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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 9  |  Issue : 1  |  Page : 41-48

Esthetic outcome of cleft lip repair with the use of tissue adhesive as opposed to suture for skin closure – A retrospective comparative study


1 Burns and Plastic Surgery, AIIMS, Bhubaneswar, Odisha, India
2 Trauma and Emergency Medicine (Burns and Plastic Surgery), AIIMS, Bhubaneswar, Odisha, India

Date of Submission23-Aug-2021
Date of Acceptance01-Nov-2021
Date of Web Publication01-Jan-2022

Correspondence Address:
Dr. Sunil Kumar Rout
A – 104, Infocity Greens Apartment, Sailashree Vihar, Bhubaneswar - 751 021, Odisha
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jclpca.jclpca_31_21

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  Abstract 


Background: Suture removal in infants and children operated for cleft lip is one of the cumbersome task for the surgeons because of missing compliance. For this reason, tissue adhesives have gained popularity among the surgeons as well as the patients over the past two decades for skin wound closure. Although there are several published reports of case series using tissue adhesive for skin closure during cleft lip repair, very few have established its advantage over conventional suture technique. Objective: The objective of this study was to compare the esthetic outcome of skin closure in cleft lip repair with suture technique and tissue adhesive, with respect to the quality of scar. Methodology: A retrospective observational study was conducted by analyzing the photographic records of patients who underwent surgical repair of cleft lip between January 2015 and December 2017. The patients were divided into two groups, one for whom skin closure performed with 5-0 monofilament polyamide suture and the other with tissue adhesive. Esthetic outcome in terms of the quality of scar was assessed using a 5 point Likert's scale by 10 independent observers who remained blind of the surgeon performed the surgery, to reduce the assessor-related bias to minimum. The statistical analysis was performed using the SPSS version 27.0 and the difference between mean scores of both the groups was calculated. Results: A total of 70 patients were included in this study with 35 in each group. The mean follow-up period of adhesive and the suture group was 13.97 and 17.85 months, respectively. Overall mean of the total scores of the entire patient population was 3.92 (+/‒0.38). For the tissue adhesive group, the mean score was 3.88 (+/‒0.367) and for the suture group, the mean score was 3.96 (+/‒0.401). The difference between mean scores of individual parameters of both the groups as well as the difference between the overall mean scores of both the groups was not found to be statistically significant. Conclusion: The use of tissue adhesive for the closure of skin during cleft lip repair is as good as sutures, with respect to esthetic outcome of scar. Hence, any of these two techniques can be used for this purpose depending on the surgeon's preference.

Keywords: Aesthetic outcome, cleft lip repair, facial anomalies, skin closure, suture, tissue adhesive


How to cite this article:
Rout SK, Panda R, Mallik M. Esthetic outcome of cleft lip repair with the use of tissue adhesive as opposed to suture for skin closure – A retrospective comparative study. J Cleft Lip Palate Craniofac Anomal 2022;9:41-8

How to cite this URL:
Rout SK, Panda R, Mallik M. Esthetic outcome of cleft lip repair with the use of tissue adhesive as opposed to suture for skin closure – A retrospective comparative study. J Cleft Lip Palate Craniofac Anomal [serial online] 2022 [cited 2022 Jul 6];9:41-8. Available from: https://www.jclpca.org/text.asp?2022/9/1/41/333646




  Introduction Top


Cleft lip with or without cleft palate is the most common congenital facial anomaly varying in prevalence across the continents from 1.57 in Asia to 0.57 in Africa/1000 live births.[1] The main indication for its treatment is the esthetically unacceptable appearance of the child, hence the goal to achieve an esthetically pleasing lip and nose. The surgical technique for cleft lip repair has been evolving and getting refined over more than a century. However, in summary, almost all the techniques revolve around two major principles, either rotation advancement or triangular flap originally described by Millard and Tennison, respectively.[2],[3] Monofilament polyamide suture has enjoyed its role as the gold standard for the closure of skin wounds be traumatic or surgical, owing to the easy availability, low price, and better knot security. However, suture removal in infants and children is encountered as a herculean task for surgeons, leading to the evolution of nonsuture techniques of wound closure. For this reason, tissue adhesives have gained popularity among the surgeons and the patients over the past two decades for skin wound closure. Although several published case series exist using tissue adhesive for skin closure during cleft lip repair, very few reports are available comparing the outcome of this with conventional suture technique. To evaluate the difference between the outcomes of these two techniques, we retrieved the photographic record of the patients operated for cleft lip by the senior author (first author) with skin closure using both the techniques.

Objective

The objective of this study was to compare the esthetic outcome of skin closure in cleft lip repair with suturing as opposed to tissue adhesive, with respect to the quality of scar.

Hypothesis

Suture technique is superior to tissue adhesive for skin closure in cleft lip repair considering esthetic outcome, in terms of the quality of scar.

Null hypothesis

There is no difference between the esthetic outcome of skin closure being performed by suture technique or tissue adhesive in cleft lip repair, with respect to the quality of scar.


  Methodology Top


Study design, duration, and population

This is a retrospective observational study comparing two groups of cleft lip patients, in one skin closure done with sutures and the other with tissue adhesive. The study included patients operated between January 2015 and December 2017, in the Department of plastic surgery in a multispecialty private hospital (a high-volume cleft lip and palate treatment center). The patients operated during the study period for cleft lip, cheiloplasty performed by all surgical techniques, operated by the same surgeon (senior author), skin closure done with either tissue adhesive or sutures, with follow-up for at least 3 months were included in this study. Patients not operated within the study period, not operated by the senior author, operated for complex facial anomalies and having a follow-up of <3 months were excluded from this study. Two different techniques were used for the closure of skin (sutures and tissue adhesive) during that period depending on the logistics. A total of 87 patients in the suture group and 72 in the tissue adhesive group, operated within this study period. Of them, 48 in the suture group and 39 in the adhesive group followed up for more than 3 months, hence qualified for inclusion in this study. To make it easy for calculations, the number was rounded up to 35 for each group and the consecutive cases of each group were picked up for final inclusion in this study.

Surgical technique

Almost all the cases of unilateral cleft lip were operated by the triangular flap technique (using Sawhney's method).[4] Bilateral cleft lips were repaired using the Mulliken technique.[5] Cheiloplasty was performed with the closure of tissue in three layers– mucosa, muscle, and skin. The entire technique remained conventional (three-layer closure) for both the groups, except for the skin closure. In the suture group, the skin was closed with monofilament polyamide (5-0). In the tissue adhesive group, skin margins were approximated with few interrupted dermal sutures using 5-0 poliglecaprone (monocryl). Then, the epidermal margins were approximated with Brown Adson's toothed forceps, liquid bioadhesive (isoamyl 2-cyanoacrylate) applied in that position, and allowed to air dry for approximately 2 min before the forceps released. Postoperative care remained the same for both the groups of patients. The same bioadhesive (commercially available as Amcrylate) was used for all the patients during this period, because it was economical compared to its competitive brands (Authors declare no conflict of interest in this regard). For the patients in whom sutures were used for skin closure, sutures removed on the 5th postoperative day and supported further with micropore tape for 5 more days.

Outcome assessment

Esthetic outcome was assessed in terms of the quality of scars. Standardized follow-up photographs were retrieved from the electronic archive of the hospital. All the photographs were captured with a digital camera (6 megapixels), from same distance (1.5 feet), without magnification, fixed background, and by one person.

A rectangular sections of the pictures of the central face were cropped using Adobe photoshop 2021 to show only the nose, upper lip, and lower lips including both the medial canthi and oral commissures [Figure 1] and [Figure 2]. The pictures were arranged in the form of a PowerPoint presentation without disclosing the techniques being used. The presentation was sent to 10 independent observers from different surgical specialties to assess scars, blinded of the techniques, and the operating surgeon's name to avoid bias. The independent observers included five plastic surgeons, two pediatric surgeons, one general surgeon, one neurosurgeon, and one onco-surgeon. They were selected by a surgeon who was not a member of the team conducting this study and the clinical data were sent from his mailbox.
Figure 1: Central rectangular selection of face of the patients from the tissue adhesive group (Mean Likert score = 4.32, 4.58, 4.2, and 3.4 from left to right)

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Figure 2: Central rectangular selection of face of the patients from the suture group (Mean Likert score = 4.74, 4.48, 3.8, and 3.18 from left to right)

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Five parameters were used to assess the scar. They included–

  1. Width of the scar
  2. Color/pigmentation of the scar
  3. Hypertrophy of scar
  4. Scar contracture
  5. Overall lip appearance


The scars were assessed and scored using a Likert's scale of 1 through 5, as mentioned in [Table 1].[6]
Table 1: Likert's Scale used for outcome analysis

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Statistical analysis

The mean of the scores given by 10 observes was analyzed to test the hypothesis. Statistical analysis was done by evaluating the difference between the means with the help of IBMs SPSS software version 27.0 (IBM SPSS Statistics for Windows, Version 27.0. Armonk, NY, USA: IBM Corp).

The difference between individual parameters was analyzed using independent sample t-test and difference between overall mean scores of both the groups were analyzed using Mann–Whitney U-test with a P < 0.05 to be statistically significant for both the tests.


  Results Top


A total of 70 patients who underwent cleft lip repair were included in this study which included 37 males and 33 females. The patient population was 35 in each group (suture and adhesive). Of the total 70 patients, 46 had unilateral, 23 bilateral, and 1 midline cleft lip. In the adhesive group, there were 23 unilateral, 11 bilateral, and 1 midline cleft lip cases. Whereas in the suture group, there were 23 unilateral and 12 bilateral cleft lip cases. The minimum age of the patients in the entire study population was 9 months and the maximum 14.5 years with a mean of 25.23 months. The minimum and maximum period of follow-up was 3 and 48 months respectively, with a mean of 15.88 months. In the tissue adhesive group, there were 19 males and 16 females. The minimum and maximum age was 9 months and 4.5 years respectively, with a mean of 1.7 years. The suture group composed of 18 males and 17 female patients. The mean age of patients in the suture group was 2.4 years, with a minimum of 9 months and maximum 14.5 years. The mean follow-up period of adhesive and the suture group was 13.97 and 17.85 months, respectively. The minimum follow-up for the adhesive group was 3 months and maximum 48 months. The minimum follow-up in the suture group was 3 months and maximum 50 months. The distribution of general patient characteristics such as age, gender, and follow-up period between both the groups were statistically not significant [Table 2].
Table 2: General characteristics of patients

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Analysis of individual parameters was performed to evaluate the effect of suture and adhesive technique on the scar characteristics. Suture technique was found to score better than adhesive in all the scar characteristics except scar contracture [Table 3]. However, the differences were subtle as obvious from the box plots for each one of the parameters [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]. Independent sample t-test revealed the mean difference being negligible and the P– for none of the parameters was <0.05 [Table 4]. Hence, the difference was not statistically significant.
Table 3: Analysis of individual parameters

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Table 4: Individual parameters difference (independent sample t-test)

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Figure 3: Box plot for width of scar

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Figure 4: Box plot for color/pigmentation of scar

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Figure 5: Box plot for scar hypertrophy

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Figure 6: Box plot for scar contracture

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Figure 7: Box plot for overall lip appearance

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Overall mean of the total scores (mean of the total scores of 10 observers) of the entire patient population was 3.92 with a standard deviation of 0.38. The minimum score was 3.16 and maximum 4.74. For the tissue adhesive group, the mean score was 3.88 (+/‒0.367) with a minimum of 3.16 and maximum 4.58. For the suture group, the mean score was 3.96 (+/‒0.401) with a minimum of 3.18 and maximum 4.74. Comparing both the groups [Figure 8], there was minimal difference in the distribution of scores. Comparing the difference between the means of both the groups with the use of the Independent Sample t-test, the mean difference was– 0.07457 assuming equal variances. One-sided P was calculated to be 0.210 and the two-sided P = 0.421. Both the values were >0.05, so the difference not statistically significant.
Figure 8: Box plot comparing mean Likert's score of both the groups

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Using Independent-Samples Mann–Whitney U-Test with significance level 0.050 [Table 5], asymptomatic significance was found to be 0.401. This suggests the distribution of score is same across both the categories of technique used [Table 6], hence retaining the null hypothesis.
Table 5: Independent-samples Mann-Whitney U test summary

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Table 6: Testing hypothesis using independent-samples Mann-Whitney U test

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  Discussion Top


This study incorporated a reasonable sample size, essential scar characteristics, involved an adequate number of independent skilled observers to avoid assessor-related bias and used 5-point Likert's scale to analyze the parameters in an objective manner. The mean follow-up period was long enough (13.97 and 17.85 months for the adhesive and suture group, respectively), to allow the scar to mature. The difference between mean scores across the groups was neither found to be significant statistically comparing individual parameters of the scars studied nor the total scores.

Although the use of suture has remained the gold standard for closure of skin wounds, its removal in infants and children is often traumatic for the patients as well as the family as experienced by surgeons.[7] Many surgeons prefer to do this procedure under anesthesia or deep sedation. This carries obvious risk to the patients, requires adequate preparation of the patients, utilization of operation room, as well as anesthesia time. Some of the surgeons attempted skin closure with absorbable suture to avoid this and even adhesive skin tapes have also been used with their consequent complications such as scar hypertrophy and wound dehiscence.[8],[9] Every surgeon and the patient dream to have a suture-less skin closure with minimal consequent scar. For this reason, the tissue adhesives once approved for medical application, gained momentum in the surgical practice. The outcome of tissue adhesive for skin closure has been reported since the late 90 s.[10],[11],[12],[13],[14],[15] Likert's scale is a simple and convenient method available at present to assess the esthetic outcome of cleft lip scar, though several other methods have been used by different authors. Most of the studies have utilized the clinical evaluation, analysis of photographic records, video graphic assessment, and three-dimensional analysis as the modes of assessment since no validated robust assessment tool is available so far.[16],[17],[18],[19] Likert's scale has already been used for converting subjective parameters of evaluation to an objective one, in different fields of plastic surgery. This has also been used for the evaluation of cleft lip scar with satisfactory results.[20] However, the score given depends on the keenness of the observer and his perception. To avoid this bias, we conducted the assessment using 10 independent observers, none from the team conducting this study. There could also be a possibility of bias if the observer was aware of the technique used for an individual case, the name of the operating surgeon, or the hospital's name. This bias was also minimized by keeping the observers blind and sending the materials through a different person. Hence, all the possible measures were adopted to minimize the bias arising from the Likert scale.

There are sporadic reports of single-arm case series using tissue adhesive for skin closure during cleft lip repair, which lack comparison with the conventional suturing technique, obvious to have a bias. The authors claimed to have advantages such as shorter operative time, short hospital stay, less requirement of surgical site care after surgery, and no need for suture removal.[21],[22]

Our study compared between tissue adhesive and the conventional suturing technique, analyzing scar characteristics by 10 independent observers, qualified enough to assess a postoperative scar. Finally, we observed no statistically significant difference between the esthetic outcomes of both the groups. Knott et al. conducted a comparison between tissue adhesive and suture for this purpose and also found the difference not statistically significant.[23] However, they had a small sample size (11 in each group), included only 3 plastic surgeons as observers. Wilson ADH and Mercer N published their comparison between tissue adhesive and steri-strips and found the difference not being statistically significant.[9] Although their study included 307 consecutive patients, that was also retrospective, not properly designed and no details about the observers were mentioned. Furthermore, they studied only hypertrophy of scar and not assessed the scar in a holistic manner as in our study. Halli et al., compared tissue adhesive and suture with a sample size of 30 in each group.[24] They found no statistically significant difference between the scores given by the observers for esthetic outcome. Whereas the difference was significant statistically considering the scores given by the parents of the patients for esthetic appearance. However, the study was retrospective, with only five observers whose skill to assess the outcome of surgery is not clearly understood. Furthermore, including patient relatives in an outcome assessment study always invites bias. Further, overall cosmetic outcome of a cleft lip repair does not depend solely on the closure of skin. Several other factors such as orbicularis oris muscle realignment and geometry of flaps contribute to it. Only scar components of the outcome should be analyzed and compared wherever different techniques are used for skin closure. This principle is appropriately followed in our study with the use of various scar characteristics. A prospective, nonrandomized study was conducted by Desai et al., comparing adhesive and suture for skin closure.[25] However, their sample size was small (total 24 with 12 in each group) and the number of observers or their skill for this purpose is not mentioned. Furthermore, they did not mention about their findings in terms of esthetic outcome. They observed a significant difference between the two groups, in terms of duration of hospitalization only. A prospective randomized controlled trial on this subject has been published recently by James et al.[26] They also had a small sample size (20 and 18 in two groups) and a short follow-up period (3 months). It is well known in the surgical community that scar maturation may take more than 6 months; 3 months follow-up period is too short to assess the resulting scar. They included only two independent observers which is too less in number to avoid assessor-related bias.

Irrespective of the technique used for skin closure, additional supportive maneuvers such as massage of scar with emollients, local application of pressure, and use of silicone either in the form of gel or self-adhesive patch can be used to improvise the scar of cleft lip repair. The only supportive maneuver used in our entire series was application of micropore tape over the repaired lips of both the groups up to 10th postoperative day, to avoid undue stretching of scars and dehiscence. The behavior of scar also varies with the racial origin and many other factors of an individual, which should always be kept in mind and explained to the patients or the guardians before contemplating surgery. Our patients were primarily from the eastern region of India, where skin quality not very conducive to yield better scar.

The age at which surgery is performed, also known to influence the final scar. The age of the patients in our study was observed to have a wide range, with the suture group having a comparatively older population. However, the mean age of our patients was 1.7 years and 2.4 years in the adhesive and suture group respectively, and the difference statistically insignificant (P = 0.122). Hence, in this study, age may not be considered to be a confounding factor to affect the esthetic outcome of scars in any study group.

Although the price of the tissue adhesive was high in comparison to nylon suture (price of adhesive was about thrice the price of the nylon suture), patients in whom skin closure done with adhesive could be discharged early. Curtailed period of hospitalization was observed to reduce the overall hospital bill and loss of wage of the parents as well, hence proving the technique to be economical (exact financial gain or loss was not a part of this study and not calculated).

The present study has its limitation of being a retrospective review of records and as a consequence, putting the level of evidence on a lower side. Furthermore, only clinical photographs were used as the study tool to assess the outcome. To reestablish the finding of this study, a well-designed prospective, randomized control study with large sample size is necessary using patients physically, for outcome assessment. Inclusion of functional outcome of the scars in the future studies may also add scientific value to the obtained data.


  Conclusion Top


The use of tissue adhesive for the closure of skin during cleft lip repair is as good as sutures with respect to the esthetic outcome of the scar. Hence, any of these techniques can be used for this purpose depending on the surgeon's preference and as the situation demands. Tissue adhesive may be preferred over skin sutures to obviate the need for suture removal, which is cumbersome, especially in pediatric patients.

Acknowledgments

The authors would like to acknowledge the contribution of all the surgical specialists acting as independent observers for this study. Notable among them are Dr. Falguni Ray, Dr. Laxmikant Mishra, Dr. Jayant Kumar Dash, Dr. Santosh Kumar Mahallik, Dr. Subrat Kumar Sahoo, Dr. Dillip Kumar Muduly, Dr. Pankaj Kumar, and Dr. Ranjan Kumar Jena.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Panamonta V, Pradubwong S, Panamonta M, Chowchuen B. Global birth prevalence of orofacial clefts: A systematic review. J Med Assoc Thai 2015;98 Suppl 7:S11-21.  Back to cited text no. 1
    
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Mulliken JB. Principles and techniques of bilateral complete cleft lip repair. Plast Reconstr Surg 1985;75:477-87.  Back to cited text no. 5
    
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Kim SM. Importance of various skin sutures in cheiloplasty of cleft lip. J Korean Assoc Oral Maxillofac Surg 2019;45:374-6.  Back to cited text no. 8
    
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Wilson AD, Mercer N. Dermabond tissue adhesive versus Steri-Strips in unilateral cleft lip repair: An audit of infection and hypertrophic scar rates. Cleft Palate Craniofac J 2008;45:614-9.  Back to cited text no. 9
    
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Watson DP. Use of cyanoacrylate tissue adhesive for closing facial lacerations in children. BMJ 1989;299:1014.  Back to cited text no. 10
    
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Adeola AO, Oladimeji AA. Developing a visual rating chart for the esthetic outcome of unilateral cleft lip and palate repair. Ann Maxillofac Surg 2015;5:55-61.  Back to cited text no. 16
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Sinko K, Cede J, Jagsch R, Strohmayr AL, McKay A, Mosgoeller W, et al. Facial aesthetics in young adults after cleft lip and palate treatment over five decades. Sci Rep 2017;7:15864.  Back to cited text no. 20
    
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Malhotra V, Dayashankara Rao JK, Arya V, Sharma S, Singh S, Luthra P. Evaluating the use of octyl-2-cyanoacrylate in unilateral cleft lip repair. Natl J Maxillofac Surg 2016;7:153-8.  Back to cited text no. 21
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Knott PD, Zins JE, Banbury J, Djohan R, Yetman RJ, Papay F. A comparison of dermabond tissue adhesive and sutures in the primary repair of the congenital cleft lip. Ann Plast Surg 2007;58:121-5.  Back to cited text no. 23
    
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Halli R, Joshi A, Kini Y, Kharkar V, Hebbale M. Retrospective analysis of sutureless skin closure in cleft lip repair. J Craniofac Surg 2012;23:e40-4.  Back to cited text no. 24
    
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Desai AK, Kumar N, Ganesh P, Kundalswamy G, Lakkundi B. A comparitive study of tissue adhesive versus sutures in congenital cleft lip repair. Int J Oral Maxillofac Surg 2013;42:1196-6.  Back to cited text no. 25
    
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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