gingival benefit more from the procedure. Since dosage was the
display of 5.3 mm had positive postinjection gingival same for all 30 subjects regardless of amount of
display values. Another outlying patient with baseline exposure, further studies with varying doses and sites
exposure of 10.7 mm (excluded from statistical analy- for patients with 3.5 to 5.0 mm of exposure are
sis) also had a positive postinjection value. Mean presently being performed by the author. However, for
gingival reduction for these 20 subjects was 4.9 mm, exposure levels of 5.0 mm or higher, the doses and the
and a mean reduction of 5.1 mm for the entire sample injection sites used in this investigation proved to be
was attained. Nine subjects with a mean baseline adequate.
gingival display of 4.3 mm had postinjection negative Of 8423 subjects evaluated for selection into this
gingival display with slight incisor coverage by their study, 76 met the inclusion criteria. The incidence of
lips of 1.0 mm (mean). Subjects with exposure of 3 to gummy smile secondary to hyperfunctional upper lip
5 mm before injection and negative lip-gingival margin elevator musculature in this sample was 0.0902%.
values after treatment were slightly less satisfied with Further investigation on its prevalence is indicated. A
their results, when compared with subjects having marked tendency for greater incidence of excessive
values of zero or greater postinjection. For this reason, gingival display appears to be present in females. Of
American Journal of Orthodontics and Dentofacial Orthopedics Polo 203
Volume 133, Number 2

the 76 subjects with gummy smiles who were initially 8. Sarver DM. The importance of incisor positioning in the esthetic
considered as candidates for this study, only 3 were smile: the smile arc. Am J Orthod Dentofacial Orthop 2001;120:
98-111.
male (3.95%). The final sample had a similar sex 9. Rubin LR, Mishriki Y, Lee G. Anatomy of the nasolabial fold:
composition. This finding correlates with those of Tjan the keystone of the smiling mechanism. Plast Reconstr Surg
et al28 and Peck et al,12 suggesting sexual dimorphism 1989;83:1-10.
of the vertical dimension of the smile. 10. Pessa JE. Improving the acute nasolabial angle and medial
nasolabial fold by levator alae muscle resection. Ann Plast Surg
CONCLUSIONS 1992;29:23-30.
11. Rubin LR. The anatomy of a smile: its importance in the
BTX-A injections (2.5 units in both right and left treatment of facial paralysis. Plast Reconstr Surg 1974;53:384-7.
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