Scleral exposure alterations following Le Fort I osteotomy (with and without maxillary impaction) in skeletal class III patients: A before-and-after clinical trial

Scleral exposure alterations following Le Fort I osteotomy (with and without maxillary impaction) in skeletal class III patients: A before-and-after clinical trial

Accepted Manuscript Scleral exposure alterations following Le Fort I osteotomy (with and without maxillary impaction) in skeletal class III patients: ...

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Accepted Manuscript Scleral exposure alterations following Le Fort I osteotomy (with and without maxillary impaction) in skeletal class III patients: A before-and-after clinical trial Amin Norouzi, M.D., Gerald Chi, M.D., Shahrooz Shafaeefar Fard, M.D., Mehdi Sezavar, M.D., Farzin Sarkarat, M.D., Vahid Rakhshan, M.D., Farima Kahe, M.D. PII:

S1010-5182(18)30404-9

DOI:

10.1016/j.jcms.2018.06.006

Reference:

YJCMS 3033

To appear in:

Journal of Cranio-Maxillo-Facial Surgery

Received Date: 7 December 2017 Revised Date:

24 May 2018

Accepted Date: 5 June 2018

Please cite this article as: Norouzi A, Chi G, Fard SS, Sezavar M, Sarkarat F, Rakhshan V, Kahe F, Scleral exposure alterations following Le Fort I osteotomy (with and without maxillary impaction) in skeletal class III patients: A before-and-after clinical trial, Journal of Cranio-Maxillofacial Surgery (2018), doi: 10.1016/j.jcms.2018.06.006. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Scleral exposure alterations following Le Fort I osteotomy (with and without maxillary impaction) in skeletal class III patients: A before-and-after clinical trial

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Amin Norouzi, M.D.1; Gerald Chi, M.D.2; Shahrooz Shafaeefar Fard, M.D.1; Mehdi Sezavar, M.D.1; Farzin Sarkarat, M.D.1; Vahid Rakhshan, M.D.1; Farima Kahe, M.D.2

Craniomaxillofacial Research Center and Department of Oral and Maxillofacial Surgery,

Dental Branch, Islamic Azad University, Tehran, Iran

Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United

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States

Address for correspondence:

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Amin Norouzi, M.D.

Department of Oral and Maxillofacial Surgery,

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Islamic Azad University Emam Ali Hwy

Tehran Province, Tehran, District 13, Iran Telephone: +98-21-3334-8035 Fax: +98-21-3334-8035

Email: [email protected]

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Summary

Purpose: Exposure of sclera below the iris in natural head positions is aesthetically undesirable.

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Studies on post-surgical changes in inferior scleral exposure following orthognathic surgery are scarce and mostly retrospective. The aim of this clinical trial is to examine the effect of Le Fort I osteotomy, a procedure for correction of malocclusion and maxillo-mandibular deformities, on

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the inferior scleral exposure and overall scleral surface area in skeletal class III patients.

Materials and Methods: This trial was performed on 40 eyes of 20 skeletal class III patients

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undergoing Le Fort I osteotomy without impaction (n=20 eyes) and with impaction (n=20 eyes). Standard true-size frontal photography was performed pre-operatively and post-operatively at 6 months. After measuring the overall eye height and the height of visible inferior sclera, the ratio of inferior sclera to overall eye height (S:E) was calculated three times. Also, overall surface area

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of the sclera was measured three times. The average of three attempts was considered the main measurement. Changes in the sclera after the surgery and between both methods were compared. Results: The average age of patients (9 men, 11 women) was 24.5 years. Age and gender were

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balanced between the two groups (P>0.05). S:E ratios decreased in both groups after surgery (P<0.05, Wilcoxon test). The decrease was greater in the impaction group (P<0.05, Mann-

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Whitney test). Similar results were observed for overall sclera surface areas. Conclusion: Maxillary advancement, with or without impaction, reduced the inferior scleral exposure and overall scleral surface area. The effect was more pronounced in the impaction group.

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Keywords: orthognathic surgery; maxillary advancement; Le Fort I osteotomy; aesthetics;

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inferior scleral exposure

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INTRODUCTION Facial aesthetics play a crucial role in people’s quality of life and psychological health (Rustemeyer et al., 2012; Khosravanifard et al., 2013; Oh et al., 2013). Therefore, moderate to

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severe class III malocclusions are frequently treated with orthodontic procedures and

orthognathic surgeries to improve dental malocclusion and facial aesthetics (Jensen et al., 1992; Enacar et al., 1999; Soncul et al., 2004; Ko et al., 2009; Oh et al., 2013; Hemmatpour et al.,

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2016).

Alteration of bone tissues by surgery can affect the appearance of their overlying soft

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tissues, which necessitates predicting the extent of soft tissue modifications after skeletal surgery (Hemmatpour et al., 2016). Although the predictability has not always been high (Legan et al., 1980; Choi et al., 2014), previous studies have examined the associations of hard tissue changes with overlying soft tissues (Raschke et al., 2015).

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One of the major soft-tissue determinants of facial aesthetics is the appearance of the eyes and orbital region (Soydan et al., 2014). The visible portion of the eye comprises three important elements: the iris, pupil, and sclera, which appears white because of the high density of fibrous

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tissue (Gunter et al., 1997; Soydan et al., 2014). Aesthetically speaking, when the forehead and the eyebrows are relaxed and the head is in a neutral position, sclera should not be visible

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between the lower lid margin and the lowermost point of the iris (inferior limbus) (Lee et al., 2012; Soydan et al., 2014). However, in patients with midfacial retrognathia or hypoplasia, the sclera below the iris can be exposed. Orthognathic surgeries can affect the amount of visible sclera by changing the position of the lower eyelid (Flowers, 1987). Nevertheless, unlike other post-surgical soft tissue changes that are thoroughly investigated, scleral exposure corrections as a result of orthognathic surgeries are evaluated only in a few recent, mostly retrospective studies,

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with only one retrospective study concerning types of Le Fort I osteotomy (Soydan et al., 2014; Magraw et al., 2015; Posnick et al., 2015) Therefore, this before-and-after controlled clinical trial

on the extent of inferior scleral exposure and overall scleral area.

MATERIALS AND METHODS

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Study design

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was conducted to evaluate the result of Le Fort I orthognathic surgery, with or without impaction,

This prospective before-and-after controlled clinical trial was performed on 20 skeletal

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class III Iranian patients (Caucasians) who had some degrees of inferior sclera exposure scheduled for standard Le fort I surgery during the years 2015-2016. The inclusion criteria were as follows: (1) anteroposterior maxillary deficiency with or without vertical maxillary excess; (2) some degrees of inferior sclera show in the frontal view (clinically approved by an experienced

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surgeon); and (3) requiring mono- or bi-maxillary advancement with or without impaction (according to an orthodontist and a surgeon, based on cephalometric analyses and clinical examinations). Patients were excluded if they had previous trauma to orbital, maxillary, or

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midface, a history of orthognathic surgery or blepharoplasty, maxillary canting, systemic problems such as hyperthyroidism, Sjögren syndrome, Ehlers-Danlos syndrome, or craniofacial

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syndromes. The study protocol were approved in accordance with the Declaration of Helsinki by the Research Committee of the University. Treatment plans were not affected by the research aim, but were determined only according to surgical needs ascertained by orthodontists and surgeons, and only for clinical purposes. Written informed consent was obtained from all patients after thorough explanation of the study.

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Sample size calculation Sample size was determined as twice as that of a previous retrospective study (16) and about 70% larger than an earlier prospective study, both of which had reached sufficient

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statistical power (Magraw et al., 2015). Since the current sample size sufficed to provide proper test powers (>0.8), it was deemed sufficient and sampling was stopped. The sampling was

performed sequentially until 10 patients were acquired with indication of maxillary advancement

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only (Group 1) and 10 other patients needing advancement and impaction of maxilla (Group 2).

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Photography

Standardized true-size (1× magnification) frontal photographs were taken immediately before the surgery and 6 months after it by a professional photographer (with >5 years of training in orthodontic/medical photography) using a fixed digital camera equipped with a Tele lens (Tele

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18-125) and a 300ppi resolution (D7, Canon, Tokyo, Japan). All the appointments were scheduled in the evening when the periorbital edema and swelling were at minimal level. In addition, all photographs were obtained 1 hour after patient arrival in office to reduce fatigue and

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stress as much as possible. Patient were seated in natural head position (NHP) with the soft tissue, neck, and shoulders at rest. The intra-class correlation coefficient values ranged from 0.79 to

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0.91, and the inter-class values ranged from 0.78 to 0.88, representing acceptable reliability for pitch, yaw and roll. Interpupillary plane (the horizontal plane connecting the center of the pupils) was used as the reference plane to ensure the orientation of the head position. The camera was aligned vertically at the interpupillary plane level. Before taking the photograph, patients swallowed their saliva, and blinked twice in order relax the eyebrows, eyelids, forehead, and cheek muscles. On all the slides, the focal distance (camera to patient) was 100 cm, and the

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distance between patients and the blue curtain behind them was 50 cm. In each session, the above procedures were repeated three times to take three different photographs. After comparing those three photographs, the best one with the highest standards was selected as the main image

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according to the following criteria: (1) landmarks for each eye (i.e., upper eyelid margin, inferior limbus, and lower eyelid margin) can be clearly identified; (2) interpupillary plane is parallel to the floor plane; and (3) vertical positioning of the mid-facial plane. Three-dimensional (3D)

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facial image (main image) was re-oriented into natural head position by using 3D

stereophotogrammetry, and the pitch, roll and yaw angles of the image were corrected by using

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this method before and 6 months after surgery (angulation deviation within ± 0.3 degree).

Surgical procedures

All surgeries were performed by the same team of surgeons. All surgeries were monomax

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or bimax standard Le Fort I surgeries. After injecting local anesthetics, a V-shaped vestibular incision was cut 7 mm above the mucogingival junction. Muscle and periosteum connections were cut. Osteotomy line was marked 5 mm above the roots of the canines and molars and at

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least 5 mm above the lower edge of the pyriform. Osteotomy line continued linearly (and not stepped) from the lateral side of the pyriform downward and backward. Finally, maxillary

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osteotomy was performed. The extent of advancement was determined using an intermediate surgical splint. In patients without impaction treatment plans, the maxilla was advanced and fixed after osteotomy. In patients with impaction treatment plans, a segment of inferior maxilla was cut and removed, and the maxilla was advanced, impacted, and fixed in the position. In both groups, the maxilla was fixed (rigid fixation) on each side with two 4-hole titanium plates and a sufficient number of screws. Fixation areas were pyriform areas and buttress maxillae. Inter-alar

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cinch was performed using 2/0 nylon sutures. Afterwards, the incision lines were sutured using 0/3 Vicryl sutures with the V-Y closure technique. Upper lip taping was performed for all patients for 3 days with 3m bands. All patients were hospitalized for 2 days. They were

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prescribed proper home care and medications depending on their surgeries.

Anatomical measurements

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An image editing program (Photoshop CS5, Adobe, USA) was used to measure the sclera show and other measurements at a 0.01-mm accuracy. For each eye, the following procedures

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were performed in each of the three measuring sessions: First, three landmarks were identified on each eye: upper eyelid margin (A point), inferior limbus (B point), lower eyelid margin (C point) (Figure 1). Overall eye height (E height) was defined as the distance between A and C points, while inferior sclera show (S height) was defined as the distance between B and C points

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(Figure 1). In order to standardize the sclera show by the size of the eye, the S:E ratio (sclera height/eye height) was calculated for each eye as well. Measurement of the whole sclera surface area was also recorded as the number of pixels (Magraw et al., 2015). The eyes had been cropped

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out of face images, and patient names were coded (e.g., left or right of patient #1 before or after surgery). There were 40 eye images before the surgery, and 40 eye images after the surgery

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(Figure 2). Measurements were done three times on each eye (3 × 80 measurements), with 1week intervals between sessions. After finishing all three sessions on all 80 eyes, the average of three values recorded for each measurement was calculated as the final measurement for the 80 eyes. Sclera measurements of each eye before and after the surgery were subtracted from each other in order to evaluate the extent of changes in the sclera show.

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Statistical analysis Age and gender distributions were compared between two groups using a t-test and chisquare test. Within each group (each eye of each of groups 1 and 2), changes were compared

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using a Wilcoxon test. Between each left or right eye of both groups, the difference in

at 0.05.

RESULTS

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measurements was compared using the Mann-Whitney U test. The level of significance was set

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There were four men and six women in group 1, and five men and five women in group 2. Average ages of patients in groups 1 and 2 were 24 ± 3.2 and 25 ± 4.2, respectively. Age averages and gender distributions were not significantly different between two groups, according to the t-test and chi-square, respectively (P > 0.1). The average weight change was about −3.5%

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in group 1 and −4.4% in group 2 patients. These changes were not significant (P > 0.05) and probably occurred as a result of inter-maxillary fixation, the elastic therapy period, and/or the soft diet after surgery.

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Pre-surgery S:E ratios were not significantly different in groups 1 and 2 (P > 0.1). Compared to the pre-surgery measurements, the post-surgery S:E ratio was reduced about 24%

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in both right and left eyes in group 1 (both P values < 0.010) and about 84% in right eyes and about 80% in left eyes in group 2 (both P values < 0.0001) (Table 1). This reduction was significantly greater in right and left eyes in group 2 compared to right and left eyes in group 1, respectively (both P values < 0.0001, Table 1). Post-surgical measurements of either of left or right eyes in group 2 were smaller than post-surgical measurements of the same-name eye in group 1 (both P values < 0.002, Table 1).

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Pre-surgery overall scleral surface areas were not significantly different in groups 1 and 2 (P > 0.5). Compared to the pre-surgery measurements, the post-surgery sclera area was reduced about 4.9% in the right eye and 6.3% in the left eye in group 1 (both P values < 0.001) and about

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9.5% in either the right or left eye in group 2 (both P values < 0.0001) (Table 2). This reduction was significantly greater in the right and left eyes in group 2 compared to right and left eyes in group 1, respectively (both P values < 0.001) (Table 2). However, post-surgical measurements of

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group 2 were not significantly different from post-surgical values in group 1 (both P values > 0.1)

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(Table 2).

DISCUSSION

The findings of this study indicate that both evaluated techniques of maxillary advancement could reduce the inferior sclera show and overall sclera surface area; however, the

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advancement together with impaction was much more successful in this regard. Only a few studies have evaluated the effect of Le Fort I osteotomy on scleral show. Soydan et al retrospectively evaluated 47 patients who had undergone Le Fort I osteotomies with or without

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impaction. In line with our finding, they reported decreases in the S:E ratio after either method (Soydan et al., 2014). However, the decrease was nonsignificantly greater in the isolated

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advancement group compared to the advancement plus impaction group. This result contrasted with findings of this study, in which the impaction method had caused a greater extent of reduction in inferior scleral exposure, possibly as a result of different advancement or impaction extents done in two studies or other methodological variations such as possible differences in ethnicity and pre-treatment forms of eyes. Posnick and Sami evaluated retrospectively 10 longface patients who had undergone Le Fort I osteotomy with impaction, and reported a decrease in

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the amount of inferior scleral presence (Posnick et al., 2015). Magraw et al performed a prospective study on 13 patients needing Le Fort III osteotomies, and reported a predictable reduction in the inferior exposure of sclera or its overall surface area (Magraw et al., 2015). The

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reason for the success of these treatments in reducing the inferior scleral visibility might be an increase in the skeletal support of soft-tissue below the inferior eyelid and the eyelid itself, and pushing it upward over the eyeball. The change in scleral show might also be attributed to

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stabilization appliances and position in the pyriform rim and infraorbital areas. In maxillary advancements, the plates are often contoured, and the lifting of the lower eyelid might be a result

allow further analysis of this affect.

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of this factor. Including the amount of advancement and/or impaction in future studies might

This study was limited by several factors. A larger sample would favor the reliability of results. However, the current sample sufficed to provide high test powers, and was considered

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sufficient. Moreover, enrollment of patients from two different groups might improve the generalizability. Although a post-surgical period of 6 months is acceptable for evaluation of softtissue changes, it was better to wait for 1 year to minimize the swelling artefact (Rosen, 1988;

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Chung et al., 2008; Park et al., 2012; Hemmatpour et al., 2016). Three-dimensional surface scanning or CBCT assessment of the scleral show would present more comprehensive

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information in terms of profile changes as well as overall 3D changes. However, what relates most to esthetics is the frontal view, where patients mostly see themselves in the mirror (Vasudavan et al., 2012; Hemmatpour et al., 2016). Also, X-ray exposure without clinical justification was not ethical (Hemmatpour et al., 2016). Besides, 3D methodology is complicated and more difficult to interpret (Park et al., 2006; Park et al., 2012). Finally, analyses in this study did not account for confounding factors for the measurement of scleral show such as weight

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changes, fatigue, and stress. Although the method for measuring scleral show is consistent with previous studies, future research is warranted to validate the precision and reliability of this

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measuring technique (Magraw et al., 2015; Posnick et al., 2015).

CONCLUSION

Maxillary advancement might reduce the inferior scleral exposure in skeletal class III

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patients with an original excess inferior scleral show. Impaction of maxilla together with its

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advancement might provide better results than advancement alone.

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Conflict of interest The authors declare that they have no conflict of interest.

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Funding

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This study did not receive funding.

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