Breast asymmetry is a nonspecific clinical term describing differences in breast size, shape, and position. In fact, most women have mild degrees of breast asymmetry. This is especially true during the early stages of breast development.1,2 However, some cases of asymmetry may be severe and persist beyond adolescence.3 A variety of acquired or congenital conditions may result in considerable breast differences in young women, including but not limited to unilateral breast hypertrophy (macromastia), unilateral breast hypoplasia, tuberous breast deformity, and Poland syndrome (underdevelopment or absence of the pectoralis major muscle and overlying breast).4–7
Our team has demonstrated that breast asymmetry of benign cause significantly hinders patients’ psychological well-being and self-esteem.8 However, outcomes data following surgical treatment for this population are severely lacking. Although countless studies have examined the impact of surgery on health-related quality of life in patients with asymmetry secondary to breast cancer treatment,9–19 analogous studies in the nononcologic population are limited to a handful of small, often retrospective series.20–23 As such, there are marked discrepancies in how the public, providers, and third-party payors view and cover surgical reconstruction in these groups.
This longitudinal study prospectively quantifies changes in the health-related quality of life of young women with benign breast asymmetry following surgical intervention. The effects of patient age, degree of asymmetry, and diagnosis on postoperative quality-of-life outcomes are investigated. In addition, these changes in health-related quality of life are compared to those of female, adolescent control participants. It is hypothesized that surgery will yield significant overall postoperative health-related quality-of-life improvements in the asymmetry cohort, regardless of age, severity, and diagnosis, and will return these patients to a level of functioning commensurate with their peers.
PATIENTS AND METHODS
Breast Asymmetry Participants
This study was part of the Adolescent Breast Research Program approved by the Boston Children’s Hospital Committee on Clinical Investigation (protocol number X08-10-0492). From 2008 through 2018, eligible participants between the ages of 12 and 21 years at initial consultation, with no prior breast surgery, were prospectively enrolled. Written informed consent was obtained from all participants and a parent or guardian, as applicable.
All patients in the present study were Tanner stage V and skeletally mature. They were evaluated by a pediatric plastic surgeon and were deemed to have breast asymmetry of benign cause with at least one cup size difference between breasts. Patients diagnosed with unilateral macromastia, Poland syndrome, tuberous breast deformity, unilateral or asymmetric hypoplasia, or amazia were also included. Patients with unilateral macromastia were so deemed when one breast met the modified Schnur criteria.24,25 All patients underwent surgery at our institution, and were followed postoperatively by the same clinical team. As breast asymmetry is associated with psychosocial distress, breast participants with past or current psychopathology were included. Patients received psychosocial and weight management support as needed.
Concurrently, female controls of the same age range were enrolled during their regularly scheduled appointments at the Department of Plastic and Oral Surgery. To reduce bias, only noncosmetic control participants were recruited from this clinic. Controls were also recruited during routine sick visits and annual physical examinations with their primary care physician through the Division of Adolescent/Young Adult Medicine at the same institution. All controls were in a current state of good health, without considerable medical or surgical history. Patients with a current or prior breast-related diagnosis, or present diagnosis of a psychiatric or eating disorder, were excluded from enrollment.
Clinical Presentation and Biometrics
Clinical staff measured patient height and weight at every office visit. For patients aged 20 years and older, body mass index was categorized using the Centers for Disease Control and Prevention Adult Body Mass Index Calculator, with the following category designations: underweight (body mass index <18.5 kg/m2), healthy weight (body mass index of 18.5 to 24.9 kg/m2), overweight (body mass index of 25 to 29.9 kg/m2), and obese (body mass index ≥30 kg/m2).26 The body mass index percentiles of younger patients were computed using the Centers for Disease Control and Prevention Child and Teen Body Mass Index Calculator, which takes into account patients’ age and sex.27 For these younger participants, body mass index categories were defined as underweight (body mass index less than the fifth percentile), healthy weight (body mass index between the fifth and eighty-fourth percentiles), overweight (body mass index between the eighty-fifth and ninety-fourth percentiles), and obese (body mass index greater than or equal to the ninety-fifth percentile). Baseline body mass index category was used as a covariate in analyses.
Subjects completed three self-administered surveys—the Short-Form 36v2, the Rosenberg Self-Esteem Scale, and the Eating Attitudes Test-26—at baseline and at several postoperative/follow-up intervals: 6 months and at 1, 3, 5, 7, and 9 years. These surveys have been validated in numerous populations and used in studies concerning adolescents and adults with breast asymmetry and other breast disorders.8,21,23,28,29 The Short-Form 36v2 measures quality of life across eight domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health.30 A higher Short-Form 36v2 domain score correlates with better health-related quality of life. Self-esteem is assessed using the Rosenberg Self-Esteem Scale.31 Scores range from 10 to 40, with a higher score indicative of higher self-esteem.32 The Eating Attitudes Test-26 measures eating attitudes and behaviors.33 Scores at or above the threshold of 20 are suggestive of potential disordered eating thoughts and behaviors, and require further evaluation.
Data Management and Statistical Methods
Data were collected and stored using the secure, electronic database Research Electronic Data Capture.34 Data analysis was conducted using IBM SPSS Version 23 (IBM Corp., Armonk, N.Y.). Independent two-sample t test and Pearson chi-square test were used to compare demographics and clinical information. Baseline age, age at surgery, follow-up time, and the volume difference between breasts were all distributed normally. Transformed survey scores for the Short-Form 36v2 domains, Rosenberg Self-Esteem Scale, and Eating Attitudes Test-26 were computed using algorithms provided by Ware et al.,35 Rosenberg,31 and Garner et al.,33 respectively. Linear regression models with baseline body mass index category as a covariate were fit to determine the effect of breast asymmetry on baseline and postoperative survey scores. Most recent postoperative/follow-up survey scores were compared across age at the time of surgery, asymmetry severity, and diagnosis using one-way analysis of variance testing. Age at surgery, asymmetry severity, and diagnosis were all transformed into dichotomous variables. Asymmetry participants were characterized as either younger or older if they were younger than 18 years or 18 years or older at the time of surgery, respectively. Those patients with a volume difference between breasts below the sample mean were deemed to have less severe asymmetry, whereas volume asymmetry above the mean was considered to be more severe. Lastly, diagnosis was categorized as either hypoplastic (breast insufficiency) or hyperplastic (breast hypertrophy). A maximum threshold of 20 percent missing data was used for all analyses, and a value of p < 0.05 was considered statistically significant for all analyses.
Forty-five adolescents with benign breast asymmetry and 101 female controls completed baseline and follow-up surveys (Table 1). The majority of participants with asymmetry (69 percent) had hypoplastic forms of asymmetry, with the remainder of the breast cohort (31 percent) having unilateral breast overgrowth. Most patients in our breast cohort had asymmetry without a formal diagnosis (40 percent), although tuberous breast deformity (27 percent) and unilateral macromastia were the most common diagnoses observed (20 percent) (Table 2). The asymmetry group had a mean self-reported size difference between breasts of 2.2 ± 1.3 cup sizes, or 221.9 ± 151.8 ml as measured using the Mentor volume sizing system (Mentor Worldwide, Irvine, Calif.). A larger proportion of participants with asymmetry (58 percent) were overweight or obese at baseline compared to controls (29 percent; p = 0.003) (Table 1). Roughly half of all control participants were recruited at appointments for skin lesion excision (49 percent), with the remaining controls recruited during sick visits and annual examinations with their primary care provider (36 percent), and office visits for hand injuries (6 percent), lacerations (5 percent), and noncosmetic septorhinoplasties (4 percent).
Table 1. -
Asymmetry and Control Participants’ Characteristics
|Mean baseline age ± SD, yr
||17.3 ± 1.8
||17.2 ± 2.6
|Baseline BMI category
|Past or current mental health diagnosis at baseline
|Mean follow-up time ± SD, mo
||42.0 ± 30.0
||40.8 ± 21.6
|Mean follow-up age ± SD, yr
||21.5 ± 2.8
||20.6 ± 3.2
|Survey response rate
| 6 mo
| 1 yr
| 3 yr
| 5 yr
| 7 yr
| 9 yr
Table 2. -
Asymmetry Participants’ Clinical Details
| Breast asymmetry, without deformation or macromastia
| Tuberous breast deformity
| Unilateral macromastia
| Poland syndrome
|Age at surgery, yr
| Mean ± SD
||18.1 ± 1.7
| Augmentation mammaplasty, unilateral or bilateral
| Reduction mammaplasty, with or without contralateral mastopexy
| Mastopexy only
| Augmentation and contralateral reduction mammaplasty
Asymmetry participants manifested no difference in baseline survey scores based on age at the time of surgery, severity of asymmetry, or underlying diagnosis across all study measures (p > 0.05 for all). Participants performed significantly worse than unaffected controls at baseline on the Rosenberg Self-Esteem Scale and Short-Form 36v2 Social-Functioning and Role-Emotional domains (p < 0.05, all), even after controlling for differences in body mass index category. Both cohorts scored comparably on the Eating Attitudes Test-26 and in six Short-Form 36v2 domains (i.e., Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Mental Health; p > 0.05, all).
The most common surgical intervention in our asymmetry cohort was augmentation mammaplasty (62 percent) (Table 2). In two-thirds of these patients, unilateral augmentation was performed, and the remaining one-third underwent bilateral augmentation. Four patients underwent prior tissue expansion before a permanent implant could be placed. Unilateral reduction mammaplasty was performed in 31 percent of cases. Participants with asymmetry were on average 18.1 ± 1.7 years old at the time of surgery. Asymmetry participants were followed postoperatively for a mean of 3.5 years (range, 6 months to 9.1 years), whereas controls were followed for 3.4 years on average (range, 6 months to 7.6 years; p = 0.93). The majority of asymmetry and control participants completed 6-month, 1-year, and 3-year follow-up surveys (Table 1).
Within-subject analyses were conducted for both cohorts using participants’ most recent follow-up survey data. Asymmetry participants had significant postoperative improvements on the Rosenberg Self-Esteem Scale and in three Short-Form 36v2 domains (i.e., Role-Physical, Social Functioning, and Mental Health; p < 0.05, all) (Fig. 1). Postoperative improvement on the Eating Attitudes Test-26 approached significance (p = 0.07). Physical Functioning, Bodily Pain, General Health, Vitality, and Role-Emotional Short-Form 36v2 domain scores remained stable from baseline to follow-up (p > 0.05, all). Control participants, however, had significant declines on the Rosenberg Self-Esteem Scale, Eating Attitudes Test-26, and in the General Health and Mental Health Short-Form 36v2 domains (p < 0.05, all), with all other scores remaining stable (p > 0.05, all other measures).
At follow-up, asymmetry participants performed similarly to controls in six Short-Form 36v2 domains and on the Rosenberg Self-Esteem Scale and Eating Attitudes Test-26 when controlling for differences in baseline body mass index category (p > 0.05, all) (Fig. 1). Postoperative asymmetry patients scored more favorably than controls at follow-up in the Mental Health (p = 0.04) and Bodily Pain Short-Form 36v2 domains (p = 0.07, approached significance). Asymmetry patients scored similarly to, or more favorably, than controls at the 6-month and 1-, 3-, and 5-year follow-up time points (Table 3).
Table 3. -
Comparison of Asymmetry and Control Group Postoperative/Follow-Up Scores at Various Time Points
||Asymmetry and Control Score Difference* (95% CI)
||Asymmetry and Control Score Difference* (95% CI)
||Asymmetry and Control Score Difference*(95% CI)
||Asymmetry and Control Score Difference* (95% CI)
||Asymmetry and Control Score Difference* (95% CI)
||6.4 (0.9 to 11.8)
||0.5 (−9.3 to 10.2)
||−3.1 (−12.1 to 5.9)
| Physical Functioning
||−5.3 (−12.3 to 1.7)
||4.0 (0 to 8.1)
||4.5 (−1.9 to 10.9)
||−6.8 (−16.8 to 3.2)
||−0.7 (−11.0 to 9.5)
| Role Physical
||−6.5 (−14.5 to 1.4)
||3.8 (−8.3 to 6.8)
||5.3 (−1.1 to 10.1)
||−2.2 (−9.2 to 4.9)
||2.2 (−8.8 to 13.3)
| Bodily Pain
||0.3 (−5.8 to 6.3)
||1.5 (−5.3 to 8.2)
||4.7 (−3.7 to 13.1)
||−1.5 (−10.0 to 7.0)
||2.0 (−9.6 to 13.5)
| General Health
||−6.8 (−13.2 to −0.4)
||−2.4 (−9.8 to 5.1)
||7.2 (0.4 to 13.0)
||−1.0 (−8.6 to 6.6)
||−0.7 (−11.8 to 10.4)
||−1.6 (−6.8 to 3.7)
||4.1 (−1.7 to 9.9)
||1.7 (−7.3 to 10.6)
||0.5 (−9.1 to 10.1)
||1.6 (−11.5 to 14.7)
| Social Functioning
||−10.2 (−17.2 to −3.2)
||−0.5 (−8.1 to 7.1)
||0.3 (−9.5 to 10.0)
||0 (−11.7 to 11.7)
||−1.9 (−20.6 to 16.7)
||−10.6 (−19.2 to −2.0)
||3.2 (−2.7 to 9.1)
||6.4 (−2.1 to 14.8)
||3.0 (−6.5 to 12.5)
||1.2 (−13.3 to 15.7)
| Mental Health
||−5.4 (−11.6 to 0.8)
||4.1 (−2.5 to 10.8)
||1.2 (−1.2 to 3.6)
||0.2 (−2.6 to 3.1)
||−0.5 (−5.2 to 4.3)
||−3.3 (−5.2 to −1.4)
||0.9 (−1.3 to 3.1)
||−0.5 (−3.5 to 3.4)
||−0.6 (−4.9 to 3.7)
||2.0 (−6.1 to 10.1)
||2.3 (0 to 4.5)
||0.9 (−1.5 to 3.4)
SF-36, Short-Form 36v2, RSES: Rosenberg Self-Esteem Scale; EAT-26, Eating-Attitudes Test-26.
*Mean score difference between control and asymmetry groups. A negative value indicates a lower mean asymmetry score relative to controls.
†Independent samples t test.
Effect of Surgical Age, Asymmetry Severity, and Diagnosis on Health-Related Quality-of-Life Outcomes
There were no significant differences in the postoperative/follow-up scores of controls and asymmetry patients younger than 18 years (n = 20) and those aged 18 years or older (n = 25) across all survey measures (p > 0.05, all). At follow-up, participants with less (n = 22) and more severe asymmetry (n = 23) performed comparably to controls and to each other on all measures (p > 0.05, all). There were also no significant differences in postoperative/follow-up survey scores of breast participants with hypoplastic (n = 31) or hyperplastic conditions (n = 14) and control participants (p > 0.05, all).
Characterization of Nonresponders
At the 1-year follow-up, control survey nonresponders were significantly older than controls who responded to the surveys (p = 0.001); this difference was not observed at other time points (p > 0.05, all). There were no significant demographic differences between responders and nonresponders for both cohorts at all other time points (p > 0.05, all).
This study is the first prospective investigation to quantify quality-of-life changes following surgery in young women with benign breast asymmetry using previously validated surveys, a control group, and a relatively large sample size. Surveys were administered to both cohorts at baseline and at follow-up/postoperatively at regular intervals spanning roughly a decade.
Subjects with breast asymmetry had significant preoperative deficits in social functioning, emotional well-being, and self-esteem compared with controls. Postoperatively, this cohort experienced significant improvements in social functioning, mental health, self-esteem, and their work and activity-related physical functioning (Role-Physical Short-Form 36v2 domain). Following surgery, asymmetry participants returned to a level of functioning commensurate with controls, and these improvements were largely sustained for the duration of the follow-up period. It must also be noted that postoperatively asymmetry participants scored significantly higher than controls on the Short-Form 36v2 Mental Health domain, and their more favorable Bodily Pain Short-Form 36v2 domain score approached significance. These overall findings mirror those of smaller series concerning adolescents and adult women with congenital breast asymmetry and those with asymmetry secondary to breast cancer treatment.9–19 Our findings also support those of Neto et al., who examined postoperative quality-of-life changes in a cohort of adolescents and adult women with benign breast asymmetry using the Short-Form 36v2 and Rosenberg Self-Esteem Scale, in that the majority of postoperative improvements were largely psychosocial.23
Breast asymmetry is a nonspecific term referring to differences in breast size, shape, and position. Although minor differences are expected for all bilateral anatomical structures, moderate to extreme differences in breast size are common in adolescents and may persist into adulthood.1–3 Asymmetry in this population is invariably benign in origin and as a result is frequently dismissed as simply a “cosmetic” concern. This categorization along with a reluctance for many young women to vocalize concerns about their breasts can often lead to delayed referrals for assessment and possible intervention. When management is pursued, the most useful therapy for the adolescent is reassurance. Reassurance for some may simply be an explanation that some degree of breast asymmetry is to be expected in women, especially during puberty when breasts are developing. In others, reassurance may take the form of a diagnosis and acknowledgment of the patient’s concerns. Although it may be apparent that asymmetry in some may persist without surgical intervention, our group has found success using oncologic breast prostheses to mask asymmetry and improve social functioning in adolescents who are not yet ready or do not wish to pursue surgery.36 Once breast size has stabilized, our findings suggest that surgical intervention may be considered in developmentally and psychologically mature young women with persistent breast asymmetry to alleviate the associated distress.
The Women’s Health and Cancer Rights Act of 1998 guarantees women with breast asymmetry secondary to breast cancer treatment insurance coverage to reconstruct both the affected and unaffected breasts to ensure symmetry.37 Although this does not correct a “functional impairment,” the provision recognizes the importance of breast symmetry for a woman’s psychosocial well-being. However, this protection is not generalizable to other causes of breast asymmetry. Similar discrepancies persist in how young women with breast asymmetry are viewed compared to those with bilateral macromastia. Although it is true that breast asymmetry typically lacks the physical sequelae associated with bilateral macromastia, both groups suffer from similar psychosocial impairment.8,28 Most benign forms of asymmetry arise during adolescence when general body image concerns are common, and may be conflated with significant aberrations in breast development. This can lead to dismissing these considerable developmental differences as simply “cosmetic” concerns. There are relatively few data to demonstrate the impact of breast asymmetry on young women,8,20–23 and there are no long-term outcome studies looking at this untreated population over time. The present study affirms that significant decrements in health-related quality of life exist in young women with moderate to severe breast asymmetry, and that surgical intervention can correct these deficits.
Our findings show that postoperative quality of life did not vary by age at the time of surgery, diagnosis type, or severity of breast asymmetry. Younger patients who had not yet reached 18 years at the time of surgery performed just as well postoperatively as their older peers and the control group. These findings indicate that age cut-offs imposed by surgeons and third-party payors may be arbitrary. Instead, developmental and psychological maturity and breast growth stabilization may be more meaningful markers of surgical readiness. Surgery should also not be withheld in appropriate patients with less severe asymmetry or those with hypoplastic asymmetry who typically require augmentation mammaplasty, a procedure commonly regarded as cosmetic unless used for breast cancer patients. The present study demonstrates that these patients share the same baseline psychosocial deficits as their more severe and hyperplastic counterparts and enjoy the same postoperative improvements in quality of life.
Study limitations must be acknowledged. The health-related quality-of-life surveys used in this study have been validated across a myriad of populations and have been used in other studies concerning adolescents and women with breast disorders, including breast asymmetry. However, these surveys have not yet been validated specifically for adolescents and young women with breast asymmetry. The minimal clinical important difference for our health-related quality-of-life measures could not be reported, as further research is needed to derive them for adolescents with breast conditions. Currently, no normative Short-Form 36v2 values exist for younger adolescents, and as such, a control group was incorporated. Interestingly, control participant scores worsened on the Rosenberg Self-Esteem Scale, Eating Attitudes Test-26, and two in Short-Form 36v2 domains (i.e., General Health and Mental Health) during the follow-up period. However, adolescence comes with its own unique set of psychological and social challenges and may explain why control survey scores fluctuated over time. This finding may be attributable to potential sampling bias or may be indicative of natural changes in health-related quality of life during adolescence. As a result, it is possible that postoperative/follow-up score differences between groups may be amplified. Follow-up body mass index data were unavailable for breast and control participants. As such, baseline body mass index category was used as a covariate in linear regression models. Within-subject analyses comparing baseline to postoperative quality of life were unable to be conducted when stratifying the breast cohort by their age, asymmetry severity, and diagnosis, as analyses would be considerably underpowered because of relatively low sample sizes. Likewise, the survey scores of the asymmetry and control groups at the 7- and 9-year follow-up time points could not be compared because of low sample sizes. Lastly, results may not be generalizable because participants were recruited from a single, large tertiary care facility.
Young women with moderate to severe breast asymmetry of various benign causes may benefit from surgery. The present study demonstrates that, postoperatively, patients enjoy significant and sustained improvements in their psychosocial quality of life, and are returned to a level of functioning commensurate with their peers. Providers should be aware of the potential positive impact that surgical treatment can provide developmentally and psychologically mature young women with symptomatic asymmetry and consider surgery when nonsurgical options fail.
Dr. David B. Sarwer, associate dean for research, professor of social and behavioral sciences, director of the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pa.
For many women, the breast is an important element of personal identity. Dissatisfaction with the size and shape of the breasts is a common complaint of women throughout the Western world. While women with objectively normal or average-sized breasts are often dissatisfied with their appearance, the greatest levels of dissatisfaction are seen in women who believe that their breasts are overly small or large. As demonstrated repeatedly in the plastic surgery literature, breast augmentation and breast reduction dramatically improve this dissatisfaction and also, for some, improve body image, self-esteem, and quality of life.
Far fewer studies have investigated the psychosocial experiences of young women with congenital breast deformity. Previous work by this research team and published in Plastic and Reconstructive Surgery found that young women who sought treatment for several types of congenital breast deformity reported impairments in psychosocial functioning and self-esteem. This dissatisfaction likely motivated the pursuit of treatment. The current investigation followed these women postoperatively and compared changes in self-esteem, quality of life, and eating behavior to those of an unaffected comparison group. Women who underwent surgical treatment reported improvements in self-esteem, social functioning, and their overall mental health.
The study has a number of important methodological strengths. The research team thoughtfully selected theoretically relevant psychosocial constructs and assessed them with psychometrically validated and widely used measures. The team did an impressive job in their efforts to follow these patients over time; retaining adolescents in research studies as they move through high school and into early adulthood is notoriously difficult. Exploration of the relationship between changes in psychosocial functioning and the type or degree of deformity was important. These relationships did not reach statistical significance, as seen in many other studies. These observations are a reminder that the size or scope of a physical deformity is often unrelated to the level of psychosocial distress reported by the patient.
The study also provides a strong foundation for additional work in this area. While the psychometric measures used are a methodological strength, all are rather general. More specific patient-reported outcome measures developed since the study was initiated, such as the BREAST-Q, are recommended for future studies. The percentage of young women with overweight and obesity is somewhat higher than seen in the general population. Young women with macromastia often report reluctance to exercise secondary to physical or psychological discomfort. Following breast reduction, some report more regular engagement in exercise and experience weight loss. Eating behaviors and dietary choices are likely the primary drivers of weight loss in these women. In the present study, eating behaviors improved postoperatively but did not reach statistical significance. However, the overall sample size and loss to follow-up of some participants may have left the study underpowered to detect statistically significant changes. Future studies are encouraged to look at changes in weight, diet, eating behavior, and physical activity.
The authors end the article with an important reminder about the continued need for advocacy for insurance coverage for many plastic surgery procedures not regularly covered. As those of us who work in the field know, the general public often thinks “cosmetic surgery” when they hear “plastic surgery.” Thus, any emotional distress is dismissed as a byproduct of vanity. Patients with congenital or acquired deformities that can be treated by plastic surgery often carry with them a significant psychosocial burden, one that is often greater than the impairment in functioning or visibility of the condition. The present study adds to a large and still growing literature demonstrating the psychosocial benefits of plastic surgery. We need to use this literature to strengthen the argument to insurance companies and lawmakers about the tremendous value of these procedures to the patients who undergo them.
Disclosure: Dr. Sarwer currently has grant funding from the National Institute of Diabetes, Digestive, and Kidney Disease (R01-DK-108628-01), the National Institute of Dental and Craniofacial Research (R01 DE026603), the Department of Defense, as well as the Commonwealth of Pennsylvania (PA CURE). He is a member of the board of directors of the Aesthetic Surgery Education and Research Foundation. He has consulting relationships with Ethicon, Merz, and Novo Nordisk.
This work was supported in part by the Plastic Surgery Foundation (grant no. 192776). The Plastic Surgery Foundation had no involvement in the study design; collection, analysis, and interpretation of data; the writing of the manuscript; or the decision to submit the manuscript for publication.
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