Abstract
Purpose.
Environmental factors such as bathing may play a role in atopic dermatitis (AD) development. This analysis utilized data from the Community Assessment of Skin Care, Allergies, and Eczema (CASCADE) Trial (NCT03409367), a randomized controlled trial of emollient therapy for AD prevention in the general population, to estimate bathing frequency and associated factors within the first 9 weeks of life.
Methods.
Data were collected from 909 parent/newborn dyads recruited from 25 pediatric and family medicine clinics from the Meta-network Learning and Research Center (Meta-LARC) practice-based research network (PBRN) consortium in Oregon, North Carolina, Colorado, and Wisconsin for the CASCADE trial. Ordinal logistic regression was used to conduct a cross-sectional analysis of the association between bathing frequency (measured in baths per week) and demographic, medical, and lifestyle information about the infant, their family, and their household. Variables were selected using a backwards-stepwise method and estimates from the reduced model are reported in the text.
Results.
Moisturizer use (OR = 2.03, 95% CI: 1.54–2.68), Hispanic or Latino ethnicity (OR = 1.97, 95% CI: 1.42–2.72), a parental education level lower than a 4-year college degree (OR = 2.48, 95% CI: 1.70–3.62), living in North Carolina or Wisconsin (compared to Oregon; OR = 2.12 and 1.47, 95% CI: 1.53–2.93 and 1.04–2.08, respectively), and increasing child age (in days; OR = 1.02, 95% CI: 1.01–1.02) were significantly associated with more frequent bathing, while pet ownership (OR = 0.67, 95% CI: 0.52–0.87) was significantly associated with less frequent bathing.
Conclusions.
We found significant ethnic, geographic, and socioeconomic variation in bathing frequency before 9 weeks of age that may be of relevance to AD prevention studies.
Keywords: Bathing, atopic dermatitis, eczema, skin care, emollients
Introduction
While parental family history and mutations in FLG, the gene encoding the skin barrier protein filaggrin, represent the strongest risk factors identified for the development of atopic dermatitis (AD), environmental factors likely play a role in AD development.1,2 Evidence for an environmental influence on AD risk includes the findings that climate, water hardness, particulate matter exposure, population migration and urbanization all impact disease prevalence.3,4 One theory proposed for AD initiation holds that weakening of the skin barrier early in life by environmental factors allows for irritants and allergen ingress, activating antigen-presenting cells in the epidermis, thus activating innate and adaptive type 2 immune responses.5 Activities that may challenge the skin barrier include excessive bathing, cleansing products, and water hardness.6,7
Although bathing is beneficial for skin hygiene and bonding between the baby and caregiver, bathing may also have deleterious effects on skin barrier function. Prolonged exposure of the skin to water and skin cleansers may impact transepidermal water loss (TEWL) and may potentially lead to dryness of the skin.8–11 Grunewald et al. report the degree of skin irritation and harm to the skin barrier increased as washing frequency increased with use of an irritant cleanser.9 Marrs et al. recently found the frequency of bathing in the first three months of life increased the risk of developing AD in a dose-dependent manner with more frequent bathing corresponding to a higher risk of AD development.12 A systematic review of skin care interventions to prevent AD did not find an increased risk of AD in RCTs of bathing practices, but outcome assessment at four weeks may not have allowed time to affect AD development.13
Although general recommendations exist14 regarding the timing of the first bath and bathing frequency in the first weeks of newborn life, the recommendations do not consider later health outcomes such as AD development. Most prominent organizations, such as the American Academy of Dermatology and the American Academy of Pediatrics recommend bathing no more than 2–3 times per week, however these recommendations are based on expert opinion.15,16 Further, there is a paucity of data evaluating actual bathing practices and bathing frequency in the real-world setting.
The Community Assessment of Skin Care, Allergies, and Eczema (CASCADE) Trial (NCT03409367) is a randomized controlled trial17 examining the effectiveness of emollient therapy for AD prevention in a general population setting. The CASCADE cohort offers an opportunity in a community-based population not selected for risk to estimate current bathing frequency associated factors in the first 9 weeks of life prior to intervention.
Methods
Study Population
The CASCADE trial is a multi-site pragmatic randomized controlled trial based out of the Oregon Health & Science University (OHSU). Parent/newborn dyads were recruited from participating primary care clinics from the Meta-network Learning and Research Center (Meta-LARC) practice-based research network (PBRN) consortium in Oregon (Oregon Rural Practice-based Research Network), North Carolina (Duke Primary Care Research Consortium), Colorado (State Networks of Ambulatory Practices and Partners), and Wisconsin (Wisconsin Research and Education Network). A total of 25 pediatric and family medicine clinics provided the setting for participant enrollment.
The study methods are described elsewhere.17 All infants under the age of 9 weeks were eligible to enroll in the CASCADE trial if they had not been diagnosed with eczema or any congenital disorders. The initial consenting procedures, screening and baseline surveys were completed by the parent or guardian of the newborn in either English or Spanish. Data were collected online, either in the primary care clinic using a tablet computer or on the participant’s personal device. The baseline data collected demographic, medical, and lifestyle information about the infant, their family, and their household.
Infants were included in the analysis if they were more than one week old and had at least one reported bath. Less than 10% of the sample were excluded case-wise from analysis if they were missing the outcome variable or any covariates of interest. Respondents who indicated they preferred not to answer a question or did not know the answer were treated as missing.
Categorization of outcome and covariates
The primary outcome variable was bathing frequency. In the baseline questionnaire, respondents were asked, “Since birth, about how many DAYS PER WEEK does your baby have a bath or shower?” Respondents provided an integer ranging from 0 to 7. Infants with zero reported baths were excluded from the analysis since “zero baths” could indicate that the infant hadn’t yet received their first bath, or the parent may not count wiping the child down with a washcloth. Responses of four, five, six, or seven reported baths were combined into a single category due to small sample sizes, resulting in four ordinal categorical outcome options: “1 bath,” “2 baths,” “3 baths,” or “4 or more baths.”
Distributions of covariates are described in Table 1, stratified by bathing frequency. Age was measured in days and analyzed as a continuous variable reported as a mean. Frequencies of categorical variables were reported, including 7 binary variables with “yes” or “no” responses (pre-term birth, family history of eczema, child history of dry skin, moisturizer use, family dog ownership, family cat ownership, and weekly contact with farm animals) as well as categorical variables for gender, delivery method (vaginal or Cesarean), ethnicity, race (collected as “check all that apply” and analyzed as an indicator variable), level of parental educational attainment (due to subgroup sizes, less than high school and high school or GED [General Education Development test] were combined into one category), and PBRN.
Table 1.
Baseline characteristics of participants by bathing frequency, CASCADE trial 2018–2021.
| Baths per Week |
|||||
|---|---|---|---|---|---|
| Covariate | N | 1 | 2 | 3 | 4+ |
|
| |||||
| Total Sample, n (%) | 909 | 300 (33.0) | 275 (30.3) | 203 (22.3) | 131 (14.4) |
| Mean Child Age, days (SD) | 29 (14.4) | 26 (13.2) | 28 (14.4) | 31 (14.6) | 32 (15.7) |
| Child born ≥ 3 weeks early, n (%) | 62 | 19 (30.7) | 20 (32.3) | 16 (25.8) | <10 |
| Delivery Method | |||||
| Vaginal, n (%) | 647 | 210 (32.5) | 204 (31.5) | 141 (21.8) | 92 (14.2) |
| C-Section, n (%) | 262 | 90 (34.4) | 71 (27.1) | 62 (23.7) | 39 (14.9) |
| Child Gender | |||||
| Male, n (%) | 500 | 152 (30.4) | 156 (31.2) | 120 (24.0) | 72 (14.4) |
| Female, n (%) | 409 | 148 (36.2) | 119 (29.1) | 83 (20.3) | 59 (14.4) |
| Family History of Eczema, n (%) | 475 | 159 (33.5) | 136 (28.6) | 108 (22.7) | 72 (15.2) |
| Child History of Dry Skin, n (%) | 364 | 126 (34.6) | 107 (29.4) | 74 (20.3) | 57 (15.7) |
| Ever Used Moisturizer on Child, n (%) | 630 | 179 (28.4) | 184 (29.2) | 161 (25.6) | 106 (16.8) |
| Child Ethnicity | |||||
| Hispanic or Latino, n (%) | 188 | 44 (23.4) | 44 (23.4) | 47 (25.0) | 53 (28.2) |
| Not Hispanic or Latino, n (%) | 721 | 256 (35.5) | 231 (32.0) | 156 (21.6) | 78 (10.8) |
| Child Racea | |||||
| Asian, n (%) | 58 | 18 (31.0) | 17 (29.3) | 15 (25.9) | <10 |
| Black or African American, n (%) | 122 | 33 (27.1) | 29 (23.8) | 33 (27.1) | 27 (22.1) |
| White, n (%) | 773 | 269 (34.8) | 242 (31.3) | 166 (21.5) | 96 (12.4) |
| Parent/Guardian Education level | |||||
| Degree beyond college, n (%) | 300 | 108 (36.0) | 111 (37.0) | 55 (18.3) | 26 (8.7) |
| 4-year college degree, n (%) | 212 | 79 (37.3) | 66 (31.1) | 46 (21.7) | 21 (9.9) |
| Some college, n (%) | 215 | 78 (36.3) | 46 (21.4) | 55 (25.6) | 36 (16.7) |
| ≤HS diploma or GED,b n (%) | 182 | 35 (19.2) | 52 (28.6) | 47 (25.8) | 48 (26.4) |
| Family Owns Pet (Dog, Cat, or Both), n (%) | 578 | 213 (36.9) | 186 (32.2) | 119 (20.6) | 60 (10.4) |
| Weekly Contact with Farm Animals, n (%) | 36 | 15 (41.7) | <10 | <10 | 10 (27.8) |
| PBRNc | |||||
| Oregon, OHSU, n (%) | 359 | 133 (37.1) | 105 (29.3) | 72 (20.1) | 49 (13.7) |
| North Carolina, Duke, n (%) | 263 | 66 (25.1) | 86 (32.7) | 71 (27.0) | 40 (15.2) |
| Wisconsin, University of WI, n (%) | 161 | 50 (31.1) | 46 (28.6) | 36 (22.4) | 29 (18.0) |
| Colorado, University of CO, n (%) | 126 | 51 (40.5) | 38 (30.2) | 24 (19.1) | 13 (10.3) |
Respondents could indicate more than one race. “American Indian or Alaska Native,” “Native Hawaiian or Pacific Islander,” “Other,” and “Prefer not to answer” are excluded from the table due to small cell sizes (n < 10).
General Educational Development, equivalent to a high school diploma.
Practice-based Research Network.
Statistical Analysis
Adjusted (multivariable) and unadjusted (univariable) ordinal logistic regression models in the proportional odds form were used to measure the association between bathing frequency and the demographic and lifestyle characteristics described above. An ordinal logistic regression model is similar to a binary logistic regression model; however, a binary model only tests whether a single event is more likely to occur for one group compared to another, whereas an ordinal model tests the likelihood that an outcome is relatively higher for one group compared to another.18 In the example of bathing frequency in this analysis, odds ratios describe the likelihood that one group bathes “more” than another group, regardless of where the cut-point might be, simultaneously testing all cut-points (Pr[Y ≥ 1|X], Pr[Y ≥ 2|X], and Pr[Y ≥ 3|X]) in a single model. Statistical significance was determined using two-sided Wald tests; p-values < 0.05 were considered statistically significant. All statistical analyses were performed using Stata software (version 16.1, StataCorp 2021).
Results
Sample Demographics
The original data set contained data from 1,250 infants. Two hundred eleven infants were less than one week old or older than nine weeks old, and 46 additional infants had zero reported baths, leaving 993 who were eligible for inclusion. Of these, n = 26 (2.9%) were excluded because they were missing the outcome variable and n = 58 (6.4%) because of missing covariates of interest.
A total of 909 infants were included in the analysis (Figure 1). The ages ranged from 8 to 63 days, with a mean age of 28.4 days. There were more male than female infants in the sample (male: n = 500, 55%; female: n = 409, 45%). The majority of the sample was White (n = 773, 85%), and 21% of the sample was Hispanic or Latino (n = 188). The most commonly reported races other than White were Black or African American (n = 122, 13%) and Asian (n = 58, 6%); few respondents indicated that their infant was American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, other, or that they preferred not to answer. Respondents could select multiple race categories. Nearly two-thirds of the sample reported one or two baths per week (one bath: n = 300, 33%; two baths: n = 275, 30%), while three baths (n = 203, 22%) and four or more baths (n = 131, 14%) were less commonly reported (Figure 2); our sample mean was 2.3 baths per week. The characteristics of participants by bathing frequency are presented in Table 1.
Figure 1:
Flow chart describing the derivation of the analytic study sample.
Figure 2:
Histogram of newborn bathing frequency (baths/week).
Ordinal Logistic Regression, Proportional Odds Form
A model was first fit with all covariates of interest. In the full model, child age, moisturizer use, ethnicity, parental education level, pet ownership, and PBRN were significantly associated with bathing frequency (Table 2). Then, a more parsimonious model retaining only the significant variables was fit. This reduced model was compared to the full model using a likelihood ratio test. There was no strong evidence that the full model would provide better estimates than the reduced model (p = 0.342); therefore, the results from the adjusted, reduced model are reported here.
Table 2.
Results of ordinal logistic regression analysis of frequent bathing.
| Unadjusted (univariable models) | Adjusted, full model (multivariable model) | Adjusted, reduced model (multivariable model)a | ||||
|---|---|---|---|---|---|---|
|
|
||||||
| Covariate | OR (95% CI) | p-value | OR (95% CI) | p-value | OR (95% CI) | p-value |
|
| ||||||
| Child age (days) | 1.02 (1.01–1.03) | <0.001 | 1.02 (1.01–1.02) | 0.001 | 1.02 (1.01–1.02) | 0.001 |
| Child born ≥ 3 weeks early | 1.02 (0.64–1.61) | 0.939 | 0.98 (0.60–1.58) | 0.923 | -- | -- |
| Delivery Method | ||||||
| Vaginal, reference | -- | -- | -- | -- | -- | -- |
| C-Section | 1.01 (0.78–1.31) | 0.925 | 1.12 (0.85–1.46) | 0.427 | -- | -- |
| Child Gender | ||||||
| Male | 1.20 (0.95–1.52) | 0.130 | 1.14 (0.89–1.45) | 0.299 | -- | -- |
| Female, reference | -- | -- | -- | -- | -- | -- |
| Family History of Eczema | 1.04 (0.82–1.32) | 0.741 | 1.23 (0.96–1.57) | 0.100 | -- | -- |
| Child History of Dry Skin | 0.95 (0.75–1.21) | 0.669 | 0.82 (0.64–1.05) | 0.121 | -- | -- |
| Ever Used Moisturizer on Child | 2.07 (1.60–2.69) | <0.001 | 2.08 (1.56–2.76) | <0.001 | 2.03 (1.54–2.68) | <0.001 |
| Child Ethnicity | ||||||
| Hispanic or Latino | 2.37 (1.75–3.19) | <0.001 | 2.02 (1.44–2.83) | <0.001 | 1.97 (1.42–2.72) | <0.001 |
| Not Hispanic or Latino, reference | -- | -- | -- | -- | -- | -- |
| Child Raceb | ||||||
| Asian | 1.09 (0.68–1.76) | 0.719 | 1.24 (0.73–2.09) | 0.356 | -- | -- |
| Black or African American | 1.67 (1.18–2.36) | 0.004 | 1.03 (0.70–1.53) | 0.865 | -- | -- |
| White, reference | -- | -- | -- | -- | -- | -- |
| Parent/Guardian Education level | ||||||
| Degree beyond college, reference | -- | -- | -- | -- | -- | -- |
| 4-year college degree | 1.06 (0.77–1.45) | 0.714 | 1.18 (0.84–1.65) | 0.336 | 1.18 (0.85–1.64) | 0.335 |
| Some college | 1.42 (1.03–1.96) | 0.032 | 1.59 (1.11–2.27) | 0.011 | 1.58 (1.12–2.23) | 0.009 |
| ≤HS diploma or GEDc | 2.72 (1.94–3.80) | <0.001 | 2.71 (1.82–4.05) | <0.001 | 2.48 (1.70–3.62) | <0.001 |
| Family Owns Pet (Dog, Cat, or Both) | 0.53 (0.41–0.68) | <0.001 | 0.69 (0.53–0.91) | 0.008 | 0.67 (0.52–0.87) | 0.003 |
| Weekly Contact with Farm Animals | 1.23 (0.63–2.39) | 0.544 | 1.58 (0.79–3.17) | 0.198 | -- | -- |
| PBRNd | ||||||
| OHSU, Oregon, reference | -- | -- | -- | -- | -- | -- |
| Duke, North Carolina | 1.50 (1.13–1.99) | 0.006 | 2.16 (1.53–3.04) | <0.001 | 2.12 (1.53–2.93) | <0.001 |
| Wisconsin, University of WI | 1.35 (0.96–1.89) | 0.086 | 1.50 (1.05–2.13) | 0.025 | 1.47 (1.04–2.08) | 0.027 |
| Colorado, University of CO | 0.83 (0.57–1.20) | 0.325 | 0.90 (0.61–1.31) | 0.575 | 0.86 (0.59–1.25) | 0.422 |
Reduced multivariable model was compared to the full model using the likelihood ratio test. A small p-value would indicate that information is lost in using the reduced model instead of the full model. In our study there is no strong evidence that the full model is better than the reduced model (p = 0.498); therefore, the reduced model estimates are reported in the text.
All collected non-White race variables were included as indicator variables in the full model; none were significant. Only non-White categories with sufficient sample sizes are reported.
General Educational Development, equivalent to a high school diploma.
Practice-based Research Network.
Older infants were more likely to bathe more frequently than younger infants: each day in age was associated with a 2% increase in the odds of more frequent bathing (OR = 1.02, p < 0.001). Infants whose parents reported moisturizer use were more than twice as likely to be bathed more frequently than those who had never used moisturizer (OR = 2.03, p < 0.001); infants of Hispanic or Latino ethnicity were also about twice as likely to be bathed more frequently than non-Hispanic/Latino children (OR = 1.97, p < 0.001). Lower parental education levels were positively associated with more frequent bathing: compared with infants whose parents had received a degree beyond college (reference category). Infants whose parents received some college education was associated with a 58% increase in the odds of bathing more frequently, while infants whose parents received only a high school education or less was associated with a 148% increase in the odds of bathing more frequently (some education: OR = 1.58, p = 0.009; high school or less: OR = 2.48, p < 0.001). Geography also increased the odds of some infants bathing more frequently: compared to Oregon infants (reference category), living in North Carolina was associated with a 112% increase in odds in bathing more frequently (OR = 2.12, p < 0.001), while living in Wisconsin was associated with a 47% increase in odds (OR = 1.47, p = 0.027). Pet ownership was significantly associated with a reduction in bathing: infants in a family with a pet (cat, dog, or both) were 33% less likely to bathe frequently than similar households with no pet (OR = 0.67; p = 0.003).
Preterm birth, delivery method, child gender, family history of eczema, child history of dry skin, child race, and weekly contact with farm animals had no significant association to bathing frequency.
Discussion
This cross-sectional analysis of a community-based cohort of over 900 infants from the U.S. found significant ethnic, geographic, and socioeconomic variation in bathing frequency before 9 weeks of age. While the majority of the sample bathed twice weekly or fewer consistent with current recommendations of 2–3 baths per week, 36.7% of the sample reported bathing their infant 3 times per week or more. Factors found to be significantly associated with more frequent bathing in our study population included child age, moisturizer use, Hispanic/Latino ethnicity, lower parental educational attainment, not owning a pet, and geographic location (in relation to Oregon). The association with moisturizer use is likely due to newborn bathing recommendations that suggest moisturizing immediately after bathing-a form of confounding by indication.19 Factors that showed no relationship to bathing frequency included, somewhat surprisingly, a history of atopic diseases in the family (Unadjusted OR = 1.04, p = 0.741). These data add to a relatively small but growing body of information regarding bathing practice variation in infant populations – a newly recognized and potentially modifiable risk factor for AD development.
Understanding bathing practices is important as emerging data reveal the frequency of bathing may impact the development of AD. Marrs, et al found infants bathed more than once per week was associated with an increased odds of having AD on clinical exam at 3 months (OR 1.98 [1.06–3.71], p = 0.03.12 In the same study, increased bathing frequency was also associated with increased transepidermal water loss (TEWL). A possible explanation for how frequent bathing may promote increasing TEWL and AD development lies in the potential negative effects water and cleanser exposure may have on cutaneous barrier function.9 These data identified bathing frequency as a possible target for AD risk modification although basic information on the current bathing practices in the U.S. are lacking.
To our knowledge, our study is the first to describe bathing frequency in a large sample of infants from the U.S. The PBRN structure allowed us to collect information from varied geographic settings, including rural and community-based settings. The mean of 2.3 baths per week is lower than previously reported from a smaller population in Oregon that reported mean baths per week around 4.20 Bathing recommendations beyond the newborn period primarily stem from expert opinion and no prospective studies have been performed to identify optimal bathing frequencies to reduce the risk of AD. The study by Marrs, et al. of infants from England and Wales suggests there may be an optimal frequency with all frequencies over 1 per week increasing the risk of AD.12 Thus, understanding the basic bathing habits and associations with frequent bathing will help guide future educational interventions should a definitive optimal bathing frequency emerge from more rigorous prospective studies.
Our study is also the first to describe ethnic variations in newborn bathing frequency in the U.S. with reported Hispanic/Latino ethnicity reporting higher frequencies of weekly bathing. It is interesting to note that this ethnic group have been reported to have higher rates of AD and more severe disease.21,22 The reasons for the observed associations between ethnicity and frequent bathing are unclear. These differences may reflect cultural concepts of hygiene which vary globally23,24, or may be spurious as many ethnicities and cultures fall under the broad “Hispanic” classification. We found educational attainment was significantly associated with bathing frequency, with lower educational attainment being associated with more frequent bathing. A possible explanation for these results is the association between education and health literacy.25,26 People with higher levels of education tend to have high degrees of health literacy, including awareness of health guidelines and the ability to apply them.26 Sheriff, et al. found a similar association with lower maternal educational attainment to be positively correlated with higher hygiene scores, that included bathing, in a population of 15 month olds.27
Last, pet ownership was also significantly associated with a decreased likelihood of frequent bathing. The reasons for this association may be comparable to the reasons for the association between education and bathing. Pet ownership is independently linked to factors that are associated with health literacy, including high socioeconomic status and educational attainment28; in our sample, pet ownership was significantly associated with level of education (Χ2 = 27.8, df = 3, p < 0.001).
This study has several limitations. We only analyzed bathing frequency within the first 9 weeks of life, whereas bathing frequency and method of bathing (bath or shower) likely changes with age. Infants were those who enrolled in a trial and may not be representative of the general population, although enrollment through varied settings, and multiple geographic locations may increase representativeness. Additionally, the observational nature of the data limits the ability to make causal assessment. We did not collect qualitative information from families to understand how bathing decisions are made or to understand what information has been shared about bathing from medical providers. Qualitative work with parents and guardians on influences and thoughts driving bathing practices are needed.
In conclusion, slightly more than one-third of the study infants were reported to have three or more baths per week. Ethnic/cultural and socioeconomic factors may influence a family’s bathing practices. Strategies are needed to increase knowledge and adherence to proper bathing practices, although prospective trials are needed first to identify the optimal bathing frequency to reduce the risk of AD.
Supplementary Material
Acknowledgments:
The authors would like to acknowledge Cort Cox, BS, and Matthew Howard, BS, for support editing and submitting this manuscript. The study was conducted in partnership with PBRN partners at the Oregon Rural Practice-based Research Network (Lyle J. Fagnan, MD, Nancy Elder, MD, Xaviera Martinez-Armenta, MPH), the Wisconsin Research and Education Network (David Hahn, MD, Sarina Schrager, MD, Mary Henningfield, PhD, Amanda Haban, MPH, Shelbey Hagen, MPH), the Duke Primary Care Research Consortium (Rowena Dolor, MD, Brian Eichner, MD, Janna Howard, MPH), and the State Networks of Colorado Ambulatory Practices and Partners (Don Nease, MD, Mary Fisher, MPH, Meredith Warman, MPH, Cat Halliwell).
Support:
This research was supported by grant R01AR107517 from the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health and the Oregon Clinical and Translational Research Institute grant UL1TR002369. Support for study emollients was provided by Galderma Laboratories, L.P., L’Oreal USA, and Pharmaceutical Specialties, Inc. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Footnotes
Conflict of Interests Disclosures: No disclosures to report.
Prior presentations of the materials:
None
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